Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 95

Table 5.9: Example PDS for a Bone Drill Bit

Medical DeviceCo Inc.
Product Design Specification Originator Date
Project Number/Part Number Drill 200048050S Version: 1.0
Product Title: 200 mm × 4.8 stab point drill 50 mm flutes
Summary
This specification is for a reusable drill bit for producing 4.8 mm dia. holes in human bone.
It is estimated that this device is a transient, invasive device but is one that is reusable ; hence it is a reusable
surgical instrument class I .

1 Customer:

1.1 Hole diameter 4.8 mm Initial focus group

1.2 Overall length 200 mm (nominal) Initial focus group

1.3 Flute length 50 mm (nominal) Initial focus group

1.4 Device to be reusable Initial focus group

2 Regulatory and Statutory:

2.0 Device to meet essential and

general requirements of a medical
device

2.1 Initial estimate is that this is a

reusable surgical instrument and
hence CE/FDA Class I (510(k)
exempt)

93/42/EC Annex IX rule 6
CFR 21 Reg. No 888.4540

2.2 Drill material to be selected from

those approved in standards

ISO 7153
ASTM F899-09

2.3 Labeling to show it is supplied

nonsterile

93/42/EC

2.4 In EU labeling to comply with

standard

93/42/EC
BS ISO 15223-2:2010

2.5 In U.S. labeling to comply with

regulations

CFR 21

2.6 IFU to be supplied with each

drill and to include cleaning and
sterilization instructions

93/42/EC
CFR 21

2.7 Declaration of conformity

required

93/42/EC

3 Technical:

3.1 Flute helix 14° (nominal) Trade review

3.2 Material to withstand high

alkalinity (pH 13-14) in washers

Cleaning and sterilization review

3.3 Material to withstand + 130°C in

steam sterilizers

Cleaning and sterilization review