(650 days)
Gas Plasma Sterilization is intended to be used for terminal sterilization of all Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products as follows:
- Trilogy® Acctabular System (acctabular liners) .
- t Nex Gento Complete Knee Solution (articular surfaces and patellas)
Sterrad 100 Sterilization System
The provided document describes the summary of safety and effectiveness for "Gas Plasma Sterilization" for Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achievement of a sterility assurance level (SAL) of 10⁻⁶ (implied by typical sterilization standards) | A sterility assurance level (SAL) of 10⁻⁶ was achieved. (Stated as "a sterility assurance level (SAL) of 10⁻⁶") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set of the sterilization validation. It broadly mentions "Performance Testing/Sterilization Validation." It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective). Sterilization validations typically involve controlled laboratory experiments rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts or the establishment of "ground truth" in the context of a test set for this sterilization validation. Sterilization validations typically rely on established microbiological testing methods rather than expert consensus on subjective interpretations.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are usually relevant for studies involving human interpretation or subjective assessment, which is not the case for a sterilization validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not applicable as this is a sterilization validation, not a study evaluating human readers' performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in principle. A sterilization validation is inherently a standalone performance assessment of the sterilization process itself, without human intervention in the sterilization efficacy. The "device" in this context is the sterilization process.
7. Type of Ground Truth Used
The ground truth used for a sterilization validation is based on microbiological testing, specifically demonstrating the inactivation of a predefined number of highly resistant microorganisms (biological indicators) to achieve the specified Sterility Assurance Level (SAL). This is an objective, quantitative measure.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to a sterilization validation. Sterilization validations are based on established scientific principles and experimental protocols, not machine learning models that require training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a sterilization validation.
{0}------------------------------------------------
Image /page/0/Picture/3 description: The image shows the logo for Zimmer Inc. The logo features a large, stylized letter Z inside a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font. The date 5/5/99 is written at the top right of the logo.
K972774
Box 708
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness Gas Plasma Sterilization
Submitted by: .
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
-
Prepared by: .
Theodore M. Wendt, Ph.D. Vice President Regulatory and Clinical Affairs Telephone: 219-372-4113 Telefax: 219-372-4605 -
Date: ●
April 27, 1999 -
Trade Name: .
Gas Plasma Sterilization -
Common Name: ▲
Gas Plasma Sterilization -
Classilication Name: t
Sterilizer -
Predicate Devices: t
Sterrad 100 Sterilization System, Advanced Sterilization Products Gas Plasma Sterilization, DePuy, Inc. Ahtox Plazlyte™ Gas Plasma Sterilization, Abtox, Inc.
{1}------------------------------------------------
Image /page/1/Picture/3 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '7', '2', '7', '7', and '4'. The digits are written in a simple, slightly irregular style, typical of handwriting. The overall impression is that of a quickly jotted down sequence of characters.
Summary of Safety and Effectiveness Gas Plasma Sterilization (Continued)
Device Description l Sterrad 100 Sterilization System
-
. Intended Use
Gas Plasma Sterilization is intended to be used for terminal sterilization of all Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products as follows: -
. Trilogy Acetabular System (acetabular liners)
-
NexGen® Complete Knee Solution (articular surfaces and patellas) .
Performance Testing/Sterilization Validation
A sterilization validation was completed and verifies achievement of a sterility assurance level (SAL) of 10%.
RA07703K.510
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle's head with three lines representing the feathers. The eagle's head is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1099 MAY
T.M. Wendt, Ph.D. Vice President Regulatory and Clinical Affairs Zimmer, Inc. P.O. Box 708 46581-0708 Warsaw, Indiana
K972774 Re: STERRAD Gas Plasma Sterilization of Trilogy Trade Name: acetabular Liners and NexGen Articulator Surfaces (Tibial Trays) and Patellae Regulatory Class: II Product Codes: JWH, LPH, and MLR April 14, 1999 Dated: Received: April 16, 1999
Dear Dr. Wendt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - T.M. Wendt, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page 1 of 1
7 4 510(k) Number (if known): K 9 7 2
Device Name: Gas Plasma Sterilization
Indications For Use:
Gas Plasma Sterilization is intended to be used for terminal sterilization of all Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products as follows:
- Trilogy® Acctabular System (acctabular liners) .
- t Nex Gento Complete Knee Solution (articular surfaces and patellas)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
pcöééé
(Division Sign-Off)
Division of General Restorative Device K97277
510(k) Number
RA04901C.MS
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.