(650 days)
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No
The document describes a gas plasma sterilization system and its intended use for sterilizing specific UHMWPE products. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The focus is on the sterilization process itself.
No
This device is a sterilization system used for medical products, not a device directly applied to a patient for diagnosis, treatment, or prevention of a disease.
No
The device is a sterilization system, not a diagnostic device. Its intended use is for terminal sterilization of medical products, which is a treatment/prevention function, not a diagnostic one.
No
The device description clearly identifies a "Sterrad 100 Sterilization System," which is a hardware system used for sterilization. The summary focuses on the sterilization process and its validation, not on software functionality.
Based on the provided information, the device described is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the terminal sterilization of medical devices (UHMWPE products). This is a process performed on medical devices before they are used on a patient, not a test performed on a biological sample from a patient to diagnose a condition.
- Device Description: The device is a "Sterrad 100 Sterilization System," which is a sterilization unit.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
Therefore, the Sterrad 100 Sterilization System, as described, is a medical device used for sterilization, not an in vitro diagnostic device.
N/A
Intended Use / 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)
Product codes (comma separated list FDA assigned to the subject device)
JWH, LPH, MLR
Device Description
Sterrad 100 Sterilization System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A sterilization validation was completed and verifies achievement of a sterility assurance level (SAL) of 10%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sterrad 100 Sterilization System, Advanced Sterilization Products Gas Plasma Sterilization, DePuy, Inc. Ahtox Plazlyte™ Gas Plasma Sterilization, Abtox, Inc.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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