(58 days)
The subject guide wire devices are instruments in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The implant specific instruments are to be used with the Zimmer® Natural Nail® System and Zimmer® M/DN® Intramedullary Fixation System.
The subject guide wire devices are instruments intended to assist in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The guide wires are made of either L605 Cobalt-Chrome-Tungsten-Nickel Alloy (per ASTM F90) or 316L Stainless Steel (per ASTM F138). These instruments will be provided sterile by Gamma Radiation.
This is a 510(k) Pre-Market Notification for a Class II medical device, Zimmer® Guide Wire Devices, used in orthopedic surgeries. The document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria for an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical bench testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This document does not pertain to the performance of an AI/ML powered device. It is for Zimmer® Guide Wire Devices, which are instruments used in fracture fixation. The performance data presented are for non-clinical bench tests related to packaging and sterile barrier integrity.
| Acceptance Criteria (Not AI-related) | Reported Device Performance (Non-AI related) |
|---|---|
| Packaging integrity after distribution hazards | The Packaging Design Verification Protocol for the G6531 Group and G6532 Group (Reports) verified that the proposed G6531/G6532 pouch packaging system maintains the integrity of the sterile barrier system through hazards of global distribution for the proposed 70/100cm devices. Tests were conducted per ASTM F2096 (Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)), ASTM F88 (Seal Strength of Flexible Barrier Materials), ASTM F1886 (Integrity of Seals for Medical Packaging by Visual Inspection), and ASTM D4169 (Performance Testing of Shipping Containers and Systems). The testing concluded that the packaging is statistically equivalent to that of the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The "test set" in this context refers to the samples used for packaging integrity bench testing, not a dataset for an AI/ML model. The document does not specify the exact sample size for each packaging test, but states that the testing verified the packaging integrity and equivalence. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is for a physical medical device (guide wires), not an AI/ML system that requires expert ground truth labeling. The "ground truth" for packaging integrity is determined by established ASTM standards and objective measurements of physical properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses in AI/ML studies. For physical device testing like packaging integrity, "adjudication" is not a relevant concept. The results of the physical tests against pre-defined ASTM standards determine acceptance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document is not about an AI-powered device, and therefore no MRMC study for AI assistance would have been conducted or is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document does not describe an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing was based on established industry standards (ASTM) for packaging integrity and sterility barrier performance. The device's packaging design and material properties were evaluated against these measurable engineering and scientific standards.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model for which a training set's ground truth would need to be established.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 5, 2019
Zimmer, Inc Annette Minthorn Sr. Specialist, Regulatory Affairs PO Box 708 Warsaw, Indiana 46581-0708
Re: K191238
Trade/Device Name: Zimmer® Guide Wire Devices Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 6, 2019 Received: May 8, 2019
Dear Annette Minthorn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191238
Device Name Zimmer® Guide Wire Devices
Indications for Use (Describe)
The subject guide wire devices are instruments in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The implant specific instruments are to be used with the Zimmer® Natural Nail® System and Zimmer® M/DN® Intramedullary Fixation System.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo features a large, stylized letter "Z" in a blue circle above the word "zimmer" in lowercase, blue letters. The "Z" is designed with a modern, geometric style, and the overall design is clean and professional.
510(k) Summary Traditional 510(k)
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Zimmer Guide Wires 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565 |
|---|---|
| Contact Person: | Annette MinthornSr. Specialist, Regulatory AffairsTelephone: (574-372-4294)Fax: (574-372-4644) |
| Date: | 05 July 2019 |
| Subject Device: | Trade Name:• Zimmer® Guide Wire Devices |
| Common Name:• Zimmer® Guide Wires | |
| Classification Name:• HSB- Rod, Fixation, Intramedullary and Accessories (21CFR 888.3020) | |
| Predicate Device(s): | • K142281 Zimmer® M/DN Intramedullary Fixation System,(Zimmer, Inc.) |
| • K101622 Zimmer® Natural Nail™ System - RetrogradeFemoral Nail (Zimmer, Inc.) |
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized blue letter "Z" enclosed in a blue circle. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in blue.
Purpose and Device Description:
Intended Use and Indications for Use:
510(k) Summary Traditional 510(k)
- · The purpose of this submission is to request clearance for the packaging change and classification of the subject guide wire instruments. These instruments are used to assist in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The guide wires are made of either L605 Cobalt-Chrome-Tungsten-Nickel Alloy (per ASTM F90) or 316L Stainless Steel (per ASTM F138). These instruments will be provided sterile by Gamma Radiation.
- Intended Use: To assist in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing.
- . Indications for Use: The subject guide wire devices are instruments intended to assist in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The implant specific instruments are to be used with the Zimmer® Natural Nail® System and Zimmer® M/DN® Intramedullary Fixation System.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: To assist in fracture fixation and ● stabilization of long bones during the surgical procedure of intramedullary nailing.
- Indications for Use: The subject guide wire devices are instruments intended to assist in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The implant specific instruments are to be used with the Zimmer® Natural Nail® System and Zimmer® M/DN® Intramedullary Fixation System.
- Materials: L605 Cobalt-Chrome-Tungsten-Nickel Alloy ● and 316L Stainless Steel
- Design Features: The design features of the subject guide ● wires are similar to those in the currently marketed
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Image /page/5/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized blue letter "Z" enclosed in a blue circle. Below the circle, the word "zimmer" is written in lowercase blue letters, using a modern sans-serif font.
510(k) Summary Traditional 510(k)
devices cleared in K142281 and K101622. The design differences have not identified any issues that would impact the safety and effectiveness of the device.
-
Sterilization: The instruments are offered to the end user in the sterile configuration. They will be sterilized using Gamma sterilization.
Summarv of Performance Data (Nonclinical and/or Clinical) -
Non-Clinical Tests:
- Bench Testing and Conclusions conducted on the I proposed devices are summarized below:
- · Packaging Design Verification Protocol for the G6531 Group and G6532 Group (Reports): These test verified that the proposed G6531/G6532 pouch packaging system maintains integrity of the sterile barrier system through hazards of global distribution for the proposed 70/100cm devices and is statistically equivalent to that of the predicate devices per ASTM F2096, ASTM F88, ASTM F1886, and ASTM D4169.
- The data presented · Conclusions: in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.
- Bench Testing and Conclusions conducted on the I proposed devices are summarized below:
-
Clinical Performance and Conclusions: ●
- Clinical data and conclusions were not needed for I these devices to show substantial equivalence.
-
Animal Testing and Conclusions: ●
- Animal data and conclusions were not needed for 트 these devices to show substantial equivalence.
Substantial Equivalence Conclusion
The subject guide wire devices have shown to be substantially equivalent to the predicate devices. Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.