(88 days)
The Fixion Unipolar Modular Hemi-Hip System is intended for use as a hemi hip replacement in case of:
- Femoral head/neck fractures or non-unions
- Aseptic necrosis of the femoral head/neck
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement
The Fixion UH is a modular hemi-hip replacement system, which is composed of a metal stem and neck part ("stem") with an expandable femoral head in various dimensions from metal or Alumina ceramic for use during partial hip replacement.
The provided text describes a 510(k) submission for the Fixion™ Unipolar Modular Hemi-Hip System (Fixion UH), focusing on its substantial equivalence to predicate devices and adherence to performance standards. However, it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the context of AI/ML or diagnostic performance. Instead, it details the engineering and manufacturing standards for an orthopedic implant.
Therefore, many of the requested categories for AI/ML device performance cannot be filled based on the provided text. I will address the sections that can be informed by the document.
Summary of Acceptance Criteria and Device Performance (Based on available information):
| Acceptance Criteria Category | Specific Criteria (from document) | Reference Standard | Reported Device Performance (from document) |
|---|---|---|---|
| Intended Use Equivalence | Intended use and indications for use substantially equivalent to predicates | Not explicitly stated as a separate standard, but forms the basis of 510(k) | Intended use and indications for use are "substantially equivalent" to predicate devices (Depuy Elite® Modular Hip System, S-ROM Total Hip System, Link® Reconstruction Hip) |
| Material Equivalence | Materials (e.g., 316LVM Stainless Steel) comparable to predicates | Not explicitly stated as a separate standard | Stem is made of 316LVM Stainless Steel, identical cross-section to cleared Fixion™ PF Intramedullary Nail |
| Performance - Endurance | Endurance performance of stemmed femoral components with application of torsion | ISO 7206-8 (1995) | "The Fixion UH conforms to the requirements of ISO 7206-8 (1995)" |
| Performance - Femoral Stem Prostheses | Requirements for femoral stem prostheses | FDA Draft Guidance Document for Femoral Stem Prostheses (1995) | "The Fixion UH also conforms to FDA Draft Guidance Documents: Guidance Document for Femoral Stem Prostheses (1995)" |
| Performance - Modular Implant Components | Testing non-articulating, "mechanically locked", modular implant components | FDA Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (1995) | "The Fixion UH also conforms to FDA Draft Guidance Documents...Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components (1995)" |
| Performance - Ceramic Ball Hip Systems | Requirements for ceramic ball hip systems | FDA Draft Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems (1995) | "In addition, the Fixion UH conforms to FDA Draft Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems (1995)" |
| Safety & Efficacy - Fixation Method | Inflation with sterile saline does not raise new safety and efficacy issues | Comparison to cleared Fixion™ PF Nail | "The inflation of the Fixion UH Stem with saline, ... is identical to the cleared Fixion PF Nail and does not raise any new safety and efficacy issues." |
| Overall Performance | Performance characteristics meet specifications | General "bench tests" | "The performance characteristics of the Fixion UH have been tested and found to meet the specifications through a series of bench tests." |
Information Not Available in the Provided Text (Pertaining to AI/ML or Diagnostic Studies):
The provided 510(k) summary is for a physical medical device (a hemi-hip system) and therefore does not contain the following information typically found in submissions for AI/ML or software as a medical device (SaMD):
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical bench testing, not a dataset for AI/ML.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML diagnostic algorithm.
- Adjudication method for the test set: Not applicable.
- 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 device is an implant, not a diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an orthopedic implant's performance verification in this context. The "ground truth" would be the engineering specifications and ISO standards met by material and mechanical properties.
- The sample size for the training set: Not applicable for an orthopedic implant.
- How the ground truth for the training set was established: Not applicable for an orthopedic implant.
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510 (K) Summary
Disc-O-Tech Medical Technologies Ltd.'s Fixion™ Unipolar Modular Hemi-
8 2002 MAR
Hip System
K014072
page 1 of 2
Company Name Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzlia, 46728, Israel
Submitter's Name and Contact Person
Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, DC 20004 Tel.: 202-637-5794 Fax: 202-637-5910
Date Prepared
March 6, 2002
Trade/Proprietary Name
Fixion™ Unipolar Modular Hemi-Hip System ("Fixion UH")
Classification Name
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
Predicate Devices
The Fixion UH intended use, materials and accessories are substantially equivalent to those used in Depuy Orthopeadics' Elite® Modular Hip System and S-ROM Total Hip System, as well as Disc-O-Tech's Fixion™ Interlocking PF Intramedullary Nailing System. The Fixion UH is also substantially equivalent to Link America, Inc.'s Link® Reconstruction Hip and to Smith and Nephew's Biolox® Alumina Ceramic Femoral Head.
Performance Standards
The Fixion UH conforms to the requirements of ISO 7206-8 (1995) "Implants for Surgery Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion." The Fixion UH also conforms to FDA Draft Guidance Documents: Guidance Document for Femoral Stem Prostheses (1995) and Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (1995). In addition, the Fixion UH conforms to FDA Draft Guidance Document for the Preparation of Premarket Notification for Ceramic
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Ball Hip Systems (1995).
Intended Use
The Fixion Unipolar Modular Hemi-Hip System is intended for use for The Polon Chaptical use as a hemi hip replacement in case of:
- Femoral head/neck fractures or non-unions ●
- Aseptic necrosis of the femoral head/neck .
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal . acetabular involvement
K 01407d
System Description
ystem Description
The Fixion UH is a modular hemi-hip replacement system, which is composed The I Mori of I is a land neck part ("stem") with an expandable femoral of a metazie relition from in various dimensions from metal or Alumina ceramic for use during partial hip replacement.
Substantial Equivalence
The Fixion UH System has substantially equivalent intended use and indications for use as the Elite Modular Hip System and the other predicates, i.e., replacement of hips.
The performance characteristics of the Fixion UH have been tested and found to meet the specifications through a series of bench tests.
The Stem of the Fixion UH Unipolar Hemi-Hip System, like the Fixion™ PF Intramedullary Nail, is made of 316LVM Stainless Steel. The cross section of the Fixion UH stem body and the Fixion Interlocking PF Intramedullary nail is identical and circular with reinforcement bars.
Fixation of the Fixion UH Stem to the femur is further enhanced by its inflation with sterile saline similar to the Fixion PF Nail and results in the abutment of the 4 reinforcement bars to the medullary canal wall. Rotational and axial stability is aided by the shape of the Stem Neck. The inflation of the Fixion UH Stem with saline, which is a non-compressible biocompatible fluid, is identical to the cleared Fixion PF Nail and does not raise any new safety and efficacy issues.
CONFIDENTIAL
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 MAR
Disc-O-Tech Medical Technologies, LTD. c/o Mr. Johnathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004
Re: K014072
Trade Name: Fixion Unipolar Modular Hemi-Hip System (Fixion UH) Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Date: December 3, 2001 Received: December 10, 2001
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket 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) 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. The general therely, maintons of the Act include requirements for annual registration, listing of devices, Condons provision practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly in the quality by over of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Johnathan S. Kahan, Esq.
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anon-you're substantial equivalence of your device of your device to a legally prematicated 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 regulation (21 CFR Part 801 and If you desire specific da rios for for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fat 0071. Additionally, for questions on the promotion and advertising of Compilance at (301) 597 1007 First of Compliance at (301) 594-4639. Also, please note the your do roos, produced withing by reference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outler general mionmation on Jour versational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark N Mckenn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Disc-()-Tech Medical Technologies, Ltd. Fixion UH Unipolar Modular Hemi-Hip System 510(k)
Page 1 of 1
INDICATION FOR USE
| and the submit of the state of the same of the same of the same of the same of the status and the many of the many of the many of the many of the many of the many of the many | 510(K) Number (if known): | K014072 | ||
|---|---|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | --------------------------- | --------- | -- |
l'ixion Unipolar Modular Hemi-Hip System (Fixion™ UH) Device Name:
Indication for Use:
The Fixion Unipolar Modular Hemi-Hip System is intended for The Fixton 'Ompsemented use as a hemi hip replacement in cases of:
Femoral head/neck fractures or non-unions ﺳﻤ
- Aseptic necrosis of the femoral head/neck r
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip. ﺮ with minimal acetabular involvement
IP TENSE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General. Restorative and Neurological Devices
510(k) Number:
| Prescription Use | X | OR |
|---|---|---|
| (pg 21 CFR 801.109) |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Over the Counter Use_____________
510(k) Number .
CONFIDENTIAL
-41
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.