(86 days)
The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.
Indications:
- Noninflammatory joint disease including osteoarthritis and avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have failed,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This Special 510(k) submission is intended to add 36mm Orthinox® V40™ femoral head components in -5mm, +0mm, and +5mm offsets to the Exeter Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The Orthinox® V40™ femoral head components are fabricated from Orthinox®, a Stainless Steel Alloy conforming to ASTM F1586 and ISO 5832-9. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
This document describes a Special 510(k) submission for the addition of 36mm Orthinox® V40™ Femoral Heads to the Exeter Series of femoral head components. The submission asserts that the subject device is substantially equivalent to a predicate device (22mm-32mm V40™ Orthinox® Femoral Head Components cleared under K011623).
Here's an analysis of the provided information concerning acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain explicit performance acceptance criteria or reported device performance data in the way one would typically find for a medical device with an AI/algorithm component requiring performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the submission is focused on demonstrating substantial equivalence to a predicate device for a physical medical implant. The "performance" in this context is related to the material properties, manufacturing methods, and intended use being identical to the predicate device.
The closest we can come to a "table" based on the provided text is to infer the criteria for substantial equivalence:
| Acceptance Criterion (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use (identical to predicate) | Identical to predicate devices: "for use with femoral stems and acetabular components in primary or revision total hip arthroplasty." (Specific indications listed) |
| Manufacturing Methods (identical to predicate) | Identical to predicate devices |
| Materials (identical to predicate or equivalent) | Orthinox® Stainless Steel Alloy conforming to ASTM F1586 and ISO 5832-9 (same as predicate) |
| Packaging (identical to predicate) | Identical to predicate devices |
| Sterilization (identical to predicate) | Identical to predicate devices |
| Design Principles (analogous for new size variant) | 36mm Orthinox® V40™ femoral head components in -5mm, +0mm, and +5mm offsets, an extension of the existing V40™ design. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the document. The submission is not for a software-based AI device that would undergo testing with a "test set" of data in the common sense for AI. It's for a physical implant. The evaluation for substantial equivalence relies on comparing the new device features (size, form, function) and material specifications to those of legally marketed predicate devices, not on a dataset of patient outcomes or imagery.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. There is no "ground truth" establishment in the context of an AI algorithm for this type of medical device submission. The FDA reviews the technical documentation and comparisons to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There is no "test set" for adjudication as this is not an AI/algorithm-driven device.
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
This information is not applicable and not provided. This submission is for a physical medical implant (a femoral head component), not for an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This is not an algorithm-only device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and not provided. For a physical implant like a femoral head, the "ground truth" for its safety and effectiveness is established through adherence to recognized manufacturing standards, material specifications, biocompatibility testing, mechanical testing (e.g., fatigue strength, wear resistance, dimensional accuracy), and clinical performance of predicate devices that have a similar design and use history. The substantial equivalence argument itself acts as the "proof" based on these established standards and predicate performance.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. There is no "training set" or corresponding ground truth establishment process for this type of medical device submission.
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AUG 2 9 2003
Special 510(k) Summary - Addition of 36mm Orthinox® V40™ Femoral Heads To The Exeter Series
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Proprietary Name: | 36mm Orthinox® V40™ FemoralHead Components | 22mm-32mm V40™ Orthinox®Femoral Head Components |
| Common Name: | Femoral Head Component | Femoral Head Component |
| Classification Name andReference: | 21 CFR §888.3350Hip Joint Metal/ Polymer Semi-constrained Cemented Prosthesis | 21 CFR §888.3350Hip Joint Metal/ Polymer Semi-constrained Cemented Prosthesis |
| Proposed Regulatory Class: | II | II |
| Device Product Code: | (87) JDI | (87) JDI |
| For Information contact: | Jennifer A. Daudelin, Regulatory AffairsHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677(201) 831-5379Fax: (201) 831-6038Email: jdaudelin@howost.com | |
| Date Summary Prepared: | May 27, 2003 |
This Special 510(k) submission is intended to add 36mm Orthinox® V40™ femoral head components in -5mm, +0mm, and +5mm offsets to the Exeter Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The predicate Orthinox® V40™ femoral bearing components were found substantially equivalent via the 510(k) process in K011623. The Orthinox® V40™ femoral head components are fabricated from Orthinox®, a Stainless Steel Alloy conforming to ASTM F1586 and ISO 5832-9. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body and wings.
AUG 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debra Bing Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route17 Allendale, New Jersey 07401
Re: K031730
Trade/Device Name: Addition of 36mm Orthinox® V40™ Femoral Heads to the Exeter Series Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: August 5, 2003 Received: August 5, 2003
Dear Ms. Bing:
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. 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.
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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Debra Bing
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,
Sincerely yours,
Mark A Milken
Celia 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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Indications for Use
510(k) Number (if known):
Device Name: 36mm Orthinox® V40™ Femoral Heads
Indications for Use:
The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.
Indications:
- Noninflammatory joint disease including osteoarthritis and avascular necrosis, ●
- . Rheumatoid arthritis,
- Correction of functional deformity, ●
- Revision procedures where other treatments or devices have failed, .
- . Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR Over-The-Counter Use
(Per 21 CFR 801.109) of Mark N Milkerm (Optional Format 1-2-96)
for
Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number _ K031730
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.