(68 days)
The ESOP® Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameter for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra-long collars), and of different diameter.
This document is a 510(k) premarket notification for a medical device called "Metallic Femoral Head" (later referred to as ESOP® Co-Cr Femoral Heads). This type of submission is for substantiating that a new device is "substantially equivalent" to an already legally marketed predicate device, rather than proving its effectiveness through clinical studies with acceptance criteria in the way a diagnostic AI device would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically applied to performance claims of AI/diagnostic devices, is not applicable to this 510(k) submission for a metallic femoral head.
Instead, the submission focuses on demonstrating substantial equivalence by comparing material, design, and intended use with existing predicate devices, and supported by non-clinical (laboratory) performance data.
Here's a breakdown of why each point is not applicable in this context:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for a mechanical orthopedic implant, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy. The "performance data" mentioned refers to "Testings conducted to characterize the materials under defined laboratory conditions," which are typically mechanical and material property tests (e.g., fatigue, wear, strength). No specific acceptance criteria or reported performance values are detailed in the provided text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of clinical images or patient data for this device. The testing would involve mechanical samples of the device, not a set of clinical cases.
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. There is no "ground truth" to establish for a mechanical implant in the way there is for an AI diagnostic algorithm. The material and mechanical properties are assessed through standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation of cases. This is not relevant to the mechanical testing of an orthopedic implant.
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 device is a metallic femoral head, not an AI-powered diagnostic tool. MRMC studies are completely irrelevant to this type of medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. Again, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For mechanical implants, "ground truth" typically refers to established standards for material properties (e.g., tensile strength, fatigue limits) and biomechanical performance in a laboratory setting, rather than clinical outcomes or diagnostic interpretations.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth.
Summary of the K021109 Submission:
The K021109 submission for the "Metallic Femoral Head" is a 510(k) premarket notification. Its purpose is to demonstrate "substantial equivalence" to predicate devices already on the market, meaning it is as safe and effective as those devices.
- Device: Metallic Femoral Head (later ESOP® Co-Cr Femoral Heads)
- Intended Use: Prosthetic replacement of the femoral head associated with hip prosthesis.
- Predicate Devices: Headloc™ Femoral Head, Primaloc® Cementless Hip System (K953977), Intrinsic® Cementless Total Hip System (K923911), Exactech AcuMatch Hip System (K010081).
- Comparison Basis: Same intended use, made of the same material (chrome cobalt), similar size, and collar + cone dimensions as the predicate devices.
- Performance Data: "Testings conducted to characterize the materials under defined laboratory conditions are provided to support a finding of substantial equivalence." (These are generally mechanical and material characterization tests, not clinical performance studies comparing diagnostic accuracy).
- Conclusion: The device is substantially equivalent to predicate devices in terms of intended use, safety, and effectiveness.
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| JUN 12 2002 | K021109page 1 of 2 |
|---|---|
| 510 (K) SUMMARY - Metallic Femoral Head | |
| Submitter name: | Fournitures Hospitalières Industrie |
| Submitter adress: | 6 Rue Nobel, Z.I. de KernevezQUIMPER, France 29000 |
| Contact person: | Mrs Christine QUENDEZ |
| Phone Number: | +33.2.98.55.68.95 |
| Fax Number: | +33.2.98.53.42.13 |
| Date prepared: | April 5, 2002 |
| Device Trade Name: | Metallic Femoral Head |
| Device common name: | Femoral head |
| Classification name: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis |
| Predicate Device: | Headloc™ Femoral HeadPrimaloc® Cementless Hip System (K953977)Ortho Development CorporationIntrinsic® Cementless Total Hip System (K923911)Ortho Max. Inc.Exactech AcuMatch Hip System (K010081) |
| Device description: | The Metallic Femoral Heads are intended to be adapted tospecial cones machined for this purpose. Femoral head areavailable in several diameter for use in full hip orintermediary replacement. The length of the neck on thefemoral stem can be adjusted by using the heads availablein different insertion depths (short, medium, long and extra-long collars), and of different diameter. |
| Intended use: | Prosthetic replacement of the femoral head associated withhip prosthesis, which cone is compatible with the head'scone and with a prosthetic acetabular cup, whose diameteris compatible with the head. |
| K021109page 2 of 2 | |
| Characteristics andComparison to PredicateDevices: | Femoral heads made of chrome cobalt (Ø 28 & 32 mm),short collar, medium collar long collar & extra-long collarwith cone dimensions 12/14, 5°43' & 10/12, 6°. Theidentified predicate devices have the same intended use,are made of the same material, have the same size, andcollar + cone dimensions are of the same order ofmagnitude. |
| Performance Data: | Testings conducted to characterize the materials underdefined laboratory conditions are provided to support afinding of substantial equivalence. |
| Conclusion: | The Metallic Femoral Heads are substantially equivalent topredicate devices in terms of intended use, safety, andeffectiveness. |
Device Technological
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
JUN 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fournitures Hospitalières Industrie c/o Dr. Andre Weith Director, Pro-Active Healthcare c/o PharmaNet, Inc. 815 Connecticut Avenue NW, Suite 800 Washington, D.C. 20006
Re: K021109
Trade/Device Name: ESOP® Co-Cr Femoral Heads Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 5, 2002 Received: April 5, 2002
Dear Dr. Weith:
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 - Dr. Andre Weith
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark N. Millenson
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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Sponsor: Pro-Active
510(k) Number (if known):
K02ii09
page 1 of 1
Device Name:
ESOP® Co-Cr Femoral Heads
Indications for Use:
The ESOP® Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
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| Concurrence of CDRH; Office of Device Evaluation (ODE) | ||
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| for | ||
| (Division Sign-Off) | ||
| Division of General, Restorative and Neurological Devices |
| Prescription Use (Per 21 CFR 801.109) | 510(k) NumberK021109OR Over-The-Counter Use | 510(k) Number | K021109 | OR Over-The-Counter Use | |
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| 510(k) Number | K021109 | ||||
| OR Over-The-Counter Use |
(Optional Format 1-2-96)
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.