(17 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 diameters 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 diameters.
The provided text describes a 510(k) submission for the ESOP® Co-Cr Femoral Head, a medical device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.
Therefore, the input does not contain the kind of information requested in the prompt, such as pre-defined acceptance criteria, details of a study (sample sizes, ground truth, experts, adjudication, MRMC, standalone performance, training set details), or the reported device performance against such criteria.
The submission focuses on comparing the new device (ESOP® Co-Cr Femoral Head) to existing legally marketed predicate devices (ESOP® Co-Cr Femoral Heads (K021109) and Total Hip Femoral Head - 12/14 Taper (K021673)) in terms of intended use, material, size, and dimensions, to demonstrate that the new device is substantially equivalent. It states that "Verification/validation and design control activities demonstrate the safety and effectiveness," but does not detail the specifics of these activities in the way requested for acceptance criteria and study results.
Therefore, I cannot provide the requested information from the given text. The document describes a regulatory submission for a medical device built on the principle of substantial equivalence, not a study designed to establish and meet specific performance acceptance criteria for a novel device.
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Applicant: Pro-Active
KO23375
Page 1 of 2
510 (K) SUMMARY – ESOP® Co-Cr Femoral Head
OCT 2 5 2002
| Submitter name: | Fournitures Hospitalières Industrie |
|---|---|
| Submitter address: | 6 Rue Nobel, Z.I. de KernevezQUIMPER, France 29000 |
| Contact person: | Mrs Christine QUENDEZ |
| Phone Number:Fax Number: | +33.2.98.55.68.95+33.2.98.53.42.13 |
| Date prepared: | October 4, 2002 |
| Device Trade Name: | ESOP® Co-Cr Femoral Head |
| Device common name: | Femoral head |
| Classification name: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis |
| Predicate Device: | ESOP® Co-Cr Femoral Heads (K021109), FournituresHospitalières IndustrieTotal Hip Femoral Head - 12/14 Taper (K021673), Smith &Nephew, Inc. |
| Device description: | The Metallic Femoral Heads are intended to be adapted tospecial cones machined for this purpose. Femoral headare available in several diameters 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 diameters. |
| Intended use: | Prosthetic replacement of the femoral head associatedwith hip prosthesis, which cone is compatible with thehead's cone and with a prosthetic acetabular cup,whose diameter is compatible with the head. |
| Device TechnologicalCharacteristics andComparison to PredicateDevices: | Femoral heads made of chrome cobalt (Ø 22, 28 & 32mm), short collar, medium collar, long collar & extra-longcollar with 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: | Verification/validation and design control activitiesdemonstrate the safety and effectiveness of the ESOP®Co-Cr Femoral Heads. |
| Conclusion: | The ESOP® Co-Cr Femoral Heads are substantiallyequivalent to predicate devices in terms of intended use,safety, and effectiveness. |
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KOZ3375
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 00 Corporate Boulevard ockville MD 20850
Dr. Andre Weith Director, Pro-Active Healthcare c/o Pharmanet, Inc. 815 Connecticut Ave., NW Suite 800 Washington, DC 20006
Re: K023375
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: Class II Product Code: LPH Dated: October 4, 2002 Received: October 8, 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
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Page 2 - Dr. Andre Weith -
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.
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" (21 CFR 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 A. Millman
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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510(k) Number (if known):
K0233345
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.
(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) |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
(Optional Format 1-2-96)
| 510(k) Number | K023373 |
|---|---|
| --------------- | --------- |
§ 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.