(72 days)
The Accin™ Hip System components are for use in total hip arthroplasty as a result of: Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip Correction of functional deformity Avascular Necrosis Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results These components are single use only and are intended for implantation without bone cement.
The Accin™ Hip System consists of plasma spray coated titanium alloy femoral component, a cobalt chrome femoral head, a plasma spray coated titanium alloy acetabular shell, bone screws and a polyethylene acetabular insert.
The provided document, K073068, describes the Accin™ Hip System, a medical device. This document is a summary of safety and effectiveness, indicating the device's comparison to predicate devices and the testing performed. However, it does not contain detailed information regarding acceptance criteria and a study that proves the device meets those criteria in the format requested.
Specifically, the document states:
- "Testing has shown that the proposed device meets the requirements of the current FDA Guidance documents on total hip arthroplasty product and the proposed device is equivalent to the predicate device."
- "Tests were performed on the Hip System. The tests performed can be found in the guidance documents entitled 'Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements;' 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cermented or Uncom of the Prosthesis;' and 'Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses.'"
This indicates that testing was conducted to demonstrate equivalence to predicate devices and adherence to FDA guidance documents, which serve as the implicit acceptance criteria for this type of device. However, the document does not provide:
- A specific table of acceptance criteria and reported device performance. It only generally states that the device meets requirements and is equivalent.
- Sample size used for the test set or data provenance. The document only states "Tests were performed on the Hip System."
- Number of experts, their qualifications, or adjudication methods. These are not applicable as the tests described are mechanical/material performance tests, not clinical studies involving expert interpretation or ground truth establishment in a diagnostic context.
- Information on any Multi Reader Multi Case (MRMC) comparative effectiveness study. This type of study is not relevant for a hip implant's mechanical and material safety/effectiveness demonstration.
- Standalone algorithm performance. This is not applicable as the device is a physical hip implant, not an AI algorithm.
- Type of ground truth used. The document refers to FDA guidance documents and predicate device equivalence as the basis for evaluation, implying engineering and material standards rather than expert consensus, pathology, or outcomes data in a clinical trial sense.
- Sample size for the training set or how ground truth was established for it. These concepts are not relevant for the type of device and testing described.
Therefore, based only on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory approval through substantial equivalence to predicate devices and adherence to existing guidance for materials and mechanical testing, rather than a detailed clinical study report with the specified metrics.
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K073068 (pg 1/1)
Summary of Safety and Effectiveness
| Submitter: | Michael KvitnitskyAccelerated Innovation, LLC1033 US Highway 46, Suite A204Clifton, NJ 07103JAN 10 2008 | |
|---|---|---|
| Date Prepared: | October 10, 2007 | |
| Device: | Accin™ Hip System | |
| Classification: | 87 LPH - Hip joint metal/polymer/metal semi-constrained uncemented prosthesis,21 CFR 888.3358, Class II and 87 HWC and screw, fixation, bone, 21 CFR888.3040, Class II | |
| Predicate Device: | Provident Hip System - K935484, K946371, K960180, K991622 K001745, andK002796 and Stelkast Bone Screws - K934162 | |
| Device Description: | The Accin™ Hip System consists of plasma spray coated titanium alloy femoralcomponent, a cobalt chrome femoral head, a plasma spray coated titanium alloyacetabular shell, bone screws and a polyethylene acetabular insert. | |
| Intended Use: | The Accin™ Hip System components are for use in total hip arthroplasty as a result of:Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative jointdisease, osteoarthritis, and arthritis resulting from biologic or mechanical traumato the hipCorrection of functional deformityAvascular NecrosisTreatment of non-unions, femoral neck and trochanteric fractures of the proximalfemurDifficult clinical management problems involving persistent pain and physicalimpairment where conventional arthodesis is not likely to achieve satisfactoryresultsThese components are single use only and are intended for implantation without bonecement. | |
| Comparison to Predicates: The Accin™ Hip system consists of cobalt chrome femoral head, titanium alloy femoral stem, acetabular |
components plasma spray coated with CP Titanium, bone screws and an acetabular polyethylene insert. The device is equivalent to the Stelkast Provident Hip System, which also has the same components manufactured from the same materials.
Accin™ has determined that any differences in the proposed device will not impact the safety or effectiveness of the hip system for its intended use. Testing has shown that the proposed device meets the requirements of the current FDA Guidance documents on total hip arthroplasty product and the proposed device is equivalent to the predicate device.
Synopsis of Test Methods and Results:
Tests were performed on the Hip System. The tests performed can be found in the guidance documents entitled "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements;" "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cermented or Uncom of the Prosthesis;" and "Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses."
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Public Health Service
JAN 10 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Accelerated Innovation, LLC % Mr. Michael Kvitnitsky 1033 US Highway 46 Suite A204 Clifton, NJ 07103
Re: K073068 Trade/Device Name: Accin™ Hip System 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, HWC Dated: December 21, 2007 Received: December 27, 2007
Dear Mr. Kvitnitsky:
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 -- Mr. Michael Kvitnitsky
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K073068 (pg 1/1)
Indications for Use Form
510(k) Number (if known):
Device Name: Accin™ Hip System
Indications for Use:
Indications for Use:
The Accin™ Hip System components are for use in total hip arthroplasty as a result of:
- Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint . disease, osteoarthritis and arthritis resulting from biologic or mechanical trauma to the hip
- Correction of functional deformity .
- Avascular necrosis .
- Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur .
- Difficult clinical management problems involving persistent pain and physical impairment . where conventional arthodesis is not likely to achieve satisfactory results.
These components are single use only and are intended for implantation without bone cement.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K073068
§ 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.