(96 days)
The Accin™ Unipolar Head is intended to be implanted for use in the reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Avascular Necrosis; The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip Stems.
The Accin™ Unipolar Head System consists of a cobalt chrome modular endo prosthesis femoral head.
This document is a 510(k) premarket notification for a medical device called the "Accin™ Unipolar Head System." It seeks to demonstrate substantial equivalence to a predicate device, rather than proving a new device's absolute safety and effectiveness through clinical trials with established acceptance criteria and detailed performance studies.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available within this document. This type of information is typically found in clinical study reports, scientific publications, or more extensive premarket approval (PMA) submissions where a novel device's performance needs to be rigorously proven.
Here's a breakdown of why this information is absent in this context:
- 510(k) Premarket Notification: This regulatory pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. The primary goal is to show similarity in intended use, technological characteristics, and safety and effectiveness profiles, not necessarily to re-prove efficacy or establish new performance benchmarks.
- Focus on Substantial Equivalence: The document explicitly states: "Testing has shown that the proposed device is equivalent to the predicate device." This "testing" would likely refer to bench testing (e.g., mechanical, material properties) to ensure it performs identically to the predicate, rather than human clinical studies comparing outcomes or algorithm performance.
- Device Type: The Accin™ Unipolar Head is a physical implant (a component of a hip prosthesis). Its performance is assessed through its mechanical properties, biocompatibility, and manufacturing quality, not through an algorithm's diagnostic accuracy or a human-AI collaboration.
Therefore, I cannot provide the requested table and study details as they are not pertinent to or present within this 510(k) submission document. The document's purpose is to establish equivalence to an already approved device, not to present a new performance study with acceptance criteria.
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Accin™ Unipolar Head Premarket Notification Submission - 510(k)
JUN - 2 2008
Summary of Safety and Effectiveness
Michael Kvitnitsky Submitter: Accelerated Innovation, LLC 1033 US Highway 46, Suite A204 Clifton, NJ 07103
- Date Prepared: February 3, 2008
- Accin™ Unipolar Head Device:
87 JDI - Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, 21 Classification: CFR 888.3350. Class II
Stelkast Endo Prosthesis Femoral Head - K952461 Predicate Device:
Device Description: The Accin™ Unipolar Head System consists of a cobalt chrome modular endo prosthesis femoral head.
- The Accin™ Unipolar Head is intended to be implanted for use in the Intended Use: reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from:
- Osteoarthritis: .
- Rheumatoid Arthritis; .
- Traumatic Arthritis; �
- Avascular Necrosis ●
The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip Stems.
Comparison to Predicates:
The Accin™ Unipolar Head consists of cobalt chrome femoral head. The device is equivalent to the Stelkast Unipolar Head System, which also has the same component manufactured from the same material.
Accin™ has determined that any differences in the proposed device will not impact the safety or effectiveness of the unipolar system for its intended use. Testing has shown that the proposed device the proposed device is equivalent to the predicate device.
JUN - 2 2008
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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Accin Corporation % Mr. Michael Kvitnitsky Chief Operating Officer 1033 U.S. Highway 46 East Suite A204 Clifton, New Jersey 07013
JUN - 2 2008
Re: K080539
Trade/Device Name: Accin™ Unipolar Head System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulation Class: Class II Product Code: JDI Dated: May 9, 2008 Received: May 12, 2008
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
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Page 2 - Mr. Michael Kvitnitsky
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), 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 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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
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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Indications for Use Form
K080539 510(k) Number (if known):
Device Name: Accin™ Unipolar Head (Modular Endo Head)
Indications for Use:
The Accin™ Unipolar Head is intended to be implanted for use in the reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from:
- Osteoarthritis; ◆
- Rheumatoid Arthritis; .
- Traumatic Arthritis; �
- Avascular Necrosis; .
The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip Stems.
Prescription Use × (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)
Neil R. P. Leslie, M.D.
Page 1 of 1
Division of General, Restorative. and Neurological Devices
510(k) Number K080539
§ 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.