(73 days)
The Atlantech Graft Fixation Screw is an interference screw for use in the fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery.
The Atlantech Graft Fixation Screw is for fixation of grafts in cruciate ligament reconstructive surgery. Standard features include a tapered rear profile, which museuzes graft impingement post implantation. The screw is cannulated to accept 1.2mm A-Fech Controlled Flexion Guidewire.
This document (K031937) is a 510(k) summary for a medical device called the "Atlantech Graft Fixation Screw". It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
Based on the provided information, the document does NOT contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the submission argues for "substantial equivalence" based on:
- Indications for Use: The Atlantech Graft Fixation Screw is for fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery, which is the same as the predicate devices.
- Technological Characteristics: The document states that the device's technological characteristics are substantially equivalent to the predicate devices.
- Prior Commercial Availability: It explicitly mentions, "Atlantech Graft Fixation Screws have been commercially available in Europe since 1996 and do not differ markedly from others on the market." This suggests a history of safe use, but not specific performance testing conducted for the 510(k) submission.
Therefore, many of the requested elements for describing a study and acceptance criteria cannot be extracted from this 510(k) summary.
Here's a breakdown of what can be inferred or stated from the provided text, and where information is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (as stated in 510(k)) |
|---|---|
| Safety and Effectiveness for Intended Use: Be as safe and effective as predicate devices for fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery. | "The Atlantech Graft Fixation Screw... is substantially equivalent to the predicate device with respect to the indications for use and technological characteristics." |
| Technological Characteristics: Possess similar design, materials, and operating principles to predicate devices. | "The Atlantech Graft Fixation Screw... is substantially equivalent to the predicate device with respect to... technological characteristics." |
| Commercial History (Implicit): Demonstrate a history of safe use, especially if commercially available elsewhere. | "Atlantech Graft Fixation Screws have been commercially available in Europe since 1996 and do not differ markedly from others on the market." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- None provided. The submission does not detail any specific performance testing with a test set. Substantial equivalence claims often rely on comparison to existing devices and their known performance rather than new, experimental test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or expert ground truth establishment for a performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process is described.
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:
- No such study was done or described. This device is a mechanical fixation screw, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No specific ground truth data for performance evaluation of the device itself (beyond general safety and effectiveness of the device type) is mentioned in this submission. The "ground truth" for a 510(k) in this context is the regulatory standard of substantial equivalence to predicate devices, supported by existing knowledge and potentially published literature on similar devices.
8. The sample size for the training set:
- Not applicable. This submission does not describe an AI or statistical model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This submission does not describe an AI or statistical model requiring a training set.
In summary, this 510(k) submission for the Atlantech Graft Fixation Screw relies on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a new clinical or performance study with defined acceptance criteria and test results. It highlights the device's intended use, technological similarity to existing devices, and its commercial history in Europe as evidence for its safety and effectiveness.
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SEP - 4 2003
31937
page 1 of 2
510(k) Summary
ArthroCare Corporation Atlantech Graft Fixation Screw
General Information
| Submitter Name/Address: | ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-2936 |
|---|---|
| Phone Number: | (408) 736-0224 |
| Contact Person: | Valerie Defiesta-NgDirector, Regulatory Affairs |
| Manufacturers Name/Address: | Atlantech Medical Devices, Ltd.(Subsidiary of ArthroCare Corporation)Atlantech House, 38 Freemans WayHarrogate Business Park, HarrogateNorth Yorkshire, HG3 IDHUnited Kingdom |
| Date Prepared: | June 16, 2003 |
| Device Description | |
| Trade Name: | Atlantech Graft Fixation Screw |
| Generic/Common Name: | Screws, Fixation, Bone |
| Classification Name: | Smooth or threaded metallic bone fixationfastener (21 CFR 888.3040) |
| Predicate Devices | |
| RCI Fixation Screws | K992945, cleared November 18, 1999 |
| Arthrex Cannulated Interference Screw | K915424, cleared February 9, 1993 |
Product Description
The Atlantech Graft Fixation Screw is for fixation of grafts in cruciate ligament reconstructive surgery. Standard features include a tapered rear profile, which museuzes graft impingement post implantation. The screw is cannulated to accept 1.2mm A-Fech Controlled Flexion Guidewire.
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K031937 page 2 of 2
Intended Uses
The Atlantech Graft Fixation Screw is an interference screw for use in the fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery.
Substantial Equivalence
Based on the indications for use statement and technological characteristics to the predicate devices, the Atlantech Graft Fixation Screw is substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
Summary of Safety and Effectiveness
The Atlantech Graft Fixation Screw, as described in this 510(k), is substantially equivalent to the predicate device with respect to the indications for use and technological characteristics. The use of interference screws for the fixation of grafts in cruciate ligament reconstructive surgery is well established. Atlantech Graft Fixation Screws have been commercially available in Europe since 1996 and do not differ markedly from others on the market.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three horizontal lines forming its wings and two wavy lines below representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 4 2003
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-2936
Re: K031937
Trade/Device Name: Atlantech Graft Fixation Screw Regulation Numbers: 21 CFR 888.3040 Regulation Names: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HWC Dated: June 16, 2003 Received: June 24, 2003
Dear Ms. Defiesta-Ng:
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. Valerie Defiesta-Ng
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,
Mark n Mellers
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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Indications for Use Statement
Device Name
Atlantech Graft Fixation Screw
K_031937 510(k) Number:
Indications for Use:
The Atlantech Graft Fixation Screw is an interference screw for use in the fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use the text is the following: Prescription Use X OR Over-the-Counter Use (Per 21 CFR 801.109) for Mark N Millen (Division Sign-Off) Division of General, Restorative and Neurological Devices Koz 1937
510(k) Number .
ix
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.