(73 days)
Not Found
No
The summary describes a mechanical screw for graft fixation and makes no mention of AI or ML.
Yes
Explanation: The device is used for fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery, which is a medical treatment.
No.
The device is used for fixation of bone-tendon-bone grafts in surgery, not for diagnosing a condition.
No
The device description clearly states it is a physical screw used for fixation in surgery, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Atlantech Graft Fixation Screw is an implantable device used within the body during surgery to fix a graft to bone. It is a surgical tool and implant, not a device for testing biological samples.
The provided information clearly describes a surgical implant used for mechanical fixation during reconstructive surgery, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
HWC
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cruciate ligament
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-2936 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | (408) 736-0224 |
| Contact Person: | Valerie Defiesta-Ng
Director, Regulatory Affairs |
| Manufacturers Name/Address: | Atlantech Medical Devices, Ltd.
(Subsidiary of ArthroCare Corporation)
Atlantech House, 38 Freemans Way
Harrogate Business Park, Harrogate
North Yorkshire, HG3 IDH
United 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 fixation
fastener (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.
1
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.
2
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.
3
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
4
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 .
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