(159 days)
No
The summary describes a physical implant made from bovine bone for graft fixation and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is used for graft fixation and reconstruction, which are surgical procedures, not therapeutic treatments. It functions as a structural component rather than providing therapy itself.
No
The device description states its use is for "graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries," which is a treatment or surgical function, not a diagnostic one.
No
The device description clearly states it is manufactured from bovine bone and is a physical implant (screw eyelet). This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for graft fixation in surgical procedures (cruciate ligament reconstruction). This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical implant made from bovine bone, designed to be used with a specific screw during surgery. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly intended for direct surgical implantation to support tissue repair, which falls under the category of a surgical device or implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.
Product codes
HWC, JDR
Device Description
The Sterling IF Screw Eyelet is manufactured from bovine bone processed with the BioCleanse® Tissue Sterilization Process. The Sterling IF Screw Eyelet is 25mm long by 8mm wide with an oval eyelet. The subject Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT cleared via K060253.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LinX HT, Sterling Interference Screw ST, Sterling Interference Screw HT
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.
0
Regeneration Technologies, Inc. K063584 STERLING® IF Screw Evelet
510(K) Summarv
MAY - 9 2007
Date: May 4, 2007 Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4326 Fax: 386-462-1627
Proprietary Name: Sterling® IF Screw Eyelet
Common Name: soft tissue graft fixation device
Product Code: HWC. Orthopedics Panel
Code Section: 21 CFR 888.3040
Substantial Equivalence:
The Sterling IF Screw Eyelet is substantially equivalent to the LinX HT in design and function, and substantially equivalent to the Sterling Interference Screw ST and Sterling Interference Screw HT in materials and function.
Description:
The Sterling IF Screw Eyelet is manufactured from bovine bone processed with the BioCleanse® Tissue Sterilization Process. The Sterling IF Screw Eyelet is 25mm long by 8mm wide with an oval eyelet. The subject Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT cleared via K060253.
Intended Use:
This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.
Summary of Technological Characteristics:
The Sterling IF Screw Eyelet, Sterling Interference Screw ST and Sterling Interference Screw HT are composed of the same materials processed in the same manner. The source of bovine bone used in the manufacture of the Sterling IF Screw Eyelet is a closed herd located in the U.S.A. A viral inactivation study using a worst-case representation of the BioCleanse® Tissue Sterilization Process, used in the manufacture of the Sterling IF Screw Eyelet, has shown a reduction of a panel of viruses to below detectable limits.
1
Public Health Service
OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Regeneration Technologies, Inc. % Ms. Lisa Simpson Director of Regulatory Affairs 11621 Research Circle Alachua, Florida 32616-2650
MAY - 9 2007
Re: K063584
Trade/Device Name: Sterling® IF Screw Eyelet Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, JDR Dated: April 20, 2007 Received: April 23, 2007
Dear Ms. Simpson:
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Lisa Simpson
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbari bucherp
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
510(k) Number (if known): K063584
Device Name: Sterling® IF Screw Eyelet
Indications for Use:
This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.
Over-The-Counter Use Prescription Use X AND/OR · (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Laubare Buckup
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K063584