(19 days)
Not Found
Not Found
No
The description focuses on mechanical fixation and does not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as allowing for dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures, and its compression and holding together of these fragments promote healing at the repair site. These functions align with the definition of a therapeutic device, as they are intended to treat or manage a medical condition (damaged bone, tissue, ligament, and tendon) and promote healing.
No
Explanation: The TranSet™ System is described as a fixation device used for dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments during surgical procedures, promoting healing. Its function is to physically secure anatomical structures, not to identify, monitor, or analyze health conditions or diseases, which are characteristics of a diagnostic device.
No
The device description explicitly lists multiple hardware components including a cannulated drill, lead button or anchor, flexible material, metallic crimp, and a manual hand held crimping instrument.
Based on the provided information, the TranSet™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the "dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures." This describes a device used in vivo (within the body) for structural support and repair.
- Device Description: The description details components like drills, buttons, flexible materials, crimps, and a crimping instrument, all used for physically securing tissues within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. The TranSet™ System is a surgical implant and fixation device, which falls under a different category of medical devices.
N/A
Intended Use / Indications for Use
The TranSet™ System are fixation devices indicated in bone, tissue, ligament, and tendon repair. The system allows for dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system can also be used as fixation posts for distributing suture tension over areas of bone, tissue, ligament, and tendon repair. The compression and holding together of bone, tissue, ligament, and tendon fragments of the system further promotes healing at the repair site. The system consists of single patient use metallic crimping devices that secure the following flexible materials running across a repair site:
- Up to USP Size No. 2 Suture,
- Up to USP Size No. 2 High Tensile Suture,
- Metallic Cable, and
- Metallic Wire.
Product codes
HTY
Device Description
The TranSet™ System intended use is in the dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system consists of a cannulated drill, a lead button or anchor, a flexible material that runs across a repair site, a metallic crimp, and a manual hand held crimping instrument. The flexible material is tensioned and secured with a metallic crimp by the manual hand held instrument allowing a compressive load to be applied across the repair site. This compression and holding together of the bone, tissue, ligament, and tendon fragments further promotes healing at the repair site. Lead buttons or anchors with a corresponding flexible material are provided sterile for single patient use. Cannulated drills for delivery of the implant materials are single patient use. The reusable crimping instrument and a sterilization tray for autoclaving complete the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, tissue, ligament, and tendon
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)
Design verification testing identified and conducted as part of the I reacult Comparison. Dompared the mechanical strengths and failure modes of the modified TranSet™ System to predicate devices. Results demonstrated that the modified TranSet™ System is statistically equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Multitak SS Button system
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
Image /page/0/Picture/0 description: The image shows the logo for Bonutti Technologies. The word "BONUTTI" is in large, bold, black letters on the top line. Underneath, in smaller letters, is the word "TECHNOLOGIES". The logo is simple and modern.
gham, IL 62401
FEB 2 2 2006
Phone: 217.342.3412 217 342 3460 http://www.bonuttitec.com
Bonutti Research, Inc. - Modification to TranSetTM System Special 510(k) February 1, 2006
510(k) SUMMARY
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
| Contact Person: | Patrick Balsmann, MBA, MS, RAC |
|---|---|
| Director, Regulatory/Clinical Affairs & QA | |
| Bonutti Research, Inc., | |
| P.O. Box 1367, Effingham, Illinois 62401 | |
| Phone: (217) 342-3412, ext. 321 | |
| Fax: (217) 342-1043 |
Date Prepared: February 1, 2006
Proprietary Name: TranSetTM System
Common Name: Fixation Device
Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue. Smooth or threaded metallic bone fixation fastener.
Device Description: The TranSet™ System intended use is in the dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system consists of a cannulated drill, a lead button or anchor, a flexible material that runs across a repair site, a metallic crimp, and a manual hand held crimping instrument. The flexible material is tensioned and secured with a metallic crimp by the manual hand held instrument allowing a compressive load to be applied across the repair site. This compression and holding together of the bone, tissue, ligament, and tendon fragments further promotes healing at the repair site. Lead buttons or anchors with a corresponding flexible material are provided sterile for single patient use. Cannulated drills for delivery of the implant materials are single patient use. The reusable crimping instrument and a sterilization tray for autoclaving complete the system.
1
Bonutti Research, Inc. - Modification to TranSet™ System 510(k) Summary - February 1, 2006 Page 2
Indications for Use: The TranSet™ System are fixation devices indicated in bone, tissue, Indications 101 User The Transes on allows for dynamic stabilization and linear fixation Ingancin, and tendon ropan. "The Byevents in surgical procedures. The system can also be used as fixation posts for distributing suture tension over areas of bone, tissue, ligament, oc tased as main posse compression and holding together of bone, tissue, ligament, and and concon repair. The system further promotes healing at the repair site. The system consists of single patient use metallic crimping devices that secure the following flexible materials running across a repair site:
- Up to USP Size No. 2 Suture, .
- Up to USP Size No. 2 High Tensile Suture, .
- Metallic Cable, and .
- Metallic Wire. .
Predicate Device(s): The modified TranSet™ System is similar in design and intended use to the existing Multitak SS Button system and to stainless steel beaded cable systems and Steinmann pins commonly used in bone fracture repairs.
Predicate Comparison: Design verification testing identified and conducted as part of the I reacult Comparison. Dompared the mechanical strengths and failure modes of the modified TranSet™ System to predicate devices. Results demonstrated that the modified TranSet™ System is statistically equivalent to predicate devices.
Submitted by:
Phillip Boden
Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a stacked formation. The profiles are depicted with flowing, curved lines, giving the impression of movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2006
Mr. Patrick Balsmann Director, Regulatory/Clinical Affairs & QA - -Bonutti Research, Inc. PO Box 1367 Effingham, Illinois 62401
Re: K060283
Trade/Device Name: TranSet™ System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: February 1, 2006 Received: February 8, 2006
Dear Mr. Balsmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & have 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 - Mr. Balsmann
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally premailed predicated. The Pro Pin 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 If you desire specific advice 101-10-10120. 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 other general informational 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,
Herbert Leuner us
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: TranSet™ System
Indications For Use: The TranSet™ System are fixation devices indicated in bone, tissue, ligament, and tendon repair. The system allows for dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system can also be used as fixation posts for distributing suture tension over areas of bone, tissue, ligament, and tendon repair. The compression and holding together of bone, tissue, ligament, and tendon fragments of the system further promotes healing at the repair site. The system consists of single patient use metallic crimping devices that secure the following flexible materials running across a repair site:
- Up to USP Size No. 2 Suture, ●
- Up to USP Size No. 2 High Tensile Suture, .
- Metallic Cable, and ●
- Metallic Wire. ●
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(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_ico60283