(19 days)
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.
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.
The provided document describes a Special 510(k) submission for a modification to the TranSet™ System, a fixation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through design verification testing.
Therefore, the study described is a predicate comparison study focusing on mechanical strength and failure modes, rather than an AI or clinical performance study. Many of the requested details about acceptance criteria for AI devices, and the characteristics of a clinical study, are not applicable in this context.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strengths: The modified TranSet™ System must demonstrate mechanical strengths statistically equivalent to predicate devices. | Results demonstrated that the modified TranSet™ System is statistically equivalent to predicate devices in mechanical strengths. |
| Failure Modes: The modified TranSet™ System must exhibit failure modes comparable to predicate devices. | Results demonstrated that the modified TranSet™ System is statistically equivalent to predicate devices in failure modes. |
Explanation of the "Implied" Criteria: The document directly states that "Design verification testing identified and conducted as part of the predicate comparison compared the mechanical strengths and failure modes of the modified TranSet™ System to predicate devices." The positive outcome ("Results demonstrated that the modified TranSet™ System is statistically equivalent to predicate devices") implies these were the critical acceptance criteria for this specific 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the design verification testing. It only states that "Design verification testing identified and conducted as part of the predicate comparison compared the mechanical strengths and failure modes..."
- Data Provenance: This was retrospective data in the sense that the testing was performed on the modified device and compared against existing predicate devices. The country of origin for the data is not explicitly stated, but given the company (Bonutti Research, Inc.) is based in Illinois, USA, it's reasonable to assume the testing and data generation occurred in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This was a mechanical engineering design verification study, not a clinical study requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" would be objective measurements of mechanical properties.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this was a mechanical engineering study. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical data, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not mention any MRMC study. This is a 510(k) for a mechanical fixation device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is not an AI algorithm. The device itself (TranSet™ System) is the "standalone" component being evaluated for its mechanical properties.
7. Type of Ground Truth Used
- The ground truth in this context was objective mechanical measurements (e.g., tensile strength, displacement at failure, etc.) obtained through design verification testing. These are empirical measurements, not expert consensus, pathology, or outcomes data in the medical sense.
8. Sample Size for the Training Set
- Not Applicable. This product is a mechanical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As this is not an AI model, there is no training set or ground truth in that context.
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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.
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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
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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.
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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
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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
§ 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.