(28 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to a predicate device, with no mention of AI or ML.
Yes
The device is described as an implantable T-Pin intended for the repair of fractures, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is described as an implantable pin for repairing fractures, not for diagnosing conditions.
No
The device description clearly states it is a "threaded and cannulated stainless steel Steinmann pin," which is a physical implantable hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of fractures in the wrist. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable pin made of stainless steel, designed to fix bones. This is a physical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples taken from the body. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Union Surgical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.
Product codes
JDW
Device Description
The Union Surgical. LLC T-Pin® is a threaded and cannulated stainless steel Steinmann pin used for the repair of wrist fractures. The device incorporates a break-off shank. The device is ontionally supplied with removal tools that permit pin extraction and a sterilization tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
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)
A 13-point comparison of technological characteristics of the Union Surgical, LLC T-Pin® and the Taras Threaded Fixation Pin was performed. The devices were found to be substantially equivalent.
The Union Surgical. LLC T-Pin® complies with the following standards, practices, and guidances:
. ASTM F366 82 (Reapproved 2000), Standard Specification for Fixation Pins and Wires
. ASTM F138 - 97, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
. ASTM F899 - 95, Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical
The Union Surgical, LLC T-Pin® is substantially equivalent to Taras Threaded Fixation Pins that are legally marketed and distributed by Union Surgical, LLC. This has been demonstrated through a 13-point technological comparison of features and a 3-parameter comparison of mechanical performance.
The Implantable and tissue contact materials used to fabricate the T-Pin® and Instruments have a long history of safe usage in medical devices. Since the Union Surgical, LLC T-Pin® meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as, or better than, the predicate device. The T-Pin® will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
JAN 1 3 2006
K0535/3 p1/2
Page 17 of 18
Summary of Safety and Effectiveness for the T-Pin®
submitted by Union Surgical, LLC 834 Chestnut Street Philadelphia, PA 19107 Phone: (215)-521-3009
| Contact Person: | Al Weisenborn |
|---|---|
| Device Trade Name: | T-Pin® |
| Common Name: | Cannulated Fixation Screw |
| Classification Name: | Smooth or threaded metallic bone fixation fastener per 21 CFR § 888.3040 |
Identification of a Legally Marketed Predicate Device
The Union Surgical, LLC T-Pin® is substantially equivalent to Taras Threaded Fixation Pin that is legally marketed and distributed by Union Surgical, LLC pursuant to K032532.
Device Description
The Union Surgical. LLC T-Pin® is a threaded and cannulated stainless steel Steinmann pin used for the repair of wrist fractures. The device incorporates a break-off shank. The device is ontionally supplied with removal tools that permit pin extraction and a sterilization tray.
Intended Use
The Union Surgical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.
Summary of Technological Characteristics
A 13-point comparison of technological characteristics of the Union Surgical, LLC T-Pin® and the Taras Threaded Fixation Pin was performed. The devices were found to be substantially equivalent.
Summary of Performance Data
The Union Surgical. LLC T-Pin® complies with the following standards, practices, and guidances:
- . ASTM F366 82 (Reapproved 2000), Standard Specification for Fixation Pins and Wires
1
- . ASTM F138 - 97, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- . ASTM F899 - 95, Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical
The Union Surgical, LLC T-Pin® is substantially equivalent to Taras Threaded Fixation Pins that are legally marketed and distributed by Union Surgical, LLC. This has been demonstrated through a 13-point technological comparison of features and a 3-parameter comparison of mechanical performance.
The Implantable and tissue contact materials used to fabricate the T-Pin® and Instruments have a long history of safe usage in medical devices. Since the Union Surgical, LLC T-Pin® meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as, or better than, the predicate device. The T-Pin® will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
દ્રિક
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2006
John Taras, M.D. President Union Surgical, LLC 834 Chestnut Street, Suite G- 114 Philadelphia, PA 19107
Re: K053513
Trade/Device Name: T-Pin® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: December 12, 2005 Received: December 16, 2005
Dear Dr. Taras:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neve reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assured in 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
3
Page 2 - John Taras, M.D.
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. 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" (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/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson for Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use - Indications for Users
K053513 510(k) Number (if known): _
Device Name: T-Pin®
Indications for Use:
The Union Surqical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.
Prescription Use_ X (Per 21 CFR 801 Subpart D) AND/OR
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_ Los 353
Union Surgical, LLC
834 Chestnut Street, Philadelphia, PA 19107
Revised: January 5, 2006