(83 days)
Not Found
No
The summary describes a mechanical bone fixation device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for the fixation of bone fractures or bone reconstructions, which are therapeutic interventions.
No
The "TAC'pin®" is a self-tapping threaded wire intended for fixing bone fractures or for bone reconstruction. Its function is to provide mechanical support, not to diagnose a condition.
No
The device description clearly states it is a "self tapping threaded wire" intended for implantation, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the TAC'pin® is for the fixation of bone fractures or bone reconstructions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a self-tapping threaded wire designed for implantation into bone.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The TAC'pin® is an implantable surgical device, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
- INTENDED USE: The TAC'pin® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
- INDICATIONS FOR USE: The "new" TAC'pin® is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
Fixation of small bone fragments, in long bones or small bones fractures.
Arthrodesis in hand or foot surgery.
Mono or Bi-cortical osteotomies in the foot or hand.
Distal or proximal metatarsal or metacarpal osteotomies.
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
Product codes
JDW
Device Description
The TAC'pin® is a self tapping threaded wire. It is used with standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the threaded wire into one surface. The lengths of threads available are the following: the boss pin is designed with a variable pitch, for a true and adapted compression.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones (hand, foot, long bones, small bones)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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.
0
Image /page/0/Picture/0 description: The image shows the logo and contact information for a company called "newdeal". The text below the logo includes the company name "NEWDEAL SA" and their address: "31 RUE DE LA CONVENTION, PARC D'ACTIVITÉS GARIGLIANO, 38200 VIENNE, FRANCE". The phone number is also listed as "TEL: (33) 04 74 78 15 15".
(33) 04 INTERNET EMAIL : NEWDEALFR
KO11875
p. 1/2
SEP = 6 2001
SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION A.
NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE Tél. : (33) 4 74 78 15 15 Fax : (33) 4 74 78 15 16
ESTABLISHMENT B. 9615741 REGISTRATION NUMBER:
OFFICIAL CONTACT PERSON C.
Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 estrin@yourFDAconsultant.com Tel. : (301) 279-2899 Fax : (301) 294-0126
- D. DATE OF PREPARATION June 14, 2001 OF THIS SUMMARY:
- TAC'pin® PROPRIETARY (TRADE) NAME: E.
- Bone fixation wire, self tapping threaded wire COMMON NAME: F.
- CLASSIFICATION NAME AND REFERENCE G. Smooth or threaded metallic bone fixation fastener (21 CFR, Section 888.3040)
SA au capital de 1.000.000 F - Nº Sirel 412 111 510 000 19 - NAF 331B - 412 111 510 RCS Vienne
1
KDII 875
PROPOSED REGULATORY CLASS: H.
Class II
- DEVICE PRODUCT CODE: 87JDW I.
- 87 OR PANEL CODE: J.
- DESCRIPTION OF DEVICE: The TAC'pin® is a self tapping threaded wire. K. DESCRIT TION OF DE PERFECT and re standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the threaded who 'is 'into one surface. The lengths of threads available are the following prouding partue the boss pin is designed with a variable pitch, for a true and adapted compression.
- INTENDED USE: The TAC'pin® is intended to be implanted for fixation of L. bone fractures or for bone reconstructions.
- INDICATIONS FOR USE: The "new" TAC'pin® is indicated for fixation of M. bone fractures or for bone reconstruction. Examples include:
Fixation of small bone fragments, in long bones or small bones fractures.
- Arthrodesis in hand or foot surgery .
- Mono or Bi-cortical osteotomies in the foot or hand .
- Distal or proximal metatarsal or metacarpal osteotomies .
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc.)
- The "new" TAC'pin® is technically equivalent to the PREDICATE DEVICE N. TAC'pin® currently approved (K993910). The "new" TAC'pin® is substantially equivalent to the Threaded fixation pin manufactured by Sgarlato laboratories (K982931), and the Kirschner wires and Steinmann pins manufactured by Syntec-Taichung Medical Instruments (K983121).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 0.
The "new" TAC'pin® is technically equivalent to the device currently approved. They have the same intended use, the same material, and the design of the active part (threaded part) has not changed. The following design change should however be noted : The diameter of the proximal (non threaded) part of the pin has been decreased from 1.7mm to 1.6mm, for a better adaptation to power drills (wire drivers) commonly used by the surgeons. This has not changed anything to the "active" part of the pin, as this proximal part of diameter 1.6mm is cut by the surgeon once the pin is in place. It does not remain in the patient.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top and left side of the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2001
New Deal SA c/o Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K011875
Trade/Device Name: TAC'pin® Regulation Number: 888.3040 Regulatory Class: II Product Code: JDW Dated: June 14, 2001 Received: June 15, 2001
Dear Dr. Estrin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Norman F. Estrin, Ph.D., RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Susan Walker, M.D.
fr
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
CONFIDENTIAL
Page 1 of 1
510(k) Number (if known): K O II 875
TAC' pin ® Device Name:
Indications for Use:
The "new" TAC'pin® is indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
Fixation of small bone fragments, in long bones or small bones fractures. .
Arthrodesis in hand or foot surgery .
Mono or Bi-cortical osteotomies in the foot or hand .
Distal or proximal metatarsal or metacarpal osteotomies .
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) .
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
Use Over-the-Counter
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off) (Division Sign-Ord), Restorative Division of Sical Devices
510(2) Number Ko 11875
000014