MODIFICATION TO THE TAC' PIN

• K Number: K011875
• Device Name: MODIFICATION TO THE TAC' PIN
• Manufacturer: NEWDEAL S.A.
• Date Cleared: 2001-09-06 ( 83 days)
• Product Code: JDW , 87J
• Regulation Number: 888.3040
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K993910 , K982931 , K983121
• Predicate For: N/A

Intended Use

The "new" TAC'pin® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
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.)

Device Description

The TAC'pin® is a self tapping threaded wire. The TAC'pin® is designed to be introduced with 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "TAC'pin®". It focuses on establishing substantial equivalence to previously approved devices, rather than presenting a performance study with specific acceptance criteria and detailed outcomes of a standalone or comparative effectiveness study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment is not available in these documents.

Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria. Instead, it relies on proving substantial equivalence to existing legally marketed devices. The "performance" reported is that the "new" TAC'pin® is "technically equivalent" to the previously approved TAC'pin® (K993910) and "substantially equivalent" to other threaded fixation pins (K982931, K983121).

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices in intended use, material, and design of the active part.	The "new" TAC'pin® is technically equivalent to the currently approved TAC'pin® (K993910) and substantially equivalent to predicate devices K982931 and K983121.
The design change (decreased proximal diameter) does not affect the "active" part or patient safety.	The diameter of the proximal (non-threaded) part was decreased from 1.7mm to 1.6mm for better adaptation to power drills. This part is cut by the surgeon and does not remain in the patient, thus not impacting the active part or patient safety.
Fulfillment of stated Indications for Use.	The "new" TAC'pin® is indicated for fixation of bone fractures or bone reconstructions, with examples including small bone fragments, arthrodesis, osteotomies in hand/foot, and Hallux Valgus treatment.

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission, not a clinical trial or performance study involving a test set of data. The "test" is the comparison to predicate devices based on design and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of a performance study, is not established here. The assessment is based on regulatory and technical comparison.

4. Adjudication method for the test set

Not applicable. There's no test set in the sense of a data study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (bone fixation wire), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

Not applicable. Ground truth for a performance study is not used. The basis for approval is substantial equivalence to legally marketed predicate devices, which relies on regulatory precedent and technical comparison of device characteristics.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI-based study.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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: [phone]".

(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. : [phone] Fax : [phone]

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 [e-mail] Tel. : [phone] Fax : [phone]

• 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

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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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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

Regulation Number and Section

§ 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.