The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires. Examples of protruding wires include: Osteotomies, arthrodesis or fractures management in the foot or hand. Fixation of small bone fragments, in long bones or small bones fractures.

Device Description

The K-Fix® pin protector is a simple and reliable system to protect patients or hospital staff from K-wire sharp ends and reduce bandages size. It presents an ergonomic profile. Thanks to its patented "Push, Lock and Twist" system, its fixation requires no instrument. An optional possibility for using K-Fix on wires bent at right angle allows manual rotational and axial maneuvers for the removal of the pin. Delivered sterile, it can be used intraoperatively to protect temporarily the surgeon from cuts and pricks when placing multiple wires in a small area.

AI/ML Overview

Here's an analysis of the provided text regarding the K-FIX® device, focusing on acceptance criteria and study details.

Based on the provided document, the K-FIX® is a K-Wire end protector, and the provided text is a 510(k) summary for regulatory clearance, not a study report detailing performance data and acceptance criteria.

Therefore, most of the requested information regarding a study that proves the device meets acceptance criteria is not present in this document. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.

However, I can extract the following information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics in this document. The implicit acceptance criterion for 510(k) clearance is "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective as the predicate devices.
Reported Device Performance: The document describes the device's function and attributes, which implicitly define its intended performance.

Acceptance Criterion (Implicit)	Reported Device Performance
Protection of protruding ends of wires	"The K-Fix® pin protector is a simple and reliable system to protect patients or hospital staff from K-wire sharp ends and reduce bandages size." "The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires."
Ergonomic profile	"It presents an ergonomic profile."
Fixation method	"Thanks to its patented "Push, Lock and Twist" system, its fixation requires no instrument."
Compatibility with right-angle bent wires	"An optional possibility for using K-Fix on wires bent at right angle allows manual rotational and axial maneuvers for the removal of the pin."
Sterility	"Delivered sterile..."
Intraoperative use (temporary protection)	"...it can be used intraoperatively to protect temporarily the surgeon from cuts and pricks when placing multiple wires in a small area."
Material composition	"K FIX® (Newdeal)...are made of polymer."
Fit comparable ranges of wire diameters	"K FIX® (Newdeal)...fit comparable ranges of wires diameters."
Substantially equivalent to predicate devices (K-CAP-ES, Jurgan pin Ball®)	The entire 510(k) submission is predicated on demonstrating this.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document does not describe a performance study with a test set. It's a regulatory submission demonstrating substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No performance study with a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No performance study with a test set is described.

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 physical medical device (K-wire end protector), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices (K-CAP-ES and Jurgan pin Ball®). The K-FIX® is deemed safe and effective if it shares the same technological characteristics and indications for use as these predicate devices without raising new questions of safety or effectiveness.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable. As above, no training set for a machine learning model.

Summary of the Document's Purpose:

This document is a "Summary of Safety and Effectiveness" (a 510(k) summary) submitted to the FDA for the K-FIX® K-wire end protector. Its primary goal is to demonstrate that the K-FIX® device is substantially equivalent to legally marketed predicate devices (K-CAP-ES and Jurgan pin Ball®). This equivalence is established by comparing indications for use, technological characteristics (e.g., polymer material, sterility, fit for wire diameters, external device), and addressing the same clinical problem (protection of protruding wire ends). The FDA's letter confirms that based on this submission, the device is substantially equivalent and can be legally marketed. It does not contain primary performance study data or explicitly defined acceptance criteria in the analytical or clinical sense.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for New Deal. The logo consists of the word "newdeal" in a sans-serif font, with a circle of five dots to the left of the word. The "R" in a circle is to the right of the word.

NEWDEAL SA . 31, RUE DE LA CONVENTION PARC D'ACTIVITÉS GARIGLIANO 3 8 2 0 0 0 VIENNE ● ● FRANCE TEL : +33 (0) 4 74 78 15 15 FAX : +33 (0) 4 74 78 15 16 w w w . neew deeal . i n f o Емать : пе w d e alfr @ a o l . c o m

SUMMARY OF SAFETY AND EFFECTIVENESS 3.

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

B. ESTABLISHMENT REGISTRATION NUMBER:

9615741

C. OFFICIAL CONTACT PERSON Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 Tel.: (301) 279 -2899 Fax: (301) 294-0126

D. DATE OF PREPARATION OF THIS SUMMARY: August 3, 2002

E. PROPRIETARY (TRADE) NAME: K-FIX®
F. COMMON NAME: K-Wire End Protector
G. CLASSIFICATION NAME AND REFERENCE Smooth or threaded metallic bone fixation fastener
H. PROPOSED REGULATORY CLASS : Class II
DEVICE PRODUCT CODE: I. LYT HTY
J. REFERENCE: 21 CFR par. 888.3040
K. PANEL CODE: 87 OR Orthopedic

01 0009

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×022597

L. DESCRIPTION OF DEVICE:

M. INDICATIONS FOR USE:

The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires.

Examples of protruding wires include:

Osteotomies, arthrodesis or fractures management in the foot or hand.

Fixation of small bone fragments, in long bones or । small bones fractures

PREDICATE DEVICE: The K-FIX® is substantially equivalent to K-CAP-ES N. external protective caps from Westcon orthopedics (K914812), the Jurgan pin Ball® (K831072) from Jurgan Development and Mfg.

0. COMPARISON OF TECHNOLOGICAL

CHARACTERISTICS: K FIX® (Newdeal), K-CAP-ES external protective caps (Westcon Orthopedics) and the Jurgan pin Ball® (Jurgan Development and Mfg.) are indicated for use in the protection of protuding ends of surgical wires.

Both of the K FIX®(Newdeal) and K-CAP-ES external protective caps (Westcon) are delivered sterile in a dispenser box of several units whereas the Jurgan pin Ball® (Jurgan Development and Mfg.) is included in a sterilizable polymer case (filled in any combination of models).

K FIX® (Newdeal), K-CAP-ES external protective caps ( (Westcon Orthopedics) and the Jurgan pin Ball" (Jurgan Development and Mfg.) are made of polymer. They are all external devices.

K FIX® (Newdeal), K-CAP-ES external protective caps (Westcon Orthopedics) and the Jurgan pin Ball® (Jurgan Development and Mfg) fit comparable ranges of wires diameters.

2 04 ನ್ನ

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Image /page/2/Picture/1 description: The image shows the text "Public Health Service" in a simple, sans-serif font. The text is black and appears to be against a white background. The words are stacked on a single line and are easily readable.

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

NOV 0 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Norman F. Estrin, Ph.D. Consultant to NewDeal SA Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K022597

Trade/Device Name: K-Fix® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: July 28, 2002 Received: August 5, 2002

Dear Dr. Estrin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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. Iisting 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 - Norman F. Estrin, Ph.D.

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 and additionally 21 CFR Part 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 Part 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,

Mark A. Wilkinson

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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K02 2597

Page 1 of 1

Indications for Use :

The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires.

Examples of protruding wires include :

-Osteotomies, arthrodesis or fractures management in the foot or hand.

-Fixation of small bone fragments, in long bones or small bones fractures.

Mark A. Millerson

17 Sisti. eral. Restorative

510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use

Over -the-counter Use

(Per 21 CFR 801.109)

(Optional format 1-2-96)

રુપર : ઉપદ

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.