IQL Bone Plates and Screws are used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.

Device Description

IQL Bone Plates and Screws are used for the same indications as stainless steel bone plates and screws that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into bones for fixation of fractures, or the fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Bone screws are used to attach the plates to the bone and stabilize bone fragments until bone union has occurred. A wide variety of bone plates similar to those included in this submission have been in commercial distribution since prior to May 28, 1976.

AI/ML Overview

The provided text describes a 510(k) premarket notification for IQL Stainless Steel Bone Plates and Screws. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/software device.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's an explanation based on the provided document:

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

Not Applicable: This document does not present acceptance criteria for performance metrics in the way an AI or software device would. The approval is based on substantial equivalence to predicate devices, material standards, and intended use. The "performance" is inherently tied to meeting the material standards and having the same indications and technological characteristics as the predicates.

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

Not Applicable: There is no "test set" in the context of an FDA 510(k) for this type of hardware device. Performance is largely demonstrated through material standards (e.g., ASTM F-138 and ASTM F-139 for stainless steel) and equivalence to established predicate devices.

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 sense of expert consensus on data is not relevant for this device. The 'truth' is based on the known performance and safety profile of the predicate devices and the material properties.

4. Adjudication method for the test set

Not Applicable: No test set or adjudication method 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 hardware medical device (bone plates and screws), not an AI or imaging device. 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 hardware device; no algorithm is involved.

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

Not Applicable: As mentioned, the concept of "ground truth" for data labeling is not applicable here. The "truth" for this submission is related to the established safety and effectiveness of the predicate devices and compliance with material standards.

8. The sample size for the training set

Not Applicable: Not an AI/software device; no training set.

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

Not Applicable: Not an AI/software device; no training set.

Summary of Device and Approval Basis from the Document:

Device Name: IQL Basic Fragment Plate Set, IQL Basic Fragment Screw Set, IQL Small Fragment Set, IQL Mini Fragment Set (collectively, IQL Stainless Steel Bone Plates and Screws).
Classification Name: Plate, Fixation, Bone (21 CFR 888.3030); Screw, Fixation, Bone (21 CFR 888.3040).
Device Classification: Class II.
Product Code: HRS (plates), HWC (screws).
Intended Use/Indications for Use: For adult or pediatric patients for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Specific bones include tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
Basis for Approval (Substantial Equivalence): The device is substantially equivalent to various stainless steel bone plates and screws sold by Biomet Inc. (OEC) prior to May 28, 1976. Similar devices were included in the Kirschner (Biomet) Small Fragment Fixation System cleared under K864924 in March 1987.
Technology Summary: Utilizes standard technology, commonly known and used in commercially available metallic internal fixation devices prior to May 28, 1976.
Material Standards: The stainless steel used conforms to ASTM F-138 and ASTM F-139.

This 510(k) essentially argues that because the IQL Bone Plates and Screws are made of materials meeting established standards and are technologically identical to and intended for the same uses as legally marketed devices from before 1976 and later cleared devices, they are equally safe and effective.

Summary

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K020221

APR 2 2 2002

Page 1 of a

Summary of Safety and Effectiveness

Applicant/Sponsor: Industrias Quirurgicas de Levante, S.L. Islas Baleares, 50 Poligono Fuente del Jarro Paterna, Valencia Spain 46988 Establishment Registration Number: 9610576

Lonnie Witham Contact Person: Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Fax: (219) 372-1683

Proprietary Name: IQL Basic Fragment Plate Set, IQL Basic Fragment Screw Set. IQL Small Fragment Set, IQL Mini Fragment Set

Common or Usual Name: Stainless Steel Bone Plates & Bone Screws

Classification Name: Plate, Fixation, Bone (21 CFR 888.3030) Screw. Fixation. Bone (21 CFR 888.3040)

Device Classification: Class II

Device Product Code: HRS (plates), HWC (screws)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed: These devices are substantially equivalent to various stainless steel bone plates and screws sold by Biomet Inc. (OEC) prior to May 28,1976. Similar devices were included in the Kirschner (Biomet) Small Fragment Fixation System cleared under K864924 in March 1987.

Device Description: IQL Bone Plates and Screws are used for the same indications as stainless steel bone plates and screws that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into bones for fixation of fractures, or the fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Bone screws are used to attach the plates to the bone and stabilize bone fragments until bone union has occurred. A wide variety of bone plates similar to those included in this submission have been in commercial distribution since prior to May 28, 1976.

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page 2 of 2

000093

Intended Use: IQL Bone Plates and Screws are used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.

Summary of Technology: This device utilizes standard technology that is commonly known by physicians. This technology has been used in commercially available metallic internal fixation devices prior to May 28, 1976. The stainless steel used to manufacture these inplants conforms to material standards published by the American Society for Testing and Materials ASTM F-138 and ASTM F-139.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2002

Mr. Lonnie Witham Biomet, Inc. P.O. Box 587 Warsaw, In 46581-0587

Re: K020221

Trade/Device Name: IQL Stainless Steel Bone Plates and Screws – Various Styles Regulation Number: 21 CFR 888.3030 and 888.3040

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener

Regulatory Class: Class II Product Code: HRS, HWC Dated: January 21, 2002 Received: January 22, 2002

Dear Mr. Witham:

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, 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. Lonnie Witham

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,

for Mark n Mcherson

Celia 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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Page 1 of

STATEMENT OF INDICATIONS FOR USE

510(k) Number	K020221------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------and the first for the country of the province of the country of the county of
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510(k) Number

K020221------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------and the first for the country of the province of the country of the county of

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Device Name: IQL Stainless Steel Bone Plates & Screws - Various Styles

Indications for Use:

IQL Bone Plates and Screws are used for adult or pediatric patients as indicated for IQL Bone Flates and OOOve are are as as a see a can fixation of bones that have been surgically prepared (ostentomy) for correction of deformity or arthrodesis. Surgically propared (ostedits) / For tibia, fibula, fibula, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use __
(Optional Format 1-2-96)

for

Mach N Millere
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number __K020221

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.