This device is intended for use in surgical procedures to repair Pectus Excavatum. It is intended to be used in pediatric (children and adolescents) populations.

Device Description

The Pectus Support Bar and stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity. The Pectus Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. The device should be removed when remodeling is evident. These devices are offered as flat (unbent) bars requiring intraoperative shaping, or alternatively may be prebent to patient anatomy. These devices are intended to be used in professional healthcare facilities.

The Pectus Support Bar are made of titanium alloy (ASTM F1472) or stainless steel (ASTM F138). The Pectus Stabilizers are made of stainless steel (ASTM F138) or titanium alloy (ASTM F136). The Pectus Support Bar system is provided non-sterilization by the end user.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Pectus Support Bar System." This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. However, it does not include information about AI/ML device performance, acceptance criteria, or a study proving it meets those criteria, as it's a structural implant and not an AI/ML diagnostic or prognostic device.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details as an AI/ML device. The document explicitly states:

"Clinical data was not required for the determination of substantial equivalence."
The performance testing described is focused on material properties, mechanical strength, MR compatibility, and biocompatibility, as relevant for an implantable device, not AI/ML performance.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it for the requested information.

Summary

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March 11, 2022

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Biomet Microfixation % Christine Scifert Official Correspondent MRC Global 9085 East Mineral Circle, Suite 110 Centennial. Colorado 80112

Re: K213712

Trade/Device Name: Pectus Support Bar System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 23, 2021 Received: November 24, 2021

Dear Christine Scifert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For: Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213712

Device Name Pectus Support Bar System

Indications for Use (Describe)

This device is intended for use in surgical procedures to repair Pectus Excavatum. It is intended to be used in pediatric (children and adolescents) populations.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Pectus Support Bar System – K213712 February 11, 2022

Company:	Biomet Microfixation1520 Tradeport DriveJacksonville, FL 32218
Primary Contact:	Danielle BesalDanielle.Besal@askmrcglobal.comPhone: (901) 827-8670
Company Contact:	Mark Wladkowskimark.wladkowski@zimmerbiomet.comPhone: (904) 362-3940
Trade Name:	Pectus Support Bar System
Common Name:	Plate, Fixation, Bone
Classification:	Class II
Regulation Number:	21 CFR 888.3030: Single/multiple component metallic bone fixationappliances and accessories
Panel:	87- Orthopedic
Product Code:	HRS: Plate, Fixation, Bone

Device Description:

Indications for Use:

This device is intended for use in surgical procedures to repair Pectus Excavatum. It is intended to be used in pediatric (children and adolescents) populations.

Predicate Device:

K061384: Biomet Microfixation, Lorenz Pectus Support Bar System

The similarities of the subject devices to the predicate devices are as follows:

Intended use
Support bar geometry ●
Materials of construction for stainless steel implants and titanium stabilizer

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Stabilizers are identical ●
Sterilization method

The differences of the subject devices compared to the predicate devices are as follows:

. Changing the material standard from ASTM F136 to ASTM F1472 for Pectus Support Bars
. Addition of intermediate sizes of the Pectus Support Bars to the system
Addition of instruments for the new sizes and removal procedures
Updates to labeling, including "MR Conditional" labeling ●

Performance Testing:

Engineering analysis of the Pectus Support Bars was performed per ASTM F382 and concluded that the change in titanium alloy material standard results in equivalent performance to the predicate device. MR compatibility testing was performed in compliance with the following standards: ASTM F2052-15. ASTM F2213-17. ASTM F2182-19. and ASTM F2119-07. The results of the testing showed the devices are MR Conditional, which is reflected in the product labeling. Biological safety risk assessments in compliance with ISO 10993-1:2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use. Clinical data was not required for the determination of substantial equivalence.

Substantial Equivalence:

The subject devices are substantially equivalent to the predicate Lorenz Pectus Support Bar System, K061384. The subject components are similar in indications, sizing and geometry, technological characteristics, and materials to the predicates as described in this 510(k). Any differences in technological characteristics between the subject and predicate devices do not raise any new questions of safety and effectiveness and the subject device is as safe and effective as the predicate. It is concluded that the information in this 510(k) supports substantial equivalence of the devices.

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.