For use during surgical procedures to repair Pectus Excavatum and other sternal deformities with Lorenz Pectus Support Bar 510(k) number K972420 when additional stabilization is necessary.

Device Description

Stabilizer for a single bar: Two designs will be offered for stabilization of a single bar. One design will be an elongated plate and one will be a triangular plate which will be added at the ends of the Lorenz Pectus Support Bar. The stabilizers have a dovetail slot in the center of the plate for the pectus bar to slide into. Two lips come up over the bar to secure the pectus bar within the slot of the stabilizers bave two holes on either side of the slot to suture the stabilizer to the lateral chest wall together with the support bar preventing lateral movement and flipping of the bar.

Stabilizer for two bars: The design is a triangular plate with two dovetail slots to slide the Lorenz Pectus Support Bars into. Two lips will come up over the bars to secure the pectus bars within the stabilizer. The stabilizer will have a single hole to suture the stabilizer and the bars to the lateral chest wall preventing lateral movement and flipping of the bar.

AI/ML Overview

This document is a 510(k) summary for a medical device modification, the Lorenz Pectus Support Bar Stabilizer. It describes the device's intended use and design but does not contain information about a study proving the device meets acceptance criteria.

Therefore, many of the requested details, such as specific acceptance criteria and study parameters, cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document describes the device modification and its intended use but does not present any performance data or acceptance criteria for a study.

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

Cannot be provided. No study or test set information is present in the document.

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)

Cannot be provided. No study or ground truth establishment information is present.

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

Cannot be provided. No study or adjudication method information is present.

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

Cannot be provided. This device is a mechanical stabilizer, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance would not be applicable.

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

Cannot be provided. This device is a mechanical stabilizer, not an algorithm. Standalone performance as described (algorithm only) is not relevant.

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

Cannot be provided. No study or ground truth establishment information is present.

8. The sample size for the training set

Cannot be provided. No study or training set information is present.

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

Cannot be provided. No study or training set information is present.

Summary of available information related to the device:

Device Modification Name: Lorenz Pectus Support Bar Stabilizer
Previously cleared 510(k) for base device: Lorenz Pectus Support Bar - 510(k) K972420
Classification Name and Reference: Plate, Fixation, Bone 87 HRS (CFR 888.3030)
Intended Use: For use during surgical procedures to repair Pectus Excavatum and other sternal deformities with Lorenz Pectus Support Bar (K972420) when additional stabilization is necessary.
Device Description: Two designs for single bar stabilization (elongated plate, triangular plate) and one design for two bars (triangular plate with two dovetail slots). All designs feature dovetail slots for the pectus bar(s) and holes for suturing to the lateral chest wall to prevent lateral movement and bar flipping.
Potential Risks: The same as the pectus support bar alone and any long-term metallic implant (e.g., metal sensitivity, pain, surgical trauma, skin irritation, infection, pneumothorax, fracture, migration, loosening, inadequate remodeling or return of deformity).
Regulatory Decision: Substantially equivalent to legally marketed predicate devices. The FDA clearance letter (K981789) indicates that the device can be marketed.

Conclusion: The provided document is a regulatory submission for device clearance, focusing on safety and effectiveness based on substantial equivalence to existing devices. It does not include data from a clinical or performance study that would answer the requested questions about acceptance criteria and study methodology.

Summary

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JUL 1 3 1998

98178

Summary of Safety and Effectiveness

Device Modification Name: Lorenz Pectus Support Bar Stabilizer

Name of previously cleared 510(k): Lorenz Pectus Support Bar - 510(k) K972420

Classification Name and Reference: Plate, Fixation, Bone 87 HRS (CFR 888.3030)

Intended use:

For use during surgical procedures to repair Pectus Excavatum and other sternal deformities with Lorenz Pectus Support Bar 510(k) number K972420 when additional stabilization is necessary.

Device Modification Description:

Potential Risks:

The potential risks associated with the stabilizer used in conjunction with the support bar are the same as with the pectus support bar alone and any long-term, metallic implant. These include but are not limited to the following;

Metal sensitivity reactions or allergic reaction to the implant material. ●
Pain, discomfort, or abnormal sensation due to the presence of the device. .
Surgical trauma; permanent or temporary nerve damage, permanent or temporary ● damage to heart, lungs, and other organs, body structures or tissues.
Skin irritation, infection, and pneumothorax. .
Fracture, breakage, migration, or loosening of the implant. ●
. Inadequate or incomplete remodeling of the deformity or return of deformity, proor to or after removal of implant.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

.111 1 3 1998

Ms. Diana Preston Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218-2480

Re: K981789

Trade Name: Lorenz Pectus Support Bar Stabilizer Regulatory Class: II Product Code: HRS Dated: May 19, 1998 Received: May 20, 1998

Dear Ms. Preston:

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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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 vour 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 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 1_ of _ 1

981789 510(k) Number (if known): unknown

Device Name: Lorenz Pectus Support Bar Stabilizer

Indications For Use: For use during surgical procedures to repair Pectus Excavatum and other sternal deformities with Lorenz Pectus Support Bar 510(k)number K972420 when additional stabilization is necessary.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(D
Sign-Off)
DIV General RecNO Devices
510(k) Number K9 81789

Prescription Use
(Per 21 CFR 801.109)
OR

Over-The-Counter Use__
(Optional Format 1-2-96)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number _

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.