Park's Pectus System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest. This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.

Park's Pectus System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.

AI/ML Overview

The provided text does not contain information about an AI device or a study proving its performance against acceptance criteria. It discusses the "Park's Pectus System," which is a medical device for correcting pectus excavatum, comprising pectus bars and stabilizers. The document is an FDA 510(k) premarket notification and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study against acceptance criteria typically associated with AI/software devices.

Therefore, many of the requested details, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set information, and ground truth establishment for an AI device, are not applicable to this document.

However, I can extract the acceptance criteria and performance information as presented for the Park's Pectus System in relation to its predicate device. This will be based on the substantial equivalence discussion.

Here's a summary of the information available in the document, framed as acceptance criteria and reported performance in the context of substantial equivalence to a predicate device:

Acceptance Criteria and Reported Device Performance (Park's Pectus System vs. Predicate Device)

The "acceptance criteria" for the Park's Pectus System, as presented in this 510(k) summary, are its features and performance demonstrating substantial equivalence to the predicate device, Lorenz Pectus Support Bar System (K061384), and reference devices (TDM Plate and Screw System K171808/K190391).

Acceptance Criteria (Comparison to Predicate)	Reported Device Performance (Park's Pectus System)	Conclusion on Equivalence
Indication for Use: Intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.	Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities. (Identical to predicate)	Substantial Equivalence
Indication: Congenital deformity of the sternum and anterior chest wall.	Congenital deformity of the sternum and anterior chest wall. (Identical to predicate)	Substantial Equivalence
Contraindications: - Patients with mental/neurological conditions unwilling/incapable of following instructions. - Patients with metal sensitivity reactions. - Patients with insufficient quantity or quality of bone/fibrous tissue. - Infection.	- Patients with mental or neurological conditions who are unwilling or incapable of following instructions. - Patients presenting metal sensitivity reactions. - Patients with insufficient quantity or quality of bone or fibrous tissue to allow remodeling. - Infection. (Identical to predicate)	Substantial Equivalence
Raw Material: Titanium Alloy (ASTM F136), Stainless Steel (ASTM F138 & ASTM F139).	Titanium Alloy (ASTM F136), Stainless Steel (ASTM F138 & ASTM F139). (Identical or comparable to predicate; predicate lists ASTM F138). Materials are also identical to cleared TDM plate and screw systems (K171808/K190391).	Substantial Equivalence
Features (Key aspects): Rounded ends/blunt edges for minimal tissue destruction, variety of lengths (7-17 inches for predicate), instruments for Nuss Procedure simplicity, container size, specialized bars for nickel allergies, special/pre-bent bars.	- Rounded ends and blunt edges to minimize tissue destruction. - Variety of lengths (6-17 inches). - Instruments designed for Nuss Procedure simplicity. - Container in two sizes. - Specialized titanium bars/stabilizers for nickel allergies. - Includes special sized and pre-bent bars based on CT scans. (Comparable to predicate; Pectus Bar length range slightly different: 6-17 inch vs. 7-17 inch for predicate).	Substantial Equivalence (differences in length range considered acceptable based on overall equivalence and testing)
Surgical Procedure: MIRPE (Minimally Invasive Repair of Pectus Excavatum).	MIRPE (Minimally Invasive Repair of Pectus Excavatum). (Identical to predicate)	Substantial Equivalence
Single Use: Yes.	Yes. (Identical to predicate)	Substantial Equivalence
Non-Sterile Packaging: Yes.	Yes. (Identical to predicate)	Substantial Equivalence
Target Population: Patients with congenital deformity of the sternum and anterior chest wall.	Patients with congenital deformity of the sternum and anterior chest wall. (Identical to predicate)	Substantial Equivalence
Anatomical Site: Sternum and anterior chest wall.	Sternum and anterior chest wall. (Identical to predicate)	Substantial Equivalence
Location of Use: Use only by professional orthopedists.	Use only by professional orthopedists. (Identical to predicate)	Substantial Equivalence
Biocompatibility: All user-directly contacting materials comply with ISO10993 requirements.	All user directly contacting materials are compliance with ISO10993 requirements. Additionally, materials are identical to previously cleared TDM plate and screw systems (K171808/K190391) and literature review shows no conclusive evidence of carcinogenesis for these materials.	Substantial Equivalence
Mechanical Performance: Equivalent mechanical properties to predicate for relevant tests (e.g., 4-point bending, fatigue, vertical tensile) based on worst-case scenarios.	Non-clinical performance tests (4-point bending, 4-point bending fatigue, vertical tensile) were performed. The selection rationale was based on the worst-case scenario (longest and thinnest bar: 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick). Both stainless and titanium bars, and both rounded and serrated end bars were tested. Tests demonstrate comparable performance to the predicate device.	Substantial Equivalence (tests comparing performance to predicate were conducted and demonstrated comparable results, supporting substantial equivalence)

Study Information (Non-AI device context):

Sample size used for the test set and the data provenance:
- Test set: The document refers to "worst case scenario" samples for mechanical testing: a pectus bar with dimensions of 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick. Both stainless and titanium pectus bars were tested, as were pectus bars with rounded and serrated ends.
- Data provenance: Not explicitly stated, but these were non-clinical, in-vitro tests conducted by the manufacturer (TDM Co. Ltd.) to compare its device against the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/diagnostic software. The "ground truth" for non-clinical performance refers to established engineering standards (e.g., ASTM F382-14) and direct comparison to the predicate device under specific test conditions.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study involving human readers or interpretation.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For material properties and biocompatibility: Compliance with ISO10993 requirements, use of well-established medical-grade materials (ASTM F136, ASTM F138 & F139), and equivalence to previously cleared devices (K171808/K190391).
- For mechanical performance: Comparison to a legally marketed predicate device (Lorenz Pectus Support Bar System, K061384) under specific ASTM-standardized mechanical tests (ASTM F382-14 for metallic bone plates). The "ground truth" is that the new device performs comparably to the predicate under these conditions.
The sample size for the training set:
- Not applicable. This is not an AI device, so there is no training set in the AI sense.
How the ground truth for the training set was established:
- Not applicable.

Summary

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March 19, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.

TDM Co. Ltd. % Dave Kim Medical Device Regulatory Affairs Dave Kim 1830 Buffalo Speedway Houston, Texas 77025

Re: K191057

Trade/Device Name: Park's Pectus 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: April 10, 2019 Received: April 22, 2019

Dear Dave Kim:

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,

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) K191057

Device Name Park's Pectus System

Indications for Use (Describe)

Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities

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 K191057

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92

Date: 2/17/2020

1. 510K Applicant / Submitter:

TDM CO., LTD. 69, Cheomdan venture so-ro 37beon-gil, Buk-gu, Gwangju, 61003, REPUBLIC OF KOREA Tel: +82-62-971-7460 Fax: +82-62-971-7461 Establishment registration number: 3014257776

2. Submission Contact Person

Dave Kim, MBA Mtech Group 7707 Fannin St. Ste 200. V111 Houston, TX 77054 Phone: 713-467-2607 Email: davekim@mtech-inc.net

3. Device

- Trade / Device Name :	Park's Pectus System
-------------------------	----------------------

-. Common Name : Pectus Excavatum System
-. Classification Name : Plate, Fixation, Bone
-. Regulation Number : 21 CFR 888.3030
-. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
-. Regulatory Class : II
-. Product Code : HRS

4. Primary predicate Device

-. Trade / Device Name : Lorenz Pectus Support Bar System
II
-. 510(k) Number : K061384
-. Regulation Number : 21 CFR 888.3030
-. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
-. Regulatory Class :
-. Product Code : HRS

5. Reference Device

5.1 Reference Device #01

-. Trade / Device Name :	TDM Plate and Screw System
-. 510(k) Number :	K171808
-. Regulation Number :	21 CFR 888.3030

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-. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
-. Regulatory Class :
-. Product Code : HRS. HWC

5.2 Reference Device #02

-. Trade / Device Name : TDM Plate and Screw System
II
-. 510(k) Number : K190391
-. Regulation Number : 21 CFR 888.3030
-. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
-. Regulatory Class : II
-. Product Code : HRS. HWC

6. Description:

7. Indications for Use

Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.

8. Substantial Equivalence Discussion:

The Park's Pectus System is substantially equivalent to Lorenz Pectus Support Bar System (K061384). The following comparison table is presented to demonstrate substantial equivalence.

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Park's Pectus System and the primary predicate device[Lorenz Pectus Support Bar System (K061384)] have identical indication for use statements and the same intended use.

The device specifications and materials are equal to the primary predicate device/Lorenz Pectus Support Bar System (K061384)] in all parameters.

The materials and sterilization method for Parks Pectus System including class I and class II accessories are identical to TDM plate and screw systems cleared by FDA (K190391)

Therefore, the Park's Pectus System is substantially equivalent to the primary predicate device[Lorenz Pectus Support Bar System (K061384)].

9. Performance Tests (Non-clinical)

Non-clinical performance tests, including 4-point bending test, 4-point bending fatigue test, vertical tensile test, were performed by comparing Park's pectus system with Lorenz pectus support bar system (K061384). The selection rationale of the test sample was based on the worst case scenario, a pectus bar with the longest and thinnest in size. All Park's pectus bar has the same width. The size of Park's pectus bars tested are 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick. For material, both stainless and titanium pectus bars were tested. Pectus bars with both rounded end and serrated end were also tested. Other accessories (fixator driver, applier, bar removal bender, clamp, flipper, table top bender, easy crane system, flare compressor, and fixator container) were not considered in this test since there have been well established safety and effectiveness history for class I stainless and titanium surgical instruments.

-. ASTM F382-14 Standard Specification and Test Method for Metallic Bone Plates

10. Biocompatibility Tests

The materials for Parks Pectus System including class I accessories are identical to TDM plate and screw systems (K171808/K190391) cleared by FDA.

ASTM F138 & ASTM F139 stainless steel, the same materials used for Park's Pectus Bar System. have been raised in literature; no studies have conclusive evidence that metal wear debris or metal ions are carcinogenic.

"The [Titanium Alloy(ASTM F136)] of Park's Pectus Bar in its final finished form is identical to the [Titanium Alloy(ASTM F136)] of the [TDM Plate And Screw System (K171808/ K190391) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."

" Park's Pectus Bar in its final finished form is identical to [TDM Plate And Screw System (K171808/K190391) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold release agents)."

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11. Summary of Clinical Tests

Clinical testing was not required to demonstrate the substantial equivalence of the Park's Pectus System to its primary predicate device.

12. Conclusions:

Based on the information provided in this premarket notification, TDM CO., LTD. concludes that the Park's Pectus System is substantially equivalent to the primary predicate as described herein.

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.

	Candidate Device	Primary predicate	SubstantialEquivalenceAnalysis
510(k) Number	K191057	K061384	-
Device Name	Park's Pectus System	Lorenz Pectus Support Bar System	-
Common Name	Single/multiple componentmetallic bone fixation appliancesand accessories	Single/multiple componentmetallic bone fixation appliancesand accessories	-
Manufacturer	TDM CO., LTD. (Korea)	Biomet Microfixation Inc. (USA)	-
Indication forUse	Park's Pectus System is intendedfor use in surgical procedures torepair Pectus Excavatum and otheranterior chest wall deformities.	This device is intended for use insurgical procedures to repairPectus Excavatum and other chestwall deformities.	SubstantialEquivalence
Indication	Congenital deformity of thesternum and anterior chest wall	Congenital deformity of thesternum and anterior chest wall	SubstantialEquivalence
Contraindication	- Patients with mental orneurological conditions who areunwilling or incapable of followinginstructions.- Patients presenting metalsensitivity reactions.	- Patients with mental orneurological conditions who areunwilling or incapable of followinginstructions.- Patients presenting metalsensitivity reactions.	SubstantialEquivalence

	- Patients with insufficient quantityor quality of bone or fibrous tissueto allow remodeling.- Infection	- Patients with insufficient quantityor quality of bone or fibrous tissueto allow remodeling.- Infection
Raw Material	Titanium Alloy (ASTM F136)Stainless Steel (ASTM F138 &ASTM F139)	Titanium Alloy (ASTM F136)Stainless Steel (ASTM F138)	SubstantialEquivalence
Feature	- The Pectus Bar's rounded endsand blunt edges help minimizetissue destruction during implantinsertion.- The Pectus Bar comes in a varietyof lengths ranging from 6 inches to17 inches to accommodate mostPectus Excavatum correctionprocedures- All instruments in the PectusSystem are designed to increasesimplicity during the NussProcedure.- The Pectus System Containercomes in two sizes andconveniently houses the entirerange of Pectus implants andinstruments- Specialized titanium bars andstabilizers available for patientswith nickel allergies- Pectus-size bars available for thefollowing:① Special sized bars② Pre-bent bars developed inaccordance with patients' CT scans	- The Pectus Bar's rounded endsand blunt edges help minimizetissue destruction during implantinsertion.- The Pectus Bar comes in a varietyof lengths ranging from 7 inches to17 inches to accommodate mostPectus Excavatum correctionprocedures.- All instruments in the PectusSystem are designed to increasesimplicity during the NussProcedure.- The Pectus System Containercomes in two sizes andconveniently houses the entirerange of Pectus implants andinstruments- Specialized titanium bars andstabilizers available for patientswith nickel allergies- Pectus-size bars available for thefollowing:① Special sized bars② Pre-bent bars developed inaccordance with patients' CT scans	SubstantialEquivalence
SurgicalProcedure	MIRPE(Minimally Invasive Repair ofPectus Excavatum)	MIRPE(Minimally Invasive Repair ofPectus Excavatum)	SubstantialEquivalence
Pectus BarLength	6 inch ~ 17 inch	7 inch ~ 17 inch	SubstantialEquivalence
Single use	Yes	Yes	SubstantialEquivalence
Non-SterilePackaging	Yes	Yes	SubstantialEquivalence
TargetPopulation	Patients with congenital deformityof the sternum and anterior chestwall	Patients with congenital deformityof the sternum and anterior chestwall	SubstantialEquivalence
Anatomical Site	Sternum and anterior chest wall	Sternum and anterior chest wall	SubstantialEquivalence
Location of Use	Use only by professionalorthopedists	Use only by professionalorthopedists	SubstantialEquivalence
Bio-compatibility	All user directly contactingmaterials are compliance withISO10993 requirements.	All user directly contactingmaterials are compliance withISO10993 requirements.	SubstantialEquivalence