The TRACKER Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Description

The TRACKER Kyphoplasty System (KS) comprises the TRACKER-X, P (GSK System) and the TRACKER-I (GCD System). The TRACKER-X, P and the TRACKER-I System are packaged in their own containers and are then packaged together in a TRACKER Kyphoplasty System container. The TRACKER-I System is sold only as a System. The individual System Accessories are not sold separately. The GSK System consists of the TRACKER-P balloon expander and the TRACKER-X balloon catheter. The TRACKER-I is a cement dispenser kit intended for percutaneous access to bone and delivery of bone cement.

AI/ML Overview

The provided document is an FDA 510(k) summary for a medical device called the "TRACKER Kyphoplasty System." This document is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study where the device meets specific acceptance criteria in the context of diagnostic performance or clinical outcomes.

Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for an AI/diagnostic device is not applicable to this document.

This document describes a kyphoplasty system, which is a surgical tool used for reducing fractures and creating voids in bone, typically in kyphoplasty procedures. The "acceptance criteria" and "study" described here pertain to the engineering and material performance of the device, establishing its safety and effectiveness by demonstrating its equivalence to a predicate device.

Here's an breakdown of the device performance presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria	Reported Device Performance
Balloon Deflation	Not explicitly stated as a numerical criterion, but implied to meet functional requirements.	Functioned as intended; satisfactory results.
Burst Pressure	Not explicitly stated as a numerical criterion, but implied to meet functional requirements.	Functioned as intended; satisfactory results.
Fatigue Strength	Not explicitly stated as a numerical criterion, but implied to meet functional requirements.	Functioned as intended; satisfactory results.
Unconstrained Burst Strength	Not explicitly stated as a numerical criterion, but implied to meet functional requirements.	Functioned as intended; satisfactory results.
Inflated Dimension	Not explicitly stated as a numerical criterion, but implied to meet functional requirements.	Functioned as intended; satisfactory results.
Insertions and Withdrawal Force	Not explicitly stated as a numerical criterion, but implied to meet functional requirements.	Functioned as intended; satisfactory results.
Tensile Bond	Not explicitly stated as a numerical criterion, but implied to meet functional requirements.	Functioned as intended; satisfactory results.
Sterilization Validation	In accordance with ISO 11138-2, ISO 11135-1, ISO 1422.	Tests performed in accordance with standards.
Shelf Life Validation	Not explicitly stated as a numerical criterion, but validated for 3 years.	Test results validated 3-year shelf life (ASTM F 1980).
Biocompatibility	In accordance with ISO 10993-1, 5, 7, 10, 11 (includes in vitro cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogen tests).	All biocompatibility tests met endpoints required by ISO 10993.

2. Sample size used for the test set and the data provenance:
The document does not specify general "sample sizes" in terms of patient data. The tests performed are engineering and material tests on the device itself.

Data provenance: Not applicable in the context of patient data for a diagnostic study. The tests are laboratory-based and performed on the device components.

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. The "ground truth" for these tests relates to engineering specifications and international standards (e.g., ISO for sterilization and biocompatibility, ASTM for shelf life). Experts would be engineers and scientists overseeing and conducting these specific types of technical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for ambiguous diagnostic cases, not for objective engineering or material performance tests.

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 not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" is defined by established engineering standards and specifications (e.g., ISO standards for sterilization and biocompatibility, ASTM for shelf life). The device's performance is measured against these pre-defined technical criteria.

8. The sample size for the training set:
Not applicable. This is not an AI/diagnostic device, and therefore no "training set" in that context exists.

9. How the ground truth for the training set was established:
Not applicable.

Summary of the Study:

The "study" presented here is a series of non-clinical performance tests conducted on the TRACKER Kyphoplasty System to demonstrate its safety and effectiveness through substantial equivalence to a predicate device (MEDINAUT Kyphoplasty System K153296).

The tests covered:

Functional performance: Balloon Deflation, Burst Pressure, Fatigue Strength, Unconstrained Burst Strength, Inflated Dimension, Insertions and Withdrawal Force, Tensile Bond. For these, the document states "In all instances the device functioned as intended and all results were satisfactory and met all performance specifications."
Sterilization validation: Performed according to ISO 11138-2, ISO 11135-1, and ISO 1422.
Shelf life validation: Conducted per ASTM F 1980, validating a 3-year shelf life.
Biocompatibility testing: Performed according to ISO 10993-1, 5, 7, 10, 11, including tests for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity. All tests met required endpoints.

The conclusion is that the TRACKER Kyphoplasty System is as safe and effective as the predicate device because it shares the same intended uses, indications, technological characteristics, principles of operation, and its performance data are satisfactory against relevant engineering and biocompatibility standards.

Summary

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December 4, 2019

GS Medical Co., Ltd. % Barry Sands President ROMIS. Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01860

Re: K192335

Trade/Device Name: TRACKER Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone bement Regulatory Class: Class II Product Code: NDN, HRX Dated: November 6, 2019 Received: November 12, 2019

Dear Mr. Sands:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Laura Rose, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K192335

Device Name TRACKER Kyphoplasty System

Indications for Use (Describe)

The TRACKER Ky phoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

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

GS Medical 's TRACKER Kyphoplasty System 510k Submission

l. SUBMITTER

GS Medical Co. Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Cheongwon-gun Chungcheongbuk-do 363-951 Korea

Phone: 352.327.4641 Fax: 352.378.2617

Contact Person: Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 Phone: +1 (978) 358-7307 Fax: +1 (978) 477-0206

Date Prepared: 14 November 2019

II. DEVICE

Trade/Device Name:	TRACKER Kyphoplasty System
Common or Usual Name:	Inflatable Bone Tamp
Classification Name:	Orthopedics
Regulation Number:	21 CFR 888.3027
Regulatory Class:	Class II
Product codes	NDN, HRX

III. PREDICATE DEVICES

Primary Predicate Device Manufacturer FDA Number Medinaut Kyphoplasty System Imedicom Co. Ltd. K153296 Secondary Predicate FDA Number Device Manufacturer Medinaut Kyphoplasty System Imedicom Co. Ltd. K133669

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IV. DEVICE DESCRIPTION

Indications for Use:

Description:

The TRACKER-I System is sold only as a System. The individual System Accessories are not sold separately.

The GSK System consists of the TRACKER-P balloon expander and the TRACKER-X balloon catheter. The TRACKER-I is a cement dispenser kit intended for percutaneous access to bone and delivery of bone cement.

V. SUBSTANTIAL EQUIVALENCE

Technological Comparison

As explained in the 510(k) submission, the TRACKER Kyphoplasty System is substantially equivalent to other legally marketed inflatable bone tamps. Specifically, the TRACKER Kyphoplasty System is substantially equivalent to MEDINAUT Kyphoplasty System. As explained in more detail in the 510(k) submission, the TRACKER Kyphoplasty System has the same general intended use, indications, technological characteristics, and principles of operation as the previously cleared primary predicate MEDINAUT Kyphoplasty System (K153296). The TRACKER Kyphoplasty System also has the same general intended use, technological characteristics, and principles of operation as the previously cleared additional predicate MEDINAUT Kyphoplasty System (K133669).

Performance Comparison

In all instances the device functioned as intended and all results were satisfactory and met all performance specifications. The tests performed were:

Balloon Deflation ●
Burst Pressure
Fatigue Strength

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Unconstrained Burst Strength .
Inflated Dimension
Insertions and Withdrawal Force
Tensile Bond .

Comparison to the Predicate Device

	Subject Device	Predicate Device	Predicate Device
Device Name	TRACKER KyphoplastySystem	MEDINAUT KyphoplastySystem	MEDIANUT KyphoplastySystem
510k Number	-	K133669	K153296
Manufacturer	GS Medical Co., Ltd.	IMEDICOM Co., Ltd.	IMEDICOM Co., Ltd.
Product Code	HRX, NDN	HRX, NDN	HRX, NDN
Common Name	Inflatable Bone Tamp	Inflatable Bone Tamp	Inflatable Bone Tamp
Indications forUse	The TRACKERKyphoplasty System isintended to be used forthe reduction offracturesand/or creation of avoidin cancellous bone inthespine, tibia, radius, andcalcaneus. This includespercutaneous vertebralaugmentation. Thesystem is to be usedwithcleared spinalpolymethylmethacrylate(PMMA) bone cementsindicated for use duringpercutaneous vertebralaugmentation, such askyphoplasty.	The MEDINAUTKyphoplasty System isintended to be used forthe reduction of fractureand/or creation of a voidin cancellous bone in thespine. This includes useduring percutaneousvertebral augmentation.This system is tobe used with clearedspinalPolymethylmethacrylate(PMMA) bone cementsindicated for use duringpercutaneous vertebralaugmentationprocedures, such askyphoplasty.	The MEDINAUTKyphoplasty System isintended to be used forthe reduction of fracturesand/or creation of a voidin cancellous bone in thespine, tibia, radius, andcalcaneus. This includespercutaneous vertebralaugmentation. Thesystem is to be used withcleared spinalpolymethylmethacrylate(PMMA) bone cementsindicated for use duringpercutaneous vertebralaugmentation, such askyphoplasty.
Components	- Bone Catheter- Expander Syringe- Kit(Needle Pipe, NeedlePin,Expander, Cannula,Spacer, Guide Wire,Wire	- Bone Catheter- Expander Syringe- Kit(Needle Pipe, NeedlePin, Expander, Cannula,Spacer, Guide Wire,WirePin, Cement Pusher	Same as PrimaryPredicateDevice(K133669)
	Pin, Cement Pusher,Cement Filler, andGuidewire)	Cement Filler, and Guidewire)
Balloon Size	10mm, 15mm, 20mm	10mm, 15mm, 20mm	Same as PrimaryPredicateDevice(K133669)
Bone TampMax. InflationPressure	350 PSI	350 PSI	Same as PrimaryPredicateDevice(K133669)
Composition ofMaterial	ThermoplasticPolyurethanePlatinumPolycarbonate & ABSStainless Steel & ABS	ThermoplasticPolyurethanePlatinumPolycarbonate & ABSStainless Steel & ABS	Same as PrimaryPredicateDevice(K133669)
Packaging	Pouch, Tyvek BlisterTray,Cardboard Box	Pouch, Tyvek BlisterTray,Cardboard Box	Same as PrimaryPredicateDevice(K133669)
Biocompatibility	Meets ISO 10993	Meets ISO 10993	Same as PrimaryPredicateDevice(K133669)

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VI. NON-CLINICAL TESTING

Sterilization validation testing has been performed in accordance with ISO 11138-2 and ISO 11135-1 and ISO 1422.
The tests to validate the shelf life of the device were conducted and the test results validated 3-year shelf life. (ASTM F 1980)
Biocompatibility tests were performed in accordance with ISO 10993-1, 5, 7, 10, 11. . These tests included:
- O Test for in vitro cytotoxicity
- O Skin Sensitization test
- O Intracutaneous Reactivity test
- Acute Systemic Toxicity test o
- Pyrogen test o

All biocompatibility tests met endpoints required by ISO 10993.

VII. CONCLUSION

The TRACKER Kyphoplasty System is as safe and effective as the MEDINAUT Kyphoplasty System (K153296). The TRACKER Kyphoplasty System has the same intended uses and indications, technological characteristics, and principles of operation as its predicate device. Performance data demonstrate that the TRACKER Kyphoplasty System is as safe and effective

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as the MEDINAUT Kyphoplasty System. Thus, the TRACKER Kyphoplasty System is substantially equivalent.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”