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K Number
K192335
Device Name
TRACKER Kyphoplasty System
Manufacturer
GS Medical Co., Ltd.
Date Cleared
2019-12-04

(98 days)

Product Code
NDNHRX
Regulation Number
888.3027
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

K153296, K133669

K153296, K133669

No
The document describes a mechanical system for kyphoplasty and does not mention any AI or ML components or functionalities.

Yes
The device is intended for the reduction of fractures and/or creation of a void in cancellous bone and uses bone cement, which are therapeutic interventions.

No

The device is described as a "Kyphoplasty System" intended for the "reduction of fractures and/or creation of a void in cancellous bone" and for "delivery of bone cement," which are therapeutic and interventional functions, not diagnostic ones.

No

The device description explicitly lists physical components like balloon expanders, balloon catheters, and a cement dispenser kit, indicating it is a hardware-based system.

Based on the provided information, the TRACKER Kyphoplasty System is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes a surgical procedure performed in vivo (within the body) to treat bone fractures. It involves physical manipulation of bone and delivery of bone cement.
  • Device Description: The device components are instruments used for this surgical procedure (balloon expanders, catheters, cement dispenser).
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.

IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. The TRACKER Kyphoplasty System is a surgical device used directly on the patient's body.

N/A

Intended Use / Indications for Use

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.

Product codes

NDN, HRX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

spine, tibia, radius, and calcaneus

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The tests performed were:

  • Balloon Deflation
  • Burst Pressure
  • Fatigue Strength
  • Unconstrained Burst Strength
  • Inflated Dimension
  • Insertions and Withdrawal Force
  • Tensile Bond

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

Key Metrics

Not Found

Predicate Device(s)

K153296, K133669

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.”

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".

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

1

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 codesNDN, 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:

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.

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.

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 DevicePredicate DevicePredicate Device
Device NameTRACKER Kyphoplasty
SystemMEDINAUT Kyphoplasty
SystemMEDIANUT Kyphoplasty
System
510k Number-K133669K153296
ManufacturerGS Medical Co., Ltd.IMEDICOM Co., Ltd.IMEDICOM Co., Ltd.
Product CodeHRX, NDNHRX, NDNHRX, NDN
Common NameInflatable Bone TampInflatable Bone TampInflatable Bone Tamp
Indications for
UseThe 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
percutaneous vertebral
augmentation. The
system is to be used
with
cleared spinal
polymethylmethacrylate
(PMMA) bone cements
indicated for use during
percutaneous vertebral
augmentation, such as
kyphoplasty.The MEDINAUT
Kyphoplasty System is
intended to be used for
the reduction of fracture
and/or creation of a void
in cancellous bone in the
spine. 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
procedures, such as
kyphoplasty.The MEDINAUT
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
percutaneous vertebral
augmentation. The
system is to be used with
cleared spinal
polymethylmethacrylate
(PMMA) bone cements
indicated for use during
percutaneous vertebral
augmentation, such as
kyphoplasty.
Components- Bone Catheter
  • Expander Syringe
  • Kit
    (Needle Pipe, Needle
    Pin,
    Expander, Cannula,
    Spacer, Guide Wire,
    Wire | - Bone Catheter
  • Expander Syringe
  • Kit
    (Needle Pipe, Needle
    Pin, Expander, Cannula,
    Spacer, Guide Wire,
    Wire
    Pin, Cement Pusher | Same as Primary
    Predicate
    Device(K133669) |
    | | Pin, Cement Pusher,
    Cement Filler, and
    Guide
    wire) | Cement Filler, and Guide
    wire) | |
    | Balloon Size | 10mm, 15mm, 20mm | 10mm, 15mm, 20mm | Same as Primary
    Predicate
    Device(K133669) |
    | Bone Tamp
    Max. Inflation
    Pressure | 350 PSI | 350 PSI | Same as Primary
    Predicate
    Device(K133669) |
    | Composition of
    Material | Thermoplastic
    Polyurethane
    Platinum
    Polycarbonate & ABS
    Stainless Steel & ABS | Thermoplastic
    Polyurethane
    Platinum
    Polycarbonate & ABS
    Stainless Steel & ABS | Same as Primary
    Predicate
    Device(K133669) |
    | Packaging | Pouch, Tyvek Blister
    Tray,
    Cardboard Box | Pouch, Tyvek Blister
    Tray,
    Cardboard Box | Same as Primary
    Predicate
    Device(K133669) |
    | Biocompatibility | Meets ISO 10993 | Meets ISO 10993 | Same as Primary
    Predicate
    Device(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.