TRACKER Plus Kyphoplasty System

K211797 · GS Medical Co., Ltd. · NDN · Oct 28, 2021 · Orthopedic

Device Facts

• Record ID: K211797
• Device Name: TRACKER Plus Kyphoplasty System
• Applicant: GS Medical Co., Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Oct 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRACKER Plus 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, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Story

The TRACKER Plus Kyphoplasty System is an inflatable bone tamp used for percutaneous vertebral augmentation and fracture reduction in cancellous bone. The system comprises a balloon catheter, cement dispenser kit, and cement mixing system. During a procedure, the balloon catheter is inserted into the target bone; the balloon is inflated to create a void or reduce a fracture; the balloon is then deflated and removed. Cleared PMMA bone cement is subsequently injected into the created void using the dispenser and mixing components. The device is operated by clinicians in a surgical or clinical setting. The output is a physical void in the bone and subsequent stabilization via cement, which aids in fracture reduction and pain management. The device is a mechanical tool; it does not involve electronic processing or software-based decision support.

Clinical Evidence

Bench testing only. Performance testing conducted per ISO 10555-4 to evaluate balloon deflation, burst pressure, fatigue strength, unconstrained burst strength, inflated dimension, tensile bond strength, and insertion/withdrawal force. All results met performance specifications.

Technological Characteristics

Materials: Thermoplastic Polyurethane, Platinum, Polycarbonate, ABS, Stainless Steel, Nitinol. Sensing/Actuation: Mechanical balloon inflation (max 350 PSI). Dimensions: 10mm, 15mm, 20mm balloon sizes. Sterilization: Ethylene Oxide (EO). Biocompatibility: Meets ISO 10993. Connectivity: None (mechanical device).

Indications for Use

Indicated for reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, and calcaneus, including percutaneous vertebral augmentation, using cleared spinal PMMA bone cements.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• TRACKER Kyphoplasty System (K192335)
• 11G InterV Kyphoplasty Catheter (Flex) (K162453)

Submission Summary (Full Text)

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October 28, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

GS Medical Co. Ltd. % Barry E. Sands Founder and President RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury, Massachusetts 01913

Re: K211797

Trade/Device Name: TRACKER Plus Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: September 23, 2021 Received: September 24, 2021

Dear Barry 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

Device Name

TRACKER Plus Kyphoplasty System

#### Indications for Use (Describe)

The TRACKER Plus 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, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethacrylate (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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!"

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (6/20)

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PSC Pishlishing Services [phone] EF

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## 510(k) SUMMARY

GS Medical 's TRACKER Plus Kyphoplasty System 510k Submission

## I. SUBMITTER

GS Medical Co. Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu, Cheongju-si Chungcheongbuk-do 28161 Korea Phone: [phone] Fax: [phone]

#### Contact Person:

Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 Phone: [phone] Fax: [phone]

Date Prepared: September 23, 2021

## II. DEVICE

Trade/Device Name: TRACKER Plus 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

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## III. PREDICATE DEVICES

| Device | Predicate | Regulation | Product<br>Code | Manufacturer | 510(k)<br>Number |
|----------------------------------------------|-----------|--------------------|-----------------|------------------------|------------------|
| TRACKER<br>Kyphoplasty<br>System | Primary | 21 CFR<br>888.3027 | NDN, HRX | GS Medical Co.<br>Ltd. | K192335 |
| 11G InterV<br>Kyphoplasty<br>Catheter (Flex) | Secondary | 21 CFR<br>888.3027 | NDN, HRX | Pan Medical Ltd. | K162453 |

# IV. DEVICE DESCRIPTION

The TRACKER Plus 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. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The TRACKER Plus Kyphoplasty System consists of the balloon catheter, cement dispenser kit, and cement mixing system. The cement dispenser kit and the cement mixing system are intended to be used with the balloon catheter, but are sold separately.

# V. SUBSTANTIAL EQUIVALENCE

# Technological Comparison

The TRACKER Plus Kyphoplasty System is substantially equivalent to other legally marketed inflatable bone tamps. Specifically, the TRACKER Plus Kyphoplasty System is substantially equivalent to TRACKER Kyphoplasty System. The TRACKER Plus Kyphoplasty System has the same general intended use and indications for use and has only minor differences in technological characteristics and principles of operation as the previously cleared primary predicate TRACKER Kyphoplasty System (K192335). The TRACKER Plus Kyphoplasty System also has the same general intended use, technological characteristics, and principles of operation as the previously cleared secondary predicate 11G InterV Kyphoplasty Catheter (Flex) (K162453).

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# 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
- Unconstrained Burst Strength
- Inflated Dimension
- •Tensile bond strength test
- •Insertion and withdrawal force test

# Comparison to the Predicate Device

| | Subject Device | Primary Predicate<br>Device | Secondary Predicate<br>Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TRACKER Plus<br>Kyphoplasty System | TRACKER Kyphoplasty<br>System | 11G InterV Kyphoplasty<br>Catheter (Flex) |
| 510k Number | - | K192335 | K162453 |
| Manufacturer | GS MEDICAL Co., Ltd. | GS MEDICAL Co., Ltd. | Pan Medical Ltd. |
| Product Code | HRX, NDN | HRX, NDN | HRX, NDN |
| Common Name | Inflatable Bone Tamp | Inflatable Bone Tamp | Inflatable Bone Tamp |
| Indication for<br>use | The TRACKER Plus<br>Kyphoplasty System is<br>intended to be used for<br>the reduction of<br>fractures and/or<br>creation of a void in<br>cancellous bone in the<br>spine, tibia, radius, and<br>calcaneus. This includes<br>percutaneous vertebral<br>augmentation. The<br>system is to be used<br>with cleared spinal<br> | The TRACKER<br>Kyphoplasty System is<br>intended to be used for<br>the reduction of<br>fractures and/or<br>creation of a void in<br>cancellous bone in the<br>spine, tibia, radius, and<br>calcaneus. This includes<br>percutaneous vertebral<br>augmentation. The<br>system is to be used<br>with cleared spinal<br>polymethylmethacrylat<br>e (PMMA) bone<br>cements indicated for<br>use during<br>percutaneous vertebral<br>augmentation, such as<br>kyphoplasty. | 8G InterV Kyphoplasty<br>Catheter, 11G InterV<br>Kyphoplasty Catheter<br>(Mini), 13G InterV<br>Kyphoplasty Catheter<br>(Micro) and 11G InterV<br>Kyphoplasty Catheter<br>(Flex) are intended to<br>be used for reduction<br>and fixation of<br>fractures and/or<br>creation of a void in<br>cancellous bone in the<br>spine during balloon<br>kyphoplasty (for use<br>with cleared spinal<br>polymethylmethacrylat<br>e (PMMA) bone<br>cements). |
| Components | - Bone Catheter<br>- Expander Syringe<br>- Kit<br>(Needle Pipe, Needle<br>Pin, Expander, Cannula,<br>Spacer, Guide Wire,<br>Wire Pin, Cement<br>Pusher, Cement Filler,<br>and Guide wire) | - Bone Catheter<br>- Expander Syringe<br>- Kit<br>(Needle Pipe, Needle<br>Pin, Expander, Cannula,<br>Spacer, Guide Wire,<br>Wire Pin, Cement<br>Pusher, Cement Filler,<br>and Guide wire) | - Balloon Catheter |
| Balloon Size | 10mm, 15mm, 20mm | 10mm, 15mm, 20mm | 20mm |
| Bone Tamp<br>Max. Inflation<br>Pressure | 350 PSI | 350 PSI | 400 PSI |

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| Composition of<br>Material | Thermoplastic<br>Polyurethane<br>Platinum<br>Polycarbonate & ABS<br>Stainless Steel & ABS | Thermoplastic<br>Polyurethane<br>Platinum<br>Polycarbonate & ABS<br>Stainless Steel & ABS | Balloon Material:<br>Polyurethan |
|----------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------|
| Guide Wire<br>Material | Stainless Steel, Nitinol | Stainless Steel | Nitinol |
| Packaging | Pouch, Tyvek Blister<br>Tray,<br>Cardboard Box | Pouch, Tyvek Blister<br>Tray,<br>Cardboard Box | Pouch,<br>Cardboard Box |
| Sterilization | EO Sterilization | EO Sterilization | EO Sterilization |
| Biocompatibility | Meets ISO 10993 | Meets ISO 10993 | Meets ISO 10993 |

# VI. NON-CLINICAL TESTING

The performance test was conducted using Tracker Plus Balloon Catheter to evaluate balloon deflation, burst pressure, fatigue strength, unconstrained burst strength, and inflated dimension as per "ISO 10555-4: Intravascular catheters – Sterile and Single use catheters – Part 4: Balloon dilation catheters."

# VII. CONCLUSION

The TRACKER Plus Kyphoplasty System is as safe and effective as the TRACKER Kyphoplasty System (Primary Predicate, K192335) and 11G InterV Kyphoplasty Catheter (Flex) (K162453). The TRACKER Kyphoplasty System has the same intended uses and indications for use and has only minor differences in technological characteristics and principles of operation as the previously cleared primary predicate. The TRACKER Plus Kyphoplasty System also has the same general intended use, technological characteristics, and principles of operation as the previously cleared secondary predicate. The technological differences between the subject device and the predicates do not raise new questions of safety and effectiveness. Performance data demonstrate that the TRACKER Plus Kyphoplasty System is as safe and effective as the primary and secondary predicate. Thus, the TRACKER Kyphoplasty System is substantially equivalent to predicate devices.