TRACKER Kyphoplasty System

K192335 · GS Medical Co., Ltd. · NDN · Dec 4, 2019 · Orthopedic

Device Facts

• Record ID: K192335
• Device Name: TRACKER Kyphoplasty System
• Applicant: GS Medical Co., Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Dec 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

The TRACKER Kyphoplasty System is an inflatable bone tamp used for percutaneous vertebral augmentation and fracture reduction in the spine, tibia, radius, and calcaneus. The system consists of the TRACKER-P balloon expander, TRACKER-X balloon catheter, and the TRACKER-I cement dispenser kit. Operated by a physician in a clinical setting, the device is inserted percutaneously into the target bone. The balloon is inflated to create a void or reduce a fracture; the void is then filled with cleared spinal PMMA bone cement delivered via the cement dispenser kit. This procedure aims to stabilize fractures and restore bone structure. The device is provided sterile for single use.

Clinical Evidence

Bench testing only. Performance testing included balloon deflation, burst pressure, fatigue strength, unconstrained burst strength, inflated dimension, insertion/withdrawal force, and tensile bond. Biocompatibility testing conducted per ISO 10993-1, 5, 7, 10, 11. Sterilization validated per ISO 11138-2, ISO 11135-1, and ISO 1422. Shelf life validated to 3 years per ASTM F 1980.

Technological Characteristics

Inflatable bone tamp system. Materials: Thermoplastic Polyurethane, Platinum, Polycarbonate, ABS, Stainless Steel. Balloon sizes: 10mm, 15mm, 20mm. Max inflation pressure: 350 PSI. Sterilization: Ethylene Oxide (implied by ISO 11135). Biocompatibility: ISO 10993 compliant. Shelf life: 3 years (ASTM F 1980).

Indications for Use

Indicated for reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus, including percutaneous vertebral augmentation. Used with 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

• Medinaut Kyphoplasty System (K153296)
• Medinaut Kyphoplasty System (K133669)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]

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

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:

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 Device | Predicate Device | Predicate Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TRACKER Kyphoplasty<br>System | MEDINAUT Kyphoplasty<br>System | MEDIANUT Kyphoplasty<br>System |
| 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 for<br>Use | The TRACKER<br>Kyphoplasty System is<br>intended to be used for<br>the reduction of<br>fractures<br>and/or creation of a<br>void<br>in cancellous bone in<br>the<br>spine, tibia, radius, and<br>calcaneus. This includes<br>percutaneous vertebral<br>augmentation. The<br>system is to be used<br>with<br>cleared spinal<br>polymethylmethacrylate<br>(PMMA) bone cements<br>indicated for use during<br>percutaneous vertebral<br>augmentation, such as<br>kyphoplasty. | The MEDINAUT<br>Kyphoplasty System is<br>intended to be used for<br>the reduction of fracture<br>and/or creation of a void<br>in cancellous bone in the<br>spine. This includes use<br>during percutaneous<br>vertebral augmentation.<br>This system is to<br>be used with cleared<br>spinal<br>Polymethylmethacrylate<br>(PMMA) bone cements<br>indicated for use during<br>percutaneous vertebral<br>augmentation<br>procedures, such as<br>kyphoplasty. | The MEDINAUT<br>Kyphoplasty System is<br>intended to be used for<br>the reduction of fractures<br>and/or creation of a void<br>in 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 with<br>cleared spinal<br>polymethylmethacrylate<br>(PMMA) bone cements<br>indicated for use during<br>percutaneous vertebral<br>augmentation, such as<br>kyphoplasty. |
| Components | - Bone Catheter<br>- Expander Syringe<br>- Kit<br>(Needle Pipe, Needle<br>Pin,<br>Expander, Cannula,<br>Spacer, Guide Wire,<br>Wire | - Bone Catheter<br>- Expander Syringe<br>- Kit<br>(Needle Pipe, Needle<br>Pin, Expander, Cannula,<br>Spacer, Guide Wire,<br>Wire<br>Pin, Cement Pusher | Same as Primary<br>Predicate<br>Device(K133669) |
| | Pin, Cement Pusher,<br>Cement Filler, and<br>Guide<br>wire) | Cement Filler, and Guide<br>wire) | |
| Balloon Size | 10mm, 15mm, 20mm | 10mm, 15mm, 20mm | Same as Primary<br>Predicate<br>Device(K133669) |
| Bone Tamp<br>Max. Inflation<br>Pressure | 350 PSI | 350 PSI | Same as Primary<br>Predicate<br>Device(K133669) |
| 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 | Same as Primary<br>Predicate<br>Device(K133669) |
| Packaging | Pouch, Tyvek Blister<br>Tray,<br>Cardboard Box | Pouch, Tyvek Blister<br>Tray,<br>Cardboard Box | Same as Primary<br>Predicate<br>Device(K133669) |
| Biocompatibility | Meets ISO 10993 | Meets ISO 10993 | Same as Primary<br>Predicate<br>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.