INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL

K132620 · Pan Medical , Ltd. · NDN · Apr 16, 2014 · Orthopedic

Device Facts

• Record ID: K132620
• Device Name: INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
• Applicant: Pan Medical , Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Apr 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InterV Kyphoplasty Catheter is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).

Device Story

InterV Kyphoplasty Catheter is a single-use, double-lumen catheter with a low-profile, cylindrical polyurethane balloon at the distal tip. Used in balloon kyphoplasty procedures to compress cancellous bone or move cortical bone in the spine. Operated by physicians in a clinical setting. The device is inserted into the spine; the balloon is inflated with 60% contrast medium to create a void or reduce fractures. It withstands internal pressures up to 400 psi (27 ATM). Radiopaque marker bands on the inner tubing assist in positioning under fluoroscopic guidance. Following void creation, the balloon is deflated and removed, allowing for subsequent injection of cleared PMMA bone cement. The device facilitates fracture reduction and stabilization, potentially alleviating pain and restoring vertebral height.

Clinical Evidence

No clinical tests were conducted for this submission; bench testing only.

Technological Characteristics

Single-use double-lumen catheter; polyurethane balloon; stainless steel guide wire/stylet; radiopaque marker bands. Cylindrical balloon shape. Compatible with 8G (4.2mm) cannulas. Inflation medium: 60% contrast. Max pressure: 400 psi (27 ATM). Max volume: 4ml (10/15mm sizes) or 6ml (20mm size). Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring reduction and fixation of spinal fractures or creation of a void in cancellous bone during balloon kyphoplasty procedures using cleared 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

• Kyphon Inflatable Bone Tamp (K981251)
• Kyphx® Xpander Inflatable Bone Tamps (K041454)

Submission Summary (Full Text)

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APR 1 6 2014

K132620 - Page 1 of 3

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InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission

## Premarket Notification [510(k)] Summary

.

## SUBMITTER INFORMATION

| Manufacturer's Name: | Pan Medical Ltd |
|-----------------------------|-----------------------------------------------|
| Manufacturer's Address: | Barnett Way, Barnwood, Gloucester, GL4 3RT UK |
| Telephone (DDI): | [phone] |
| Fax: | [phone] |
| Establishment Registration: | 3005146147 |
| Contact Person: | · Jennie Budding (Director of R&D/Production) |
| Date Prepared: | 16-April-2014 |

### DEVICE INFORMATION

| Trade Name: | InterV Kyphoplasty Catheter |
|-------------------------------|---------------------------------------------------------------------------------------|
| Common Name: | Inflatable Bone Tamp |
| Device Class: | II |
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement<br>Arthroscope |
| Classification Panel: | Orthopedic Devices |
| Classification Regulation: | 21 CFR 888.3027<br>21 CFR 888.1100 |
| Product Code(s): | NDN<br>HRX |
| Predicate Device: | Kyphon Inflatable Bone Tamp, K981251<br>Kyphx® Xpander Inflatable Bone Tamps, K041454 |
| Reason for 510(k) submission: | New Device |

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Pan Medical Ltd.

InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission

Device Description:

InterV Kyphoplasty Catheter is designed for use in balloon kyphoplasty; it comes as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The balloon is designed to withstand bone resistance leading to an a internal pressure of up to 400 psi (27 ATM). The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component

Intended use:

InterV Kyphoplasty Catheter is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES

| Characteristic | New device | Predicate Device |
|------------------------------------------------------------|--------------------------------|---------------------------------------------------------------------------------------------|
| Trade name | InterV Kyphoplasty<br>catheter | Kyphon Inflatable Bone Tamp,<br>K981251<br>Kyphx® Xpander Inflatable Bone<br>Tamps, K041454 |
| Compatible Cannula Size | 8 G / 4.2 mm | 8 G / 4.2 mm |
| Balloon Inflation Medium | 60% Contrast | 60% Contrast |
| Balloon Material | Polyurethane | Polyurethane |
| Balloon Size (Deflated Length) | 10, 15 and 20 mm | 10, 15 and 20 mm |
| Guide wire (Stylet) | Stainless Steel | Stainless Steel |
| Balloon Shape | Cylindrical | Cylindrical |
| Maximum Recommended Inflation<br>Pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum Recommended Inflation<br>Volume (10 mm and 15 mm) | 4 ml | 4 ml |
| Maximum Recommended Inflation<br>Volume (20 mm) | 6 ml | 6 ml |

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InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission

| Characteristic | Test Method | Results Summary |
|----------------------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Inflation<br>pressure | Constrained Burst<br>Test | The balloon catheter exceeded the requirements for the<br>minimum burst pressure in a constrained environment |
| Inflation<br>Volume | Unconstrained Burst<br>Test | The balloon catheter exceeded the requirements for the<br>minimum burst volume in a constrained environment |
| Inflated Balloon<br>Dimensions | Balloon Inflation<br>Test | The inflated balloon dimensions were substantially<br>equivalent to those of the predicate devices |
| Balloon Double<br>Wall Thickness | Calibrated<br>Measurement | The double wall thickness of the balloons was substantially<br>equivalent to those of the predicate devices |

#### SUMMARY OF NON-CLINICAL TESTS

#### SUMMARY OF CLINICAL TESTS

N/A- No clinical tests were conducted for this submission

#### CONCLUSION DRAWN FROM NON-CLINICAL DATA

The results of the non-clinical tests show that the InterV Kyphoplasty Catheter meets or exceeds all performance requirements, and are substantially equivalent to the predicate devices.

.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 16, 2014

Pan Medical Ltd. Ms. Jennie Budding Director of R&D/Production Barnett Way, Barnwood Gloucester GL4 3RT United Kingdom

Re: K132620

Trade/Device Name: InterV Kyphoplasty Catheter Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: February 28, 2014 Received: March 4, 2014

Dear Ms. Budding:

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. 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 requirements, including, but not limited to: registration and listing

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#### Page 2 - Ms. Jennie Budding

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pan Medical Ltd.

InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission

## Indications for Use

510(k) Number (if known): K132620

Device Name: InterV Kyphoplasty Catheter

Indications for Use:

InterV Kyphoplasty Catheter is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132620

Indications For Use Statement