InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)

K150322 · Pan Medical , Ltd. · NDN · Mar 6, 2015 · Orthopedic

Device Facts

• Record ID: K150322
• Device Name: InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
• Applicant: Pan Medical , Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Mar 6, 2015
• Decision: SESE
• Submission Type: Special
• 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

Single-use double-lumen catheter with distal inflatable balloon; used in balloon kyphoplasty to compress cancellous bone or move cortical bone to create void for PMMA bone cement. Operated by physicians in clinical settings. Device includes radiopaque marker bands for visualization. Inflation via external device using contrast medium. Modifications include increased inflation pressure (up to 50 ATM) and smaller shaft diameter (6 Fr) for 'Mini' version. Benefits include fracture reduction and stabilization.

Clinical Evidence

No clinical tests were conducted for this submission; substantial equivalence is supported by bench testing.

Technological Characteristics

Single-use double-lumen catheter; polyurethane balloon; stainless steel guide wire/stylet. Dimensions: 30 cm overall length, 22 cm effective length. Shaft diameters: 6 Fr and 8 Fr. Max inflation pressure: 50 ATM (750 psi). Sterilization: Ethylene Oxide (EtO). Shelf life: 3 years.

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.

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

• InterV Kyphoplasty Catheter (K132620)

Submission Summary (Full Text)

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

March 6, 2015

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

Re: K150322

Trade/Device Name: InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini) Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, HRX Dated: February 6, 2015 Received: February 9, 2015

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

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# Indications for Use

510(k) Number (if known): K150322

Device Name: InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini)

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)

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# Special [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: | 06-Febraury-2015 |

## DEVICE INFORMATION

| Trade Name: | InterV Kyphoplasty Catheter & InterV Kyphoplasty Catheter (Mini) |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Identification of the<br>unmodified legally marketed<br>device: | InterV Kyphoplasty Catheter cleared under 510(k) Number K132620 |
| Device Description: | Both the unmodified predicate and the subject modified InterV<br>Kyphoplasty Catheter are designed for use in balloon kyphoplasty;<br>they come as a single-use double lumen catheter with a low profile<br>balloon mounted on the distal tip. The balloon is designed to compress<br>cancellous bone and/or move cortical bone as it inflates. The key<br>components are the balloon, shaft, Y-connector and two radiopaque<br>marker bands positioned on the inner tubing/lumen at the<br>proximal and distal ends of the inflatable component. |

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Both the unmodified predicate and the subject modified InterV Intended use: Kyphoplasty Catheter are 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 COMPARISON OF TECHNICAL ATTRIBUTES OF THE MODIFIED INTERV KYPHOPLASTY CATHETER TO ITS LEGALLY MARKETED PREDICATE (K132620)

| TECHNOLOGICAL CHARACTERISTICS | INTERV KYPHOPLASTY<br>CATHETER CLEARED UNDER<br>K132620;<br>MANUFACTURED BY PAN<br>MEDICAL LTD .;<br>INTV-10, INTV-15 AND INTV-20 | PROPOSED MODIFIED INTERV<br>KYPHOPLASTY CATHETER;<br>MANUFACTURED BY PAN<br>MEDICAL LTD .;<br>INTV-10, INTV-15; INTV-20;<br>INTVMN-10, INTVMN-15 AND<br>INTVMN-20 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Balloon Length (Deflated) | 10, 15 and 20 mm | 10, 15 and 20 mm |
| Maximum Recommended Inflation<br>Volume | 10 mm balloon: 4 ml<br>15 mm balloon:4 ml<br>20 mm balloon: 6 ml | 10 mm balloon: 4 ml<br>15 mm balloon:4 ml<br>20 mm balloon: 6 ml |
| Maximum Recommended Inflation<br>Pressure | 27 ATM (400 psi) | 50 ATM (750 psi) |
| Shaft Diameter | 8 Fr | 8 Fr & 6 Fr |
| Compatible Cannula Size | 4.2 mm | 4.2 mm & 3 mm |
| Overall Length of the Catheter | 30 cm | 30 cm |
| Effective Length of the Catheter | 22 cm | 22 cm |
| Balloon Shape | Cylindrical | Cylindrical |
| Balloon Material | Polyurethane | Polyurethane |
| Guide wire (Stylet) Material | Stainless Steel | Stainless Steel |
| Balloon Inflation Medium | 60% Contrast | 60% Contrast |
| Sterilitv | Delivered sterile (EtO) | Delivered sterile (EtO) |
| Shelf Life | 3 years from the date of<br>Sterilization | 3 years from the date of<br>Sterilization |

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### ACCESSORIES KIT

Bone access tools (Bone access needle, Kirschner wire, Bone access drill, Curette, Bone access cannula); Cement delivery tools (Cement delivery cannula, Cement dispenser) and Inflation device

## SUMMARY OF NON-CLINICAL TESTS

Verification activities including mechanical and functional testing as required by the risk analysis for the modifications were performed to confirm that the subject device functions as intended and does not raise any new issues of safety or effectiveness. The results from the testing demonstrated that the predetermined acceptance criteria were met and the device does not raise any new issues of safety or effectiveness.

#### SUMMARY OF CLINICAL TESTS

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

### CONCLUSION

As the predicate and the subject modified InterV Kyphoplasty Catheter

- have the same indications for use,
- . incorporate the same materials.
- use the same operating principle, ●
- have the same shelf life and ●
- are packaged and sterilised using the same materials and processes

And based on the results from risk analysis associated verification testing, we believe that the subject modified InterV Kyphoplasty Catheter is substantially equivalent to the currently marketed predicate InterV Kyphoplasty Catheter.