PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON

K122503 · Neuro Therm, Inc. · NDN · Jun 25, 2013 · Orthopedic

Device Facts

• Record ID: K122503
• Device Name: PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
• Applicant: Neuro Therm, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Jun 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Story

The NeuroTherm Parallax Balloon Inflatable Bone Tamp is a surgical instrument used during percutaneous vertebral augmentation. It consists of a double-lumen catheter shaft with an inflatable balloon at the distal end and a central lumen for a stiffening stylet. The device is inserted into the spine to compress cancellous bone or move cortical bone, creating a void for subsequent cement injection. It features radiopaque markers for visualization and a balloon length indicator. The device is operated by a physician in a clinical setting. It is used in conjunction with FDA-cleared balloon inflation syringes and spinal PMMA bone cement. The inflation of the balloon allows for controlled bone reduction and void creation, facilitating the stabilization of spinal fractures.

Clinical Evidence

Bench testing only. No clinical data provided. Bench testing demonstrated that the device performs as expected for its intended use.

Technological Characteristics

Double-lumen catheter shaft; inflatable balloon; radiopaque markers; balloon length indicator; stiffening stylet. Materials: Not specified. Sterilization: Ethylene Oxide (EtO). Standards: ASTM F 565-04, ANSI/AAMI/ISO 11135:2007, ISO 10993-7:2008, ISO 594-1/2, ISO 10555-1/2/3/4.

Indications for Use

Indicated for patients requiring reduction and fixation of spinal fractures or creation of a void in cancellous bone during percutaneous vertebral augmentation (kyphoplasty). Used with cleared spinal PMMA bone cement.

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 Xpander II Inflatable Bone Tamp (K101864)
• KyphX Inflatable Bone Tamp (K010246)
• KyphX Xpander Inflatable Bone Tamp (K041454)

Submission Summary (Full Text)

{0}------------------------------------------------

### Traditional 510(k) Summary

# JUN 2 5 2013

A) SUBMITTED BY: NeuroTherm, Inc. 30 Upton Drive, Suite 2 Wilmington, MA 01887-1083 Registration # 1226344

CONTACT: F. David Rothkopf MEDIcept Inc. 200 Homer Ave Ashland. MA 01721 617-899-3449 Phone [phone] Fax

B) DEVICE NAME: NeuroTherm Parallax Balloon Inflatable Bone Tamp

COMMON NAME: Arthroscope, Tamp

DEVICE CLASS/: 21 CFR 888.1100 Class II Arthroscope, product code HRX PRODUCT CODE 21 CFR 888.4540 Class I Orthopedic manual surgical instrument, product code HXG (Tamp) Accessory to 21 CFR 888.3027, Cement/Bone Vertebroplasty, product code NDN

### C) PREDICATES:

- . Kyphon Xpander II Inflatable Bone Tamp K101864
- KyphX Inflatable Bone Tamp . K010246
- . KyphX Xpander Inflatable Bone Tamp K041454

# D) DEVICE DESCRIPTION:

The NeuroTherm Parallax Balloon Inflatable Bone Tamp with an inflatable component at the distal end. The tamp is designed to compress cancellous bone and/or move cortical bone as it inflates. The catheter shaft contains an outer lumen for the tamp inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows for a uniform balloon that is concentric to the catheter shaft. The wire mandrel provides stiffness to the balloon catheter to facilitate insertion through the access cannula. The NeuroTherm Parallax Balloon Inflatable Bone Tamp may be used with FDA cleared balloon inflation syringes.

{1}------------------------------------------------

# E) INTENDED USE/INDICATIONS FOR USE:

The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

{2}------------------------------------------------

K122503 page 3/4

# SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION E)

. . . . . .

| Product codes | NeuroTherm Parallax Balloon Inflatable<br>Bone Tamp | KyphX Xpander<br>Bone Tamp | KyphX Inflatable<br>Bone Tamp |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | HRX, HXG<br>Accessory to NDN | K101864/K041454<br>HRX, HXG | K010246<br>HRX |
| Intended Use<br>Indication for Use | The NeuroTherm Parallax Balloon<br>Inflatable Bone Tamp is intended to be used<br>as a conventional bone tamp for the<br>reduction and fixation of fractures and/or<br>creation of a void in cancellous bone in the<br>spine. This includes use during<br>percutaneous vertebral augmentation. The<br>Parallax Balloon Inflatable Bone Tamp is to<br>be used with cleared spinal<br>polymethylmethacrylate (PMMA) bone<br>cement indicated for use during<br>percutaneous vertebral augmentation, such<br>as kyphoplasty. | The KYPHON Xpander is<br>intended to be used as a<br>conventional bone tamp for the<br>reduction of fractures and/or<br>creation of a void in cancellous<br>bone in the spine (including use<br>during balloon kyphoplasty with a<br>PMMA-based bone cement that is<br>cleared for use in kyphoplasty<br>procedures) hand, tibia, radius and<br>calcaneus. | KyphX Inflatable Bone Tamps<br>are intended to be used as<br>conventional bone tamps for<br>the reduction of fractures<br>and/or creation of a void in<br>cancellous bone in the spine<br>(including use during balloon<br>kyphoplasty with KyphX HV-<br>R Bone Cement), hand, tibia,<br>radius and calcaneus. |
| Description | | | |
| Tamp | Inflatable bone tamp consisting of a double lumen catheter shaft constructed from two coaxially aligned tubings | | |
| Side adaptor | A side arm adapter provides access to the catheter lumens allowing inflation and deflation | | |
| Straight arm port | A continuous straight arm port in inner catheter lumen allows placement of a non-removable stiffening stylet which<br>attaches to the Luer fitting of the straight arm | | |
| Markers | Radiopaque markers for balloon visualization | Exit marker band | |
| Balloon length<br>indicator | Yes<br>Printed band | Yes<br>Color coded band | Unknown |
| Sterilization | EtO | Gamma irradiation | |

.

4-3

{3}------------------------------------------------

### (F) CONCLUSION

The NeuroTherm Parallax Balloon Inflatable Bone Tamp is similar to or the same as the predicate devices for use as follows:

- Technology .
- . Intended use/Indication for Use in the spine
- Technical specifications or range of technical specifications .

Any differences between the NeuroTherm Parallax Balloon Inflatable Bone Tamp and the predicate devices do not raise new issues of safety or effectiveness. Therefore, the NeuroTherm Parallax Balloon Inflatable Bone Tamp is substantially equivalent to the predicate devices.

### G) PERFORMANCE TESTING

There are no applicable performance Consensus Standards or Guidance documents associated with this device.

Bench - Bench testing supports that the NeuroTherm Parallax Balloon Inflatable Bone Tamp performs as expected.

### H) COMPLIANCE WITH STANDARDS

- ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of . Orthopedic Implants and Instruments (pub date 10/04/2010)
- ANSI/AAMI/ISO 11135:2007 Sterilization of health care products Ethylene oxide -. Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical device sterilization for EtO sterilized devices i
- ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
- ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other ● medical equipment - Part 1: General requirements
- ISO 594-2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other . medical equipment - Part 2: Lock fittings
- ISO 10555-1 First edition 1995-06-5 AMENDMENT 2 2004-05-15 Sterile, single-use . intravascular catheters - Part 1: General requirements
- ISO 10555-2: 1996 Sterile, single-use intravascular catheters -- Part 2: Angiographic . catheters
- ISO 10555-3:1996/ Corrigendum 1:2002 Sterile, single-use intravascular catheters Part . 3: Central venous catheters
- . ISO 10555-4: 1996 Sterile, single-use intravascular catheters -- Part 4: Balloon dilatation catheters

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 25, 2013

NeuroTherm, Incorporated % MEDIcept, Incorporated Mr. F. David Rothkopf 200 Homer Avenue Ashland, Massachusetts 01721

Re: K122503

Trade/Device Name: NeuroTherm Parallax Balloon Inflatable Bone Tamp Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN. HRX Dated: May 13, 2013 Received: May 15, 2013

Dear Mr. Rothkopf:

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{5}------------------------------------------------

# Page 2 - Mr. F. David Rothkopf

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 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin J. Keith

For

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

Enclosure

{6}------------------------------------------------

### Indications for Use Form

### 510(k) Number (if known): K122503

Device Name: NeuroTherm Parallax Balloon Inflatable Bone Tamp

Indication for Use:

The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use 21CFR 801.109

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122503