PMT HALO SYSTEM

K090733 · Pmt Corp. · HAX · Jul 28, 2009 · Neurology

Device Facts

• Record ID: K090733
• Device Name: PMT HALO SYSTEM
• Applicant: Pmt Corp.
• Product Code: HAX · Neurology
• Decision Date: Jul 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5960
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provides cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries. The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions: - Static magnetic field of 1.5T and 3T only . - Maximum spatial gradient magnetic field of 720 Gauss/cm or less . - Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

Device Story

PMT Halo System provides external cervical spine immobilization and traction; allows patient mobility during recovery. System components include ring set (open/closed back), superstructure (headblocks, upright bars), vest, liner, and wrench. Utilizes non-magnetic materials (titanium, carbon graphite, brass, Zytel polymer) to ensure MR compatibility. Used in clinical settings; applied by healthcare professionals. Provides stabilization for cervical spinal cord injuries; enables patient to resume normal activities while immobilized. MR Conditional status allows safe imaging at 1.5T and 3T under specified SAR and gradient field limits.

Clinical Evidence

Bench testing only. Device performance verified against ASTM F1559:1994 for halo rings and skull pins. Materials tested for MR compatibility under specified conditions (1.5T/3T, SAR limits). No clinical data provided.

Technological Characteristics

System components: graphite ring set, polyethylene vest, brass positioning pins, Delrin/Zytel head/buckle/chest blocks, titanium screws and skull pins (ASTM F136-08c1), aluminum traction bail. MR Conditional (1.5T/3T). Sterilization: ETO (ANSI/AAMI/ISO 11135:2007, EN556:2001). Mechanical design for cervical traction/immobilization.

Indications for Use

Indicated for patients requiring cervical immobilization for healing and rehabilitation of cervical spinal cord injuries.

Regulatory Classification

Identification

Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.

Predicate Devices

• PMT Halo System (834047)
• Jerome Medical Skull Pins (040363)

Submission Summary (Full Text)

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K090733

## EXHIBIT 5

# PMT Corporation 510(k) Summary

JUL 28 2009

## Submitter's Name, Address, and Date of Submission

Eric Caillé General Manager PMT Corporation 1500 Park Road Chanhassen, MN Phone: [phone] Fax: [phone]

Submitted:

| Device Name | PMT Halo System |
|----------------------|----------------------------------------|
| Trade Name: | PMT Halo System |
| Classification Name: | HAX, Skull Tongs for Traction 882.5960 |
| Common/Usual Name: | Halo |
| Predicate Device: | |

## Predicate Device

PMT Halo System (834047) Jerome Medical Skull Pins (040363)

### Indication for Use

The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provides cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.

The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions:

- Static magnetic field of 1.5T and 3T only .
- Maximum spatial gradient magnetic field of 720 Gauss/cm or less .
- Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

### Device Description

The PMT Halo System is designed for positioning and stabilization of the cervical spine area. It provides optimum external immobilization and traction for the cervical region while allowing the patient to leave the hospital and resume their normal activities.

To enhance the magnetic resonance imaging compatibility, the PMT Halo system utilizes non-magnetic titanium skull pins and hardware, brass positioning pins, and advanced non-metallic support materials such as carbon graphite upright bars and composite head fixation subassemblies.

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K090733

# Technological Characteristics and Performance

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The technological characteristics of the product are not affected in this submission.

| Characteristic | PMT Halo System |
|---------------------------|-----------------------------------------------------------------------------------------------------------|
| System components | Ring set (open and closed back), superstructure (headblocks and upright bars),<br>vest, liner, and wrench |
| Component materials: | |
| Ring set | Graphite |
| Vest | Polyethylene |
| Positioning pins | Sterile, brass |
| Head block | Delrin or Zytel Polymer |
| Buckle block | Delrin or Zytel Polymer |
| Screws | Titanium |
| Traction Bail | Aluminum |
| Fasteners (MRI nuts) | Zytel Polymer |
| Vest liner | Lambswool or Acrylic |
| Fasteners (hook and loop) | Velcro |
| Chestblock | Zytel Polymer |
| Skull pins | Titanium (ASTM F136-08c1) |
| Sterility | Skull pins, rings, and positioning pins ETO Sterilized to ANSIAAMI/ISO |
| | 11135:2007 and EN556:2001 |
| Imaging Capability | Compatible with C-ray, CT and 3-Tesla MR Conditional |
| Performance | Halo ring and skull pins meet ASTM F1559:1994 |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PMT® Corporation c/o Eric Caillé General Manager 1500 Park Road Chanhassen, MN 55317

JUL 2 8 2009

Re: K090733

Trade/Device Name: PMT Halo System Regulation Number: 21 CFR 882.5960 Regulation Name: Skull Tongs for Traction Regulatory Class: II Product Code: HAX Dated: June 22, 2009 Received: June 23, 2009

Dear Mr. Caillé:

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.

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 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.

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# Page 2 - Mr. Eric Caillé

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Eric G. Anderson

Malvina B. Eydelman, Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## 510(k) Number (if known)

K090733

Device Name PMT Halo

#### Indications for Use

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The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and John Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provide: cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.

The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions:

- Static magnetic field of 1.5T and 3T only
- Maximum spatial gradient magnetic field of 720 Gauss/cm or less
- Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------|--------------------------------------------------------------------------|-------------------------|--|
| Prescription Use | X | Over the Counter Use | |
| Per 21 CFR 801.109 | | | |
| | JOE HUTTER<br>OR<br>(Division Sign-Off) | | |
| | Division of Ophthalmic, Neurological and Ear,<br>Nose and Throat Devices | (Optimal Format 1-2-96) | |
| 510(k) Number | K090733 | | |