(131 days)
PMT Halo System (834047), Jerome Medical Skull Pins (040363)
Not Found
No
The summary describes a mechanical device for cervical immobilization and mentions its MRI compatibility. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making capabilities.
Yes
The device is described as providing cervical immobilization necessary for "healing and rehabilitation of cervical spinal cord injuries," directly indicating a therapeutic purpose.
No
The device is used for cervical immobilization and stabilization, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of titanium, brass, carbon graphite, and composite materials, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries." This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on positioning, stabilization, and external immobilization of the cervical spine. It mentions materials used for MRI compatibility, but the core function is mechanical support.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. This device is used externally on the patient's body for structural support and immobilization.
N/A
Intended Use / Indications 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).
Product codes
HAX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
C-ray, CT and 3-Tesla MR Conditional
Anatomical Site
cervical spine area, cervical region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PMT Halo System (834047), Jerome Medical Skull Pins (040363)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5960 Skull tongs for traction.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: 952-470-0866 Fax: 952-470-0865
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.
1
Technological Characteristics and Performance
イ
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), |
| 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.
3
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 (800) 638-2041 or (240) 276-3150 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
4
Indications for Use Statement
510(k) Number (if known)
Device Name PMT Halo
Indications for Use
Pr (P
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 | |||
| OR | |||
| (Division Sign-Off) | |||
| Division of Ophthalmic, Neurological and Ear, | |||
| Nose and Throat Devices | (Optimal Format 1-2-96) | ||
| 510(k) Number | K090733 |