JEROME GLASS RING

K023959 · The Jerome Group, Inc. · HAX · Feb 21, 2003 · Neurology

Device Facts

• Record ID: K023959
• Device Name: JEROME GLASS RING
• Applicant: The Jerome Group, Inc.
• Product Code: HAX · Neurology
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5960
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jerome Glass Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.

Device Story

The Jerome Glass Ring is a closed-loop halo ring designed to hold the skull firmly in place relative to the torso. It functions as a component of a halo system to immobilize cervical vertebrae following surgery or injury. The device is constructed from fiberglass (E-glass), making it non-conductive and compatible with X-ray, CT, and MR imaging. It is used in clinical settings by healthcare professionals. By providing rigid cranial fixation, the device stabilizes the cervical spine, facilitating healing and preventing further injury.

Clinical Evidence

Bench testing only. The device was evaluated for mechanical integrity in accordance with ASTM F 1831-97 standards. No clinical data was required or provided.

Technological Characteristics

Closed-loop halo ring; material: E-glass (fiberglass); non-conductive; 31 pin sites; 3 sizes; EtO sterilized; compatible with X-ray, CT, and MR imaging; meets ASTM F 1831-97 for mechanical integrity.

Indications for Use

Indicated for patients requiring cervical spine immobilization or traction following surgery or injury.

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

• Generation 80 Halo Ring (K822780)
• Bremer Halo System (K864746)
• Friddle Halo System (K980689)
• PMT Halo Systems
• V1 Halo Ring (K930153)

Reference Devices

• Lerman Low Profile Halo System

Submission Summary (Full Text)

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November 22, 2002

023959
page 10f1

## 510(k) Summary As required by section 807.92(c)

Trade Name: Jerome Glass Ring

FEB 2 1 2003

Common Name: Halo Ring

Classification Name: Tong, Skull for Traction, Sec. 882.5960, Neurological Devices, Class II, HAX

Substantially Equivalent to: Generation 80 Halo Ring (K822780) also manufactured by Jerome Medical. Also similar to Halo Rings included in Lerman Low Profile Halo System, Bremer Halo System (K864746), (now DePuy Acromed - Johnson & Johnson), Friddle Halo System (K980689), PMT Halo Systems, and the V1 Halo Ring (K930153). Copies of product literature for each are included in Competition (Tab 10).

Description: The Fiberglass Halo Traction Ring is similar to other halo rings which. when used as part of a Halo System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury. An engineering drawing of a Standard size Glass Ring is at page 2-2.

Technological Characteristics Summary:

| | Jerome Glass Ring | Generation 80 |
|-----------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Design | Closed Loop Halo Ring | Closed Loop Halo Ring |
| Materials | E-glass (fiberglass) | 6061 T6 Aluminum |
| Sterility | EtO Sterilized | EtO Sterilized |
| Sizes | 3 sizes | 3 sizes |
| Pin Sites | 31 | 19 |
| Electrical Safety | Non-conductive | Conductive |
| Imaging Compatibility | Compatible w/X-ray,<br>CT, MR | Compatible w/X-ray,<br>CT, MR |
| Performance | Meets requirements of<br>ASTM F 1831 - 97 for<br>Mechanical Integrity of<br>Halo Rings | Meets requirements of<br>ASTM F 1831 - 97 for<br>Mechanical Integrity of<br>Halo Rings |

9-1

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2003

Mr. Bernie Tatro Director of Marketing Jerome Medical 305 Harper Drive Moorestown, New Jersey 08057-3239

Re: K023959 Trade Name: Jerome Glass Ring Regulation Number: 21 CFR 882.5960 Regulation Name: Skull tongs for traction Regulatory Class: II Product Code: HAX Dated: November 25, 2002 Received: November 27, 2002

Dear Mr. Tatro:

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 such 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); 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. Bernie Tatro

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K023959

Device Name: Jerome Glass Ring

## Indications for Use:

The Jerome Glass Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.

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

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

(Optional Format 3-10-98)

(Posted July 1, 1998)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023959