(86 days)
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any software-driven analysis or processing.
Yes
The device is used to immobilize and provide traction for a cervical spine injury, which is a therapeutic purpose.
No
The device description clearly states its purpose is to immobilize and/or provide traction for a cervical spine injury, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "Fiberglass Halo Traction Ring," indicating it is a physical hardware component, not software.
Based on the provided information, the Jerome Glass Ring is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "immobilize and/or provide traction for a cervical spine injury" when used with a Jerome Halo Vest. This is a mechanical function applied externally to the body for structural support and stabilization.
- Device Description: The description reinforces its function as a component of a Halo System designed to "hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized." This is a physical, non-diagnostic action.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze biological samples (blood, urine, tissue, etc.), or provide information about a patient's health status through in vitro testing.
- Input Imaging Modality: While compatible with imaging modalities like X-ray, CT, and MR, these are used to assess the placement and effectiveness of the device, not as input for the device itself to perform a diagnostic function.
- Performance Studies: The performance study mentioned is related to "Mechanical Integrity," which is relevant to the structural function of the device, not its diagnostic capability.
In summary, the Jerome Glass Ring is a medical device used for external immobilization and traction, not for performing in vitro diagnostic tests.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HAX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Compatible w/X-ray, CT, MR
Anatomical Site
cervical spine, skull
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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, | |
| CT, MR | Compatible w/X-ray, | |
| CT, MR | ||
| Performance | Meets requirements of | |
| ASTM F 1831 - 97 for | ||
| Mechanical Integrity of | ||
| Halo Rings | Meets requirements of | |
| ASTM F 1831 - 97 for | ||
| Mechanical Integrity of | ||
| Halo Rings |
9-1
1
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.
2
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
3
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