(33 days)
No
The summary describes a mechanical device for cervical spine immobilization and traction, with no mention of AI/ML terms or functionalities.
Yes
The device is used to immobilize the cervical spine following injury, which is a therapeutic function.
No
Explanation: The device is intended for immobilization and traction of a cervical spine injury, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "Halo Traction Ring," which is a physical component used in a Halo System. It is not described as software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "immobilize and/or provide traction for a cervical spine injury." This is a therapeutic and mechanical function performed directly on the patient's body.
- Device Description: The description reinforces its function as a device designed to "hold the skull immobilized." This is a physical intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any biological specimens.
The device is a medical device used for external support and immobilization of the cervical spine.
N/A
Intended Use / Indications for Use
The ReSOLVE Open Back Halo Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.
Product codes
HAX
Device Description
The ReSOLVE Open Back Halo Traction Ring is similar to other rings which, when used as part of a Halo System, are designed to hold the skull hings which, when used as part of a hale of the eyes 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
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)
Non-clinical Tests: Both the ReSOLVE Open Back and ReSOLVE Closed Back were tested to the standard of ASTM F 1831-97, Section 11. Each met the were tested to the otandard on Hoes not adversely affect product performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Page 1 of 2
Image /page/0/Picture/1 description: The image shows a logo for "Jerome Cervical Spine System". The logo has a stylized spine graphic on the left, followed by the word "JEROME" in large, bold letters. Below "JEROME" is the text "CERVICAL SPINE SYSTEM" in a smaller font. The tagline "Helping You Meet The Challenge" is at the bottom of the image.
AUG 1 7 2005
05/9/8
July 14, 2005
510(k) Summary
As required by section 807.92(c)
ReSOLVE Open Back Halo Ring Trade Name:
Common Name: Halo Ring
Tong, Skull for Traction, Sec. 882.5960, Neurological Classification Name: Devices, Class II, HAX
ReSOLVE Closed Back Halo Ring (K023959) Substantially Equivalent To: Oubstantially Equivalian Also similar to the V1 Halo Ring (K930153) manufactured by Jerome Medical.
Description: The ReSOLVE Open Back Halo Traction Ring is similar to other rings which, when used as part of a Halo System, are designed to hold the skull hings which, when used as part of a hale of the eyes are immobilized following surgery or injury.
Technological Characteristics Summary:
| | ReSOLVE Open Back
Ring | ReSOLVE Closed Back
Ring |
|-----------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Design | Open back halo ring | Closed loop halo ring |
| Materials | E-glass (glass composite) | E-glass (glass composite) |
| Sterility | EtO Sterilized | EtO Sterilized |
| Electrical Safety | Nonconductive | Nonconductive |
| Imaging Compatibility | Compatible w/X-ray, CT,
MR | Compatible w/X-ray, CT,
MR |
| Performance | Meets or exceeds
requirements of ASTM F
1831-97 for Mechanical
Integrity of Halo Rings | Meets or exceeds
requirements of ASTM F
1831-97 for Mechanical
Integrity of Halo Rings |
The ReSOLVE Open Back Ring is substantially equivalent to the ReSOLVE The ReGOEVE Open Back Aing local aspects. The only variation is the shape of the ring. Laboratory tests confirm that the new open back design meets the the ling. Edad for mechanical integrity as the previously approved ReSOLVE Closed Back Ring.
Jcrome Medical, 305 Harper Drive, Moorestown, NJ 08057-3239 • (800) 257-8440 • FAX (856) 778-5333
1
Non-clinical Tests: Both the ReSOLVE Open Back and ReSOLVE Closed Back were tested to the standard of ASTM F 1831-97, Section 11. Each met the were tested to the otandard on Hoes not adversely affect product performance.
Intended Use: The ReSOLVE Open Back Halo Ring is intended for use in intended 000: "The Neoone Halo Vest, Superstructure and Accessories (Halo System) that provide cervical immobilization and/or traction for healing and rehabilitation of cervical spinal cord injuries.
Conclusions: The ReSOLVE Open Back Halo Ring is similar to the ReSOLVE Closed Back Halo Ring in material, function and indications for use. The devices are substantially equivalent.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal features a stylized eagle with its head turned to the left. The eagle's body is composed of three curved lines. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2005
Mr. Bernie Tatro Director of Marketing Jerome Medical 305 Harper Drive Moorestown, New Jersey 08057-3239
Re: K051918
Trade/Device Name: ReSOLVE Open Back Halo Ring Regulation Number: 21 CFR 882.5960 Regulation Name: Skull tongs for traction Regulatory Class: II Product Code: HAX Dated: July 14, 2005 Received: July 19, 2005
Dear Mr. Tatro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications ferenced above and have acterials and marketed predicate devices marketed in interstate for use stated in the encreate) ve tegains and the Medical Device Amendments, or to commerce proc to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been receised in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general volurols provision 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 if your device is elassinod (over a controls. Existing major regulations affecting your device can may oe subject to back adderal 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 or any I odolar statuation and 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.
3
Page 2 - Mr. Bernie Tatro
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to organ maing of substantial equivalence of your device to a legally premailted 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 If you desire spochis aarroliance at (240) 276-0120. Also, please note the regulation entitled, eoniael the Office of Dremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnal 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/industry/support/index.html.
Sincerely yours,
Mark N. Molkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K051918
ReSOLVE Open Back Halo Ring __________________________________________________________________________________________________________________________________________________ Device Name:
Indications for Use:
The ReSOLVE Open Back Halo Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
200
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051918
23