(28 days)
The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
The ReSolve Tongs are similar to other traction tongs which are used to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
1. Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets requirements of ASTM F 1831-97 for Mechanical Integrity of Cranial Traction Tongs | Meets requirements of ASTM F 1831-97 for Mechanical Integrity of Cranial Traction Tongs. Laboratory tests confirm the new nonconductive design meets this standard. |
| Substantial equivalence to predicate device (JTongs Traction Tongs) for indications of use and function. | The ReSolve Tongs are similar to the predicate device JTongs in function and indications for use and are substantially equivalent. |
| Electrical safety (nonconductive) | Nonconductive design. |
| Sterility | EtO Sterilized. |
| Imaging Compatibility | Compatible with X-ray, CT, MR imaging. (Predicate was compatible with X-ray, CT). |
2. Sample size and data provenance:
No human or patient data was used in this evaluation. The "sample size" refers to the tested tongs. The description indicates "Laboratory tests" without specifying the number of tongs tested. The provenance is likely from the manufacturer's internal testing facilities.
3. Number of experts and their qualifications:
Not applicable. This device is a mechanical tool, and its performance was evaluated through a non-clinical, objective standard (ASTM F 1831-97), not by expert interpretation.
4. Adjudication method:
Not applicable. The evaluation was based on meeting a pre-defined objective standard (ASTM F 1831-97), not on subjective assessment requiring adjudication.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable. This is a mechanical device, not an AI or imaging diagnostic tool that would involve human readers.
6. Standalone (algorithm only without human-in-the-loop) performance:
The device's performance was evaluated in a standalone manner against the ASTM F 1831-97 standard. This is akin to a "standalone" evaluation for a mechanical device.
7. Type of ground truth used:
The ground truth was established by the ASTM F 1831-97 standard for Mechanical Integrity of Cranial Traction Tongs. This is an objective, standardized test method defining acceptable mechanical performance.
8. Sample size for the training set:
Not applicable. This is a mechanical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There was no training set for this mechanical device.
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MAY 2 5 2007
ÖSSUR
Life Without Limitations
April 24, 2007
510(k) Summarv As required by section 807.92(c)
Trade Name: ReSolve Tongs Traction Tongs
Common Name: Traction Tongs
Classification Name: Tong, Skull for Traction, Sec. 882.5960, Neurological Devices, Class II, HAX
Substantially Equivalent To: JTongs Traction Tongs (K930021) manufactured by Jerome Medical . Also similar to the ReSolve Open Back Halo Ring (K051918) manufactured by Jerome Medical .
Description: The ReSolve Tongs are similar to other traction tongs which are used to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
Technological Characteristics Summary:
| ReSolve Tongs | JTongs | |
|---|---|---|
| Design | Open tong | Open tong |
| Materials | E-glass (fiberglass) | Carbon composite |
| Sterility | EtO Sterilized | EtO Sterilized |
| Electrical Safety | Nonconductive | Conductive |
| Imaging Compatibility | Compatible w/X-ray, CT,MR | Compatible w/X-ray, CT |
| Performance | Meets requirements ofASTM F 1831-97 forMechanical Integrity ofCranial Traction Tongs | Meets requirements ofASTM F 1831-97 forMechanical Integrity ofCranial Traction Tongs |
The ReSolve Tongs are substantially equivalent to the predicate JTongs in all technological aspects except electrical safety. Laboratory tests confirm that the new nonconductive design meets the same standard for mechanical integrity as the previously approved JTongs.
Now Ossur Americas
internet www.ossur.com
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Non-clinical tests: The ReSolve Tongs were tested to the standard of ASTM F 1831-97, Section 10. They met the standard. The design change does not adversely affect product performance.
14071173
Intended Use: The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
Conclusions: The ReSolve Tongs are similar to the predicate device JTongs in function and indications for use. The devices are substantially equivalent
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ossur Americas, Orthopaedics c/o Mr. Bernie Tatro Director of Distribution 1414 Metropolitan Avenue Paulsboro, New Jersey 08066
MAY 2 5 2007
Re: K071173
Trade/Device Name: ReSolve Tongs Traction Tongs Regulation Number: 21 CFR 882.5960 Regulation Name: Skull Tongs for Traction Regulatory Class: II Product Code: HAX Dated: April 26, 2007 Received: April 27, 2007
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
Mark N. Millken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
67-1173 510(k) Number
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)
§ 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).