(360 days)
This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.
The Friddle Halo system is very similar to several halo systems, which are designed to hold the skull firmly in place relative to the torso so that the cervical vertabrae are immobolized after surgery or injury. The system is comprised of a ring, rods, and braces system made of a carbon fiber-epoxy composite which is placed over a vest made of high-density polyethylene, lined with Kodel or sometimes sheepskin. The skull pins are made of CP titanium. The titanium skull pins, carbon fiber-epoxy composite rods, high-density polyethylene, Kodel, and sheepskin are used throughout the industry.
The provided text is a 510(k) summary for the Friddle Halo System™, a medical device for cervical spine immobilization and traction. This document focuses on demonstrating substantial equivalence to already-marketed predicate devices rather than providing a study proving its performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth for a performance study is not available in the provided document.
Here's why and what the document does provide:
- Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or that any differences do not raise new questions of safety and effectiveness. It does not typically require a full clinical performance study with acceptance criteria in the same way a Premarket Approval (PMA) would.
- Performance Standards: The document explicitly states "Performance standards: None." This further indicates that there wasn't a formal set of acceptance criteria that the device's performance was measured against in a clinical study for this submission. The titanium alloy meeting ASTM specifications is a material characteristic, not a performance metric of the device in use.
Information that can be extracted from the document related to the request:
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A table of acceptance criteria and the reported device performance:
- Not applicable (N/A). The document does not define specific performance acceptance criteria for a study demonstrating efficacy or safety of the device itself beyond material specifications.
- Reported Device Performance: The primary claim is "substantial equivalence" to other halo systems.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No formal test set or clinical study to assess performance beyond comparison to predicate devices is described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. As no formal test set or clinical study is described, there's no mention of experts establishing ground truth for such a study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method is mentioned as there is no described test set or performance study.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a mechanical medical device (halo system), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a mechanical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. For this 510(k) submission, the "ground truth" for demonstrating equivalence largely relies on comparing the design, materials, and intended use of the Friddle Halo System to predicate devices that have already been cleared by the FDA.
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The sample size for the training set:
- N/A. There is no mention of a training set as this is not an AI/algorithm device.
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How the ground truth for the training set was established:
- N/A. There is no mention of a training set or its ground truth.
In summary, the provided document is a 510(k) premarket notification, which establishes substantial equivalence rather than presenting data from a clinical performance study against pre-defined acceptance criteria.
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2/18/99
XII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)
- A. Submitter; Frank Friddle, Jr., Friddle's Orthopedic Appliances, Inc., 12306 Belton Honea Path Hwy, Honea Path, SC, 29654
- I. Classification: Class II.
- II. Common or usual name: Halo traction or immobilization system,
III. Proprietary Name: Friddle's Halo System™
IV. Registration No .: 1053709
V. Classification Name: Cranial Skull Tongs, 84HAX, CFR 882.5960, Class II.
VI. Performance standards: None. Titanium alloy meets ASTM specifications.
VII. Description:
The Friddle Halo system is very similar to several halo systems, which are designed to hold the skull firmly in place relative to the torso so that the cervical vertabrae are immobolized after surgery or injury. The system is comprised of a ring, rods, and braces system made of a carbon fiber-epoxy composite which is placed over a vest made of high-density polyethylene, lined with Kodel or sometimes sheepskin. The skull pins are made of CP titanium. The titanium skull pins, carbon fiber-epoxy composite rods, high-density polyethylene, Kodel, and sheepskin are used throughout the industry.
VIII. Labels and Labeling: Labels and Instructions for Use are provided. Competitive labels and labeling are provided.
IX. Indications for Use: To provide traction/immobilize a patient with a cervical spine injury (fracture or dislocation)
- X. Substantial Equivalence:
The Friddle Halo System is substantially equivalent to the classified device and to other devices cleared for marketing by the 510(k) process such as the "Halo Traction Cervical Immobilizer" (K822885), "Bremer Imaging Tongs, MRI model" (K924506), "Ace Cervical Traction Halozs, Tongs, and Pins," (K954069), the "Halo Ring" (K930153), and is most similar to the PMT Halo/Orthopedic Jacket System (K834047). Several of these products are listed below for convenient reference. The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Mr. Frank E. Friddle, Jr. President Friddle's Orthopedic Appliances 12306 Belton-Honea Path Highway P.O. Box 207 Honea Path, South Carolina 29654
Re: K980689 Trade Name: Friddle Halo System™ Regulatory Class: II Product Code: HAX Dated: January 20, 1999 Received: January 21, 1999
Dear Mr. Friddle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Frank E. Friddle, Jr.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IX. Indications for Use: [Separate Page]
510(k) Number: # K980689
Device Name: Friddle Halo System™.
Indications for Use: This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | K980689 |
| 510(k) Number |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
Over The Counter Use
(Optional Format 1-2-96)(repl. p. 4)
(Optional Pormal 1-2-90,
§ 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).