(90 days)
The Bremer Halo System Titanium Skull Pins are intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, which provide cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.
The Bremer Halo System Titanium Skull Pin described in this submission is a modification of the previously cleared Bremer Halo System Sterile Cervical Traction Skull Pin, The modified pin is longer than the previously cleared pin and the tip is a drill bit rather than a pointed tip. The Bremer Halo System Titanium Skull Pin is manufactured from implant grade titanium alloy that conforms to ASTM standard F-136.
The provided text describes a 510(k) submission for a medical device (Bremer Halo System Titanium Skull Pin) and focuses primarily on its substantial equivalence to an existing device rather than a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for an AI device is not available in the given document.
However, I can extract the relevant information that is present and indicate where information is missing based on the prompt's requirements.
Here's a breakdown of what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Hypothesized) | Reported Device Performance |
|---|---|
| Material Conformance | Manufactured from implant grade titanium alloy conforming to ASTM standard F-136. |
| Mechanical Performance | "Testing was presented to evaluate the performance characteristics of the Bremer Halo System Titanium Skull Pin." (Specific results not detailed in this summary.) |
| Design Equivalence | Modified pin is longer and has a drill bit tip compared to the previously cleared pin with a pointed tip. (This is a design characteristic, not a performance metric in the same vein as clinical efficacy). |
| Intended Use Equivalence | Intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, providing cervical immobilization for spinal cord injuries. This matches the predicate device's intended use. |
| Substantial Equivalence | Based on equivalence in intended use, materials, design, and relative indications and contraindications to the existing Bremer Halo System Sterile Cervical Traction Skull Pin. |
| (Other performance metrics) | Not specified in the summary. |
Explanation: The document explicitly states that the device's substantial equivalence is "based on an equivalence in intended use, materials, design, and relative indications and contraindications to the existing Bremer Halo System Sterile Cervical Traction Skull Pin." This implies that the 'acceptance criteria' are primarily related to matching or demonstrating comparable characteristics to the predicate device, rather than achieving specific quantitative performance thresholds like an AI system might. "Testing was presented to evaluate the performance characteristics," but the results of this testing against specific, quantified acceptance criteria are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The document refers to "testing" but does not specify the sample size of any test sets (e.g., number of pins tested, number of simulated applications, etc.) nor the provenance of any data used for such tests. Given the nature of the device (a mechanical titanium skull pin), "test set" here would refer to the physical units tested, not a clinical data set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable to this type of device submission. This information is typically relevant for AI/ML devices where expert review is needed to establish ground truth for training or evaluating diagnostic accuracy. For a mechanical device like a skull pin, "ground truth" would be established through material science tests, mechanical load tests, and design validation, rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable and not available. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts when establishing ground truth, typically for diagnostic AI. For a mechanical device, performance is evaluated against engineering specifications and standards, not through physician adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable and not available. MRMC studies are specific to evaluating diagnostic AI systems, comparing human reader performance with and without AI assistance. This device is a mechanical medical implant, not a diagnostic AI system.
6. Standalone (Algorithm Only) Performance Study
This is not applicable and not available. This concept is for AI algorithms. The device is a physical, mechanical skull pin.
7. Type of Ground Truth Used
The "ground truth" for this device would have been established through engineering specifications, material standards (e.g., ASTM F-136), mechanical testing results (e.g., strength, fatigue), and biocompatibility data. The document mentions conformance to ASTM standard F-136 for the material and that "Testing was presented to evaluate the performance characteristics," implying engineering and material science tests rather than pathology, outcomes data, or expert consensus in a clinical diagnostic sense.
8. Sample Size for the Training Set
This is not applicable and not available. Training sets are used for machine learning algorithms. This device is a mechanical component, not an AI system.
9. How the Ground Truth for the Training Set Was Established
This is not applicable and not available. As there is no training set mentioned for an AI algorithm, the method for establishing its ground truth is irrelevant here.
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K99309
DEC I 5 1999
510(k) Summarv
SUBMITTER:
DePuv AcroMed 326 Paramount Drive Ravnham. MA 02767 Fax (508) 828-3797
Bremer Medical 4801 Dawin Road Jacksonville.FL 32207
- CONTACT PERSON: Frank Maas (508) 828-3390 Lisa Gilman (508) 880-8287
DATE PREPARED: 12-8-99
CLASSIFICATION NAME AND REFERENCE: Smooth or threaded metallic bone fastener, §888.3040 Skull tong for traction, §888.3070
COMMON NAME: Traction Skull Pin
Bremer Halo System Titanium Skull Pin PROPRIETARY NAME:
PURPOSE: Modification of an existing device.
DESCRIPTION:
The Bremer Halo System Titanium Skull Pin described in this submission is a modification of the previously cleared Bremer Halo System Sterile Cervical Traction Skull Pin, The modified pin is longer than the previously cleared pin and the tip is a drill bit rather than a pointed tip.
The Bremer Halo System Titanium Skull Pin is manufactured from implant grade titanium alloy that conforms to ASTM standard F-136.
Testing was presented to evaluate the performance characteristics of the Bremer Halo System Titanium Skull Pin.
The substantial equivalence of the Bremer Halo System Titanium Skull Pin is based on an equivalence in intended use, materials, design, and relative indications and contraindications to the existing Bremer Halo System Sterile Cervical Traction Skull Pin.
The Bremer Halo System Titanium Skull Pin is intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories (Halo System), which provide cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 1999
Mr. Frank Maas Manager, Regulatory Affairs DePuy AcroMed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K993099
Trade Name: Bremer Halo System Titanium Skull Pin Regulatory Class: II Product Code: JEC and HWC Dated: September 13, 1999 Received: September 16, 1999
Dear Mr. Maas:
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.
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.
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Page 2 -- Mr. Frank Maas
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) 594-4659. 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil A. P. Ogden
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K993099
Device Name:
Indications for Use:
The Bremer Halo System Titanium Skull Pins are intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, which provide cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.
Ro for
(Division Sign-Off)
Division of General Restorative Devices K993099
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (per 21 CRF 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.