(72 days)
The Dall-Miles Cable Grip is intended to be used for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy.
The Dall-Miles Cable Grip (A-Grip) described in this submission is a modification of the previously cleared Osteonics FX-Cablelok™ grip components. The two proximal hooks in the current grip have been reduced to one centrally positioned hook in the new grip. This central hook is available with and without a cannulated groove for the passage of cable. A hole in the central hook allows for the passage of cable that provides the vertical fixation feature of the device. The flares on the anterior and posterior limbs (used for the passage of cable during vertical fixation) have been removed. Two new designs have been developed to provide for vertical fixation. The first design incorporates a crimping mechanism in each of the distal hooks of the grip. The cable is passed through the grip and a "tension band" device (that is placed below the trochanter, similar to the existing FX-Cablelok sleeve design) and secured by crimping the hooks on the grip. The second design incorporates a crimping mechanism directly in the tension band component. With this design, the cable is passed through the grip and the tension band device and secured by crimping the tension band component. The standard method for horizontal fixation on the current design is still provided in both of the new designs.
This document is a 510(k) Pre-Market Notification submission for a medical device called the "Dall-Miles Cable Grip." It details modifications made to an existing device and argues for its substantial equivalence to previously cleared devices.
Based on the provided text, the device is a mechanical bone fixation device, not an AI or imaging-based diagnostic tool. Therefore, the questions related to AI studies, reader performance, ground truth, and sample sizes for training/test sets are not applicable to this submission.
The acceptance criteria for mechanical devices like this are typically based on:
- Safety and Efficacy: The device must perform its intended function without causing harm and achieve the desired clinical outcome.
- Biocompatibility: The materials used must be compatible with the human body.
- Mechanical Performance: The device must withstand the forces it will encounter in vivo without failure (e.g., strength, fatigue resistance).
- Sterilization: The device must be able to be effectively sterilized.
- Substantial Equivalence: The primary "study" proving acceptance for a 510(k) submission is typically a comparison to a legally marketed predicate device, demonstrating that the new device is as safe and effective.
Here's how the provided information relates to the acceptance criteria for a mechanical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Common for Mechanical Fixation Devices) | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence (to predicate) | "The intended use of the modified device is the same as the current device; for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy." |
| Material Equivalence (to predicate) | "The substantial equivalence of the modified Dall-Miles Grip is based on the equivalence in ... materials..." |
| Design Equivalence (to predicate) | "The substantial equivalence of the modified Dall-Miles Grip is based on the equivalence in ... design..." (with detailed description of modifications, implying they do not negatively impact function compared to predicate) |
| Operational Principles Equivalence (to predicate) | "The substantial equivalence of the modified Dall-Miles Grip is based on the equivalence in ... operational principles..." (describes how the new crimping mechanisms and vertical fixation work, retaining the standard horizontal fixation) |
| Indications/Contraindications Equivalence (to predicate) | "The substantial equivalence of the modified Dall-Miles Grip is based on the equivalence in ... and indications and contraindications..." |
| Safety and Efficacy (demonstrated via equivalence) | The FDA's finding of "substantial equivalence" implies that the device is considered as safe and effective as the predicate devices. There is no explicit performance data (e.g., tensile strength, fatigue life) provided in this summary. |
The following points are not applicable to this 510(k) submission for a mechanical device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a 510(k) submission for a mechanical device, not an AI/diagnostic device that relies on a "test set" of clinical data in the same way. Performance is typically demonstrated through bench testing and comparison to predicates.
3. 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)
- Not applicable. No "ground truth" establishment by experts in this context. The "ground truth" for a mechanical device largely revolves around its physical properties meeting engineering specifications and historical clinical performance of similar devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No "test set" in the context of diagnostic performance.
5. 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
- Not applicable. This is a mechanical bone fixation device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/diagnostic sense. The "ground truth" for demonstrating safety and effectiveness of a mechanical implant typically comes from:
- Bench Testing Data: Mechanical tests (tensile strength, fatigue, torsional strength, etc.) comparing the modified device to the predicate device and established engineering standards.
- Biocompatibility Testing: Ensuring materials are safe for human implantation.
- Clinical History of Predicate Devices: Relying on the established safety and effectiveness of the existing devices to which this modified device is substantially equivalent.
8. The sample size for the training set
- Not applicable. There is no "training set" for this type of device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set."
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1984432
510(k) Summary
Proprietary Name: Dall-Miles Cable Grip
Common Name: Bone Fixation Cerclage
Classification Name and Reference: Bone Fixation Cerclage 21 CFR 888.3010
Proposed Requiatory Class: Class II
Device Product Code: OR(87) JDQ
For information contact:
Frank Maas Manager, Regulatory Affairs Howmedica Osteonics 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 12-11-98
The Dall-Miles Cable Grip (A-Grip) described in this submission is a modification of the previously cleared Osteonics FX-Cablelok™ grip components. The intended use of the modified device is the same as the current device; for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy. The vertical fixation feature of the device aids in the fixation of the trochanter in those instances where additional stabilization may be required, for example revision cases. These grips are intended to be used in conjunction with the Dall-Miles cables and sleeves and the FX-Cablelok System.
The design modifications are outlined below:
The two proximal hooks in the current grip have been reduced to one centrally positioned hook in the new grip. This central hook is available with and without a cannulated groove for the passage of cable. A hole in the central hook allows for the passage of cable that provides the vertical fixation feature of the device.
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The flares on the anterior and posterior limbs (used for the passage of cable during vertical fixation) have been removed. Two new designs have been developed to provide for vertical fixation. The first design incorporates a crimping mechanism in each of the distal hooks of the grip. The cable is passed through the grip and a "tension band" device (that is placed below the trochanter, similar to the existing FX-Cablelok sleeve design) and secured by crimping the hooks on the grip. The second design incorporates a crimping mechanism directly in the tension band component. With this design, the cable is passed through the grip and the tension band device and secured by crimping the tension band component.
The standard method for horizontal fixation on the current design is still provided in both of the new designs.
The substantial equivalence of the modified Dall-Miles Grip is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Osteonics' FX-Cablelok Grip Components (K980594) and Howmedica's Dall-Miles Trochanter Cable Grip System (K844068, K900926, and K971741).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 eagle with three curved lines representing its wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Mr. John Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K984432 Re : Dall-Miles Cable Grip Modification Trade Name: Regulatory Class: II Product Code: JDQ and LYT Dated: December 11, 1998 December 14, 1998 Received:
Dear Mr. Dichiara:
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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation (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 In addition, FDA may publish further announcements action. 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. John Dichiara
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) 594-4659. 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 (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 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): k 984432
Device Name: Dall-Miles Cable Grip (A-Grip)
Indications for Use:
.
The Dall-Miles Cable Grip is intended to be used for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy.
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
(Division Sign-Off)
| Division: | Restorative Devices |
|---|---|
| 510(k) Number | K984432 |
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.