(43 days)
The Wristore™* Distal Radius Fracture Fixator is indicated for external fixation of the upper extremity.
The Wristore Distal Radius Fracture Fixator is a single use external fixator designed to provide stable fracture fixation. The lightweight, radiolucent construct incorporates self-drilling bone pins and K-wires to provide secure fracture fixation and to capture fracture fragments.
Here's an analysis of the provided text regarding the Wristore™ Distal Radius Fracture Fixator's acceptance criteria and study information:
Based on the provided Traditional 510(k) Premarket Notification for the Zimmer Wristore™ Distal Radius Fracture Fixator, the information regarding acceptance criteria and detailed study specifics for device performance is very limited. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical or standalone performance study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit acceptance criteria are not defined in the provided document. | The document states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: The document only mentions "non-clinical (laboratory) performance testing." There is no indication of human subject data, country of origin, or whether it was retrospective or prospective.
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 as no human-expert-validated ground truth is mentioned for the "non-clinical (laboratory) performance testing." The evaluations were likely based on engineering or mechanical criteria rather than expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication method is mentioned.
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:
- No. The document describes a medical device (external fixator), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device. The "non-clinical (laboratory) performance testing" is analogous to a standalone performance evaluation of the device's mechanical properties, but it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "non-clinical (laboratory) performance testing," the ground truth would typically be established based on engineering standards, biomechanical benchmarks, and material specifications. This would involve mechanical testing (e.g., strength, stiffness, fatigue) and possibly biocompatibility tests. No clinical ground truth (like pathology or outcomes data) is referenced here, as it's a pre-market notification relying on substantial equivalence and laboratory testing, not clinical trials.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
Summary of the Study Proving Device Meets Acceptance Criteria:
The provided document indicates that the device's safety and effectiveness were demonstrated through "non-clinical (laboratory) performance testing." This implies a series of mechanical, material, and/or benchtop tests designed to evaluate the physical properties and functionality of the external fixator. The specific details of these tests, including methodologies, performance metrics, and the results beyond a general statement of "safe and effective," are not included in this summary. The 510(k) process often relies heavily on demonstrating substantial equivalence to predicate devices, and the laboratory testing primarily serves to confirm that the new device performs comparably or acceptably under defined conditions.
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Image /page/0/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a sans-serif font. The logo is black and white.
Traditional 510(k) Premarket Notification
| NOV 1 7 2004 | Summary of Safety and Effectiveness |
|---|---|
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
| Contact Person: | Noah BartschSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8552Fax: (574) 372-4605 |
| Date: | 10-04-2004 |
| Trade Name: | Wristore™* Distal Radius Fracture Fixator |
| Common Name: | External Fixator |
| Classification Name: | Smooth or threaded metallic bone fixation fastenerSingle/multiple component metallic bone fixationappliances and accessories |
| Classification Reference: | 21 CFR § 888.3040, 3030 |
| Predicate Devices: | Millennium Medical Technologies, Inc., WristoreFixator, K012294, cleared March 4, 2002 |
| Immedica, Inc, TransFx Self-Drilling ExternalFixation Anchor Pin, K001228, cleared July 7, 2000 | |
| Device Description: | The Wristore Distal Radius Fracture Fixator is asingle use external fixator designed to providestable fracture fixation. The lightweight,radiolucent construct incorporates self-drilling bonepins and K-wires to provide secure fracture fixationand to capture fracture fragments. |
| Intended Use: | The Wristore Distal Radius Fracture Fixator isindicated for external fixation of the upperextremity. |
| Comparison to Predicate Device: | The Wristore Distal Radius Fracture Fixator has thesame intended use, has similar performancecharacteristics, is manufactured from similarmaterials using similar processes, and is similar indesign to the predicate devices. |
| Performance Data: | The results of non-clinical (laboratory) performancetesting demonstrate that the device is safe andeffective. |
- Trademark of Millennium Medical Technologies, Inc.
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Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized "Z" inside of a circle, followed by the word "zimmer" in a bold, sans-serif font. The "Z" in the circle is black, and the word "zimmer" is also black.
*Trademark of Millennium Medical Technologies, Inc.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2004
Mr. Noah Bartsch Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581
Re: K042761
Trade/Device Name: Wristore™ Distal Radius Fracture Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 4, 2004 Received: October 5, 2004
Dear Mr. Bartsch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered pror to rias 2011-11-11 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 r ou may) ater see or visions 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 If your de ree 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Noah Bartsch
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with a a your e FDA finding of substantial equivalence of your device to a legally premailed predicated 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark H. Mellum
Celia M. Witten, Ph.D., M.D. 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:
Wristore™* Distal Radius Fracture Fixator
*Trademark of Millennium Medical Technologies, Inc.
Indications for Use:
The Wristore™* Distal Radius Fracture Fixator is indicated for external fixation of the upper extremity.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Ot7)
Division of General, Restorative, and Neurological Devices
510(k) Number K042761
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.