(35 days)
The Fragment Specific fixator is intended for use in adult male and females from skeletal maturity to the geriatric population who have sustained an unstable extra-articular distal radius fracture that cannot be managed by casting, or a 3- or 4-part intra-articular fracture provided the medial fragment is large enough for the insertion of 2 separate 2.5mm - 3.0mm threaded cortical pins. The device can be used in a nonjoint bridging configuration which allows for immediate wrist motion during the fracture healing period of 6-8 weeks. It may alternatively be used in a joint bridging manner to provide ligamentotaxis to obtain and maintain the fracture reduction during the healing period.
The Fragment Specific Fixator is a single use external fixator designed to provide stable fracture fixation in a nonjoint bridging application that does not cross the wrist or in a joint bridging application that obtains and maintains fracture reduction through ligamentotaxis. The lightweight, radiolucent construct attaches to self drilling bone pins to provide secure fracture fixation and to capture fragments.
This is a medical device 510(k) premarket notification for an external fixator, specifically for the treatment of distal radius fractures. The provided document focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or specific study results in the format requested for AI/software-based devices.
Therefore, many of the requested sections regarding AI/software performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be extracted from this document because they are not applicable to this type of device submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria or detailed device performance metrics in the context of an AI/software study. It states:
| Criterion Type | Acceptance Criteria (Not explicitly stated for AI/software) | Reported Device Performance (Not explicitly stated for AI/software) |
|---|---|---|
| Mechanical Performance | (Implied: Device must meet mechanical integrity and stability requirements typical for external fixators) | "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." (No specific quantitative values provided in this summary.) |
| Biocompatibility | (Implied: Materials must be biocompatible) | "manufactured from similar materials" to predicate devices (Implied that similar materials are biocompatible) |
| Functional Equivalence | (Implied: Device should perform its intended function of fracture fixation) | "has the same intended use, has similar performance characteristics... and is similar in design to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable / Not provided. This is a mechanical device, not a software or AI device that would have a "test set" in the context of pattern recognition or image analysis. Performance was assessed through non-clinical (laboratory) testing.
- Data Provenance: Not applicable / Not provided in the context of a dataset. Performance data came from "non-clinical (laboratory) performance testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth as typically defined for AI/software (e.g., expert consensus on image labels) is not relevant for this mechanical device. The "ground truth" for a mechanical device revolves around engineering specifications, material properties, and mechanical testing standards.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of expert adjudication for this mechanical device's performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI/software device, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This is a physical, mechanical device, not an algorithm.
7. Type of Ground Truth Used:
- For mechanical devices, "ground truth" is typically defined by objective engineering measurements, material specifications, and adherence to established mechanical testing standards (e.g., strength, durability, fatigue resistance). The summary states "non-clinical (laboratory) performance testing," implying that such objective measurements were performed.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/software device that undergoes "training."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. No training set is involved for this type of device.
Key Takeaway from the Document:
The provided 510(k) summary establishes substantial equivalence by demonstrating that the Fragment Specific Fixator has the same intended use, similar performance characteristics, is made from similar materials using similar processes, and has a similar design to two predicate devices: Millennium Medical Technologies, Inc., Wristore Distal Radius Fracture Fixator (K042761) and Howmedica Osteonics Corp., Hoffmann II Micro External Fixation System (K050048). The basis for its safety and effectiveness relies on "non-clinical (laboratory) performance testing."
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JCT 17 2005
510(k) Summary
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| Submitter: | David J. Slutsky M.D.South Bay Hand Surgery Center3475 Torrance Blvd., Ste FTorrance, CA 90503 |
|---|---|
| Contact person: | David J. Slutsky M.D.Phone: (310) 792-1809FAX: (310) 792 1811 |
| Date: | September 10, 2005 |
| Trade Name: | Fragment Specific Fixator |
| Common Name: | External Fixator |
| Classification Name: | Smooth or threaded metallic bone fixation fastener.Single/multiple component metallic bone fixationappliances and accessories. |
| Classification Reference: | 21 CFR 888.3040, 3030 |
| Predicate Devices: | Millennium Medical Technologies, Inc., WristoreDistal Radius Fracture Fixator, K042761, clearedNovember 17, 2004.Howmedica Osteonics Corp., Hoffmann II MicroExternal Fixation System, K050048, cleared March4, 2005. |
| Device Description: | The Fragment Specific Fixator is a single useexternal fixator designed to provide stable fracturefixation in a nonjoint bridging application that doesnot cross the wrist or in a joint bridging applicationthat obtains and maintains fracture reductionthrough ligamentotaxis. The lightweight, radiolucentconstruct attaches to self drilling bone pins toprovide secure fracture fixation and to capturefragments. |
| Intended Use: | The Fragment Specific fixator is intended for use in |
| the geriatric population who have sustained anunstable extra-articular distal radius fracture thatcannot be managed by casting, or a 3- or 4-partintra-articular fracture provided the medial fragmentis large enough for the insertion of 2 separate2.5mm - 3.0mm threaded cortical pins. The devicecan be used in a nonjoint bridging configurationwhich allows for immediate wrist motion during thefracture healing period of 6-8 weeks. It mayalternatively be used in a joint bridging manner toprovide ligamentotaxis to obtain and maintain thefracture reduction during the healing period. | |
| Comparison to Predicate Device: | The Fragment Specific Fixator has the sameintended 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. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David J. Slutsky, M.D. South Bay Hand Surgery Center 3475 Torrance Boulevard, Suite F Torrance, California 90503
Re: K052498 Trade/Device Name: Fragment Specific Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bonc fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 10, 2005 Received: September 12, 2005
Dear Dr. Slutsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becomed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or 10 conniner co may 20, 1978) in accordance with the provisions of the Federal Food, Drug, de vices that have occh receasined in quire approval of a premarket approval application (PMA). and Cosmetic For (110) that the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controls proving 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 may be subject to back adderal 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 r rouse or hose made a determination that your device complies with other requirements of the Act that 1197 has intatutes and regulations administered by other Federal agencies. You must or any I 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 - David J. Slutsky, M.D.
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 premated nevice 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 in you don't 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 other Echeral 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/industry/support/index.html
Sincercly yours,
2
Cow Mark N. Melkerson Acting 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: 052498
Device Name: Fragment Specific Fixator
Indications for Use:
The Fragment Specific fixator is intended for use in adult male and females from The Tragment Openiation who have sustained an unstable extra-SKeletal maturity to the gonation in managed by casting, or a 3- or 4-part intraarticular fracture provided the medial fragment is large enough for the insertion of 2 anticular nacture provided the modial nagli pins. The device can be used in a nonjoint Separate 2.0mm - 0.0mm thrallows for immediate wrist motion during the fracture bridging configuration which allowy alternatively be used in a joint bridging manner to nealing perfou of o o woner in and maintain the fracture reduction during the healing period.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) And/Or
Over-the-Counter Use -(21 CFR 801 Subpart C)
YELEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.