(12 days)
The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.
The modified Distal Volar Radius Anatomical Plate System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Distal Volar Plates • Distal Dorsal Nail Plate • Pegs • Screws. Included in the sterilization tray are the following re-useable instruments: • Peg drivers • Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: • F.A.S.T. Guide Technology Drill Guide; and • Drill bits
The provided text describes a medical device, the "Distal Volar Radius Anatomical Plate System," seeking 510(k) clearance. However, the document does not contain specific acceptance criteria for device performance or the study details that would prove the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance criteria through a detailed clinical or performance study with acceptance thresholds.
Here's an analysis based on the information provided, highlighting the absence of the requested details:
Acceptance Criteria and Device Performance
Not applicable/Not provided in the document. The document states:
- "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act."
- "The modified Distal Volar Radius Anatomical Plate System is substantially equivalent to the predicate Distal Volar Radius Repair System. The equivalence was confirmed through pre-clinical testing."
This indicates that the submission relied on demonstrating equivalence to an already legally marketed device rather than proving performance against specific quantitative acceptance criteria in a study. The "pre-clinical testing" mentioned is likely mechanical testing to show similar physical properties to the predicate, not a study with performance metrics in a clinical context.
Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Standards | Not established by FDA. | Not applicable. |
| Substantial Equivalence | Demonstrates equivalence (e.g., in design, materials, indications for use, and performance where applicable) to the predicate device: Distal Volar Radius Plate System (510(k) # K032705). | "The modified Distal Volar Radius Anatomical Plate System is substantially equivalent to the predicate Distal Volar Radius Repair System." (Confirmed through pre-clinical testing). |
| Biocompatibility | The titanium used meets requirements of ASTM F 136-96 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications). | "The implantable components... do not require biocompatibility testing because the titanium used in fabrications meets the requirements of ASTM F 136-96." |
Study Details
Based on the provided text, the specific study details for proving performance against acceptance criteria (as would be typical for an AI/diagnostic device) are not present. The submission relies on "pre-clinical testing" to demonstrate substantial equivalence, which typically involves mechanical and material testing rather than studies involving ground truth from experts or multi-reader reviews in a clinical setting.
Therefore, the following points will indicate "Not applicable" or "Not provided" as the information is absent in this 510(k) summary.
- Sample size used for the test set and the data provenance: Not provided (no clinical test set described). The "pre-clinical testing" typically involves material samples or mechanical models.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided (no independent ground truth establishment described, as the focus is on substantial equivalence confirmed by pre-clinical testing).
- Adjudication method for the test set: Not applicable/Not provided.
- 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 medical implant, not an AI diagnostic device).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (Not an algorithm-based device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided (No ground truth, in the clinical sense, is discussed for performance evaluation). Instead, the "truth" for this submission is established by the accepted performance and safety profile of the predicate device.
- The sample size for the training set: Not applicable/Not provided (No AI model training described).
- How the ground truth for the training set was established: Not applicable/Not provided.
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APR 2 6 2005
K050932 000043
510(k) Summary of Safety and Effectiveness
| GeneralProvisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Distal Volar Radius Anatomical Plate System | Plate Fixation Bone | |
| Name ofPredicateDevices | The device is substantially equivalent to:• Distal Volar Radius Plate System (510(k) # K032705 – October 1, 2003) – HandInnovations, Inc. | |
| Classification | Class II. | |
| PerformanceStandards | Performance standards have not been established by the FDA under section 514 ofthe Food, Drug and Cosmetic Act. | |
| Indications forUse | The Distal Volar Radius Anatomical Plate System is intended for the fixation offractures and osteotomies involving the distal radius. | |
| DeviceDescription | The modified Distal Volar Radius Anatomical Plate System is a set of orthopedicplates and fasteners supplied in a sterilization tray together with several reusable anddisposable tools. The set of orthopedic plates and fasteners provided in thesterilization tray consists of the following implantable devices:• Distal Volar Plates• Distal Dorsal Nail Plate• Pegs• Screws.Included in the sterilization tray are the following re-useable instruments:• Peg drivers• Other standard surgical tools.In addition, the following are non-reusable instruments included in the sterilizationtray:• F.A.S.T. Guide Technology Drill Guide; and• Drill bits | |
| Biocompati-bility | The implantable components of the Distal Volar Radius Anatomical Plate Systemand instruments do not require biocompatibility testing because the titanium used infabrications meets the requirements of ASTM F 136-96. | |
| Summary ofSubstantialEquivalence | The modified Distal Volar Radius Anatomical Plate System is substantiallyequivalent to the predicate Distal Volar Radius Repair System. The equivalence wasconfirmed through pre-clinical testing. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved lines, possibly representing a stylized human figure or a symbol of health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2005
Mr. Ernesto Hernandez COO, Vice President RA/QA Hand Innovations, Inc. 8905 SW Avenue, Suite 220 Miami, Florida 33176
Re: K050932 Trade/Device Name: Distal Volar Radius Anatomical Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: April 13, 2005 Received: April 14, 2005
Dear Mr. Hernandez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (PMA), 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 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Ernesto Hernandez
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 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), 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/industry/support/index.html.
Sincerely yours,
Ruleta
Miriam C. Provost, Ph.D. (一 Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _______________________
Page of of ___
Device Name: Distal Volar Radius Anatomical Plate System
Indications for Use Statement
The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Erich-Thomsen
021012 018. POT ivision of General, Restorative and Neurologics! Devices
Distal Volar Radius Anatomical Plate System Special 510(k) April 13, 2005
KOS0932
§ 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.