(55 days)
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
This device is the ring component of an external fixation device. Pin/wire clamps and distractors are attached to the ring to complete a rigid construct utilized to stabilize long bone fractures or in limb lengthening or correction of bony deformities. These rings are fabricated from two beryllium-aluminum alloy rings encased in an injection-molded polycarbonate plastic.
The provided text describes a 510(k) premarket notification for a medical device called an "External Fixation Ring." This submission is for a new device claiming substantial equivalence to existing predicate devices. However, this submission does not include any information about acceptance criteria or a study proving device performance in the context of an AI/ML-driven medical device.
The document details:
- Device Name: External Fixation Ring
- Submitter: RIGID FX Orthopedics, Inc.
- Classification: Single/multiple component metallic bone fixation appliances and accessories (21 CFR section 888.3030)
- Description: Ring component of an external fixation device, made of two beryllium-aluminum alloy rings encased in injection-molded polycarbonate plastic.
- Intended Use: Stabilizes open and/or unstable fractures of long bones, joint fusions, and limb lengthening/deformity corrections.
- Technological Characteristics: Material (beryllium-aluminum alloy) differs from predicates (aluminum alloy or carbon fiber composite).
- Nonclinical Tests: "This device has similar load carrying capabilities as solid rings made of aluminum alloy." This is the only mention of performance testing, and it's a general statement, not a detailed study.
- Predicate Devices: Several external fixation systems are listed as equivalent devices.
Therefore, it is impossible to complete the requested table and answer the study-related questions as the provided input does not contain the necessary information. The submission mainly focuses on the device description, intended use, comparison to predicate devices, and a high-level statement about nonclinical testing for mechanical properties. There is no mention of an AI/ML component, acceptance criteria for an algorithm, or any study design/results related to software performance.
To answer the prompt, I would need a different type of document, specifically one that outlines a clinical or non-clinical study for an AI/ML-driven medical device, including its performance metrics and acceptance criteria.
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Date July 17, 2002
Submitter
RIGID FX Orthopedics, Inc 3601 South Congress Ave. Bldg B, Suite 300 Austin, TX 78704
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-4694
Common name
External Fixation Frame Component
Classification name
Single/multiple component metallic bone fixation appliances and accessories (per 21 CFR section 888.3030)
Equivalent Device
| Device | Company/510(k) | Description | Intended Use |
|---|---|---|---|
| Hoffman II HybridFrame System | Howmedica Osteonics/K000957 | Carbon fiber rings to receivevarious pin clamps and distractors | *see below |
| Ilizarov ExternalFixation System | Smith & Nephew | Aluminum and carbon fiber ringsto receive various pin clamps anddistractors | *see below |
| TrueLok | Encore Medical, L.P./K941048 | Aluminum rings to receive variouspin clamps and distractors | *see below |
| Taylor SpatialFrame ExternalFixation System | Smith & Nephew/K970748 | Carbon fiber rings to receivevarious pin clamps and distractors | *see below |
Device Description
This device is the ring component of an external fixation device. Pin/wire clamps and distractors are attached to the ring to complete a rigid construct utilized to stabilize long bone fractures or in limb lengthening or correction of bony deformities. These rings are fabricated from two beryllium-aluminum alloy rings encased in an injection-molded polycarbonate plastic.
Intended Use
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
Summary of Technological Characteristics Compared to Predicate Device
Material of this device is beryllium-aluminum alloy other devices are fabricated from aluminum alloy or carbon fiber composite.
Summary Nonclinical Tests
This device has similar load carrying capabilities as solid rings made of aluminum alloy.
SFP 1 7 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2002
Rigid RX Orthopedics, Inc. J. D. Webb c/o J. D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Rc: K022423
Trade/Device Name: External Fixation Ring Regulation Number: 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: July 17, 2002 Received: July 24, 2002
Dear Mr. Webb:
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. J. D. Webb
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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Galin M. Witter, Ph.D., M.D.
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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510(k) number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: External Fixation Ring
Indications for Use:
External Fixation Ring Indications for Use
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use -
(Optional format 1-2-96)
)
(Division Sign-off) Division of General, Neurological and Restorative Devices
Mark A. Miller 510(k) Number __
(Division Sign-Off) (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.