(83 days)
The Acumed Wrist Fusion Plate, an addition to the Acumed Congruent Bone Plate System, is designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.
The Acumed Wrist Fusion Plate is spherical in shape. Holes or slots offer multiple screw placement options. The plate also has holes that may be utilized for provisional tacking or positioning with Kirschner wires to the bones prior to screw installation. A threaded hole in the center of the plate allows for optional accessories to be attached to the plate.
In this 510(k) submission for the Acumed Wrist Fusion Plate (K021321), no specific performance data or studies proving the device meets acceptance criteria are provided. The submission states that "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."
The basis for clearance is substantial equivalence to predicate devices (KMI Wrist Fusion System (K991873) and Acumed Congruent Bone Plate System (K012655)), rather than direct performance testing of the device itself.
Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from the provided document. The sections on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details are not applicable as these types of studies were explicitly stated to not have been performed or required for this submission.
Summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable, as no performance study was conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no performance study was conducted.
4. Adjudication Method for the Test Set:
Not applicable, as no performance study was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done.
6. Standalone Performance Study:
No, a standalone performance study was not done.
7. Type of Ground Truth Used:
Not applicable, as no performance study was conducted.
8. Sample Size for the Training Set:
Not applicable, as no performance study was conducted.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no performance study was conducted.
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HEUMED, INC.
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
K021321
Tel (503) 627-9957
page 1 of 1
510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information: Acumed, Inc.
5885 NW Cornelius Pass Road Hillsboro, Oregon 97007 U.S.A. Phone: (503) 627-9957 Contact: Carrie McMichael, Regulatory Affairs
Classification Name: Single/multiple component metallic bone fixation and accessories Common Name: Plate, Fixation, Bone Proprietary Name: Wrist Fusion Plate Proposed Regulatory Class: Class II, 21 CFR 888.3030
Legally Marketed Equivalent Device(s): KMI Wrist Fusion System (K991873) Acumed Congruent Bone Plate System (K012655)
Device Description: The Acumed Wrist Fusion Plate is spherical in shape. Holes or slots offer multiple screw placement options. The plate also has holes that may be utilized for provisional tacking or positioning with Kirschner wires to the bones prior to screw installation. A threaded hole in the center of the plate allows for optional accessories to be attached to the plate.
Intended Use: The current Acumed Congruent Bone Plate System includes plates and screws for fractures, fusions, or osteotomies designed specifically for the clavicle, humerus, radius, ulna, metatarsals, malleoulus, tibia, fibula, and metacarpals. The Acumed Wrist Fusion Plate, an addition to the Acumed Congruent Bone Plate System, is designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. This is similar to the KMI Wrist Fusion System intended use and does not raise any new issues of safety and effectiveness.
Technological Characteristics: The Acumed Wrist fusion Plate is a spherical, metal plate made from titanium in conformance with ASTM F136. The KMI Wrist Fusion Plate is a conical, metal plate made from 316L Stainless Steel. Both materials are used in numerous bone plates and screws. There are no technological characteristics that raise new issues of safety and effectiveness.
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable
Based upon the similarities between the Acumed Wrist Fusion Plate and the predicate devices studied, the safety and effectiveness of the Acumed Wrist Fusion Plate is substantially equivalent to the predicate devices mentioned above.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2002
Ms. Carrie McMichael Regulatory Affairs Deputy Acumed. Inc. 5885 NW Cornelius Pass Road Hillsboro, Oregon 97124
Re: K021321 Trade/Device Name: Wrist Fusion Plate Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: II Product Code: HRS Dated: April 22, 2002 Received: April 25, 2002
Dear Ms. McMichael:
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 - Ms. Carrie McMichael
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" (21CFR 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.
b. Mark N. Wilkerson
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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Page 1 of 1
KOdl 30 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Wrist Fusion Plate
Indications For Use:
The Wrist Fusion Plate and accessories are designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021321
(Optional Format 3-10-98)
§ 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.