(24 days)
The Rayhack Low Profile Locking Plate is a metallic surgical implant intended for long bone fixation utilized to assist healing but not intended to replace normal body structures. The plate and screws which attach to the bone are temporary internal fixation devices which align the bone surfaces in order to permit bone healing.
The Rayhacks Low Profile Locking Plate and Instruments is an implant intended for fixation of long bones to assist healing. The implant is fabricated from stainless steel. It is fixated with two 2.7mm locking screws, four 3.5mm standard cortical screws and one 2.7 standard interfragmentary cortical screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.
The acceptance criteria and study details for the Rayhack Low Profile Locking Plate are as follows:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Holding strength and stiffness characteristics compared to the predicate device. | The testing demonstrates substantially equivalent performance between the two devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Bone Model Testing," which implies a laboratory setting, likely using a limited number of bone models.
- Data Provenance: The testing was conducted as part of the 510(k) submission process, suggesting an internal study by the manufacturer. The data provenance is not further detailed (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the performance data is based on physical bone model testing, not interpretation by human experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the performance data is based on physical bone model testing, not interpretation by human experts.
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:
This information is not applicable. The device is a bone fixation plate, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical bone fixation plate, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the bone model testing would be the measured physical properties (holding strength and stiffness) of the bone models with and without the device, and the direct comparison of these measurements to establish substantial equivalence with the predicate device.
8. The sample size for the training set:
This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
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K061955 510(K) SUMMARY
1. SUBMITTER:
AUG - 4 2006
Creative Medical Designs, Inc. 13914 Shady Shores Drive Tampa, FL 33613 813 - 875-9999 (phone) 813-961-5543 (fax)
Contact: Jane Rayhack, CEO Date Prepared: July 6, 2006
2. DEVICE:
Trade Name: Rayhack Low Profile Locking Plate and Instruments Common Name: Bone Fixation Plate Class: II Classification Name: Single/multiple component bone fixation appliances and accessories Fastener, Fixation, non-degradable soft tissue
3. PREDICATE DEVICE:
Rayhack Osteotomy System (K952766)
4. DEVICE DESCRIPTION:
The Rayhacks Low Profile Locking Plate and Instruments is an implant intended for fixation of long bones to assist healing. The implant is fabricated from stainless steel. It is fixated with two 2.7mm locking screws, four 3.5mm standard cortical screws and one 2.7 standard interfragmentary cortical screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.
5. INTENDED USE:
The Rayhack" Low Profile Locking Plate is a metallic surgical implant intended for long bone fixation utilized to assist healing but not intended to replace normal body structures. The plate and screws which attach to the bone are temporary internal fixation devices which align the bone surfaces in order to permit bone healing.
6. COMPARISON OF CHARACTERISTICS:
The proposed Rayhack Low Profile Locking Plate is fabricated from identical materials as the predicate device. In addition, the plate and instrumentation is
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K061955 (pg 2 of 2)
essentially identical to the predicate except it allows for the use of locking screws and the plate is a lower profile. Instrumentation has been modified to work with the revised plate.
7. PERFORMANCE DATA:
The following performance data was proved in support of the substantial equivalence determination:
Bone Model Testing: The holding strength and stiffness characteristics of the new plate compared to the predicate plate.
The testing demonstrates substantially equivalent performance between the two devices
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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 features a stylized depiction of an eagle or bird with three horizontal lines forming its wings. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES UNITED STATES OF AMERICA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2006
Creative Medical Design, Inc. % Ms. Jane Rayhack CEO 13914 Shady Shores Drive Tampa, Florida 33613
Re: K061955
Trade/Device Name: Rayhack® Low Profile Locking Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 10, 2006 Received: July 11, 2006
Dear Ms. Rayhack:
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
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Page 2 - Ms. Jane Rayhack
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Semmler
for
E
I
Mark N. Melkerson 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): _ ¥06 | 9 5 5
Device Name: Rayhack 6 Low Profile Locking Plate
Indications for Use:
The Rayhack Low Profile Locking Plate is a metallic surgical implant intended for long bone fixation utilized to assist healing but not intended to replace normal body structures. The plate and screws which attach to the bone are temporary internal fixation devices which align the bone surfaces in order to permit bone healing.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helut Leun
(Division Sign-Off) Page of Division of General, Restorative, and Neurological Devices
510(k) Number Ks61955
(Posted November 13, 2003)
§ 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.