(51 days)
The DARCO Locking Bone Plate System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, lengths, number of plate holes and through different grades or bridge widths.
The provided text is related to a 510(k) submission for the DARCO Locking Bone Plate System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through performance studies.
Therefore, the document explicitly states:
"Performance Data: No clinical or non-clinical tests were used in the claim of substantial equivalence."
Based on this statement, the device's acceptance criteria and studies demonstrating its performance as requested in the prompt are not applicable to this 510(k) submission.
To directly answer your questions based only on the provided information:
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A table of acceptance criteria and the reported device performance:
- No acceptance criteria or reported device performance from studies are provided, as no performance tests were conducted for substantial equivalence.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable; no test set or performance data was used.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable; no ground truth for a test set was established.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable; no test set was used.
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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:
- No MRMC comparative effectiveness study was done. This device is a bone plate system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is a medical device (bone plate system), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable; no ground truth was established for performance testing.
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The sample size for the training set:
- Not applicable; no training set was used.
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How the ground truth for the training set was established:
- Not applicable; no training set was used.
The focus of this 510(k) summary is to demonstrate that the DARCO Locking Bone Plate System is substantially equivalent to a legally marketed predicate device (Normed Titanium Osteotomy Plating System K022325) based on its technological characteristics and intended use, without requiring new performance data.
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810 Memorial Boulevard Huntington, WV 25701
AUG 1 7 2006
Telephone: (304) 522-4883 Toll Free: 3800; 999-8866 feletax: (304) 522-0037
| 510(k) Summary | ||
|---|---|---|
| ---------------- | -- | -- |
Submitter Data: Darco International, Inc. 810 Memorial Blvd. Huntington WV 25701 Phone- (304) 522-4883 Fax - (304) 522-0037 Contact: Mark S. Cooper Date: June 26, 2006 Device Name: DARCO Locking Bone Plate System Common Name: Bone Fixation Plate Classification Name: Single/Multiple component metallic bone fixation appliance (per 21 CFR 888.3030) Legally Marketed Predicate Device: Normed Titanium Osteotomy Plating System (K022325) Device Description: The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, lengths, number of plate holes and through different grades or bridge widths. Intended Use: The DARCO Locking Bone Plate system is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes. The system can be used in both adult and pediatric patients. Technological Characteristics: There are no differences in the technological characteristics of the DARCO Locking Bone Plate System and the predicate device. Performance Data: No clinical or non-clinical tests were used in the claim of substantial equivalence.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2006
DARCO International % Mr. Mark S. Cooper Director of Regulatory Affairs 810 Memorial Boulevard Huntington, West Virginia 25701
Re: K061808
Trade/Device Name: DARCO Locking Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 26, 2006 Received: June 28, 2006
Dear Mr. Cooper:
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 revistration, 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
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Page 2 - Mr. Mark S. Cooper
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(c) 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 (21 ce re re re re voy), pick "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon yotain 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) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/ip3e20t111.
Sincerely yours.
Barbara Brechup
Mark N. Me İkerson 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) Statement of Indications for Use
| 510(k) number (if known) | K061808 |
|---|---|
| Device Name | DARCO Locking Bone Plate System |
| Indications for Use | The DARCO Locking Bone Plate System is intended foruse in stabilization and fixation of fresh fractures, revisionprocedures, joint fusion, and reconstruction of small bonesof the hand, feet, wrist, ankles, fingers and toes. Thesystem may be used in both adult and pediatric patients. |
Prescription Use __XXX (Part 21 CFR 801 Subpart D)
Over the Counter Use AND/OR
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
(Division Sign-Off
Division of General. Restorative, and Neurological Devices
510(k) Number K061403
6.1
§ 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.