(64 days)
The RC Loop Anchor with Dual Orthocord Suture is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Rotator cuff repair
RC Loop with Dual Suture is a preloaded, absorbable disposable suture anchor/ inserter assembly for rotator cuff repair. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Panalok RC Loop Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
The information provided describes a 510(k) premarket notification for a medical device and not a study assessing device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and reader studies is not present in the provided text.
However, I can extract the relevant information regarding the type of assessment performed for this medical device:
Device: RC Loop Anchor with Dual Orthocord Suture
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Suture conformance to USP monograph for absorbable sutures | The ORTHOCORD suture conformed to the USP monograph for absorbable sutures. |
| Suture compatibility and deployment | Met predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not applicable. The "test set" in this context refers to physical bench testing, not a dataset of medical images or patient records. This was a bench test, and not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for bench testing is established by technical specifications and validated testing methodologies, not expert consensus in a clinical diagnostic sense.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. Bench testing results are typically evaluated against predefined engineering and material standards.
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:
- MRMC Study: No. This is a physical medical device (suture anchor), not an AI/ML diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Engineering specifications, material standards (e.g., USP monograph), and predefined technical criteria for suture compatibility and deployment.
8. The sample size for the training set:
- Sample Size: Not applicable. This refers to a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- How Ground Truth Was Established: Not applicable.
Summary of the Study:
The provided text describes a 510(k) Premarket Notification for a medical device. The "study" mentioned is a series of bench tests conducted to demonstrate that the RC Loop Anchor with Dual Orthocord Suture is "substantially equivalent" to a predicate device.
- Study Type: Bench testing (not a clinical trial, diagnostic accuracy study, or AI/ML performance study).
- Purpose: To demonstrate conformance to consensus and voluntary standards, and that the device performs as intended in terms of material properties (suture conformance to USP monograph) and functional aspects (suture compatibility and deployment).
- Conclusion: Based on the bench testing, device description, and comparison to predicate devices, the manufacturer concluded that the device is substantially equivalent to predicate devices.
{0}------------------------------------------------
Kobo553 page 'f2
MAY 4 2006
510(k) SUMMARY
RC Loop Anchor with Dual Orthocord Suture
| Submitter's Name and Address: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 |
|---|---|
| Contact Person | Kristine ChristoSenior Regulatory Affairs SpecialistDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-828-3359Facsimile: 508-977-6955e-mail: KChristo@Dpyus.jnj.com |
| Name of Medical Device | Classification Name: Screw, Fixation, Bone StapleCommon/Usual Name: Appliance for reconstruction of soft tissue to boneProprietary Name: RC Loop Anchor |
| Substantial Equivalence | RC Loop Anchor is substantially equivalent to:Panalok RC Loop Anchor, K041065, manufactured by DePuy Mitek. |
| Device Classification | Bone anchors/screws are classified by the FDA as Class II Medical Devices under the generic category of Single/Multiple component metallic bone fixation appliances and accessories.RC Loop Anchor Systems carry FDA product code JDR and is classified assingle / multiple component metallic bone fixation appliances and accessories soft tissue fastener under 21 CFR 888.3030. |
| Device Description | RC Loop with Dual Suture is a preloaded, absorbable disposable suture anchor/ inserter assembly for rotator cuff repair. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Panalok RC Loop Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L- |
510(k) Premarket Notification: Special
RC Loop Anchor with Dual Orthocord Suture
Confidential
{1}------------------------------------------------
page 2 of 2
lactide) polymer. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
Indications for Use The RC Loop Anchor with Dual Orthobond Suture is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Rotator cuff repair Safety and Performance The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria. Based on the indications for use, technological characteristics, and comparison to predicate devices, the RC Loop Anchor with Dual Orthocord Suture has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Confidential
{2}------------------------------------------------
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 caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular fashion.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2006 MAY
Depuy Mitek a Johnson & Johnson Company % Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K060553
Trade/Device Name: RC Loop Anchor with Dual Orthocord Suture Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: April 10, 2006 Received: April 11, 2006
Dear Ms. Christo:
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
{3}------------------------------------------------
Page 2 - Ms. Kristine Christo
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. 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 (301) 594-4639. 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 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,
Heleutermerics
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): K060553
Device Names: RC Loop Anchor with Dual Orthocord Suture
Indications for Use:
The RC Loop Anchor with Dual Orthocord Suture is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Rotator cuff repair
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No
(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)
Herbert Lerner ud
(Division Page 1 of Division of General, Restorative, and Neurological Devices
510(k) Number K060553
510(k) Premarket Notification: Special RC Loop Anchor with Dual Orthocord Suture
Confidential
80
§ 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.