(113 days)
The RoG 5.5mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
- Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- Elbow indications : Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
- Knee indications:- Lateral collateral ligament repair, medial collateral ligament ● repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameter of 5.5mm lengths of 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding size.
Here's an analysis of the acceptance criteria and study information for the RoGTM Sports Medicine Knotless Suture Anchor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study to Prove Performance |
|---|---|---|---|
| Mechanical Performance | Pull Testing | Equivalent to predicate device | Comparative study with K070389 |
| Fatigue Testing | Equivalent to predicate device | Comparative study with K070389 | |
| Material Safety | Biocompatibility | Compliance to ISO 10993 | Master File from PEEK supplier |
| Sterilization | Sterility | Sterility following autoclave sterilization validataed | Validation testing for autoclave sterility |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for the pull testing or fatigue testing. It only states "Testing consisted of pull testing and fatigue testing with comparison to the predicate device." The data provenance is not explicitly mentioned (e.g., country of origin), and it implies a prospective experimental design since it's a comparison of a new device against a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for this device's performance is established through objective mechanical testing (pull force, fatigue cycles) and material safety standards rather than expert clinical consensus or interpretation.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the "ground truth" for this device is objective testing, not expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The RoGTM Sports Medicine Knotless Suture Anchor is a surgical implant, and its performance is evaluated through mechanical bench testing and material safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical surgical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth used for this device's performance evaluation is based on:
- Objective Mechanical Test Results: Tensile strength/pull-out force and fatigue resistance from controlled laboratory experiments.
- Material Science Standards: Compliance with ISO 10993 for biocompatibility.
- Sterilization Validation: Demonstrated effectiveness of the sterilization process.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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510(k) SUMMARY
Premarket Notification Number: K110230
DEVICE: RoGTM Sports Medicine Knotless Suture Anchor
SPONSOR/MANUFACTURER: RoG Sports Medicine, Inc. 16450 S. 104th Ave. Orland Park, IL 60467
SUMBITTER/REGULATORY CONTACT:
Curtis Raymond Orchid Design 80 Shelton Technology Ctr. Shelton, CT 06484
FDA ESTABLISHMENT REGISTRATION NUMBER: (pending)
TRADE NAME, COMMON NAME, CLASSIFICATION:
TRADE NAME: RoG Sports Medicine Knotless Suture Anchor
COMMON NAME: Suture Anchor
CLASSIFICATION: Class II (ref .: 21 CFR 888.3040); Product Code MBI
PREDICATE DEVICE(S):
K070389 - ALLthread™ PEEK Suture Anchor (Biomet Sports Medicine)
DESCRIPTION OF SUBJECT DEVICE:
The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameter of 5.5mm lengths of 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding size.
INTENDED USE:
The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule ● repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, bicens tenodesis.
- . Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
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K110230*#2/2
- . Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- . Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
- . Knee indications :- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
PERFORMANCE CHARACTERISTICS:
The subject was evaluated in accordance with FDA's Guidance Document for Testing Bone Anchor Devices (4/20/96). Testing consisted of pull testing and fatigue testing with comparison to the predicate device. The subject device was found to be equivalent to the predicate device in such performance.
SAFETY CHARACTERISTICS:
The device is composed exclusively of polyetheretherketone (PEEK). A Master File demonstrating safety of the material has been supplied by the PEEK supplier and shows compliance to the requirements of ISO 10993. Additionally, validation testing was conducted to show the sterility of the device following autoclave sterilization.
CONCLUSION(S):
The subject device has the same design considerations, assembly configurations, performance characteristics and indications for use as the predicate device.
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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 consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 9 2011
RoG Sports Medicine, Inc. % Mr. Curtis Raymond Orchid Design 80 Shelton Technology Center Shelton, Connecticut 06484
Re: K110230
Trade/Device Name: RoG Knotless Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 12, 2011 Received: May 13, 2011
Dear Mr. Raymond:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Mr. Curtis Raymond
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
A. Ky B. n h
fen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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(Page 1 of 1)
Indications for Use
510(k) Number (if known): K110230
Device Name: RoG Knotless Suture Anchor
The RoG 5.5mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
- Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- Elbow indications : Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
- Knee indications:- Lateral collateral ligament repair, medial collateral ligament ● repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) for M. Mulkerson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110230
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.