(112 days)
The Acu-Sinch Repair System is intended to be used in conjunction with a clavicle plate of the Congruent Bone Plate System to provide fixation during the healing of clavicle fractures.
The Acu-Sinch Repair System also may be used as a stand-alone system for treatment of acromioclavicular and/or coracoclavicular ligament disruption.
The Acumed Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Acumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle.
The Acu-Sinch Repair System consists of several components (Suture Anchor, Clavicle Fracture Plate, Acu-Sinch plate, Suture Retainer, Screws, and Suture) which can be combined to create various device constructs to treat the indications listed above. The Suture Anchor can be used for fixation of suture to bone in the anatomic locations listed above.
The acceptance criteria and study proving the device meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Load to Failure | Substantially equivalent to predicate device components | Components demonstrated substantial equivalence to predicate |
| Fatigue Testing | Substantially equivalent to predicate device components | Components demonstrated substantial equivalence to predicate |
| Pull-out Comparison | Substantially equivalent to predicate device components (for 2.3mm screws with Distal Clavicle Plates) | Demonstrated substantial equivalence to predicate |
| Engineering Analysis | Substantially equivalent to predicate device plates | Demonstrated substantial equivalence to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact "sample sizes" in terms of number of devices or iterations for the preclinical testing. The testing described is preclinical (laboratory-based mechanical testing), not a clinical study involving human or animal subjects, so data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the typical sense. The testing was performed on the device components themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the "ground truth" for the preclinical mechanical tests is based on the physical properties and performance of the device components compared to established predicate devices, rather than expert interpretation of medical data.
4. Adjudication Method for the Test Set
This information is not applicable as the preclinical tests involve objective mechanical measurements and comparison to predicate devices, not expert adjudication of clinical outcomes or images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The study conducted was preclinical mechanical testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a surgical repair system, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the preclinical testing was established by the performance of legally marketed predicate devices. The acceptance criterion for the Acu-Sinch Repair System was that its mechanical performance (load to failure, fatigue, pull-out strength, and general engineering analysis) was "substantially equivalent" to these predicates.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is a medical device subject to preclinical mechanical testing, not an algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
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NOV 1 4 2011
510(k) Summary
| Device Trade Name: | Acu-Sinch Repair System and Acumed Suture Anchor |
|---|---|
| Manufacturer: | Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124 |
| Contact: | Ms. Lino TsaiRegulatory SpecialistPhone: (503) 627-9957 |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798 |
| Date Prepared: | October 28, 2011 |
| Classifications: | 21 CFR 888.3030, Single/multiple component metallicbone fixation appliances and accessories |
| and | |
| 21 CFR 888.3040, Smooth or threaded metallic bonefixation fasteners | |
| Class: | II |
| Product Codes: | HTN, HWC, MBI, and HRS |
Indications For Use:
The Acu-Sinch Repair System is intended to be used in conjunction with a clavicle plate of the Congruent Bone Plate System to provide fixation during the healing of clavicle fractures.
The Acu-Sinch Repair System also may be used as a stand-alone system for treatment of acromioclavicular and/or coracoclavicular ligament disruption.
The Acumed Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: . Shoulder: " Rolator "Our repairs, aration Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
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- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, . Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, . Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
- Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament . Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment. Ulnar or Radial Collateral Ligament . Elbow: Reconstruction
Acumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle.
Device Description:
The Acu-Sinch Repair System consists of several components (Suture Anchor, Clavicle Fracture Plate, Acu-Sinch plate, Suture Retainer, Screws, and Suture) which can be combined to create various device constructs to treat the indications listed above. The Suture Anchor can be used for fixation of suture to bone in the anatomic locations listed above.
Substantial Equivalence
The components of the Acu-Sinch Repair System are substantially equivalent to the following devices: Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device (K082095); and Arthrex TightRope™ Acromioclavicular (AC) Device (K052776) with respect to indications, materials, and technological characteristics. The suture to be used with the Acu-Sinch Repair System was cleared in K063778. When the Acu-Sinch Repair System is used as an adjunct in fracture repair, the clavicle plates are substantially equivalent to plates cleared in K012655 with respect to materials and plate strength.
The Acumed Suture Anchor is substantially equivalent to the Arthrex Corkscrew FT (K061665) with respect to indications, materials, and technological characteristics. The suture to be used with the Acumed Suture Anchor was cleared in K063778.
Preclinical Testing:
The Acu-Sinch Repair System was subjected to load to failure and fatigue testing. A pull-out comparison testing was performed to support the use of 2.3mm screws with the Distal Clavicle Plates. In addition, an engineering analysis of the plates was completed. The results demonstrate that the components are substantially equivalent to the predicate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Acumed LLC % Ms. Lino Tsai Regulatory Specialist 5885 NW Cornelius Pass Road Hillsboro, Oregon 97124-9432
NOV 1 4 2011
Re: K112111 Trade/Device Name: Acu-Sinch Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC, MBI, HRS Dated: October 10, 2011 Received: October 11, 2011
Dear Ms. Tsai:
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 - Ms. Lino Tsai
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
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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Indications for Use 4.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Acu-Sinch Repair System
The Acu-Sinch Repair System is intended to be used in conjunction with a clavicle plate of the Congruent Bone Plate System to provide fixation during the healing of clavicle fractures.
The Acu-Sinch Repair System also may be used as a stand-alone system for treatment of acromioclavicular and/or coracoclavicular ligament disruption.
V Prescription Use (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)
Page 1 of 2
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Division of Surgices Division of Surger
and Restorative Devices and Restorative Devices
K//2///
510(k) Number
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KII 2111
The Acumed Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, . Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux . Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral . Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
- Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament . Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament . Elbow: Reconstruction
Acumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle.
Prescription Use V (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 Sigh-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number `/
Page 2 of 2
§ 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.