(112 days)
No
The summary describes a mechanical repair system for bone fractures and ligament disruptions, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to provide fixation for healing of fractures and repair of ligaments and tendons, which are therapeutic interventions.
No
Explanation: The device is a repair system and plating system intended for fixation during the healing of fractures, fusions, or osteotomies, and for fixation of suture to bone. Its intended uses involve treatment and repair, not diagnosis.
No
The device description explicitly lists multiple hardware components (Suture Anchor, Clavicle Fracture Plate, Acu-Sinch plate, Suture Retainer, Screws, and Suture).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description and intended use clearly state that this device is a surgical implant system used for the fixation of bones and ligaments within the body during surgical procedures. It is used to repair fractures and ligament disruptions.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
Therefore, the Acu-Sinch Repair System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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: " Rotator "Our repairs, aration 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.
Product codes
HTN, HWC, MBI, HRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, clavicle, foot/ankle, knee, hand/wrist, elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 1 4 2011
510(k) Summary
| Device Trade Name: | Acu-Sinch Repair System and Acumed Suture Anchor |
|---|---|
| Manufacturer: | Acumed, LLC |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Contact: | Ms. Lino Tsai |
| Regulatory Specialist | |
| Phone: (503) 627-9957 | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | October 28, 2011 |
| Classifications: | 21 CFR 888.3030, Single/multiple component metallic |
| bone fixation appliances and accessories | |
| and | |
| 21 CFR 888.3040, Smooth or threaded metallic bone | |
| fixation 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
1
- 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.
2
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
3
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
4
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
5
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