(39 days)
Not Found
No
The device description and intended use are purely mechanical, describing a system for anchoring soft tissue to bone using screws and sutures. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is designed to fix soft tissue to bone for repair and reconstruction, which are therapeutic interventions.
No
The document describes a system for anchoring soft tissue to bone for reattachment, which is a therapeutic rather than a diagnostic procedure.
No
The device description clearly describes a physical implant (suture anchor) and associated instruments, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical fixation of soft tissue to bone within the human body. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a "screw designed to provide fixation to bone" with pre-attached sutures. This is a mechanical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Acumed Suture Anchor System is designed to be used for soft tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder.
The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.
Shoulder: Rotator Cuff Repair, Bankhart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Acumed Suture Anchor System is a system for anchoring soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 4.5 mm & 5.5 mm in order to accommodate differing anatomic requirements.
The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor. The system includes Class 1 instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hand, wrist, elbow, and shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical Testing: The modified Suture Anchor was subjected to static and dynamic tension along the axis of the screw as well as static and dynamic tension normal to the axis of the screw. The results demonstrate that the subject components are substantially equivalent to the predicate
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY 2 0 2014
1. 510(k) Summary
| Device Trade Name: | Acumed Suture Anchor System |
|---|---|
| Date: | April 9, 2014 |
| Sponsor: | Acumed, LLC |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Phone: (503) 627-9957 | |
| Fax: (503) 520-9618 | |
| Contact Person: | |
| Manufacturer: | Lino Tsai, Regulatory Specialist |
| Acumed, LLC | |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Phone: (503) 207 1370 | |
| Fax: (503) 520-9618 | |
| Common Name: | Screw, Fixation, Bone |
| Device Classification: | Class II |
| Classification Name: | Screw, Fixation, Bone |
| Regulation: | 21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener |
| Device Regulation Panel: | Orthopedic |
| Device Product Code: | MBI |
Device Description:
The Acumed Suture Anchor System is a system for anchoring soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 4.5 mm & 5.5 mm in order to accommodate differing anatomic requirements.
The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor. The system includes Class 1 instruments.
Intended Use:
The Acumed Suture Anchor System is designed to be used for soft tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder.
Indications for Use:
1
The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.
Shoulder: Rotator Cuff Repair, Bankhart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction.
Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: Lateral Stabilization, Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Materials:
The Acumed Suture Anchor System components are manufactured from PEEK Optima as described in ASTM F2026 and UHMWPE (High-strength suture).
Predicate Device:
A modification comparison of the proposed Suture Anchors and the predicate Suture Anchors (K133469) is provided in below Table:
| K133469 Parts | Core Diameter | Outside Diameter | Description |
|---|---|---|---|
| 55-0015 | 3.25 mm | 5.5 mm | 3.5 mm Suture Anchor |
| 55-0016 | 4.25 mm | 6.5 mm | 4.5 mm Suture Anchor |
| Modified Parts | |||
| 55-0015 | 3.25 mm | 4.5 mm | 4.5 mm Suture Anchor |
| 55-0016 | 4.25 mm | 5.5 mm | 5.5 mm Suture Anchor |
The subject 4.5 mm and 5.5 mm Suture Anchors are substantially equivalent to predicate anchors (K133469) with respect to indications, design, function, and materials.
2
Preclinical Testing:
The modified Suture Anchor was subjected to static and dynamic tension along the axis of the screw as well as static and dynamic tension normal to the axis of the screw. The results demonstrate that the subject components are substantially equivalent to the predicate
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2014
Acumed, LLC Ms. Lino Tsai Regulatory Specialist 5885 NW Cornelius Pass Road Hillsboro. Oregon 97124
Re: K140925
Trade/Device Name: Acumed Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 22, 2014 Received: April 23, 2014
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: CDRFI 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 l'ederal 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 device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set
4
Page 2 - Ms. Lino Tsai
forth in the quality 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 yours.
Lori A. Wiqqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use 4.
510(k) Number (if known): K140925
Device Name: Acumed Suture Anchor System
The Acumed Soft Tissue Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.
Shoulder: Rotator Cuff Repair, Bankhart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair. Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices