(77 days)
The Anspach Arthroscopic Knotless Anchor is indicated for use in reattachment (fixation) of soft tissues to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot. The Anspach Arthroscopic Knotless Anchor is specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.
The Anspach Arthroscopic Knotless Anchor is used with specific brands and types of suture materials including: Arthrotek "MaxBraid"; Smith & Nephew "UltraBraid"; Opus Medical "Magnum Wire"; and Linvatec "Herculine". Suture materials identified as "Braided # 2 polyester" and Arthrex # 2 "Fiberwire" are not recommended for use with The Anspach Arthroscopic Knotless Anchor.
A suture Anchor per CFR 21, Part 888.3040, is a smooth or threaded metallic bone fixation fastener and is a Class II device.
The Anspach anchor is a design modification of the existing Anspach Suture Anchor that permits soft tissue attachment to bone but does so in a manner that eliminates the need for the surgeon to have to tie sutures to the anchor.
This device can reduce surgical procedure time, surgeon frustration and fatigue associated with arthroscopic knot tying.
The Anspach Knotless Anchor is constructed of the same materials under the same manufacturing process controls as existing devices. It introduces no new or modified indications for use, risks, hazards, safety or effectiveness issues, and may help reduce surgical time which for abo, halto, fiazar as, our entient. Testing has confirmed the Knotless Anchor to be as effective (or more so) in placement and performance as other marketed devices, including the predicate Anspach device(s).
Packaging, labeling, handling and storage conditions are consistent with current designs and accessory tools used in placement of the anchor are essentially the same as existing devices. There are no changes to cleaning, storage processes from existing accessory devices.
The Anspach Knotless Anchor is distributed pre-sterilized to an SAL of 10°. Accessory surgical tools are packaged clean, non-sterile and distributed separate from the anchor device.
This document describes a medical device called the Anspach Knotless Suture Anchor, a Class II device (CFR 21, Part 888.3040) used for reattachment of soft tissues to bone. The information provided is a 510(k) summary for the device seeking substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. Instead, it makes a general statement: "Testing has confirmed the Knotless Anchor to be as effective (or more so) in placement and performance as other marketed devices, including the predicate Anspach device(s)."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications to establish ground truth.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not mention or describe an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human reader performance is a direct measure. For a physical device like a suture anchor, the effectiveness is typically measured through biomechanical testing and clinical outcomes, rather than cognitive human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable to a physical medical device like a suture anchor. "Standalone performance" typically refers to the performance of an AI algorithm without human intervention, which is not relevant for this product.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. However, given the nature of the device (suture anchor), it is highly probable that the "ground truth" for performance evaluations would be established through:
- Biomechanical testing: Measuring pull-out strength, cyclic loading, and other mechanical properties in a lab setting (e.g., using cadaveric bone or synthetic bone models).
- Clinical outcomes data: While not explicitly mentioned as a "ground truth" method for this 510(k) submission, long-term clinical studies would provide the ultimate ground truth for effectiveness. This 510(k) is based on demonstrating substantial equivalence, which often relies on bench testing and comparison to predicate devices.
8. The Sample Size for the Training Set:
The concept of a "training set" is primarily relevant for machine learning algorithms. Since this is a physical medical device, there is no training set in the AI sense. The development of such a device involves engineering design, material selection, and iterative physical testing rather than algorithmic training.
9. How the Ground Truth for the Training Set Was Established:
As explained in point 8, there is no training set in the context of this device.
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510(k) SUMMARY
Anspach Knotless Suture Anchor
A suture Anchor per CFR 21, Part 888.3040, is a smooth or threaded metallic bone fixation fastener and is a Class II device.
The Anspach anchor is a design modification of the existing Anspach Suture Anchor that permits soft tissue attachment to bone but does so in a manner that eliminates the need for the surgeon to have to tie sutures to the anchor.
This device can reduce surgical procedure time, surgeon frustration and fatigue associated with arthroscopic knot tying.
The device is indicated for use in reattachment (fixation) of soft tissues to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella inolaing the party foot. It is specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.
The Anspach Knotless Anchor is indicated for use with specific brands and types of suture materials, which include the following:
| Arthrotek: | "MaxBraid" |
|---|---|
| Smith & Nephew: | "UltraBraid" |
| Opus Medical: | "Magnum Wire" |
| Linvatec: | "Herculine" |
Suture materials identified as "Braided # 2 polyester" and Arthrex # 2 "Fiberwire" are not recommended for use with the Anspach Arthroscopic Knotless Anchor.
The Anspach Knotless Anchor is constructed of the same materials under the same manufacturing process controls as existing devices. It introduces no new or modified indications for use, risks, hazards, safety or effectiveness issues, and may help reduce surgical time which for abo, halto, fiazar as, our entient. Testing has confirmed the Knotless Anchor to be as effective (or more so) in placement and performance as other marketed devices, including the predicate Anspach device(s).
Packaging, labeling, handling and storage conditions are consistent with current designs and accessory tools used in placement of the anchor are essentially the same as existing devices. There are no changes to cleaning, storage processes from existing accessory devices.
The Anspach Knotless Anchor is distributed pre-sterilized to an SAL of 10°. Accessory surgical tools are packaged clean, non-sterile and distributed separate from the anchor device.
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Public Health Service
DEC 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
William G. Conety Director, Regulatory Affairs and Quality Assurance The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K052572
Trade/Device Name: Anspach Knotless Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: September 16, 2005 Received: September 19, 2005
Dear Mr. Conety:
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 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.
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2 Page - William G. Conety
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 (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours,
2
Sor Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K052572
Page 1 of 1
Device Name: Knotless Anchor
INDICATIONS FOR USE
The Anspach Arthroscopic Knotless Anchor is indicated for use in reattachment (fixation) of soft The Andpadh Arin applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot. The Anspach Arthroscopic aima, ternar, tible, inbular partically not intended for use in the spine of the anterior or posterior cruciate ligaments.
The Anspach Arthroscopic Knotless Anchor is used with specific brands and types of suture materials including: Arthrotek "MaxBraid"; Smith & Nephew "UltraBraid"; Opus Medical materials "Molding" Arthree "Herculine. Suture materials identified as "Braided # 2 polyester" Magham With With Live are not recommended for use with The Anspach Arthroscopic Knotless Anchor.
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)
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052572
N/A