(43 days)
The AMS soft tissue approximation system ("ASTA") is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.
The AMS soft tissue approximation system has two components: a clip and an applicator. The clip is shaped as a rod and is available in two different sizes. Each clip has a central hole through which non-absorbable suture up to and including size No. I may be threaded. The applicator is composed of a straight or curved stainless steel tube in which the tip of the clip is positioned and has a handle with a release button for clip deployment. The choice of shaft configuration and clip size depends upon the desired application.
The provided text focuses on regulatory approval (510(k) submission) for the "AMS Soft Tissue Approximation System" and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria. The submission is primarily concerned with establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed metrics against defined acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not available in the provided document.
Here's a summary of what can be extracted and what is not available from the text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission states: "Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device." However, it does not specify what acceptance criteria were used for "safe and effective," nor does it present quantitative performance data against such criteria.
2. Sample size used for the test set and the data provenance
This information is not provided. The text mentions "bench testing," which implies that a test set was used, but details on its size, composition, and provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. As no specific performance study with a test set is detailed, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication method for the test set
This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This information is not provided. The focus is on demonstrating substantial equivalence through bench testing, not a comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device described is a physical medical device (implantable clip and applicator), not an algorithm or AI system.
7. The type of ground truth used
This information is not provided. Given the nature of the device (implantable clip), "ground truth" would likely relate to material properties, mechanical performance (e.g., tensile strength, deployment success), and biocompatibility, but the specific methods for establishing ground truth for any bench testing are not detailed.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical product, not a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
In summary: The provided document is a 510(k) summary focused on regulatory clearance by demonstrating substantial equivalence to predicate devices. It references "bench testing" that showed the device is "safe and effective," but it does not provide the detailed study design, specific acceptance criteria, quantitative performance metrics, or information regarding sample sizes, ground truth establishment, or expert involvement that would be present in a comprehensive performance study.
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510(k) Summary of Safety and Effectiveness American Medical Systems, Inc.'s Soft Tissue Approximation System 510(k) Number ________________________________________________________________________________________________________________________________________________________________ KO12342
SEP - 5 2001
July 23, 2001
Submitter/Contact Name:
Avraham Biran / Elsa Linke American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 Tel: 952-933-4666 Fax: 952-930-6157
Trade Name:
AMS Soft Tissue Approximation System
Classification Name:
Implantable Clip and Applicator
Predicate Devices:
Acufex Microsurgical's T-Fix and T-Bar (K942442 and K925573, respectively) and AMS Inc's Fascial-Anchoring System (K010277).
Indication for Use:
The AMS soft tissue approximation system ("ASTA") is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.
Device Description:
The AMS soft tissue approximation system has two components: a clip and an applicator. The clip is shaped as a rod and is available in two different sizes. Each clip has a central hole through which non-absorbable suture up to and including size No. I may be threaded. The applicator is composed of a straight or curved stainless steel tube in which the tip of the clip is positioned and has a handle with a release button for clip deployment. The choice of shaft configuration and clip size depends upon the desired application.
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K∅12342
Technological Characteristics and Performance:
All materials used in the AMS soft tissue approximation system are either commonly used in medical applications or have been proven to be biocompatible through biocompatibility testing. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2001
Ms. Elsa A. Linke Regulatory Affairs American Medical Systems, Inc. 10700 Bren Road West Minnetonka, Minnesota 55343
Re: K012342
Trade/Device Name: AMS Soft Tissue Approximation System Regulation Number: 878.4300, 878.4930 Regulatory Class: II Product Code: FZP, KGS Dated: July 23, 2001 Received: July 24, 2001
Dear Ms. Linke:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and we nave acterially 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). 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 precistion, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarter rippe valy, was found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Elsa A. Linke
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Susan Walker, MD
for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Device Name:
Indications for Use:
AMS Soft Tissue Approximation system, consisting of Applicators and Clips.
The AMS Soft Tissue Approximation system is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use _ ﮯ (Per 21 CFR 801.109)
OR
Over the Counter Use_ ________________________________________________________________________________________________________________________________________________________
Susa Walk
(Division Sign-Off) (Division biggeneral, Restorative and Neurological Devices
510(k) Number K012342
510(k) Notification for the AMS Soft Tissue Approximation System
31
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.