(43 days)
Not Found
No
The description focuses on a mechanical suture retention device and its applicator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a suture retention device used to approximate soft tissue, which is a structural function rather than a therapeutic one. It facilitates a medical procedure but does not directly treat a disease or condition.
No
The device is described as a "suture retention device" used to "deploy and anchor suture internally" to "grasp, manipulate, or affix the attached tissue." Its purpose is to physically approximate tissues, not to diagnose a condition.
No
The device description clearly outlines physical components: a clip (shaped as a rod) and an applicator (composed of a stainless steel tube with a handle and release button). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "soft tissue approximation" and "suture retention," used to "grasp, manipulate, or affix the attached tissue." This describes a surgical or procedural device used directly on the patient's body.
- Device Description: The description details a physical system (clip and applicator) designed for internal deployment of suture. This is consistent with a surgical implant or tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health status. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FZP, KGS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device.
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
§ 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.
0
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.
1
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.
2
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.
3
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
4
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
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