(90 days)
Not Found
Weck Closure System™ HEMOCLIP™
No
The device description focuses on the mechanical and material aspects of a surgical clip applier and cartridge system. There is no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is used for ligation of tubular structures or vessels, which is a surgical procedure rather than a therapeutic treatment.
No
The device is described as a "Modular Clip Applier System" for the "ligation of tubular structures or vessels." Its function is to apply clips, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components made of stainless steel, plastic, and metal, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ligation of tubular structures or vessels". This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical instrument (clip applier and clip cartridge) used to apply clips during surgery. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances in a sample to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for a therapeutic purpose (ligation).
N/A
Intended Use / Indications for Use
The Applied Medical Modular Clip Applier System is indicated for ligation of tubular structures or vessels where a non-absorbable ligating device is indicated.
Product codes
DSS
Device Description
The Applied Medical Modular Clip Applier System (MCAS) is a modular reposable device intended for ligation of tubular structures or vessels where a nonabsorbable ligating device is indicated. The reusable clip applier is made of stainless steel and is similar to standard clip appliers and surgical clamp designs currently on the market. The disposable clip cartridge is made of various plastic and metal materials and will be sold sterile. The clip cartridges will be available in four sizes, small, medium/large, and large and will house six to ten titanium clips depending on the clip size to be used. The cartridges are color coded Yellow, Blue, Green and Orange respectively according to their size. The key difference between the Applied MCAS and the predicate device is the modular design which provides the user with multiple clips inside a cartridge which is loaded onto a reusable applier instead of manually loading individual clips into the applier during surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tubular structures or vessels
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)
The Applied Medical Modular Clip Applier System passed all testing to demonstrate substantial equivalence to the predicate device and introduces no new safety and effectiveness issues when used as instructed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Weck Closure System™ HEMOCLIP™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3250 Vascular clip.
(a)
Identification. A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels.(b)
Classification. Class II (performance standards).
0
JAN 2 1 1999
APPENDIX VIII 510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 26051 Merit Circle, Unit# 103 | |
| Laguna Hills, California 92653 | |
| (949) 582-6120 Ext. 310 | |
| CONTACT PERSON: | Howard V. Rowe |
| DATE OF PREPARATION: | October 22, 1998 |
| NAME OF DEVICE: | Applied Medical Modular Clip Applier System |
| (MCAS) | |
| CLASSIFICATION NAME: | Cardiovascular Surgical Instrument 21 CFR |
| 870.4500 Clip Applier, and 21 CFR 870.3250 | |
| Vascular Clip | |
| TRADE NAME: | Not established to date. |
SUMMARY STATEMENT: The Applied Medical Modular Clip Applier System (MCAS) is substantially equivalent to the predicate Weck Closure System™ HEMOCLIP™ manufactured by Weck. The Applied Medical MCAS is a modular reposable device intended for ligation of tubular structures or vessels where a nonabsorbable ligating device is indicated.
The reusable clip applier is made of stainless steel and is similar to standard clip appliers and surgical clamp designs currently on the market. The disposable clip cartridge is made of various plastic and metal materials and will be sold sterile. The clip cartridges will be available in four sizes, small, medium/large, and large and will house six to ten titanium clips depending on the clip size to be used. The cartridges are color coded Yellow, Blue, Green and Orange respectively according to their size. The key difference between the Applied MCAS and the predicate device is the modular design which provides the user with multiple clips inside a cartridge which is loaded onto a reusable applier instead of manually loading individual clips into the applier during surgical procedures.
The Applied Medical Modular Clip Applier System passed all testing to demonstrate substantial equivalence to the predicate device and introduces no new safety and effectiveness issues when used as instructed.
1
Image /page/1/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 resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
Mr. Howard V. Rowe Director, Regulatory Affairs Applied Medical Resources Corporation 26051 Merit Circle, Unit #103 Laguna Hills, CA 92653
Re: K983744 Trade Name: MCAS (Modular Clip Applier System) Regulatory Class: ı i Product Code: DSS Dated: October 22, 1998 Received: October 23, 1998
Dear Mr. Rowe:
·
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 requlation 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
2
Page 2 - Mr. Howard V. Rowe
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.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. 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 Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
APPENDIX VII
INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Applied Medical Modular Clip Applier System "Indication for Use" as required.
Not Assigned 510(k) Number:
Applied Medical Modular Clip Applier System Device Name:
The Applied Medical Modular Clip Applier System is indicated for ligation Indications for Use: of tubular structures or vessels where a non-absorbable ligating device is indicated.
Signature:
Title: Director, Regulatory Affairs Date: 10-22-98
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |
| (Optional Format -2-96) | |
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K983744 |