(90 days)
The Applied Medical Modular Clip Applier System is indicated for ligation of tubular structures or vessels where a non-absorbable ligating device is indicated.
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.
The provided text is a 510(k) summary for the Applied Medical Modular Clip Applier System (MCAS). It states that the device passed all testing to demonstrate substantial equivalence to the predicate device and introduces no new safety and effectiveness issues when used as instructed.
However, the document does not describe specific acceptance criteria or the details of any studies, including sample sizes, ground truth establishment, or expert involvement. It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's an attempt to populate the table and answer the questions based only on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Not explicitly stated | "passed all testing to demonstrate substantial equivalence to the predicate device" |
| Not explicitly stated | "introduces no new safety and effectiveness issues when used as instructed" |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No. This device is a surgical instrument (clip applier), not an AI-powered diagnostic or interpretive system, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No. This device is a mechanical surgical instrument. "Standalone performance" in the context of an algorithm or AI is not applicable here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not specified. The document refers to "testing to demonstrate substantial equivalence," which likely involved mechanical and functional testing against specifications and comparison to the predicate device, rather than a "ground truth" as might be established for diagnostic image analysis.
8. The sample size for the training set
- Sample size for training set: Not applicable/not specified. As a mechanical device, there is no "training set" in the sense of machine learning.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/not specified.
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JAN 2 1 1999
APPENDIX VIII 510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation26051 Merit Circle, Unit# 103Laguna 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 CFR870.4500 Clip Applier, and 21 CFR 870.3250Vascular 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.
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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
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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
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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 |
§ 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).