For use in a variety of open procedures, such as abdominal, pediatric, thoracic, gynecologic, etc. and for use in endoscopic and laparoscopic the assol gynocelling hemostatic transection of vessels and other tissue structures.

Device Description

Richard-Allan's Reflex AEC 35, with shorter shaft length is substantially equivalent to our currently marketed Reflex AEC 35. These instruments have the same component materials, method of manufacturing, and method of sterilization. These instruments have similar instructions for use.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Reflex AEC Linear Stapler/Cutter). It states that the device is "substantially equivalent" to an already marketed device and does not involve a study with acceptance criteria and a reported device performance as typically seen for AI/ML-based medical devices or novel technologies requiring extensive clinical trials.

The document does not contain any information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes for test or training sets, or data provenance.
Number of experts or their qualifications, or adjudication methods for ground truth.
MRMC comparative effectiveness studies or standalone algorithm performance.
Ground truth types for test or training sets.

This is because the submission is for a modification (shorter shaft length and expanded indications) of an existing device, and the primary focus is on establishing "substantial equivalence" to predicate devices, rather than proving performance against specific acceptance criteria through a formal study as would be done for a new device requiring performance validation.

The key points from the provided text related to safety and effectiveness are:

Substantial Equivalence: The Reflex AEC 35 with a shorter shaft length is substantially equivalent to the currently marketed Reflex AEC 35. This determination is based on having the "same component materials, method of manufacturing, and method of sterilization" and "similar instructions for use."
Safety and Effectiveness: The document explicitly states that the difference in shaft lengths "will not affect safety or effectiveness of our device, overall function or application intended for the use of this type of device."
Intended Use: The modified device has the same intended use as the current Reflex AEC 35, Multifire GIA, and Endo GIA 30: "hemostatic transection of vessels and other tissue structures."
Expanded Indications: The expanded indication for use (general open procedures like abdominal, thoracic, pediatric, gynecologic) is also stated "will not affect safety or effectiveness of our device, or overall function of this type of device."

Therefore, based on the provided text, a table of acceptance criteria and a study with detailed performance metrics, sample sizes, and ground truth information cannot be extracted because this type of information is not part of a 510(k) submission focused on substantial equivalence for a mechanical device modification.

Summary

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(980617

Appendix II

Summary of Safety and Effectiveness

This difference in shaft lengths will not affect safety or effectiveness of our device, overall function or application intended for the use of this type of device.

Richard-Allan's Reflex AEC 35 has the same intended use as our current Reflex AEC 35, Multifire GIA, and Endo GIA 30. These instruments are intended to achieve hemostatic transection of vessels and other tissue structures.

Richard-Allan's current Reflex AEC 35 is intended for use in a variety of laparoscopic, endoscopic, and gynecologic procedures. The Auto Suture Multifire GIA is intended for open abdominal, gynecologic, pediatric, and thoracic procedures. The Endo GIA 30 is intended for use in abdominal, gynecologic, pediatric, and thoracic endoscopic procedures.

The expanded indication for use of the Richard-Allan current and modified, shorter shaft instruments is for general open procedures, such as abdominal, thoracic, pediatric, gynecologic, etc. This difference in indications for use will not affect safety or effectiveness of our device, or overall function of this type of device.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 1998

Ms. Julie Powell ·Quality Assurance & Regulatory Affairs Director Urohealth Systems Incorporated Richard-Allan Medical Industries 8850 M-89 4 9083 Richland, Michigan

K980617 Re: Reflex AEC Linear Stapler/Cutter Trade Name: Requlatory Class: II Product Code: GDW Dated: June 17, 1997 January 23, 1998 Received:

Dear Ms. Powell:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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. Powell

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) 594-4595. 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" (21 CFR 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.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K980617 510(k) Number (if known):

Reflex AEC Device Name:

Indications for Use:

(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 Devices
510(k) Number	C980617

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The-Counter Use	_________________
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(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.