Unexplained pelvic pain .
Infertility Work-up .
. Tubal sterilization
. Diagnosis and/or treatment of ectopic pregnancy
. Evaluation, diagnosis and/or treatment of pelvic tumors, including myomata (less than 16 weeks gestational size.)
Evaluation of congenital anomalies of the pelvic organs .
. Retrieval of foreign bodies
Determination of the presence and extent of pelvic endometriosis .
Determination of the presence and extent of pelvic inflammatory disease (if not in . acute stage)
Access to abdomen for surgical procedures such as LAVH ●
Visualization, diagnosis and/or treatment of perforate abdominal (pelvic) organs. .

Device Description

The AMR Mini-laparoscope is designed and indicated for visualization of body cavities during laparoscopic procedures. The device features a stainless steel body containing light fibers encased in epoxy, an aluminum eyepiece, a light post for purposes of connecting a light source and a means of connecting to a video monitor.

AI/ML Overview

This document describes a 510(k) premarket notification for the Applied Medical Mini-Laparoscope, and as such, it does not contain the detailed study information typically found for AI/ML-driven devices. The submission relates to a medical device for visualization during laparoscopic procedures, a physical instrument, not a software algorithm.

Therefore, most of the requested information regarding acceptance criteria and studies (especially those related to AI performance, ground truth, expert adjudication, and comparative effectiveness) is not applicable to this type of traditional medical device submission.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance

The document mentions that mechanical and biocompatibility tests were performed. However, it does not provide specific acceptance criteria or quantitative performance results in a table format.

Acceptance Criteria Category	Reported Device Performance
Functional Integrity	Demonstrated functional integrity. (Specific criteria and quantitative results not provided)
Structural Integrity	Demonstrated structural integrity. (Specific criteria and quantitative results not provided)
Material Safety	Demonstrated material safety. (Specific criteria and quantitative results not provided)
Substantial Equivalence	Demonstrated substantial equivalence to the MICROLAP™ 2mm LAPAROSCOPE and INTRODUCER (IMAGYN Corp.) and similarity to the AMR Rigid Ureteroscope (K901214). Introduces no new safety and effectiveness issues.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This pertains to studies of algorithms, not physical devices undergoing mechanical and biocompatibility testing. The submission does not detail specific "test sets" in the context of data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is relevant for AI/ML performance evaluation, not for the physical and biological testing of a conventional medical device like a laparoscope.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, this is for AI/ML ground truth establishment.

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

Not applicable. This study type is for AI/ML-assisted diagnosis/interpretation, which is not what this device is. The device is a direct visualization tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. There is no algorithm being evaluated in a standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for a physical device's performance is typically established through engineering standards, test methods, and potentially animal or human cadaver studies for efficacy, rather than expert consensus on interpretive data.

8. The sample size for the training set

Not applicable. There is no algorithm requiring a "training set."

9. How the ground truth for the training set was established

Not applicable. There is no algorithm requiring a "training set."

Summary

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APPENDIX VII

510(k) SUMMARY

AUG - 6 1997

510(k) NUMBER:	PENDING
SUBMITTED BY:	Applied Medical Resources Corporation26051 Merit Circle, Unit# 103Laguna Hills, California 92653(714) 582-6120 EXT. 310
CONTACT PERSON:	Howard V. Rowe
DATE OF PREPARATION:	July 12, 1996
NAME OF DEVICE:	Applied Medical Mini-Laparoscope.
CLASSIFICATION NAME:	Endoscope
TRADE NAME:	Not Determined

SUMMARY STATEMENT: The AMR Mini-laparoscope is designed and indicated for visualization of body cavities during laparoscopic procedures. The device features a stainless steel body containing light fibers encased in epoxy, an aluminum eyepiece, a light post for purposes of connecting a light source and a means of connecting to a video monitor. The AMR Mini-laparoscope is substantially equivalent to a device marketed by IMAGYN Corp. under the name of MICROLAP™ 2mm LAPAROSCOPE and INTRODUCER.

The design configuration of the AMR Mini-laparoscope is also similar to the AMR Rigid Ureteroscope which was previously approved under K901214.

Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety of the Mini-laparoscope. All testing has demonstrated that the AMR Mini-laparoscope is comparable to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three arms or branches extending upwards. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 1997

Mr. Howard V. Rowe Regulatory Affairs Manager ... Applied Medical Resources 26051 Merit Circle, Bldg. 104 Laguna Hills, California 92653 Re: K962777

Applied Medical® Mini Laparoscope .. - -Dated: June 30, 1997 Received: July 9, 1997 Regulatory class: II 21 CFR §884.1720/Product code: 85 HET

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 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 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 marked 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) 594-4613. 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/rdrh/dsmamain.html".

Sincerely yours.

hĩ liau thi

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX IX

INDICATIONS FOR USE

Food and Drug Administration Center for Devices and Radiological Health ...................... Office of Device Evaluations (HFZ-401) '''''''' ' 9200 Corporate Boulevard Rockville, MD 20850

Applied Medical Resources is providing this separate cover page for the Applied Medical Mini-Laparoscope "Indication for Use" to reflect the revision made in the Supplement #1 labeling.

510(k) Number: K962777

AMR Mini-Laparoscope. Device Name:

Indications for Use: The AMR Mini-Laparoscope is indicated for visualization and accessing the abdomen during laparoscopic procedures such as (but not limited to):

Unexplained pelvic pain .
Infertility Work-up .
. Tubal sterilization

Signature:

. Diagnosis and/or treatment of ectopic pregnancy
. Evaluation, diagnosis and/or treatment of pelvic tumors, including myomata (less than 16 weeks gestational size.)
Evaluation of congenital anomalies of the pelvic organs .
. Retrieval of foreign bodies
Determination of the presence and extent of pelvic endometriosis .
Determination of the presence and extent of pelvic inflammatory disease (if not in . acute stage)
Access to abdomen for surgical procedures such as LAVH ●
Visualization, diagnosis and/or treatment of perforate abdominal (pelvic) organs. .

DIRECTOR Title: RECONIARY AfficsDate: 5/8/97

(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)
------------------	-------------------------------------------------------------------------------------

	Over-The-Counter Use
--	----------------------

	Colin m Pollard (Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K962777 (Optional Format -2-96)

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.