AMR MINI-LAPAROSCOPE

K962777 · Applied Medical Resources · HET · Aug 6, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K962777
• Device Name: AMR MINI-LAPAROSCOPE
• Applicant: Applied Medical Resources
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended 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 - 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 Story

AMR Mini-Laparoscope is a rigid endoscope used for visualization and access to the abdominal cavity during laparoscopic surgery. Device inputs include light transmitted via internal fibers and visual data captured from the body cavity. The device features a stainless steel body, light fibers encased in epoxy, and an aluminum eyepiece. It includes a light post for connection to an external light source and a port for video monitor connectivity. Used in clinical settings by physicians, the device provides direct or video-assisted visualization to aid in surgical decision-making and procedural guidance. It benefits patients by enabling minimally invasive diagnostic and therapeutic interventions for various pelvic conditions.

Clinical Evidence

Bench testing only. Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety. No clinical data was required or provided.

Technological Characteristics

Rigid endoscope; stainless steel body; light fibers encased in epoxy; aluminum eyepiece; light post for external light source connection; video monitor connectivity. No software or electronic components.

Indications for Use

Indicated for patients undergoing laparoscopic procedures for diagnosis or treatment of pelvic conditions, including infertility, pelvic pain, ectopic pregnancy, pelvic tumors, endometriosis, pelvic inflammatory disease, congenital anomalies, or foreign body retrieval.

Regulatory Classification

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.

Predicate Devices

• MICROLAP 2mm LAPAROSCOPE and INTRODUCER (IMAGYN Corp.)

Reference Devices

• AMR Rigid Ureteroscope (K901214)

Submission Summary (Full Text)

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APPENDIX VII
510(k) SUMMARY
AUG - 6 1997

510(k) NUMBER: PENDING

SUBMITTED BY: Applied Medical Resources Corporation
26051 Merit Circle, Unit# 103
Laguna Hills, California 92653
[phone] 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 (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. A 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 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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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
Device Name: AMR Mini-Laparoscope.

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
- 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.

Signature: _________________________ Title: Director, Regulatory Affairs Date: 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)
OR
Over-The-Counter Use ☐ (Optional Format -2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K962777