The MIST Panoramic Laparoscope is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures.
The MIST Panoramic Laparoscope is a rigid laparoscope intended for the illumination and direct visualization of body cavities, hollow organs and canals for the purpose of diagnosis of diseases and/or minimally invasive general surgeries.

Device Description

The MIST Panoramic Laparoscope is a rigid, fiber-optic laparoscope. No working channel is provided.
The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.

AI/ML Overview

This 510(k) summary for the MIST Panoramic Laparoscope does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a premarket notification for a medical device (a rigid laparoscope) to the FDA, asserting its substantial equivalence to a previously marketed device (Comeg Endoscopes under K862275). It does not present de novo performance data from a new study with explicit acceptance criteria.

Here's why the requested information is not available in these documents:

Substantial Equivalence (510(k)) Process: The 510(k) pathway is primarily about demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and intended use. It typically doesn't require the same level of new clinical study data with specific performance metrics and acceptance criteria that a PMA (Premarket Approval) or a de novo classification might.
Focus of the Document: This submission focuses on:
- Identifying the device and its intended use.
- Identifying a predicate device.
- Stating that the subject device is "identical in intended use and materials" and has "no differences in the characteristics" compared to the predicate.
- Providing basic information like cleaning and sterilization instructions.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed performance study based on the provided text. The document explicitly states: "There are no differences in the characteristics of the MIST Panoramic Laparoscope and the predicate devices. The MIST devices are identical to the predicate." This implies that the performance is presumed to be the same as the predicate device, and no new study was conducted to establish new performance criteria.

Summary

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SEP 2 3 1997

Exhibit #1 510(k) Summary Page 1 of 2

510(K) Summary MIST Panoramic Laparoscope

150

Submitter Information:

m oli

Robert Hefter Vice President of Logistics Minimally Invasive Surgical Technologies (MIST) 3310 US 70 West Smithfield, NC 27577 Telephone Number: (919) 989-6478

510(k) Summary Prepared By:

Carolann Kotula MDI Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021 Telephone Number: (516) 482-9001

Date 510(k) Summary Prepared:	March 27, 1997
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Name of the Device:

Trade or Proprietary Name:	MIST Panoramic Laparoscope, variouscatalog numbers.
Common Name:	Rigid Laparoscope

Laparoscope, General and Plastic Surgery, Classification Name: Endoscope and Accessories, including instruments (21 CFR Part 876.1500)

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Exhibit #1 510(k) Summary Page 2 of 2

ldentification of Legally Marketed Device to which the Submitter Claims Equivalence:

The MIST Panoramic Laparoscope is identical in intended use and materials to the Comeg Endoscopes marketed under K862275.

Description of the Subject Devices:

The MIST Panoramic Laparoscope is a rigid, fiber-optic laparoscope. No working channel is provided.

The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.

Intended Use of the Subject Devices

Technological Characteristics of the Subject Devices

There are no differences in the characteristics of the MIST Panoramic Laparoscope and the predicate devices. The MIST devices are identical to the predicate.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 2 3 1997

MIST c/o Ms. Carolann Kotula Official Correspondent MDI Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

Re: K971150

Trade Name: MIST Panoramic Laparoscope, a rigid laparoscope Regulatory Class: II Product Code: GCJ Dated: July 2, 1997 Received: July 7, 1997

Dear Ms. Kotula:

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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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

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Page 2 - Ms. Carolann Kotula

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 dcvices), 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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510(k) Number (if known):

Device Name: Mist Panoramic Laparoscope

Indications For Use:

The MIST Panoramic Laparoscope is a rigid laparoscope intended for the illumination and direct visualization of body cavities, hollow organs and canals for the purpose of diagnosis of diseases and/or minimally invasive general surgeries.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF HEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)
Division of Genera
3100(k) Number

ue Device
16971150

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Options) Formal 1-2-96)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.