MGB LAPALUX TELESCOPE by MGB ENDOSKOPISCHE GERATE GMBH

The MGB LAPALUX telescope is a laparoscope designed for general, gynecological and plastic surgery. It is similar in design to other telescopes currently available for commercial distribution in the United States.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MGB LAPALUX® Telescope, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from recognized standards)	Reported Device Performance (Implied by substantial equivalence)
DIN 58140, part 1 & 2 (fiber optics)	Complies and is substantially equivalent to predicate device
DIN 58105, part 1, 12/86 (medical telescopes)	Complies and is substantially equivalent to predicate device
DIN 58141, part 1 3, 8/89 and part 4, 6/90 (fiber optics testing)	Complies and is substantially equivalent to predicate device
EN 1441 (risk analysis)	Complies and is substantially equivalent to predicate device
EU Directive 93/42/EWG, appendix 1, 6/93 (Medical Device Directive)	Complies and is substantially equivalent to predicate device

Explanation: The documentation explicitly states, "Although there are no performance standards established by the FDA for these devices, the MGB LAPALUX telescope has been designed and manufactured to meet the following standards." The basis for clearance is that the device "has no significant differences in design, materials or other technological characteristics compared to the predicate device" and is therefore "substantially equivalent." This implies that by meeting these standards, the device performs equivalently to the predicate and thus meets its "acceptance criteria."

Regarding the study that proves the device meets the acceptance criteria, the provided document does not describe a clinical study with a test set, experts, or ground truth in the way one might expect for a modern AI/ML device.

This submission is a 510(k) Premarket Notification from 1998 for a rigid medical telescope (laparoscope). The primary method of demonstrating safety and effectiveness for such devices at that time, and particularly for this type of device, was Substantial Equivalence (SE) to a legally marketed predicate device.

Let's address the specific points based on a Substantial Equivalence pathway, even if they don't perfectly align with AI/ML study methodologies:

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. There was no specific "test set" in the context of a clinical study for this 510(k) submission. Substantial equivalence is primarily demonstrated through comparison of design, materials, and intended use with a predicate device.
Data Provenance: Not applicable for a clinical test set. The "data" here would be the technical specifications and design parameters of the MGB LAPALUX® Telescope and its predicate (Karl Storz Hopkins II rigid autoclavable telescope). The provenance of these specifications is likely the manufacturer's engineering and quality assurance processes in Germany (MGB Endokopische Geräte GmbH Berlin).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical "test set" was described, no external experts were used to establish ground truth in this manner. The "experts" involved would be the manufacturer's engineers and quality control personnel who ensured the device met the listed DIN and EN standards, and potentially internal medical advisors on device design.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring an adjudication method.

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 device is a passive optical instrument (a laparoscope), not an AI-based system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device is a passive optical instrument, not an algorithm, and does not operate standalone in this context (it's observed by a human).

7. The Type of Ground Truth Used

The "ground truth" in this context is established by compliance with recognized international standards (DIN, EN, EU Directive) and the documented equivalence of specifications and performance to a legally marketed predicate device. This is a technical and regulatory ground truth rather than a clinical ground truth derived from pathology or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As no training set exists, no ground truth was established for it.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS K982013

Dated: May 29, 1998 1. Submitter's Information: MGB Endokopische Geräte GmbH Berlin Rudower Chaussee D-12489 Berlin

Contact Person: Bob Leiker, VP Regulatory Affairs Medison America. Inc. 6616 Owens Drive Pleasanton, CA 94588

1. Common or Usual Name: Laparoscope, rigid telescope MGB LAPALUX® Telescope Proprietary Name: Laparoscope, 21 CFR 876.1500 Classification Names: Class II, Product Code: 78 GCJ

Predicate Device: Karl Storz Hopkins II rigid autoclavable telescope. 510(k) number: K935279
Description of Device: The MGB LAPALUX telescope is a laparoscope designed for general, gynecological and plastic surgery. It is similar in design to other telescopes currently available for commercial distribution in the United States.
Statement of intended use: The MGB LAPALUX telescope is used to allow access and observation of body cavities during endoscopic procedures.
Statement of technological characteristics: The MGB LAPALUX telescope has no significant differences in design, materials or other technological characteristics compared to the predicate device.

The intended use and the technological characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to the predicate device.

Performance Standards: Although there are no performance standards established by the FDA for these devices, the MGB LAPALUX telescope has been designed and manufactured to meet the following standards:

DIN 58140, part 1 & 2 (fiber optics) .
DIN 58105, part 1, 12/86 (medical telescopes) .
DIN 58141, part 1 3, 8/89 and part 4, 6/90 (fiber optics testing) .
EN 1441 (risk analysis) ●
EU Directive 93/42/EWG, appendix 1, 6/93 (Medical Device Directive) 0

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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Mr. Bob Leiker Vice President of Regulatory affairs and Quality Assurance c/o Medison America, Inc. 6616 Owens Dr. Pleasanton, California 94588

K982013 Re: MGB LAPALUX® Telescope Trade Name: Regulatory Class: II Product Code: GCJ Dated: September 18, 1998 Received: September 21, 1998

Dear Mr. Leiker:

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 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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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

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Page 2 - Mr. Bob Leiker

Product Radiation Control provisions, or other Federal laws or requlations.

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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 ene regaracion choreiod, "Moreanding a" (2) 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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TAB 1

510(k) Number: K982013

Device Name: MGB LAPALUX® Telescope

Indications for Use:

For use to allow access and observation of body cavities during endoscopic . and/or laproscopic procedures:
- General endoscopic and laparoscopic surgical procedures. .
- Plastic, reconstructive, and aesthetic surgical procedures. .
- Thoracic cavity diagnostic and therapeutic procedures. .
- Athroscopy of body joints during diagnostic and therapeutic procedures. .

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Concurrence of CDRH, Office of Device Evaluation (ODR)

pcostello

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982013

Prescription Use (Per 21 CFR 801.109) \

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.