The Endoscopic Camera MC404/C3 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

Device Description

The Endoscopic Camera MC404/C3 is a 1-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera MC404/C3 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 25 mm endofocus objective but may also be used with a 16 mm, 30 mmm or zoom (f = 13 to 28 mm) objective. The device is programmable by two head key bottons and offers focusing for both right-handed and left-handed users.

AI/ML Overview

The provided text is a 510(k) summary for the Endoscopic Camera MC404/C3. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria and detailed statistical analysis often seen with novel devices or AI/ML-based products.

Therefore, many of the requested categories for acceptance criteria and study details cannot be fully answered from this document. The document primarily confirms compliance with general safety and performance standards rather than specific clinical performance metrics.

Here's an analysis of what information is available from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (What was measured)	Reported Device Performance (Result/Standard adhered to)
Electrical Safety	Complies with IEC 601-1, UL2601-1 (to be tested)
Electromagnetic Compatibility (EMC)	Complies with IEC 601-1-2, EN 55011
General Medical Device Requirements	Conforms to Medical Device Directive 93/42/EEC
Clinical Performance	Not explicitly stated with specific numerical criteria. The device is considered substantially equivalent to the predicate device for visualization of body cavities, hollow organs, and canals. Differences are noted as "limited to picture quality and handling convenience."

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

Not applicable. The "performance data" section refers to compliance with international and European standards for electrical safety, EMC, and general medical device requirements, not a clinical test set with human or patient data.

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 was not a study requiring expert-established ground truth for a test set.

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

Not applicable. This was not a study requiring adjudication of a test set.

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

No. This is a 2002 submission for an endoscopic camera, not an AI-based device. No MRMC study was performed or mentioned.

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

Not applicable. This is a medical device (endoscopic camera), not an algorithm or AI. Its core function is to provide an image for human interpretation.

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

Not applicable. The performance data relates to compliance with regulatory and safety standards, not diagnostic or clinical accuracy against a ground truth. The substantial equivalence argument relies on the predicate device's established use for "visualization of body cavities," implying that if the new device can also provide adequate visualization, it meets its intended purpose.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the study that proves the device meets the acceptance criteria (based on the provided text):

The "study" in this context is the submission and review process for substantial equivalence to a predicate device, along with verification of adherence to relevant safety and performance standards.

The primary "proof" that the Endoscopic Camera MC404/C3 meets its acceptance criteria (primarily its intended use as a visualization tool for endoscopic procedures) is based on:

Substantial Equivalence: The device is deemed substantially equivalent to the Karl Storz Endovision XL Endoscopic Camera System (K974391). The submitter argues that both devices serve the same intended use (visualization of body cavities, hollow organs, and canals during endoscopic procedures when attached to standard endoscopes and displaying images on standard video monitors). The differences are noted as "limited to picture quality and handling convenience," implying these differences do not raise new questions of safety or effectiveness.
Compliance with Standards: The device's performance is demonstrated through its compliance with recognized international and European standards for medical devices, specifically:
- IEC 601-1 (general medical electrical equipment safety)
- IEC 601-1-2 (electromagnetic compatibility for medical electrical equipment)
- EN 55011 (industrial, scientific and medical (ISM) radio-frequency equipment)
- Medical Device Directive 93/42/EEC (European regulatory compliance)
- UL2601-1 (Underwriters Laboratories standard for medical electrical equipment, indicated as "will be tested in accordance with").

This type of submission assumes that if the device is substantially equivalent to a legally marketed predicate and meets fundamental safety and performance standards, it is safe and effective for its stated intended use. Specific clinical performance metrics, reader studies, or AI performance validations were not required for this type of device at the time of this 2002 submission.

Summary

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K020336

MAR 1 4 2002

510(K) SUMMARY Endoscopic Camera MC404/C3

I. Submitter:

WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany

II. Device Names:

Classification Name: 1.
Common or Usual Name: 2.
1. Proprietary Name:

Accessory to an Endoscope Endoscopic Camera Endoscopic Camera MC404/C3

III. Classification:

Class II. This device is described in 21 C.F.R. § 876.1500. The product code for the device is GCJ.

IV. Predicate Devices:

Karl Storz Endovision XL Endoscopic Camera System (K974391) .

V. Intended Use:

VI. Device Description:

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K020336

510(K) SUMMARY Page -2- / -2-

VII. Substantial Equivalence:

The Endoscopic Camera MC404/C3 described in this notification is similar in design and construction to the Karl Storz Endovision XL Endoscopic Camera System (K974391) manufactured by Karl Storz Imaging, Inc.

The Endoscopic Camera MC404/C3 and the predicate device are both intended to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. The camera head of the Endoscopic Camera MC404/C3 and the camera head of the predicate device is designed to attach to standard, commercially available, endoscopes and the endoscopic image in the proposed and predicate device can be displayed on any standard video monitor.

The differences between the Endoscopic Camera MC404/C3 and predicate device are limited to picture quality and handling convenience.

Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the proposed new device, the Endoscopic Camera MC404/C3, is substantially equivalent to the predicate device currently on the market.

VIII. Performance Data:

The Endoscopic Camera MC404/C3 complies with the International Standard IEC 601-1, IEC 601-1-2, the European Standard EN 55011 and conforms to the Medical Device Directive 93/42/EEC. The device will be tested in accordance with UL2601-1.

Signed:

S Road

Susanne Raab Official Correspondent

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem 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-like figure, with its wings spread and head turned to the left. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

World of Medicine Lemke GmbH c/o Susanne Raab 91 Trowbridge Street Cambridge, Massachusetts 02138

Re: K020336

Trade Name: Endoscopic Camera MC404/C3 Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 30, 2002 Received: February 1, 2002

Dear Ms. Raab:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Susanne Raab

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

APPLICANT:	WORLD OF MEDICINE Lemke GmbH
510(K) NUMBER (if known):	K020336
DEVICE NAME:	Endoscopic Camera MC404/C3

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

Miriam C. Provost

neral, Restorative and Neurological Devices

HOLO 336 510(k) Number __

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.