The Endoscopic cameras VP-1000C ( Med Cam 100) and VP-3000A /Med Cam 300) are 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 VP-1000C ( Med Cam 100) is a 1-CCD camera, the VP-3000A (Med Cam 300) is a 3-Chip camera; both consist of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic cameras VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) take the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera heads are supplied with an standard objective with the focal length 18, 25, 30 or 40mm. A Zoom objective can be used too. The devices allow focussing for both right-handed and left-handed users.

AI/ML Overview

The provided text is a 510(k) summary for an endoscopic camera, not a study report demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be extracted from this document.

Here's an analysis based on the available information:

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

This document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics in relation to such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance testing against predefined criteria.

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

The document does not describe a clinical or performance study with a test set. The claim of substantial equivalence is based on design and technological characteristics, not on a study with a sample size of patients or images.

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. There is no mention of a test set with ground truth established by experts.

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

Not applicable. No test set or adjudication method is described.

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 an endoscopic camera, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is a hardware component (endoscopic camera) and does not involve a standalone algorithm.

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

Not applicable. Ground truth is not relevant in the context of demonstrating substantial equivalence for an endoscopic camera in this document.

8. The sample size for the training set:

Not applicable. This document does not describe any machine learning or AI component requiring a training set.

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

Not applicable. As above, there is no training set mentioned.

Summary of what the document does state regarding performance/equivalence:

Acceptance Criteria (Implied by Substantial Equivalence):

The implied acceptance criteria for this 510(k) submission are that the devices (VP-1000C/Med Cam 100 and VP-3000A/Med Cam 300) are "substantially equivalent" to predicate devices already on the market. This means they should pose the "same type of questions about safety and effectiveness" and have "no diminished safety or effectiveness" compared to predicates.

Reported Device Performance (as presented for substantial equivalence):

The document states that the new devices are "similar in design and technological characteristics" to their respective predicate devices (World of Medicine Lemke GmbH's Endoscopic Camera MC404/C3 for VP-1000C and Endoscopic Camera TC804/C4 for VP-3000A).

The key performance claims supporting substantial equivalence are:

Intended Use: Identical – "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."
Design: Both are camera systems consisting of a camera control unit (CCU), camera head, objectives, cables, and adapters.
Functionality: Both take images through standard endoscopes and display them on standard video monitors.
Differences: Described as "minor and limited to picture quality and handling convenience," implying that these differences do not negatively impact safety or fundamental effectiveness for the intended use.
Standards Compliance: The devices "will comply with the International Standard IEC 60601-1-2, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC." (Note: IEC 60601-1-2 is listed twice; likely a typo in the original text, usually refers to General Requirements for Safety and Essential Performance and Electromagnetic Disturbances).

In essence, the "study" demonstrating the device meets acceptance criteria is a demonstration of substantial equivalence through comparison of design, intended use, and technical specifications with legally marketed predicate devices, rather than a clinical trial or performance study with quantified metrics.

Summary

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2 2003 SEP

K032544

510 CUJ Summery/ Statement 8
I Submitter

MGB Endoskopische Geräte GmbH Berlin Schwarzschildstraße 6 12489 Berlin Germany

II Device Names

1.	Classification Name:	Accessory to an Endoscope
2.	Common or Usual Name:	Endoscopic camera
3.	Proprietary Name:	VP-1000C and VP-3000A for MGB brand,Med Cam 100 and Med Cam 300 for LAWTON brand

III Classification:

Class II. This device is described in21 C.F.R.§876.1500: The product code for the device is GCJ.

Predicate Device: IV

name/ manufacturer: World of Medicine Lemke GmbH For VP-1000C (Med Cam 100): Endoscopic Camera MC404/C3 labeling: For VP-3000A (Med Cam 300): Endoscopic Camera MC804/C4

V Intended Use:

The Endoscopic cameras VP-1000C ( Med Cam 100) and VP-3000A are 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.

VI Device Describtion

VII Substantial Equivalence

The submitted device pose the same type of questions about safety and effectiveness as the predicate device. The new device has no diminished safety or effectiveness.

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The VP-1000C (Med Cam 100) is similar in design and technological characteristics to the Endoscopic camera MC404/C3 (K020336), the VP-3000A (Med Cam 300) is similar in design and technological characteristics to the Endoscopic camera TC804/C4 (K014158). manufactured by World of Medicine Lemke GmbH.

The Endoscopic camera VP-1000C (Med Cam 100), VP-3000A (Med Cam 300) and the predicate devices are all intended to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. The camera head of the The Endoscopic camera VP-1000C (Med Cam 100), VP-3000A (Med Cam 300) and of the predicate devices 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 VP-1000C (Med Cam 100), VP-3000A (Med Cam 300) and the predicate devices are minor and limited to picture quality and handling convenience. Accordingly, MGB Endoskopische Geraete GmbH Berlin believes that the Endoscopic cameras VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) are substantially equivalent to the predicate devices currently on the market.

VIII Performance Data

The Endoscopic Light source VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) will comply with the International Standard IEC 60601-1-2, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2003 SEP

MBG Endoskopische Geräte GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K032544

Trade/Device Name: VP-1000C; Med Cam 100; VP-3000A; Med Cam 300 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FET Dated: August 9, 2003 Received: August 18, 2003

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 adultcration.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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) you may obtain. 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/dsmaldsmamain.html.

Sincerely yours.

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ﻟﻠﺘﺮﺍ Statement of Indications for use

Applicant:

MGB Endoskopische Geräte GmbH Berlin

510(k) Number:

K1032544

Device Name: Endoscopic Camera

i) VP-1000C (for MGB brand); Med Cam 100 (for Lawton brand)
ii) VP-3000A (for MGB brand); Med Cam 300 (for Lawton brand)

Intended Use of the Device

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 C.F.R. $ 801.109)

Nancy C. Shrodon
(Division Sign-Off)

of Reprodi iological Device

Prescription Use

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시편

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.