The ER150/M2 is a video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy.

Device Description

The ER150/M2 is a color video monitor intended to display viewable medical images transmitted by standard video signals. In particular, the device is intended for use as part of a visualisation system in endoscopic surgery. The monitor accepts and processes composite=FBAS, Y-UV, analog RGB, digital RGB, Y/C signals and NTSC, PAL and SECAM standard video signals. The ER150/M2 is designed with a digital microprocessor and offers an automatic input selection. The received signal is displayed on a 20" screen. The images can be adjusted by the user for color, contrast, hue, brightness, enhanced sharpness and color temperature (6500K or 9300K). Additional output sockets of the ER150/M2 allow the connection to further equipment including a second monitor or recording device.

AI/ML Overview

This 510(k) summary describes a medical video monitor, the ER150/M2, which is an accessory to an endoscope. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for novel acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not applicable or available in the provided text. The device is a monitor, and its "performance" is primarily defined by its ability to display signals effectively, conforming to established standards for medical monitors.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Regulatory Compliance:
21 C.F.R. § 81020.10 (Performance Standard)	Meets the requirements of 21 C.F.R. § 81020.10.
IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety)	Complies with IEC 60601-1.
IEC 60601-1-2 (Medical Electrical Equipment - General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility)	Complies with IEC 60601-1-2.
Medical Device Directive 93/42/EEC	Conforms to Medical Device Directive 93/42/EEC.
UL2601-1 (Underwriters Laboratories Standard for Medical Electrical Equipment)	Meets the requirements of UL2601-1.
Functional Equivalence to Predicate:
Ability to display viewable medical images transmitted by standard video signals during surgical/diagnostic procedures, particularly in endoscopy.	Intended use, design, and technological characteristics are similar to the Sony Trinitron Color Video Monitor PVM-1343 MD (K885042).
Ability to process various standard video signals (composite=FBAS, Y-UV, analog RGB, digital RGB, Y/C, NTSC, PAL, SECAM).	Accepts and processes these signals.
Automatic input selection.	Designed with a digital microprocessor and offers automatic input selection.
Display on a 20" screen.	Received signal is displayed on a 20" screen.
User-adjustable image parameters (color, contrast, hue, brightness, enhanced sharpness, color temperature).	Images can be adjusted by the user for these parameters.
Additional output sockets for connection to other equipment (e.g., second monitor, recording device).	Offers additional output sockets.
Differences from predicate limited to picture quality and handling convenience, not raising new safety/effectiveness questions.	Stated that differences are limited to picture quality and handling convenience and do not raise new questions of safety and effectiveness.

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

Not applicable. This submission is for product clearance based on substantial equivalence to a predicate device and compliance with general performance and safety standards, not a clinical study involving a "test set" of patient data. The "test" in this context refers to engineering and quality assurance testing against the listed standards.

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

Not applicable. As this isn't a clinical study, there was no ground truth for a test set established by medical experts in the way that would be done for an AI diagnostic device. The "ground truth" for a medical monitor is its adherence to technical specifications and regulatory standards, which are evaluated through engineering tests and regulatory review.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical ground truth requiring adjudication. Compliance with technical standards would be determined by testing procedures outlined within those standards and reviewed by the manufacturer's quality control and ultimately by the FDA.

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 is a medical monitor, not an AI-powered diagnostic tool. No MRMC study was performed, and there is no AI component described.

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

Not applicable. As described, this is a hardware device (a monitor) with no standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established technical and safety standards for medical monitors (e.g., IEC 60601-1, UL2601-1, 21 C.F.R. § 81020.10) and general device requirements for substantial equivalence. The device's performance is measured against these objective, predefined criteria through engineering and compliance testing. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device; there is no "training set" in the machine learning sense. The design and development process would involve iterative engineering and testing, but not training data for an algorithm.

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

Not applicable. There is no training set.

Summary

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510(K) SUMMARY ER150/M2

I. Submitter:

WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany

II. Device Names:

Classification Name: し.
1. Common or Usual Name:
Proprietary Name: 3.

Accessory to an Endoscope Medical Monitor ER 150/M2

KO21456

III. Classification:

The proposed device is classified as class II according to 21 C.F.R. § 876.1500. The product code for the device is GCJ.

IV. Predicate Devices:

Sony Trinitron Color Video Monitor PVM-1343 MD (K885042) ● manufactured by Sony Medical Electronics, Co.

V. Intended Use:

The ER150/M2 is a video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy.

VI. Device Description:

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VII. Performance Standards:

The ER150/M2 meets the requirements of the performance standard 21 C.F.R. 81020.10.

Voluntary Standards: VIII.

The medical monitor ER150/M2 complies with the International Standard IEC 60601-1, IEC 60601-1-2 and conforms to the Medical Device Directive 93/42/EEC. In addition, the ER150/M2 meets the requirements of the Underwriters Laboratories standard UL2601-1.

Substantial Equivalence: VIII.

The medical monitor ER150/M2 described in this notification is similar in intended use, design and technological characteristics to the Sony Trinitron Color Video Monitor PVM-1343 MD (K885042) manufactured by Sony Medical Electronics, Co.

Both the ER150/M2 and the predicate device are intended to display viewable medical images containing information on surgical or diagnostic procedures including video signals gernerated by endoscopic video equipment. The differences between the ER150/M2 and the predicate device are limited to picture quality and handling convenience and do not raise new questions of safety and effectiveness.

Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the medical monitor ER150/M2 is substantially equivalent to the predicate device which received clearance from FDA on December 22, 1988 (K885042).

Signed:

S. Rojas

Susanne Raab Official Correspondent

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 1 2002

World of Medicine Lemke GmbH c/o Mrs. Susanne Raab 91 Trowbridge Street, #21 Cambridge, MA 02138

Re: K021456

Trade/Device Name: ER 159/M2 Medical Video Monitor Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 23, 2002 Received: May 6, 2002

Dear Mrs. Raab:

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. Iisting 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 – Mrs. 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.

Sincerely yours,

Mark A. Milkerson

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):	K021456
DEVICE NAME:	ER150/M2

INDICATIONS FOR USE:

The ER150/M2 is a color video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy.

(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)

Mark N. Millhiser
(Division Sign Off)

(Division Sign-Off) Division of General and Neurological D.

tive

510(k) Number _

021456

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.