The ICCD Endocam 5502 is designed for video endoscopy and video microscopy. It can be used for both diagnostic and therapeutic interventions. The Electronic CCD Endoscopes are used for viewing the inside of the patient via natural or surgically created passages.

Indication and Field of Application:
For use in various medical disciplines, such as urology, thorax surgery, gastroenterology, by adequately trained and qualified personnel.

Device Description

The electronic CCD Endoscope is a combination of an endoscope with integrated objective lense: and CCD camera. The CCD endoscope is connected to the camera controller 5502 via a quick connector with camera cable.

AI/ML Overview

The provided 510(k) summary (K983279) describes a medical device, the 1 CCD Endocam (Models 5502, 4934), which is an endoscopic video camera system. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria in the way a modern AI/ML device submission would.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

Based on the document, there are no specific quantitative acceptance criteria or detailed device performance metrics reported for this device in the context of diagnostic accuracy or clinical outcomes. The performance data section refers to compliance with safety standards rather than clinical performance.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Safety Standards Compliance	IEC601-1, IEC601-1-2, IEC1-1-2, IEC1-2-18, UL2601-1, AAMI safe current limits	Endocam 5502 and 5507 conforms to these standards.
Medical Device Directive Compliance	Relevant provisions of Medical Device Directive 93/42/EEC	Camera system 5502 conforms to these provisions.
Functional Equivalence	Pose the same type of questions about safety and effectiveness as existing devices; new technological characteristics have not diminished safety or effectiveness.	Determined to be substantially equivalent to existing 510(k) devices (K950502, K942817).
Clinical Efficacy	N/A (No specific clinical efficacy criteria documented)	No clinical tests were performed.

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

Test Set Sample Size: Not applicable. The submission explicitly states "No clinical tests performed."
Data Provenance: Not applicable, as no clinical tests were performed to generate a test set.

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, as no clinical tests were performed and therefore no ground truth establishment for a test set was required in this submission.

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

Not applicable, as no clinical tests were performed.

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 MRMC study was done. This device is a video camera system, not an AI-powered diagnostic tool, and the submission explicitly states "No clinical tests performed." Therefore, no assessment of human reader improvement with or without AI assistance was conducted or reported.

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

No standalone algorithm performance study was done. This device is an imaging acquisition device, not an algorithm, and no clinical performance studies were conducted.

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

Not applicable, as no clinical tests were performed. The "ground truth" for this submission was primarily related to compliance with electrical and medical device safety standards and demonstration of substantial equivalence to predicate devices based on technological characteristics and intended use.

8. The sample size for the training set

Not applicable, as this device is a hardware imaging system and does not involve AI/ML requiring a training set.

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

Not applicable, as no training set was used for this device.

Summary

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K983279

力

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RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION

510(k) Summary of Safety and Effectiveness

Company / Institution name:	Richard Wolf Medical Instruments Corp.	Date of Preparation	September 16, 1998
Division name (if applicable):	N.A.	FDA establishment regulation number:	14 184 79
Street address:	353 Corporate Woods Parkway	Phone number (include area code):	(847) 913-1113
City:	Vernon Hills	State/Province:	Illinois	FAX number (include area code):	(847) 913-0924
Country:	USA	ZIP/Postal Code:	60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager

Product Information:

Trade name:	1 CCD Endocam, Electronic CCD Endoscope	Model number:	5502, 4934
Common name:	Endoscopic Video Camera System	Classification Name:	Endoscope and / or Accessories

Information on devices to which substantial equivalence is claimed:

	510(k) Number		Trade or proprietary or model name		Manufacturer
1	K950502	1	CCD Endocam	1	Richard Wolf M.I.C.
2	K942817	2	CCD Endocam Office	2	Richard Wolf M.I.C.
3		3		3
4		4		4
5		5		5
6		6		6

1.0 Description

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2.0 Intended Use

The 1CCD Endocam 5502 is designed for video endoscopy and video microscopy. It can be used for both diagnostic and therapeutic interventions. The Electronic CCD Endoscopes are used for viewing the inside of the patient via natural or surgically created passages.

3.0 Technological Characteristics

The electronic CCD Endoscope has a CCD image converter with color mosaic filter. The light falls through the integrated lenses onto the sensor which generates a signal. The signal is processed in the camera controller to a standard NTSC video signal.

The electronic CCD Endoscope is insulated from earth (type BF-Equipment, according to UL2601-1 / IEC601-1.)

4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety and effectiveness as existing devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf.

5.0 Performance Data

Independent laboratories tested Endocam 5502 and 5507 according to specified standard IEC601 1, IEC601-1-2, IEC1-1-2, IEC1-2-18 and UL2601-1, and AAMI safe current limits.

Camera system 5502 conforms to the relevant provisions of Medical Device Directive 93/42/EEC

6.0 Clinical Tests

No clinical tests performed.

7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.

By: Robert J. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: Sept 14 98

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 DEC

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K983279

Trade Name: 1 CCD Multi-Endocam 5502 with Electronic CCD Endoscope Regulatory Class: II Product Code: GCJ Dated: September 16, 1998 Received: September 18, 1998

Dear Mr. Casarsa:

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 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). 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/2/Picture/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of three curved lines.

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Page 2 - Mr. Robert L. Casarsa

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 devices), 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/dsma/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): _ K9832 79

Device Name:__1 CCD Multi-Endocam 5502 with Electronic CCD Endoscope

Intended Use:

Indication and Field of Application:

For use in various medical disciplines, such as urology, thorax surgery, gastroenterology, by adequately trained and qualified personnel.

Contraindications:

Inflammations or bacterial contamination of wounds in the operating area. Contradindications related directly to the product are currently unknown. The attending physician must determine if the intended application is appropriate. For additional information, refer to the latest specialized medical literature.

Combinations:

Electronic CCD endoscopes are used in connection with the 1 CCD Endocam 5502 and light sources with flexible light cables, as well as, endoscopic accessories, e.g. trocar sleeves.

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Concurrence of CDRH Office of Device Evaluation (ODE)

Dece

(Divisio Division 510(k) Number

Prescription Use Per 21 CRF 801.109

Over-The Counter_

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.