This camera head has been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

Device Description

HD CAMERA HEAD OTV-S7ProH-HD-L08E is an imaging device used with specified HD CAMERA FILAD OTV-811 1011 1017 1072 120 120 0ther ancillary equipment for observation of endoscopic image on a video monitor.

The new camera head is basically identical to predicate device shown in Table 14-1 in intended use, and similar in specifications, performance.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (HD CAMERA HEAD OTV-S7ProH-HD-L08E). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and study results in the typical format of a device performance study.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not explicitly present in the provided document. The document primarily compares the new device's specifications to a predicate device to argue for substantial equivalence.

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of performance targets that were tested against. Instead, it provides a "Comparison of Specifications" between the subject device and its predicate. The implication is that the subject device's performance, as outlined in these specifications, is considered acceptable because it is similar to the legally marketed predicate device.

Item	Specifications (Predicate Device)	Reported Device Performance (Subject Device)	Implied Acceptance
Dimension		O.D. 21mm x 83mm (from mount surface) L-shape
Camera Head	O.D. 40mm x 104mm (from mount surface) Straight shape		The size differences (smaller, L-shape vs. straight) are presented as design changes, not deviations from a performance requirement. These are acceptable as long as they don't negatively impact intended use or safety, which is claimed in the conclusion by stating no "significant changes in intended use, method of operation, or design."
Cable	O.D. 6.6mm x 4m	O.D. 3.3mm x 4m	Similar to above, smaller cable diameter is a design change.
Weight	100g (excluding cable)	60g (excluding cable)	Lighter weight is a design change.
Video plug	Round shape type connector	Card-edge type connector	A different type of connector, indicating a design change, but functional equivalence is implied.
Remote control switches	Separated	Embedded	Design change for convenience, still providing the function.
Observation
Pickup System	Interline type CCD solid-state image pickup	Interline type CCD solid-state image pickup	Identical, thus meeting the implied standard of the predicate device.
Auto Iris	Available	Not available	The absence of Auto Iris is a functional difference. Its acceptability hinges on the overall system performance and whether manual control is sufficient or if the NBI feature compensates. The submission implies it's acceptable.
Narrow Band Imaging (NBI) function	Not available	Available	This is an added feature. Its presence is considered an enhancement, not a failure to meet criteria.
Operating Environment
Ambient Temperature	10 to 40°C	10 to 40°C	Identical, meeting the implied standard.
Relative Humidity	30 to 85%	30 to 85%	Identical, meeting the implied standard.
Atmospheric Pressure	700 to 1060 hPa	700 to 1060 hPa	Identical, meeting the implied standard.
Reprocessing
Cleaning	Immersible in detergent solution with a water-resistant cap	Immersible in detergent solution without water-resistant cap	This indicates an improvement in design for ease of cleaning, implicitly acceptable.
Disinfection	Immersible in disinfectant solution with a water-resistant cap	Immersible in disinfectant solution without water-resistant cap	This indicates an improvement in design for ease of disinfection, implicitly acceptable.
Sterilization	Ethylene oxide gas sterilization	Ethylene oxide gas sterilization	Identical, meeting the implied standard.
Patient contacting material	No patient contacting material	No patient contacting material	Identical, ensuring no new biocompatibility concerns.

Study Details:

The document describes a comparison to a predicate device for the purpose of demonstrating "substantial equivalence" to obtain 510(k) clearance, not a clinical performance study with specific acceptance criteria and detailed statistical analysis of performance metrics.

Therefore, most of the following information is not available in the provided text.

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 / Not provided. This document does not describe a clinical study with a "test set" of patient data. The comparison is based on device specifications and design characteristics.

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 / Not provided. No ground truth establishment for a test set is mentioned.

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

Not applicable / Not provided. No adjudication method is mentioned.

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 / Not provided. This device is a camera head, not an AI-assisted diagnostic tool. No MRMC study is referenced.

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

Not applicable / Not provided. This device is a camera head, not an algorithm.

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

Not applicable / Not provided. No ground truth for a clinical study is referenced. The "truth" in this submission is the established safety and effectiveness of the predicate device, against which the new device's specifications are compared.

8. The sample size for the training set

Not applicable / Not provided. No training set for an algorithm is mentioned.

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

Not applicable / Not provided. No ground truth for a training set is mentioned.

Summary of the Document's Conclusion:

The document concludes that the HD CAMERA HEAD OTV-S7ProH-HD-L08E is "basically identical to the predicate device in intended use" (with some limitation of application to specific anatomical regions) and "similar in specifications." It highlights the addition of Narrow Band Imaging (NBI) and embedded remote control switches, as well as an L-shaped configuration and smaller dimensions, as design changes. The key statement for regulatory purposes is: "When compared to the predicate device, the HD CAMERA HEAD OTV-S7ProH-HD-L08E does not incorporate any significant changes in intended use, method of operation, or design of the device." This statement, along with the detailed specification comparison, forms the basis for the FDA's substantial equivalence determination.

Summary

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K 083,55
pg 1 of 4

510(k) SUMMARY

HD CAMERA HEAD OTV-S7ProH-HD-L08E JAN 1 3 2009

October 15, 2008

General Information 1

Official Correspondent

Applicant: E
日

해

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047

Stacy Abbatiello Kluesner, RAC Requiatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com Establishment Registration No: 2429304

SHIRAKAWA OLYMPUS CO., LTD. 3-1. Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No .: 3002808148

Device Identification 2

행 Device Trade Name:
Manufacturer:
월 Common Name:
Regulation Number: 만
Requiation Name: 대
Regulatory Class: I
Classification Panel: 원
Product Code: 曝

HD CAMERA HEAD OTV-S7ProH-HD-L08E

CAMERA HEAD

21 CFR 876.1500

Endoscope and accessories

Gastroenterology/urology

KOG - Endoscope And/Or Accessories NWB - Endoscope, Accessories, Narrow Band Spectrum

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K083155

pg 2 of 4

Predicate Device Information 3

The following table shows the primary components of the subject devices and the devices to which we claim substantial equivalence (predicate devices).

Table 14-1. Primary Components & Predicate Devices

Subject Devices(Part of this submission)	Predicate Devices	PD's510(k) No.
HD CAMERA HEADOTV-S7ProH-HD-L08E	Camera Head for rigid endoscopes (withAuto focus) MH-9721	K955404

Device Description 4

The new camera head is basically identical to predicate device shown in Table 14-1 in intended use, and similar in specifications, performance.

Indications for Use 5

6 Comparison of Technological Characteristics

The HD CAMERA HEAD OTV-S7ProH-HD-L08E is basically identical to the predicate device in intended use except for the limitation of the application to the bladder, urethra, ureter, and kidney, and similar in specifications except for addition of the Narrow Band Imaging function, embedded Remote Control Switches, and L-shaped configuration. Comparison between the subject and predicate device is shown in Table 14-2.

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. . .

Table 14-2. Comparison of Specifications

ProH-HD-L08E

PROPOSED RULES FOR

HIGH-DEFINITION VIDEO COMPRESSION

TECHNOLOGY

Draft 08

Sub-Committee on

Advanced Television Systems

Technology Advisory Committee

	Item	Specifications	Subject Device	Predicate Device
	Subject Device : HD CAMERA HEAD OTV-S7ProH-HD-L08EPredicate Device : Camera Head for rigid endoscopes (with Auto focus) MH-9721 (K955404)
	Dimension	Camera Head	O.D. 21mm x 83mm (from mount surface)L-shape	O.D. 40mm x 104mm (from mount surface)Straight shape
		Cable	O.D. 3.3mm x 4m	O.D. 6.6mm x 4m
		Weight	60g (excluding cable)	100g (excluding cable)
		Video plug	Card-edge type connector	Round shape type connector
		Remoteswitches	controlEmbedded	Separated
Observation		Pickup System	Interline type CCD solid-state image pickup	Interline type CCD solid-state image pickup
		Auto Iris	Not available	Available
		Narrow Band Imaging(NBI) function	Available	Not available
OperatingEnvironment		Ambient Temperature	10 to 40°C	10 to 40°C
		Relative Humidity	30 to 85%	30 to 85%
		Atmospheric Pressure	700 to 1060 hPa	700 to 1060 hPa
Reprocessing		Cleaning	Immersible in detergent solution withoutwater-resistant cap	Immersible in detergent solution with awater-resistant cap
		Disinfection	Immersible in disinfectant solution withoutwater-resistant cap	Immersible in disinfectant solution with awater-resistant cap
		Sterilization	Ethylene oxide gas sterilization	Ethylene oxide gas sterilization
Patientcontactingmaterial			No patient contacting material	No patient contacting material

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K 08315-5
pg 4 of 4

7 Conclusion

When compared to the predicate device, the HD CAMERA HEAD OTV-S7ProH-HD-L08E
r When compared to the predicale changes in intended use, method of operation, or design does not incorporate any orghineen energy of the device.

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Image /page/4/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, which is a common symbol of the United States.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2009

OLYMPUS MEDICAL SYSTEMS CORP. % Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K083155

Trade/Device Name: HD CAMERA HEAD OTV-S7ProH-HD-L08E Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: October 23, 2008 Received: October 29, 2008

Dear Ms. Kluesner:

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 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.

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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 not 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 elections product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, perior courted in the 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 this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3064 - You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fida.gov/cdrh/industry.suppo/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: HD CAMERA HEAD OTV-S7ProH-HD-L08E

Indications for Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aoqum Whang
(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number_

Page 1 of __ 1

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.