This instrument has been designed to be used with Olympus XLTF-VAW Laparo-Thoraco Videoscope and other ancillary equipment for CO₂ gas and water feeding to clean the distal lens during endoscopic surgery.

Device Description

The subject UCR Endoscopic CO2 Regulation Unit feeds either CO2 gas and water to clean the distal end of the XLTF-VAW Laparo-Thoraco Videoscope. The UCR unit is similar to the predicate Olympus device, the MAJ-1203 Air/Water Supply Pump unit, with the following being the major differences:

The UCR is designed for CO2 gas and water feeding to clean the distal end of . the XLTF-VAW, whereas the predicate device MAJ-1203 was designed for air and water feeding for the XLTF-VAW.
The UCR utilizes a decompression valve mechanism for gas dispensing, . whereas the design for the predicate device MAJ-1203 employs a diaphragm pump.

AI/ML Overview

The provided text describes a 510(k) summary for the "ENDOSCOPIC CO₂ REGULATION UNIT UCR". This document serves as a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. For such submissions, a "study that proves the device meets acceptance criteria" in the traditional sense of a clinical trial with specific performance metrics and statistical analyses is often not required, especially for accessories and devices demonstrating equivalence rather than novel efficacy.

Instead, the submission focuses on comparing the new device's technical characteristics and intended use to a predicate device. The acceptance criteria here are implicitly met by demonstrating that the new device is as safe and effective as the predicate, without raising new questions of safety or effectiveness.

Therefore, the response below will interpret "acceptance criteria" as the critical characteristics compared for substantial equivalence and "study that proves the device meets the acceptance criteria" as the comparison table provided in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically defined by the characteristics of the predicate device, and "reported device performance" is the comparison of the new device against these characteristics. The key "performance" here is demonstrating sufficient similarity or equivalence.

Acceptance Criteria (based on Predicate Device: MAJ-1203)	Reported Device Performance (Subject Device: UCR)
Intended Use	The UCR is basically identical to the predicate device in intended use (feeding gas and water to clean the distal end of the videoscope during endoscopic surgery).
Feeding Gas	Predicate uses Air.
Feeding Method	Predicate uses Diaphragm pump.
Feeding Pressure Indicator	Predicate has None.
Timer Function	Predicate has None.
Dimensions (WxDxH)	85(w) x 155(H)x 191(D) (mm)
Method of Operation	Similar to predicate device.
Material/Design	Similar to predicate device.
Safety and Effectiveness	Demonstrated by predicate's market history.

Summary of the "Study" (Comparison for Substantial Equivalence):

The document provides a comparative analysis (Table 1) between the subject device (UCR Endoscopic CO₂ Regulation Unit) and the predicate device (MAJ-1203 Air/Water Supply Pump Unit). This comparison serves as the "study" demonstrating that the UCR is substantially equivalent to the predicate, even with noted differences. The conclusion is that the UCR "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device" when compared to the predicate.

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

Sample Size for Test Set: Not applicable. This type of 510(k) relies on a comparison of device specifications and intended use against a legally marketed predicate device, not on a clinical test set with a specific number of cases or patients. The "test set" implicitly comprises the technical specifications and existing knowledge/history of the predicate device.
Data Provenance: Not applicable for a traditional test set. The data provenance for the predicate device's established safety and effectiveness would be its long-standing market presence and regulatory clearance (K053382).

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

Number of Experts: Not applicable. "Ground truth" in this context refers to the established characteristics, safety, and effectiveness of the predicate device. This is determined by its prior FDA clearance (K053382) and general medical acceptance, rather than a specific panel of experts for this submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the clinical sense. The "adjudication" is implicitly performed by the FDA reviewer(s) who assess the substantial equivalence claim based on the provided technical and comparative data.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an accessory (Endoscopic CO₂ Regulation Unit), not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in interpretation.

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

Standalone Performance: Not applicable. This device is a mechanical/electronic accessory for medical procedures, not an algorithm. Its function is to feed CO₂ gas and water, not to provide diagnostic interpretations or automated decisions.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety, effectiveness, and functional characteristics of the predicate device (MAJ-1203 Air/Water Supply Pump Unit) as cleared by the FDA under K053382. This is based on regulatory precedent and the understanding of its intended use in medical practice.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not developed using machine learning or AI that would require a "training set."

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

How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

Summary

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DEC 2 3 200>

510(k) SUMMARY

ENDOSCOPIC CO₂ REGULATION UNIT UCR

1 General Information

Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507Establishment Registration No: 8010047
Official Correspondent:	Laura Storms-TylerRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610Phone: 484-896-5688FAX: 484-896-7128Email:Laura.storms-tyler@olympus.comEstablishment Registration No: 2429304
Manufacturer:	Shirakawa Olympus Co., Ltd.3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura,Nishishirakawa-gun, Fukushima, JAPAN 961-8061Establishment Registration Number: 3002808148

2 Device Identification

	Device Trade Name:	UCR ENDOSCOPIC CO₂ REGULATION UNIT
	Common Name:	ENDOSCOPIC CO₂ REGULATION UNIT
	Regulation Number:	21 CFR 876.1500/884.1720
	Regulation Name:	Endoscope and accessoriesGynecologic laparoscope and accessories
	Regulatory Class:	II
	Classification Panel:	Laparoscope, gynecologic (and accessories)
	Product Code:	GCJ/HET

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Predicate Device Information 3

(1) Device Name: Common Name: 510(k) No. Manufacturer:
MAJ-1203 Air/Water Supply Pump Unit Air/Water Supply Pump Unit Part of submission of K053382 Olympus Optical Co., Ltd.

Device Description ব

The UCR is designed for CO2 gas and water feeding to clean the distal end of . the XLTF-VAW, whereas the predicate device MAJ-1203 was designed for air and water feeding for the XLTF-VAW.
The UCR utilizes a decompression valve mechanism for gas dispensing, . whereas the design for the predicate device MAJ-1203 employs a diaphragm pump.

The Laparo-Thoraco Videoscope XLTF-VAW is designed to be used with a VISERA video system center OTV-S7V, light source, documentation equipment, video monitor, endo-therapy accessories, electrosurgical unit and other anciliary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. Olympus has clearance of this system under K053382

ર Indications for Use

The Endoscopic CO2 Regulation Unit UCR is indicated for use as an accessory to the Olympus XLTF-VAW Laparo-thoraco Videoscope and other ancillary equipment for CO2 gas and water feeding to clean the distal lens during endoscopic surgery.

Comparison of Technological Characteristics ર્ણ

The UCR is basically identical to the predicate device in intended use, and similar in specifications except for the feeding gas, feeding pressure indicator and timer function. Comparison between the subject and predicate devices is shown in Table 1.

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Table 1. Comparison of Specifications Subject Device: Endoscopic CO2 Regulation Unit UCR Predicate Device: Air/Water Supply Pump Unit MAJ-1203 (K053382)

The following table is a comparison between the subject device and predicate device.

Items	Subject Device	Predicate Device
	UCREndoscopic CO2 Regulation Unit	MAJ-1203Air/Water Supply Pump Unit
510(k) Number	-	K053382
Dimensions (WxDxH)	130(w) x 156(H) x 334(D) (mm)	85(w) x 155(H)x 191(D) (mm)
Feeding gas	CO2	Air
Feeding method	Decompression valve	Diaphragm pump
Feeding pressure indicator	Five level LED indication	None
Timer function	Provided	None

7 Conclusion

When compared to the predicate device, the Endoscopic CO2 Regulation Unit does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three swooping lines representing the flow of life and health. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2008

Ms. Laura Storms-Tyler Vice President Regulatory Affairs and Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K081173

Trade/Device Name: Endoscopic CO2 Regulation Unit UCR Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: December 4, 2008 Received: December 5, 2008

Dear Ms. Storms-Tyler:

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 idenotions 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 Amendmouts 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 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, l'isting 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 it it vine 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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Page 2

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.

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 this letter;

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jorgu M. Whang

Joyce M. Whang, Ph.D. 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):

K08 1173

Device Name: UCR

Indications for Use:

ENDOSCOPIC CO2 REGULATION UNIT UCR

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)

Helmut Lense

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Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev

510(k) Number K08

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.