This instrument has been designed for insufflation of the abdominal cavity, and automatio suction and smoke evacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.

Device Description

This instrument has been designed for insufflation of the abdominal cavity, and automatic suction and smoke evacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.

This instrument is constituted of High Flow Insufflation Unit UHI-3, Suction Tube and Insufflation Tube, and they are used with Recommended Accessories (Optional) and Ancillary Equipment.

And auto smoke evacuating function of UHI-3 works by combining with the Olympus high frequency unit (UES-20 / 30) or ultrasonic surgery unit (SonoSurg-G / G2)

High Flow Insufflation Unit UHI-3
The High Flow Insufflation Unit UHI-3 has been designed for insufflating CO2 gas into abdominal cavity during a laparoscopic procedure. This provides a clear view and space for laparoscopic instrumentation to be used. The UHI-3 has suction capability for the purpose of evacuating smoke caused by HF instruments. The suction ability can also be used as a secondary system to evacuate the abdominal cavity in an over-pressure condition. The suction is controlled with an external suction unit through the pinch valve.
Suction Tube
The suction tube is designed to be used with the Olympus UHI-3 High Flow Insufflation Unit, and a trocar to assist in maintaining a clear field of view by evacuating smoke from the operating sight during laparoscopic surgery.
Insufflation Tube
The Insufflation tube is designed to be connected to the Olympus UHI-3 High Flow Insufflation Unit, to supply CO2 gas to the abdominal cavity.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a study proving the device meets them. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing performance data from studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. The document does not specify any quantitative acceptance criteria for device performance or present study results to demonstrate that the UHI-3 meets such criteria. It mentions the maximum flow rate of the UHI-3 (35 l/min) in comparison to predicate devices, but this is a specification, not an acceptance criterion with associated performance data.

2. Sample size used for the test set and the data provenance

This information is not available. The document explicitly states: "Then it is judged that clinical data is not needed." This implies that no formal test set, clinical data, or studies that would involve a sample size or data provenance were conducted to demonstrate performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available. As no clinical or performance study data is presented, there's no mention of experts establishing a ground truth for a test set.

4. Adjudication method for the test set

This information is not available. No test set or study is described, so no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No, a MRMC comparative effectiveness study was not done. The document explicitly states that clinical data was not required because the device is substantially equivalent to predicate devices.

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

This question is not applicable as the device is a medical instrument (High Flow Insufflation Unit), not an algorithm or AI system.

7. The type of ground truth used

This information is not available. As no clinical or performance study data is presented, there's no mention of the type of ground truth used.

8. The sample size for the training set

This question is not applicable for this type of medical device. There is no "training set" in the context of an insufflation unit. The device's design and functionality are based on engineering principles and comparison to existing, cleared devices.

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

This question is not applicable for this type of medical device. There is no "training set" or "ground truth" for a training set as described for AI/ML algorithms.

Summary of what is stated regarding acceptance criteria and studies:

The document explicitly states that clinical data is not needed for the Olympus UHI-3 High Flow Insufflation Unit. This decision is based on its substantial equivalence to legally marketed predicate devices, specifically the OLYMPUS High Flow Insufflation Unit (UHI, K953162) and the NORTECH Omniflator 7640 (K983326). The rationale for not requiring clinical data is that the UHI-3 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect safety and effectiveness compared to these predicate devices. The primary difference noted is the increased maximum flow rate (35 l/min for UHI-3 compared to 12 l/min for the older Olympus UHI and 40 l/min for the Omniflator 7640), which is still within the range of cleared devices.

Therefore, the "study that proves the device meets the acceptance criteria" in this context is the comparison to predicate devices and the determination of substantial equivalence, rather than a specific clinical or performance study with defined acceptance criteria and collected data.

Summary

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KO14166

JUN 2 5 2002

510(k) SUMMARY

HIGH FLOW INSUFFLATION UNIT UHI-3

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.

A. Submitter's Name, Address, Phone and Fax Number

1. Manufacturer of the subject device

Name & Address of Manufacturer;	Olympus Optical Co,. Ltd.2-3-1 Shinjuku Monolis Nishi-shinjukuShinjuku-ku, Tokyo, 163-0914Japan
Registration No :Address, Phone and Fax Numberof R&D DepartmentEndoscope Division	80100472951 Ishikawa-choHachioji-shi, Tokyo 192-8507JapanTEL 81-426-42-5177FAX 81-426-46-5613

2. Name of Contact Person Name :

Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416

B. Device Name, Common Name

Address, Phone and Fax :

1. Device Name :	UHI-3HIGH FLOW INSUFFLATION UNIT
2. Common/Usual Name :	HIGH FLOW INSUFFLATION UNIT
3. Classification Name :	Laparoscopic Insufflator21CFR884.1730, Class II

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C. Predicate Devices:

Model	Device Description &510(k)#/ Date Cleared	Manufacturer
OLYMPUSHigh Flow Insufflation UnitUHI	#K95316212/19/1995	Olympus Optical Co., Ltd.
NORTECHOmniflator 7640Model 7-640-00	#K98332602/05/1999	Northgate Technologies, Inc.

D. Description of the Device

This instrument is constituted of High Flow Insufflation Unit UHI-3, Suction Tube and Insufflation Tube, and they are used with Recommended Accessories (Optional) and Ancillary Equipment.

And auto smoke evacuating function of UHI-3 works by combining with the Olympus high frequency unit (UES-20 / 30) or ultrasonic surgery unit (SonoSurg-G / G2)

1. High Flow Insufflation Unit UHI-3

The High Flow Insufflation Unit UHI-3 has been designed for insufflating CO2 gas into abdominal cavity during a laparoscopic procedure. This provides a clear view and space for laparoscopic instrumentation to be used. The UHI-3 has suction capability for the purpose of evacuating smoke caused by HF instruments. The suction ability can also be used as a secondary system to evacuate the abdominal cavity in an over-pressure condition. The suction is controlled with an external suction unit through the pinch valve.

2. Suction Tube

The suction tube is designed to be used with the Olympus UHI-3 High Flow Insufflation Unit, and a trocar to assist in maintaining a clear field of view by evacuating smoke from the operating sight during laparoscopic surgery.

1. Insufflation Tube
  The Insufflation tube is designed to be connected to the Olympus UHI-3 High Flow Insufflation Unit, to supply CO2 gas to the abdominal cavity.

E. Intended Use of the device

F. Reason for not requiring clinical data

The subject HIGH FLOW INSUFFLATION UNIT UHI -3 is similar to the OLYMPUS High Flow Insufflation Unit (UHI) cleared in the previous 510(k) (#953162).

Though the maximum flow rate of the previous device, High Flow Insufflation Unit UHI is 12 I/min, less than 20 I/min, which is the maximum flow rate which FDA has currently cleared for marketing

laparoscopic Insufflators, the maximum flow rate of this subject device is 35 l/min over the current FDA's cleared level.

However the maximum flow rate of OMNIFLATOR 7640 MODEL 7-640-00 cleared in the previous 510(k) (#983326) is 40 l/min.

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And when compared to the predicated devices listed above, the Olympus High Flow Insufflation Unit UHI-3 does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety and effectiveness. Then it is judged that clinical data is not needed.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2002

Ms. Laura Storms-Tyler Director, Regulatory Affairs & Quality Assurance Olympus America, Inc. Two Corporate Center Drive MILVILLE NY 11747-3157 Re: K014166 Trade/Device Name: Olympus UHI-3 High

Flow Insufflation Unit Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: 85 HIF Dated: April 22, 2002 Received: April 29, 2002

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 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 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 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:

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" (21 CFR 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.

Nancy C. Snogdon

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

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number (if known):

HIGH FLOW INSUFFLATION UNIT UHI-3 Device Name: Indications for Use:

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This instrument has been designed for insufflation of the abdominal cavity, and This instrument has been skees wacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.

Concurrence of CDRH, Office of Device Evaluation ODE

Prescription Use

Prescription Use / (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

David A. Bergson

(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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.