This instrument has been designed for insufflation of abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment. This instrument is also designed for controlled CO2 insufflation to create a cavity along the saphenous vein and/or radial artery to facilitate observation during an endoscopic vessel harvesting procedure.

Device Description

The subject device , UHI-4, has new insufflation function, small mode, for insufflation of cavities along the saphenous vein and radial artery. Therefore, the insufflation pressure of small mode is designed to be less than the normal mode which is implemented in UHI-3. The small mode is not intended for pediatric use. This subject device has user-friendly displays for indicating gas flow rate, cavity pressure, and insufflated CO2 gas volume on the front panel of UHI-4. lt has several safety functions, such as follows: warning lamps, alarms for excessive pressure and tube obstruction, suction activated for excessive pressure. Gas pressure is controlled by reading sensors and switching valves. lt has a function for evacuating smoke (clearing the field of vision) when either an Electro Surgical Instrument or Ultrasonic Surgical Instrument is used during the operation. This function may be controlled with an optional foot switch. A FlexRay interface enables the UHI-4 to communicate its setting data, measured values, and other parameters between UHI-4 and the SonoSurg Generator SonoSurg-G2 or the ELECTROSURGICAL UNIT UES-40. The standard set of HIGH FLOW INSUFFLATION UNIT UHI-4 consists of an INSUFFLATION TUBE MAJ-590, a SUCTION TUBE MAJ-591 and a CYLINDER HOSE (PIN) FOR UHI-3 MAJ-1080.

AI/ML Overview

This document is a 510(k) Summary for the HIGH FLOW INSUFFLATION UNIT UHI-4. It describes the device, its intended use, a comparison to predicate devices, and a summary of nonclinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Insufflation in endoscopic harvest of saphenous vein via CABG Applicator: Control pressure in an environment saphenous vein model.	"It was confirmed that UHI-4 can control the pressure in an environment saphenous vein model and the acceptance criteria was met."
Insufflation in endoscopic harvest of radial artery via CABG Applicator: Control pressure in an environment radial artery model.	"It was confirmed that UHI-4 can control the pressure in an environment radial artery model and the acceptance criteria was met."
Simulated use testing: Accurately deliver CO2 at specified flow rates and pressure settings; provide protection from over pressurization.	"The results from the tests above demonstrate that UHI-4 can properly control each setting pressure and function as intended."
Risk analysis: Compliance with established in-house acceptance criteria based on ISO 14971:2007.	"Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
Software validation: Compliance with FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Major Level of Concern).	"The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Major Level of Concern.""

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

The document describes bench testing and simulated use testing.

Sample Size: The document does not specify exact sample sizes for the test sets (e.g., number of saphenous vein models, radial artery models, or simulated runs). It broadly states, "Bench testing demonstrates that UHI-4 performs safely and functionally..."
Data Provenance: The tests are described as nonclinical bench tests performed by the manufacturer, Olympus Medical Systems Corp. and SHIRAKAWA OLYMPUS CO., LTD. The data is thus internal, retrospective for the purpose of this submission, and originating from Japan (where the manufacturers are located) or potentially the US (where Olympus America Inc. is located and the official correspondent resides). No country of origin for the "models" or actual "data" is explicitly stated beyond the manufacturing locations.

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

The document does not mention the involvement of experts for establishing ground truth for the bench and simulated use tests. The acceptance criteria appear to be based on engineering specifications and performance targets for controlling pressure and flow in the described models.

4. Adjudication Method for the Test Set:

No adjudication method is described. The results were confirmed by the manufacturer's testing, indicating an internal assessment against pre-defined engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an insufflation unit, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance for interpretation.

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

This is not applicable in the context of an "algorithm" as typically referred to in AI/software for interpretation. The device itself is a standalone medical instrument that performs insufflation. The "software validation" mentioned implies evaluating the embedded software's performance, which is inherently "standalone" in controlling the device's functions.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests appears to be engineering specifications and established functional requirements for pressure control, flow delivery, and safety features (like protection from over-pressurization). For example, the criteria for the saphenous vein and radial artery models were met by the device's ability to "control the pressure." Risk analysis ground truth was compliance with ISO 14971:2007. Software validation ground truth was compliance with FDA guidance.

8. The Sample Size for the Training Set:

This is not applicable. The document describes a medical device (insufflator) that undergoes engineering and functional validation, not machine learning model training.

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

This is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows handwritten text that appears to be a document identifier or page number. The text includes the string 'K110294' on the first line, which likely serves as a unique identifier for the document. Below this, the text 'pg 1 of 4' indicates that this is page 1 of a 4-page document. The handwriting is somewhat stylized, with the numbers and letters clearly distinguishable.

510(k) SUMMARY

HIGH FLOW INSUFFLATION UNIT UHI-4

October 3, 2011

General Information 1

Applicant:

트

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

Official Correspondent: Stacy Abbatiello Kluesner, M.S., RAC Regulatory 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
Manufacturer: 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

비 Device Trade Name: HIGH FLOW INSUFFLATION UNIT UHI-4 ■ Common Name: INSUFFLATOR 트 21 CFR 884.1730 Regulation Number:
ll
트 Laparoscopic insufflator Regulation Name:
- Regulatory Class:
Obstetrics/Gynecology, Cardiovascular ■ Classification Panel:
미 Product Code: HIF, OSV

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Predicate Device Information 3

1	■ Device Name:	45L CORE Insufflator F114
	■ Common Name:	Carbon Dioxide Insufflator for Laparoscopy andEndoscopic Vessel Harvesting
	■ Manufacturer:	W. O. M. WORLD OF MEDICINE AG
	■ 510(k) No.	K063367
2	■ Device Name:	HIGH FLOW INSUFFLATION UNIT UHI-3
	■ Common Name:	INSUFFLATOR
	■ Manufacturer:	OLYMPUS MEDICAL SYSTEM CORP.
	■ 510(k) No.	K014166

Device Description 4

. The small mode is not intended for pediatric use.
. This subject device has user-friendly displays for indicating gas flow rate, cavity pressure, and insufflated CO2 gas volume on the front panel of UHI-4.
lt has several safety functions, such as follows: .
- warning lamps
- · alarms for excessive pressure and tube obstruction
- suction activated for excessive pressure.
Gas pressure is controlled by reading sensors and switching valves. .
lt has a function for evacuating smoke (clearing the field of vision) when either an Electro . Surgical Instrument or Ultrasonic Surgical Instrument is used during the operation. This

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K110294
Pg. 3 of 4

function may be controlled with an optional foot switch

A FlexRay interface enables the UHI-4 to communicate its setting data, measured values, . and other parameters between UHI-4 and the SonoSurg Generator SonoSurg-G2 or the ELECTROSURGICAL UNIT UES-40.
The standard set of HIGH FLOW INSUFFLATION UNIT UHI-4 consists of an INSUFFLATION TUBE MAJ-590, a SUCTION TUBE MAJ-591 and a CYLINDER HOSE (PIN) FOR UHI-3 MAJ-1080.

ട Indications for Use

Comparison of Technological Characteristics 6

The HIGH FLOW INSUFFLATION UNIT UHI-4 is basically identical to the predicate device UHI-3 (K014166) in intended use except for the ability to create small cavities along the saphenous vein/or and radial artery. It is also similar in specifications except for the addition of small mode and expanding the upper flow rate limit in normal mode.

The HIGH FLOW INSUFFLATION UNIT UHI-4 is basically identical to the predicate device 45L CORE Insufflator F114 (K063367) for the Indication for Use to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

Summary of nonclinical testing 7

Bench testing demonstrates that UHI-4 performs safely and functionally by proving that UHI-4 can control each proper setting pressure as demonstrated in clinical articles. Bench tests were conducted to verify the functionality of the UHI-4 setting used for each anatomical site indicated. Brief summaries of the tests are listed below.

미 Insufflation in endoscopic harvest of saphenous vein via CABG Applicator.
It was confirmed that UHI-4 can control the pressure in an environment saphenous vein model

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K110294
pg. 1 of 4

and the acceptance criteria was met.

Insufflation in endoscopic harvest of radial artery via CABG Applicator. ■ It was confirmed that UHI-4 can control the pressure in an environment radial artery model and the acceptance criteria was met.

= Simulated use testing to demonstrate that the UHI-4 can accurately deliver CO2 at the specified flow rates and pressure settings and that the UHI-4 provides protection from over pressurization.
The results from the tests above demonstrate that UHI-4 can properly control each setting pressure and function as intended.

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Major Level of Concern."

The following standards have been applied to the subject UHI-4:

IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
י ISO 14971
IEC 60601-1-8 .

8 Conclusion

When compared to the predicate devices, the HIGH FLOW INSUFFLATION UNIT UHI-4 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Olympus Medical Systems Corporation % Ms. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034

NOV 1 8 2011

Re: K110294

Trade/Device Name: HIGH FLOW INSUFFLATION UNIT UHI-4 Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, OSV Dated: November 16, 2011 Received: November 17, 2011

· 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related

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Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert Lewin MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K110294 510(k) Number (if known): Device Name: HIGH FLOW INSUFFLATION UNIT UHI-4

Indications For Use:

This instrument has been designed for insufflation of abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment.

This instrument is also designed for controlled CO2 insufflation to create a cavity along the saphenous vein and/or radial artery to facilitate observation during an endoscopic vessel harvesting procedure.

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)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K110294

Page 1 of

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.