This instrument is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment.

This instrument is intended 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.

This instrument is used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment.

Device Description

The HIGH FLOW INSUFFLATION UNIT UHI-4 is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment. This instrument is intended 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. This instrument is used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment

The HIGH FLOW INSUFFLATION UNIT UHI-4 has the following system functions which are identical to the predicate device:

Cavity mode
Two modes including "Normal" and "Small" can be selected according to the cavity size.

Adiustment of the cavity pressure
The pressure inside the cavity can be set in the range between 3 and 25 mmHg (or max, 15 mmHg in the Small cavity mode).

Adiustment of the gas flow rate
The CO2 flow rate can be set in the range from 0.1 - 45 1/min. (or max. 10 1/min. in the Small cavity mode). Three flow rate modes including "High", "Medium" and "Low" can be selected with a one-touch operation.

Display mode
The information displayed on the front panel can be limited as required bv the user.

Relief mode
When the cavity pressure exceeds the set value by 5 mmHg or more, the relief mode is activated to open the channels inside the instrument and release the internal gas until the cavity pressure drops to the set value. The relief mode can be set to ON or OFF as required. Default set value is ON.

Smoke evacuation
When the MAJ-1939 foot switch for smoke evacuation (optional) is used, the smoke and mist generated inside the cavity can be exhausted while maintaining the cavity pressure at a constant level.

Automatic smoke evacuation
The smoke evacuation operation can be interlocked with the output of Olympus generator units such as the SonoSurge-G2, UES-40, ESG-400 and USG-400.

AI/ML Overview

The provided document describes the K122180 Premarket Notification for the HIGH FLOW INSUFFLATION UNIT UHI-4.

1. Table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Rectal Cavity Model Validation	Not explicitly stated, but implies the model accurately represents the colon environment.	"Validation of the Rectal Cavity Model" was conducted. The acceptance criteria were met.
Insufflation Control	Not explicitly stated, but implies accurate and stable control of insufflation.	"Insufflation Control" test was conducted. The acceptance criteria were met.
Pressure Measurement	Not explicitly stated, but implies accurate measurement of internal cavity pressure.	"Pressure Measurement" test was conducted. The acceptance criteria were met.
Overpressure Protection	Not explicitly stated, but implies effective activation and function of the relief mode.	"Overpressure Protection" test was conducted. The acceptance criteria were met.
Overall Performance for Expanded Use	"Performs safely and functionally for the expanded indications for use."	"The results of these tests indicate that, when used in the colon under the recommended insufflation settings, the HIGH FLOW INSUFFLATION UNIT UHI-4 performs as intended."

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

Sample size: Not specified. The document states "Bench testing was performed...". No information on the number of individual tests or repetitions is provided.
Data provenance: Bench testing. The location of the testing is not explicitly stated, but the manufacturer is based in Japan (SHIRAKAWA OLYMPUS CO., LTD.). It is retrospective as it was conducted to support a premarket notification.

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

Not applicable. This device is a medical instrument (insufflator), and its performance testing typically involves objective measurements against engineering specifications and simulated physiological conditions (like the "Rectal Cavity Model"), rather than expert-established ground truth related to diagnostic image interpretation or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. As noted above, the testing described is bench testing of an instrument's functional performance, not clinical evaluation requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. An MRMC study is not relevant for this type of device. The study described focuses on the functional performance of the insufflator.

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

Yes, a standalone study (bench testing) was performed. This device is an instrument, not an AI algorithm. The performance evaluation focuses on the device itself operating according to its design specifications.

7. The type of ground truth used:

The "ground truth" for this device's testing would be the pre-defined engineering specifications and expected physiological responses (e.g., maintaining a set pressure within a model cavity, proper function of overpressure relief). The document refers to "acceptance criteria" which suggests predefined performance benchmarks.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device. No training set was used.

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

Not applicable. No training set was used.

Summary

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K122180

NOV 1 3 2012

Attachment 10.

510(k) SUMMARY

HIGH FLOW INSUFFLATION UNIT UHI-4

1. General Information

Applicant:	OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Official Correspondent:	Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 FAX: 484-896-7128 Email:daphney.germain-kolawole@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

2. Device Identification

Device Trade Name:	HIGH FLOW INSUFFLATION UNIT UHI-4
Common Name:	INSUFFLATOR
Regulation Number:	21 CFR 884.1730 and 876.1500
Regulation Name:	Laparoscopic insufflatorsEndoscope and accessories
Regulatory Class:	II

Attachment 10. 510(k) Summary Page 1 of 5

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510(k): Premarket Notification HIGH FLOW INSUFFLATION UNIT UHI-4

Classification Panel:
Obstetrics/Gynecology Cardiovascular Gastroenterology / Urology

= Product Code:

HIF, OSV, and FCX

3. Predicate Device Identification

3.1 Predicate Device 1

Device Name:	HIGH FLOW INSUFFLATION UNIT UHI-4
Common Name:	INSUFFLATOR
Manufacturer:	OLYMPUS MEDICAL SYSTEM CORP.
510(k) No.	K110294

3.2 Predicate Device 2

Device Name:	TRANSANAL ENDOSCOPICMICROSURGERY (TEM) COMBINATIONSYSTEM AND INSTRUMENT SET,INSTRUMENT SET FOR THE TRANSANALENDOSCOP
--------------	--------------------------------------------------------------------------------------------------------------------------------------

and Instrument Set

■ Common Name:

■ Manufacturer: RICHARD WOLF MEDICAL INSTRUMENTS CORP.

Transanal Endoscopic Surgical Insufflator System

= 510(k) No.

K000180

Attachment 10. 510(k) Summary Page 2 of 5

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4. Device Description

The HIGH FLOW INSUFFLATION UNIT UHI-4 has the following system functions which are identical to the predicate device:

Cavity mode ●

Two modes including "Normal" and "Small" can be selected according to the cavity size.

Adiustment of the cavity pressure ●

· The pressure inside the cavity can be set in the range between 3 and 25 mmHg (or max, 15 mmHg in the Small cavity mode).

Adiustment of the gas flow rate .

The CO2 flow rate can be set in the range from 0.1 - 45 1/min. (or max. 10 1/min. in the Small cavity mode). Three flow rate modes including "High", "Medium" and "Low" can be selected with a one-touch operation.

. Display mode

The information displayed on the front panel can be limited as required bv the user.

Relief mode .

When the cavity pressure exceeds the set value by 5 mmHg or more, the relief mode is activated to open the channels inside the instrument and release the internal gas until the cavity pressure drops to the set value. The relief mode can be set to ON or OFF as required. Default set value is ON.

Smoke evacuation t

When the MAJ-1939 foot switch for smoke evacuation (optional) is used, the smoke and mist generated inside the cavity can be exhausted while maintaining the cavity pressure at a constant level.

Automatic smoke evacuation .

The smoke evacuation operation can be interlocked with the output of Olympus generator units such as the SonoSurge-G2, UES-40, ESG-400 and USG-400.

Attachment 10. 510(k) Summary Page 3 of 5

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The functions of the subject HIGH FLOW INSUFFLATION UNIT UHI-4 are the same as those of the predicate devices described above.

5. Indications for Use

This instrument is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment.

This instrument is used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment.

6. Comparison of Technological Characteristics

The intended use of the HIGH FLOW INSUFFLATION UNIT UHI-4 is identical to the predicate device (K110294) except for the ability to use the device in the colon to facilitate endoscopic observation, diagnosis and treatment. Therefore, the HIGH FLOW INSUFFLATION UNIT UHI-4 with expanded indications for use has the same technological characteristics as the predicate device as follows:

Operating principle
Dimensional specifications
Electrical characteristics
Mechanical characteristics
Communication characteristics
Energy source
Material (no patient contacting material)

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7. Summary of non-clinical testing

Bench testing was performed to support that the HIGH FLOW INSUFFLATION UNIT UHI-4 performed safely and functionally for the expanded indications for use. The following tests were conducted to verify the performance of the UHI-4 in the colon:

Validation of the Rectal Cavity Model .
. Insufflation Control
Pressure Measurement .
Overpressure Protection .

The acceptance criteria were met in the tests conducted. The results of these tests indicate that, when used in the colon under the recommended insufflation settings, the HIGH FLOW INSUFFLATION UNIT UHI-4 performs as intended.

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. In summary, the HIGH FLOW INSUFFLATION UNIT UHI-4 with expanded indications for use described in this submission is substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 13, 2012

OL YMPUS MEDICAL SYSTEMS CORP. % Ms. Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034

Re: K122180

Trade/Device Name: HIGH FLOW INSUFFLATION UNIT UHI-4 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX, HIF, OSV Dated: October 16, 2012 Received: October 17, 2012

Dear Ms. Germain-Kolawole:

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 for association 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.

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Page 2 - Ms. Daphney Germain-Kolawole

You must comply with all the Act's requirements, including, but not limited to: registration and 1 ou must comply with an the mart 801); medical device reporting (reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements modified for ree related ad systems (QS) regulation (21 CFR Part 820); and if applicable, the as set form in the quality of otonis (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 11 you desire specific actives to your Centers Offices/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 note are 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,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k): Premarket Notification HIGH FLOW INSUFFLATION UNIT UHI-4

Indications for Use

K122180

510(k) Number (if known):

Device Name: HIGH FLOW INSUFFLATION UNIT UHI-4

Indications For Use:

This instrument is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment.

This instrument is used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment.

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)
Benjamin R. Fisher -S
2012.11.13 17:57:27 -05'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number	K122180

Attachment 1. Indications for Use Statement Page 1 of 1

Page 1 of 1

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.