The UHI-4 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 subject device, UHI-4, is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment, and 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. The subject device is also used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment.

The subject UHI-4 has the following system functions which are existing features/functions of the predicate device and are not new feature/function.

Cavity mode
Adjustment of the cavity pressure
Adjustment of the gas flow rate
Display mode
Relief mode
Smoke evacuation
Automatic smoke evacuation
Pressure sensor failure detection
Excessive pressure alarm & alarm delay setting

The subject device has the same technological characteristics and design as the applicable predicate devices. There have been no modifications to the device hardware design including performance specifications and physical design requirements, materials, sterilization, shelf life, reprocessing, or packaging.

The only difference between the subject device and the predicate device is the device software, and there are modifications for two existing software functions: "Pressure sensor failure detection" and "Alarm delay setting".

AI/ML Overview

This document is a 510(k) summary for the Olympus High Flow Insufflation Unit (UHI-4), seeking clearance for a software change. It is primarily a comparative analysis against a predicate device (K122180) and does not present a traditional study proving the device meets acceptance criteria through clinical or large-scale performance testing as one might expect for a novel AI/ML-based diagnostic device.

Therefore, many of the specific questions about acceptance criteria (in terms of performance metrics like sensitivity/specificity), sample size for test sets, expert involvement, and ground truth establishment are not applicable to this type of submission. The focus here is on demonstrating substantial equivalence, especially concerning a minor software modification, rather than a de novo performance validation study.

However, I can extract the information relevant to this specific K243527 submission based on the provided text, while indicating where information is not available or not applicable.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Bench Testing)

Since this is a 510(k) for a software change to an existing device, the "acceptance criteria" here are primarily demonstrated through showing the new device maintains the same performance and safety characteristics as the predicate device, validated by bench testing focused on the changed functions.

Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implied by Predicate Equivalence and Safety Focus)	Reported Device Performance (UHI-4 with software changes)
Indications for Use	Must be identical to the predicate device to maintain substantial equivalence.	Identical: For insufflating the abdominal cavity for laparoscopic observation, diagnosis, and treatment; controlled CO2 insufflation for endoscopic vessel harvesting; and insufflating the colon for endoscopic observation, diagnosis, and treatment.
Device Hardware Design	Must be identical to the predicate device.	Identical: No modifications to hardware, performance specifications, physical design, materials, sterilization, shelf life, or packaging.
Technological Characteristics	Must be substantially equivalent to the predicate.	Same as predicate: UHI-4 has existing features/functions of the predicate (Cavity mode, pressure/flow adjustment, display mode, relief mode, smoke evacuation, pressure sensor failure detection, excessive pressure alarm & delay setting). The only difference is software modification for "Pressure sensor failure detection" and "Alarm delay setting."
Overpressure Protection	Device must withstand pressure beyond its intended operating range without failure and maintain structural integrity.	Passed "Overpressure Testing": Confirmed ability to withstand pressure beyond intended range without failure, maintaining structural integrity, and posing no risks.
Tube Obstruction Management	Device must detect and appropriately manage blockages in the tubing system to prevent adverse events.	Passed "Tube Obstruction Testing": Verified ability to identify obstructions and respond appropriately to prevent adverse events like inadequate suction/gas flow.
CO2 Suction Control Accuracy/Reliability	Device must accurately and reliably regulate CO2 removal to maintain clinical effectiveness, reduce overpressures, and prevent complications.	Passed "CO2 Suction Control Testing": Validated accuracy and reliability of the CO2 suction control mechanism, ensuring appropriate CO2 removal.
Hardware Abnormality Response/Safety	Device must respond appropriately to hardware faults (component failures, power disruptions) with safety mechanisms to detect and mitigate failures.	Passed "Hardware Abnormality Testing": Assessed response to hardware faults, confirming safety mechanisms are in place to detect and mitigate failures.
Failure Communication	Device must effectively communicate failure conditions/malfunctions to the user through clear and accurate error messages or alarms, enabling prompt corrective action.	Passed "Communication of Failure Detail Testing": Verified effective communication of failure conditions through appropriate error messages/alarms, ensuring users are aware of issues for prompt corrective action.
Software Performance & Validation	Software must meet performance requirements, operate as intended under normal and abnormal conditions, and adhere to FDA guidance for software validation, ensuring reliability and no impact on patient safety. Specific to the changed functions ("Pressure sensor failure detection" and "Alarm delay setting") it must prove they do not cause over-insufflation.	Passed "Software Testing": Validated that the software meets performance requirements, operates as intended, and adheres to FDA guidance. Confirmed reliability and no errors impacting patient safety. The software change specifically addresses the prevention of over-insufflation.
Cybersecurity	Device must be resilient to cyber threats, including protection against unauthorized access, data tampering, and system vulnerabilities, in compliance with relevant standards.	Passed "Cybersecurity Testing": Evaluated resilience to cyber threats, including risk assessments, secure update mechanisms, and compliance with standards (e.g., CVSS framework), ensuring secure operation and safeguarding patient information/functions.

Here's a breakdown of the other requested information:

A table of acceptance criteria and the reported device performance: This is provided above.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable in the context of a clinical test set with patient data for this submission. The tests performed ("Overpressure Testing," "Tube Obstruction Testing," "CO2 Suction Control Testing," "Hardware Abnormality Testing," "Communication of Failure Detail Testing," "Software Testing," and "Cybersecurity Testing") were bench tests. These tests typically involve a specific number of units/simulations/iterations as defined by internal validation protocols, but not a "sample size" in the sense of a patient cohort. The document does not specify the number of units tested or the number of test runs for each bench test.
- Data Provenance: Not applicable as there is no patient data or clinical data for this specific submission. The tests were laboratory/bench-based. The submitter is Olympus Medical Systems Corporation, located in Tokyo, Japan.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No external experts were used to establish a ground truth for a test set in the conventional sense (e.g., diagnosis of images). The "ground truth" for these bench tests is defined by engineering specifications, safety standards, and the expected functional behavior of the device described by the manufacturer. The tests confirm the device meets these pre-defined engineering criteria.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. Bench testing does not involve such methods; results are typically derived from automated measurements or predefined pass/fail criteria.
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:
- No, not done. This device is an insufflation unit, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant to its clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device with embedded software controlling its functions, not a standalone algorithm. The "software testing" assessed the embedded software's performance within the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications and Safety Standards. The ground truth for the performance of this device is defined by its intended function, the engineering specifications it must meet (e.g., pressure output, flow rate, alarm thresholds), and established safety standards for medical devices of this class. The "truth" is whether the device performs within its defined parameters and safety limits when subjected to various conditions (normal operation, overpressure, obstruction, hardware faults).
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The software modifications enhance existing functions and were presumably developed and verified through standard software development life cycle (SDLC) processes, including unit testing, integration testing, and system testing. The document refers to "Software Testing" and "Cybersecurity Testing" which are validation steps for the finished software, not a training phase for a learning algorithm.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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January 13, 2025

Olympus Medical Systems Corporation % Teffany Hutto Regulatory Affairs Project Manager Olympus Corporation of the Americas 800 West Park Drive Westborough, MA 01581

Re: K243527

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, FCX Dated: November 15, 2024 Received: November 14, 2024

Dear Teffany Hutto:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device. or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these

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requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243527

Device Name High Flow Insufflation Unit (UHI-4)

Indications for Use (Describe)

The UHI-4 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.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary

1. General Information

Date Prepared:	January 8, 2025
510(K) submitter:	Olympus Medical Systems Corporation
	2951 Ishikawa-cho, Hachioji-shi, Tokyo Japan 192-8507
Contact:	Shinichiro Kawachi
	Email: shinichiro.kawachi@olympus.com

2. Device Information

Device Name:	High Flow Insufflation Unit: (UHI-4)
Model Name:	Olympus High Flow Insufflation unit (UHI-4)
Common Name:	Insufflator, Laparoscopic
Classification:	884.1730 - Laparoscopic insufflator
Regulatory Class:	II
Product Code:	HIF - Insufflator, LaparoscopicOSV - Insufflator, endoscopic vessel harvestingFCX - Insufflator, automatic carbon-dioxide for endoscope
Device Panel:	Obstetrics/Gynecology

3. Predicate Device Information

Device Name	510(k) Submitter	510(k) Number
High Flow Insufflation Unit	Olympus Medical Systems	K122180

4. Device Description

The subject UHI-4 has the following system functions which are existing features/functions of the predicate device and are not new feature/function.

· Cavity mode
Adjustment of the cavity pressure
Adjustment of the gas flow rate
Display mode

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Relief mode
Smoke evacuation
Automatic smoke evacuation
Pressure sensor failure detection
· Excessive pressure alarm & alarm delay setting

5. Indications for Use

The UHI-4 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. Predicate Comparison

The subject device does not have different indications for use as compared to the predicate device.

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K243527 Page 3 of 5

This 510(k) application is to request clearance for a change to the software that controls the insufflation function and warning function to ensure that there is no over insufflation of the abdominal cavity.

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7. Non-Clinical/Clinical Tests Summary and Conclusion

As there were no changes to the device design or principles of operation, nonclinical bench testing, animal, testing, or clinical testing were not performed.

Non-clinical testing from the applicant's own predicate (K122180) was leveraged in support of substantial equivalence for the following areas:

Intended Use / Indications for Use
Principle of Operation
Device Design
Materials
Electrical Safety
Human Factors

Software and Cybersecurity testing and documentation were provided to ensure the device's safety, performance, and protection against cybersecurity risks.

Software Testing: Validated that the software meets performance requirements, operates as intended under normal and abnormal conditions, and adheres to FDA guidance for software validation. This testing confirms the reliability of the software in supporting the device's functions without errors or failures that could impact patient safety.
Cybersecurity Testing: Evaluated the device's resilience to cyber threats, including mechanisms to protect against unauthorized access, data tampering, and system vulnerabilities. The documentation included risk assessments, secure update mechanisms, and compliance with relevant industry standards (e.g., CVSS framework). These measures ensure that the device can operate securely in clinical environments, safeguarding patient information and critical device functions.

The following bench tests were conducted to evaluate the performance of the device and ensure its safety and functionality under expected and abnormal conditions:

1. Overpressure Testing:

This test was performed to confirm that the device can withstand pressure beyond its intended operating range without failure. Overpressure testing ensures that the device maintains structural integrity and does not pose risks of leaks, malfunction, or harm to patients or operators under high-pressure scenarios.

2. Tube Obstruction Testing:

Tube obstruction testing evaluates the device's ability to detect and manage blockages in the tubing system. This test is critical to verify that the device can identify an obstruction and respond appropriately to prevent adverse events, such as inadequate suction or gas flow, which could compromise patient safety.

3. CO., Suction Control Testing:

This test was conducted to validate the accuracy and reliability of the device's CO2 suction control mechanism. It ensures that the device can appropriately regulate CO2

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removal, which is essential for maintaining clinical effectiveness, reducing overpressures, and preventing potential complications during procedures.

4. Hardware Abnormality Testing:

This test assesses how the device responds to hardware faults or abnormalities, such as component failures or power disruptions. Testing the device's performance under abnormal conditions ensures that safety mechanisms are in place to detect and mitigate failures, mitigating risks to patients or operators.

5. Communication of Failure Detail Testing:

This test verifies that the device can effectively communicate failure conditions or malfunctions to the user through appropriate error messages or alarms. Clear and accurate communication of failures ensures that users are aware of any issues and can take prompt corrective action to maintain safe and effective operation of the device.

8. Conclusion

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the UHI-4 system does not raise different questions of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness and performance.

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.

	Subject Device	Predicate Device	Comments onDifference
Item	UHI-4	UHI-4
	K243527	K122180
Manufacturer	OLYMPUS MEDICAL SYSTEMSCORP.	OLYMPUS MEDICAL SYSTEMSCORP.	Same as the predicatedevice
Indications for Use	This instrument is intended toinsufflate the abdominalcavity, and providesautomatic suction and smokeevacuation to facilitatelaparoscopic observation,diagnosis and treatment.This instrument is intendedfor controlled CO2 insufflationto create a cavity along thesaphenous vein and/or radialartery to facilitate observation	This instrument is intended toinsufflate the abdominalcavity, and provides automaticsuction and smoke evacuationto facilitate laparoscopicobservation, diagnosis andtreatment.This instrument is intended forcontrolled CO2 insufflation tocreate a cavity along thesaphenous vein and/or radialartery to facilitate observation	Same as the predicatedevice
	during an endoscopic vesselharvesting procedure.This instrument is used toinsufflate the colon to	during an endoscopic vesselharvesting procedure.This instrument is used toinsufflate the colon to
	facilitate endoscopicobservation, diagnosis andtreatment.	facilitate endoscopicobservation, diagnosis andtreatment.
Single-Use/Reuse	Reusable	Reusable	Same as the predicatedevice
Duration and type ofcontact	Indirect patient contact byCO2 gas	Indirect patient contact byCO2 gas	Same as the predicatedevice
Distension Medium	CO2 gas	CO2 gas	Same as the predicatedevice
Insufflation Modes	Normal Cavity modeSmall Cavity mode	Normal Cavity modeSmall Cavity mode	Same as the predicatedevice
Maximum Flow Rate	Small cavity mode: 10 LPMNormal cavity mode: 45 LPM	Small cavity mode: 10 LPMNormal cavity mode: 45 LPM	Same as the predicatedevice
Maximum SetPressure	Small cavity mode: 15 mmHgNormal cavity mode: 25mmHg	Small cavity mode: 15 mmHgNormal cavity mode: 25mmHg	Same as the predicatedevice
Cavity pressurecontrol	When cavity pressure reachesthe set pressure level,insufflation will stop. Whencavity pressure drops belowthe set pressure level,insufflation will start again.	When cavity pressure reachesthe set pressure level,insufflation will stop. Whencavity pressure drops belowthe set pressure level,insufflation will start again.	Same as the predicatedevice
Key Safety Features	Overpressure protection•Tube obstruction•Initial flow rate setting•Supply pressureindications•Monitoring of the volumeof gas delivered•Initial cavity mode setting	Overpressure protection• Tube obstruction•Initial flow rate setting•Supply pressureindications•Monitoring of the volumeof gas delivered•Initial cavity mode setting	Same as the predicatedevice
Filter	End user set the filter.Pore size:≤0.2µm	End user set the filter.Pore size:≤0.2µm	Same as the predicatedevice
Reprocessingmethod	End user clearing by wipingwith the cloth moisturizedwith detergent and/ordisinfectant.	End user clearing by wipingwith the cloth moisturizedwith detergent and/ordisinfectant.	Same as the predicatedevice