(60 days)
Not Found
No
The summary describes a device with standard insufflation, suction, and smoke evacuation functions, and explicitly states that the only difference from the predicate is modifications to existing software functions ("Pressure sensor failure detection" and "Alarm delay setting"). There is no mention of AI or ML.
Yes
The device is described as facilitating observation, diagnosis, and treatment, which aligns with the definition of a therapeutic device.
No
The device is primarily used to insufflate cavities and evacuate smoke to facilitate observation and treatment, not to directly produce a diagnosis. While it aids in observation which can lead to diagnosis, it is an assistive instrument rather than a diagnostic one itself.
No
The device description explicitly states that there have been no modifications to the device hardware design and that the only difference is the device software. This implies the device is a hardware device with updated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device's function is to insufflate (inflate with gas) body cavities (abdominal cavity, saphenous vein/radial artery area, colon) to facilitate observation and procedures. It also provides suction and smoke evacuation.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is entirely focused on manipulating the internal environment of the body for visualization and procedural support.
Therefore, the UHI-4 instrument, as described, is a surgical/endoscopic device, not an in vitro diagnostic device.
Yes
The clearance letter explicitly states: "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This sentence directly confirms that the device is authorized under a PCCP.
Intended Use / 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 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.
Product codes
HIF, OSV, FCX
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal cavity, saphenous vein and/or radial artery, colon.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing was conducted to evaluate the performance of the device and ensure its safety and functionality under expected and abnormal conditions. These tests included:
- Overpressure Testing: Confirmed the device can withstand pressure beyond its intended operating range without failure, maintaining structural integrity and not posing risks under high-pressure scenarios.
- Tube Obstruction Testing: Evaluated the device's ability to detect and manage blockages in the tubing system, confirming it can identify an obstruction and respond appropriately to prevent adverse events.
- CO2 Suction Control Testing: Validated the accuracy and reliability of the device's CO2 suction control mechanism, ensuring appropriate regulation of CO2 removal for clinical effectiveness and prevention of complications.
- Hardware Abnormality Testing: Assessed how the device responds to hardware faults or abnormalities, ensuring safety mechanisms are in place to detect and mitigate failures.
- Communication of Failure Detail Testing: Verified that the device can effectively communicate failure conditions or malfunctions to the user through appropriate error messages or alarms, ensuring users are aware of issues and can take prompt corrective action.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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.
1
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
2
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
3
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 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ 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, Laparoscopic |
| OSV - Insufflator, endoscopic vessel harvesting | |
| FCX - 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 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
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- 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".
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 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.
6. Predicate Comparison
The subject device does not have different indications for use as compared to the predicate device.
| | Subject Device | Predicate Device | Comments on
Difference |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Item | UHI-4 | UHI-4 | |
| | K243527 | K122180 | |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS
CORP. | OLYMPUS MEDICAL SYSTEMS
CORP. | Same as the predicate
device |
| 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 intended
for controlled CO2 insufflation
to create a cavity along the
saphenous vein and/or radial
artery to facilitate observation | 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 | Same as the predicate
device |
| | during an endoscopic vessel
harvesting procedure.
This instrument is used to
insufflate the colon to | during an endoscopic vessel
harvesting procedure.
This instrument is used to
insufflate the colon to | |
| | facilitate endoscopic
observation, diagnosis and
treatment. | facilitate endoscopic
observation, diagnosis and
treatment. | |
| Single-Use/Reuse | Reusable | Reusable | Same as the predicate
device |
| Duration and type of
contact | Indirect patient contact by
CO2 gas | Indirect patient contact by
CO2 gas | Same as the predicate
device |
| Distension Medium | CO2 gas | CO2 gas | Same as the predicate
device |
| Insufflation Modes | Normal Cavity mode
Small Cavity mode | Normal Cavity mode
Small Cavity mode | Same as the predicate
device |
| Maximum Flow Rate | Small cavity mode: 10 LPM
Normal cavity mode: 45 LPM | Small cavity mode: 10 LPM
Normal cavity mode: 45 LPM | Same as the predicate
device |
| Maximum Set
Pressure | Small cavity mode: 15 mmHg
Normal cavity mode: 25
mmHg | Small cavity mode: 15 mmHg
Normal cavity mode: 25
mmHg | Same as the predicate
device |
| Cavity pressure
control | When cavity pressure reaches
the set pressure level,
insufflation will stop. When
cavity pressure drops below
the set pressure level,
insufflation will start again. | When cavity pressure reaches
the set pressure level,
insufflation will stop. When
cavity pressure drops below
the set pressure level,
insufflation will start again. | Same as the predicate
device |
| Key Safety Features | Overpressure protection
•
Tube obstruction
•
Initial flow rate setting
•
Supply pressure
indications
•
Monitoring of the volume
of gas delivered
•
Initial cavity mode setting | Overpressure protection
• Tube obstruction
•
Initial flow rate setting
•
Supply pressure
indications
•
Monitoring of the volume
of gas delivered
•
Initial cavity mode setting | Same as the predicate
device |
| Filter | End user set the filter.
Pore size:≤0.2µm | End user set the filter.
Pore size:≤0.2µm | Same as the predicate
device |
| Reprocessing
method | End user clearing by wiping
with the cloth moisturized
with detergent and/or
disinfectant. | End user clearing by wiping
with the cloth moisturized
with detergent and/or
disinfectant. | Same as 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.