(113 days)
No
The device description and performance studies focus on basic control functions (pressure, flow rate, relief mode) and smoke evacuation, with no mention of AI or ML technologies.
Yes
The device is intended to facilitate observation, diagnosis, and treatment during various endoscopic procedures by insufflating a cavity and providing automatic suction and smoke evacuation. These functions directly support medical procedures aimed at patient care, which aligns with the definition of a therapeutic device.
No
The device is an insufflation unit used to create and maintain a cavity for observation and treatment, but it does not perform diagnostic functions itself. Its purpose is to facilitate diagnostic and treatment procedures by other instruments.
No
The device description explicitly states it is an "instrument" and a "unit," and describes physical functions like gas flow rate adjustment, pressure relief, and smoke evacuation, indicating it is a hardware device with integrated software for control.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as insufflating body cavities (abdominal, saphenous vein/radial artery, colon) to facilitate observation, diagnosis, and treatment during endoscopic procedures. This is a direct interaction with the patient's body for visualization and procedural support.
- Device Description: The description details the mechanical functions of the device, such as controlling gas flow, pressure, and providing smoke evacuation. These are all related to creating and maintaining a surgical environment within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is entirely focused on the in-vivo procedure.
Therefore, the HIGH FLOW INSUFFLATION UNIT UHI-4 is a surgical/endoscopic instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity, saphenous vein, 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)
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.
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
Not Found
§ 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.
0
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 insufflators |
| Endoscope and accessories | |
| Regulatory Class: | II |
Attachment 10. 510(k) Summary Page 1 of 5
1
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 ENDOSCOPIC
MICROSURGERY (TEM) COMBINATION
SYSTEM AND INSTRUMENT SET,
INSTRUMENT SET FOR THE TRANSANAL
ENDOSCOP |
| -------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
|---|
and Instrument Set
■ Common Name:
■ Manufacturer: RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Transanal Endoscopic Surgical Insufflator System
= 510(k) No.
Attachment 10. 510(k) Summary Page 2 of 5
2
4. 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 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
3
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 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. 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)
4
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.
5
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.
6
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
7
510(k): Premarket Notification HIGH FLOW INSUFFLATION UNIT UHI-4
Indications for Use
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 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.
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