(188 days)
Not Found
No
The description focuses on mechanical functions (insufflation, suction, smoke evacuation) and does not mention any AI/ML terms or capabilities.
No.
This device is used for insufflation, suction, and smoke evacuation during laparoscopic procedures to create and maintain a clear surgical field, not to treat a disease or condition.
No
The device is an insufflator designed for creating space in the abdominal cavity using CO2 gas, and for suction and smoke evacuation during laparoscopic procedures. While it may be used for diagnostic laparoscopy, its primary function is procedural support (insufflation, suction, smoke evacuation), not diagnosis itself.
No
The device description explicitly lists hardware components: High Flow Insufflation Unit UHI-3, Suction Tube, and Insufflation Tube.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is used during a surgical procedure (laparoscopy) to insufflate the abdominal cavity with CO2 gas, provide suction, and evacuate smoke. Its function is to create and maintain a working space and clear view within the body, not to analyze biological samples.
The intended use and device description clearly indicate its purpose is for surgical assistance and visualization during laparoscopic procedures, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
This instrument has been designed for insufflation of the abdominal cavity, and automatic suction and smoke evacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.
Product codes
85 HIF
Device Description
This instrument has been designed for insufflation of the abdominal cavity, and automatic suction and smoke evacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.
This instrument is constituted of High Flow Insufflation Unit UHI-3, Suction Tube and Insufflation Tube, and they are used with Recommended Accessories (Optional) and Ancillary Equipment.
And auto smoke evacuating function of UHI-3 works by combining with the Olympus high frequency unit (UES-20 / 30) or ultrasonic surgery unit (SonoSurg-G / G2)
-
High Flow Insufflation Unit UHI-3
The High Flow Insufflation Unit UHI-3 has been designed for insufflating CO2 gas into abdominal cavity during a laparoscopic procedure. This provides a clear view and space for laparoscopic instrumentation to be used. The UHI-3 has suction capability for the purpose of evacuating smoke caused by HF instruments. The suction ability can also be used as a secondary system to evacuate the abdominal cavity in an over-pressure condition. The suction is controlled with an external suction unit through the pinch valve. -
Suction Tube
The suction tube is designed to be used with the Olympus UHI-3 High Flow Insufflation Unit, and a trocar to assist in maintaining a clear field of view by evacuating smoke from the operating sight during laparoscopic surgery. -
Insufflation Tube
The Insufflation tube is designed to be connected to the Olympus UHI-3 High Flow Insufflation Unit, to supply CO2 gas to the abdominal cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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)
Not Found
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
KO14166
JUN 2 5 2002
510(k) SUMMARY
HIGH FLOW INSUFFLATION UNIT UHI-3
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.
A. Submitter's Name, Address, Phone and Fax Number
1. Manufacturer of the subject device
| Name & Address of Manufacturer; | Olympus Optical Co,. Ltd.
2-3-1 Shinjuku Monolis Nishi-shinjuku
Shinjuku-ku, Tokyo, 163-0914
Japan |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Registration No :
Address, Phone and Fax Number
of R&D Department
Endoscope Division | 8010047
2951 Ishikawa-cho
Hachioji-shi, Tokyo 192-8507
Japan
TEL 81-426-42-5177
FAX 81-426-46-5613 |
2. Name of Contact Person Name :
Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416
B. Device Name, Common Name
Address, Phone and Fax :
| 1. Device Name : | UHI-3
HIGH FLOW INSUFFLATION UNIT |
|--------------------------|-----------------------------------------------------|
| 2. Common/Usual Name : | HIGH FLOW INSUFFLATION UNIT |
| 3. Classification Name : | Laparoscopic Insufflator
21CFR884.1730, Class II |
1
C. Predicate Devices:
| Model | Device Description &
510(k)#/ Date Cleared | Manufacturer |
|-----------------------------------------------|-----------------------------------------------|------------------------------|
| OLYMPUS
High Flow Insufflation Unit
UHI | #K953162
12/19/1995 | Olympus Optical Co., Ltd. |
| NORTECH
Omniflator 7640
Model 7-640-00 | #K983326
02/05/1999 | Northgate Technologies, Inc. |
D. Description of the Device
This instrument has been designed for insufflation of the abdominal cavity, and automatic suction and smoke evacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.
This instrument is constituted of High Flow Insufflation Unit UHI-3, Suction Tube and Insufflation Tube, and they are used with Recommended Accessories (Optional) and Ancillary Equipment.
And auto smoke evacuating function of UHI-3 works by combining with the Olympus high frequency unit (UES-20 / 30) or ultrasonic surgery unit (SonoSurg-G / G2)
1. High Flow Insufflation Unit UHI-3
The High Flow Insufflation Unit UHI-3 has been designed for insufflating CO2 gas into abdominal cavity during a laparoscopic procedure. This provides a clear view and space for laparoscopic instrumentation to be used. The UHI-3 has suction capability for the purpose of evacuating smoke caused by HF instruments. The suction ability can also be used as a secondary system to evacuate the abdominal cavity in an over-pressure condition. The suction is controlled with an external suction unit through the pinch valve.
2. Suction Tube
The suction tube is designed to be used with the Olympus UHI-3 High Flow Insufflation Unit, and a trocar to assist in maintaining a clear field of view by evacuating smoke from the operating sight during laparoscopic surgery.
-
- Insufflation Tube
The Insufflation tube is designed to be connected to the Olympus UHI-3 High Flow Insufflation Unit, to supply CO2 gas to the abdominal cavity.
- Insufflation Tube
E. Intended Use of the device
This instrument has been designed for insufflation of the abdominal cavity, and automatio suction and smoke evacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.
F. Reason for not requiring clinical data
The subject HIGH FLOW INSUFFLATION UNIT UHI -3 is similar to the OLYMPUS High Flow Insufflation Unit (UHI) cleared in the previous 510(k) (#953162).
Though the maximum flow rate of the previous device, High Flow Insufflation Unit UHI is 12 I/min, less than 20 I/min, which is the maximum flow rate which FDA has currently cleared for marketing
laparoscopic Insufflators, the maximum flow rate of this subject device is 35 l/min over the current FDA's cleared level.
However the maximum flow rate of OMNIFLATOR 7640 MODEL 7-640-00 cleared in the previous 510(k) (#983326) is 40 l/min.
2
And when compared to the predicated devices listed above, the Olympus High Flow Insufflation Unit UHI-3 does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety and effectiveness. Then it is judged that clinical data is not needed.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2002
Ms. Laura Storms-Tyler Director, Regulatory Affairs & Quality Assurance Olympus America, Inc. Two Corporate Center Drive MILVILLE NY 11747-3157 Re: K014166 Trade/Device Name: Olympus UHI-3 High
Flow Insufflation Unit Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: 85 HIF Dated: April 22, 2002 Received: April 29, 2002
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Snogdon
Nancy C. Progdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE STATEMENT
510(k) Number (if known):
HIGH FLOW INSUFFLATION UNIT UHI-3 Device Name: Indications for Use:
ાર
This instrument has been designed for insufflation of the abdominal cavity, and This instrument has been skees wacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.
Concurrence of CDRH, Office of Device Evaluation ODE
Prescription Use
Prescription Use / (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
David A. Bergson
(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number