(63 days)
Not Found
Not Found
No
The summary describes a gas warming device with a control unit and heat exchanger, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device warms gas for abdominal distention during laparoscopy, which is a supportive function for a medical procedure rather than directly treating a disease or condition itself.
No
The device is a gas warmer used to warm gas for laparoscopic procedures. While it is used for "diagnostic and/or operative laparoscopy," it does not itself perform any diagnostic function; it merely warms the gas used during such procedures.
No
The device description explicitly states it is comprised of a control unit, reusable heat exchanger, and power cords, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Nortech Gas Warmer II warms gas used for insufflation during laparoscopic procedures. This gas is introduced into the body to create space for visualization and manipulation.
- Intended Use: The intended use clearly states it's for warming gas used for distention of the abdomen for diagnostic and/or operative laparoscopy. This is a procedure performed on the body, not a test performed on specimens from the body.
Therefore, based on the provided information, the Nortech Gas Warmer II is a medical device used in a surgical/diagnostic procedure, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
THE NORTECH GAS WARMER II IS INDICATED FOR WARMING GAS (95-105F/35-40.5C) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.
Product codes
HIF
Device Description
The CO, Gas Warmer II Unit is designed to be used in conjunction with an insufflator to provide continuous non-adjustable heating of gas to a laparoscopic instrument. The CO2 Gas Warmer II Unit is comprised of a control unit and reusable heat exchanger and power cords.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen
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)
Not Found
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
SEP 1 7 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
Insufflator, Laparoscopic Accessory Common/Usual Name:
CO., Gas Warmer II Proprietary Name:
Classification: Class II
Materials:
All materials used to manufacture the Northgate Technologies Inc. CO3 Gas Warmer II Unit are non-toxic and have been previously used to manufacture other medical devices.
Description:
The CO, Gas Warmer II Unit is designed to be used in conjunction with an insufflator to provide continuous non-adjustable heating of gas to a laparoscopic instrument. The CO2 Gas Warmer II Unit is comprised of a control unit and reusable heat exchanger and power cords.
Substantial Equivalence:
Northgate's CO2 Gas Warmer II Unit which is comprised of a control unit/heat exchanger and power cords are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Snoden Pencer and Wisap.
Intended Use:
The Nortech CO2 Gas Warmer II Unit shall be used as a means of supplying warm gas for the distention of the abdomen for diagnostic and/or operative laparoscopy.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1999
Mr. Casey Kurek Requlatory Manager Northgate Technologies Incorporated 600 Church Road Elgin, IL 60123
.
Re: K992381 CO2 Gas Warmer II Dated: August 16, 1999 Received: August 19, 1999 Requiatory Class: Il 21 CFR §884.1730/Procode: 85 HIF
Dear Mr. Kurek:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
Confidential
510(k) Number (if known
Device Name:
CO2 Gas Warmer II
Indications For Use:
THE NORTECH GAS WARMER II IS INDICATED FOR WARMING GAS (95-1059F/35-40.5°C) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.
Cury Kurek
C. Kurek, Regulatory Manager
C. Kurek, Regulatory Manager
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992381
(Optional Format 1-2-96)