(384 days)
K/DEN number: K973447
No
The summary describes a gas insufflator with adjustable flow rate and pressure monitoring, but makes no mention of AI or ML capabilities.
No
The device is used for gas distention of the abdomen for diagnostic and/or operative laparoscopy, which is typically a procedural aid rather than a direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that the device "SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY." The inclusion of "diagnostic" indicates its use in determining the nature of a disease or condition.
No
The device description clearly describes a hardware device (CO₂ Gas Insufflator) with physical components, controls, and connections for gas supply and patient monitoring. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "gas distention of the abdomen for diagnostic and / OR operative laparoscopy." This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The description details a CO₂ gas insufflator used to inflate the abdomen. This is a medical device used in a surgical or diagnostic procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Nortech® 6630 Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.
Product codes
85 HIF
Device Description
The Omniflator® Model 6630 CO₂ Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6600. The 6630 has an adjustable gas flow rate from 0-30 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank. All materials used to manufacture the Northgate Technologies Inc. Omniflator® Model 6630 and tubing sets are non-toxic and have been previously used to manufacture other medical devices.
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)
K973447 (Northgate's 6630 Insufflator/tubing sets are substantially equivalent in design, materials, and intended use to other currently marketed devices.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K973447' and are written in black ink on a white background. The handwriting is somewhat stylized, with distinct shapes for each character. The characters appear to be part of a serial number or code.
Image /page/0/Picture/1 description: The image shows the word "NORTECH" in a bold, sans-serif font. The word is underlined by a thick line. The background is dark, and the text is light, creating a high-contrast image. The image appears to be a logo or branding element.
SEP 3 0 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Common/Usual Name: Laparoscopic Insufflator
Omniflator® 6630 Proprietary Name:
Classification: CLASS II
Materials:
All materials used to manufacture the Northgate Technologies Inc. Omniflator® Model 6630 and tubing sets are non-toxic and have been previously used to manufacture other medical devices.
Description:
The Omniflator® Model 6630 CO₂ Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6600. The 6630 has an adjustable gas flow rate from 0-30 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank.
Substantial Equivalence:
Northgate's 6630 Insufflator/tubing sets are substantially equivalent in design, materials, and intended use to other currently marketed devices. Other manufacturers of similar devices are Snowden - Pencer.
Intended Use:
The Nortech® 6630 Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present. The text is likely the header of a document or website.
Image /page/1/Picture/2 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 an abstract symbol that resembles a stylized human figure or bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Mr. Casey Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Road Elgin, IL 60123
Re: K973447 Nortech Omniflator® 6630 Dated: July 14, 1998 Received: July 16, 1998 Regulatory Class: II
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 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 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 regulation (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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please 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/dsmaldsmam.n.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K973447 |
Corve active Lake
OMNIFLATOR® 6630 Device Name:
Indications For Use:
THE NORTECH OMNIFLATOR® 6630 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.
Casey Kurek 9.8.97
C. Kufek, 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 (Per 21 CFR 801.109)
OR
Over-the-Counter Use
David C. Hegmon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K973447
(Optional Format 1-2-96)