(214 days)
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No
The document describes a gas insufflator with adjustable flow rate and pressure monitoring, with no mention of AI or ML technologies.
No
The device is used for gas distention of the abdomen during diagnostic and/or operative laparoscopy, which is a procedural aid, not a device that directly treats a medical condition.
No
Explanation: The device is described as an insufflator used for gas distention of the abdomen during diagnostic and/or operative laparoscopy. While it is used in procedures that may be diagnostic, the device itself is performing a preparatory function (insufflation) rather than directly diagnosing a condition. It provides the necessary environment for a diagnostic procedure but does not perform the diagnosis.
No
The device description clearly outlines hardware components such as front panel controls, membrane switches, adjustable gas flow rate, patient pressure monitoring connector, and the ability to connect to a CO2 supply (central or E-Cylinder). This indicates it is a physical medical device with integrated software, not a software-only device.
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 in vivo (within the living body) to create space for visualization and manipulation during surgery.
- Device Description: The device is an insufflator that delivers CO2 gas into the abdomen. This is a physical process performed on the patient, not a test performed on a sample of bodily fluid or tissue in vitro (outside the living body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic tests performed on samples.
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 does not fit that description.
N/A
Intended Use / Indications for Use
The Nortech® 40LPM Abdominal Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.
The NORTECH 40LPM ABDOMINAL INSUFFLATOR®, 72-00203-0 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.
Product codes (comma separated list FDA assigned to the subject device)
85 HIF
Device Description
The Abdominal CO, Gas Insufflator (catalog # 72-00203-0) incorporates front panel controls similar to our current Omniflator® model #7640, although it utilizes membrane switches. The Abdominal Insufflator has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator® 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
abdomen
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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 word "NORTECH" in bold, black letters. The word is underlined with a thick, black line. The background is white, and there is a thick, black vertical line on the left side of the image.
SUMMARY OF SAFETY AND EFFECTIVENESS
Laparoscopic Insufflator Common/Usual Name:
Proprietary Name: 40LPM Abdominal Insufflator
Classification: CLASS II
Materials:
All materials used to manufacture the Northgate Technologies Inc. Abdominal Insufflator catalog # 72-00203-0 and tubing sets are non-toxic and have been previously used to manufacture other medical devices.
Description:
The Abdominal CO, Gas Insufflator (catalog # 72-00203-0) incorporates front panel controls similar to our current Omniflator® model #7640, although it utilizes membrane switches. The Abdominal Insufflator has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator® 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 Abdominal Insufflator / tubing sets are substantially equivalent in design, materials, and intended use to other currently marked devices. Other manufacturers of similar devices are Snowden – Penser, and W.O.M GmbH
Intended Use:
The Nortech® 40LPM Abdominal Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2003
Mr. Casey Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Road ELGIN IL 60123
Re: K022052
Trade/Device Name: 40 LPM Abdominal Insufflator . Regulation Number: 21 CFR 884.1730 Regulation Name: Insufflator, Laparoscopic Regulatory Class: II Product Code: 85 HIF Dated: December 26, 2002 Received: December 27, 2002
Dear Mr. Kurek:
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.
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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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Controllarial
510(k) Number (if known):
40LPM ABDOMINAL INSUFFLATOR® CATALOG # 72-00203-0 Device Name:
Indications For Use:
The NORTECH 40LPM ABDOMINAL INSUFFLATOR®, 72-00203-0 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.
Casey 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 (Per 21 CFR 801.109) OR
Over-the-Counter Use
Nancy C. Brogdon
Division Sign-Off
Division of Reproductive, Abdominal
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022052
(Optional Format 1-2-96)
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