(136 days)
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No
The summary describes a gas insufflator with adjustable flow rate and pressure monitoring, with no mention of AI or ML capabilities.
No
The device is used for gas distention of the abdomen during diagnostic and operative laparoscopy. This is a supportive function for a medical procedure rather than directly treating a medical condition or restoring function.
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" directly indicates its use for diagnostic purposes.
No
The device description clearly details a hardware device (gas insufflator) with physical controls, adjustable flow rate, and connectors for tubing and gas supply. 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 device is a gas insufflator used to inflate the abdomen with CO2. This is a physical intervention, not a test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on the analysis of such samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Nortech® 7640 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 7640 CO, Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6630/6600. The 7640 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's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO, 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
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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
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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.
0
5 1999 FEB
Image /page/0/Picture/1 description: The image shows the word "NORTECH" in a bold, sans-serif font. The word is white against a black background, and there is a thick black line above and below the word. To the left of the word is a thick black vertical bar. The image has a slightly grainy texture, which may be due to the image quality or the printing process.
SUMMARY OF SAFETY AND EFFECTIVENESS
Common/Usual Name: Laparoscopic Insufflator
Proprietary Name: Omniflator® 7640
Classification: CLASS II
Materials:
All materials used to manufacture the Northgate Technologies Inc. Ominflator® Model 7640 and tubing sets are non-toxic and have been previously used to manufacture other medical devices.
Description:
The Omniflator® Model 7640 CO, Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6630/6600. The 7640 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's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO, from a central supply or E-Cylinder tank.
Substantial Equivalence:
Northgate's 7640 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® 7640 Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.
C
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K983326 Nortech Omniflator® 7640 Laparsocopic Insufflator Dated: December 30,1998 Received: December 31, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF
5 1999 FEB
Casey Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Rd. Elgin, IL 60123
Dear Ms. 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). 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 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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), piease contact the Uffice 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,
t. Daniel G. Schultz, M.D.
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
510(k) Number (if known
CONF .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
THE NORTECH OMNIFLATOR® 7640 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.
Casey Kurek
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
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number