(255 days)
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No
The description focuses on pneumatic controls, displays for pressure and fluid, and humidification mechanics, with no mention of AI/ML terms or functionalities.
No
The device is used to supply humidity within the intra-abdominal cavity during laparoscopic procedures, and its intended benefits (reduced postoperative pain, diminished adhesion formation, reduced laparoscope lens fogging) are prophylactic or aimed at improving surgical conditions rather than directly treating a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" states the system is used for "supplying humidity within the intra-abdominal cavity during diagnostic and/or operative laparoscopic procedures." While it can be used during diagnostic procedures, its primary function described in the "Device Description" is to supply humidification, not to diagnose a condition itself. The device output includes displays for pressure, gas supply, mist activity, and fluid dispensed, which are operational parameters, not diagnostic measurements of a patient's condition.
No
The device description explicitly mentions hardware components such as front panel controls, pneumatics, displays, and a controller, indicating it is a physical system, not software-only.
Based on the provided information, the NORTECH IntraMyst Humidification System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply humidity within the intra-abdominal cavity during laparoscopic procedures. This is a direct interaction with the patient's body during a surgical procedure.
- Device Description: The device description details a system for controlling gas and fluid delivery to the intra-abdominal space. It focuses on physical parameters like pressure and flow, and the effects on the surgical environment and patient outcomes (pain, adhesions, lens fogging).
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of biological samples.
Therefore, the NORTECH IntraMyst Humidification System is a medical device used in vivo (within the body) during a surgical procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Nortech IntraMyst Humidification System is indicated for use as a means of supplying humidity within the intra-abdominal cavity during diagnostic and / or operative laparoscopic procedures.
Product codes
85 HIF
Device Description
Nortech's IntraMyst Humidification System incorporates front panel controls that are similar to Northgate's current Insufflators. The system is designed to provide continuous or on demand humidification to the laparoscopic environment. This may reduce the incidence of postoperative pain, diminish the likelihood of adhesion formation and reduce laparoscope lens fogging.
The controller will contain the appropriate pneumatics for supplying and controlling the gas to the catheter at 100 PSI and 5 LPM. In addition, the controller will have displays for indicating abdominal pressure, overpressure, gas supply low, mist active, active pressure sense and amount of fluid dispensed.
Northgate Technologies Inc. shall contract the appropriate testing of the system to meet standards such as UL-2601-1, CAN/CSA-C22.2 No. 601.1, EN 60601-1 and EN 60601-1-2. Also, any microbiological testing to meet ISO 10993-X shall be performed.
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
intra-abdominal cavity
Indicated Patient Age Range
Not Found
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
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Key Metrics
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Predicate Device(s)
Predicate devices are indicated in Exhibit # 5.
Reference Device(s)
Not Found
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
โมนี 2 9 2004
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Image /page/0/Picture/1 description: The image shows the word "NORTECH" in bold, sans-serif font. The word is placed on a black background. A thick black line is placed underneath the word. The image is high contrast, with the word "NORTECH" appearing in white against the black background.
Summary of Safety and Effectiveness
| Common / Usual Name: | Laparoscopic Insufflator |
|---|---|
| Proprietary Name: | Nortech IntraMyst Humidification System |
| Classification: | Class II |
| Materials: | Materials used to manufacture Nortech's IntraMyst |
| Humidification System Tubing Sets are non-toxic and have | |
| been previously utilized to manufacture other devices. | |
| Description: | Nortech's IntraMyst Humidification System incorporates |
| front panel controls that are similar to Northgate's current | |
| Insufflators. The system is designed to provide continuous | |
| or on demand humidification to the laparoscopic | |
| environment. This may reduce the incidence of | |
| postoperative pain, diminish the likelihood of adhesion | |
| formation and reduce laparoscope lens fogging. | |
| The controller will contain the appropriate pneumatics for | |
| supplying and controlling the gas to the catheter at 100 PSI | |
| and 5 LPM. In addition, the controller will have displays | |
| for indicating abdominal pressure, overpressure, gas supply | |
| low, mist active, active pressure sense and amount of fluid | |
| dispensed. | |
| Northgate Technologies Inc. shall contract the appropriate | |
| testing of the system to meet standards such as UL-2601-1, | |
| CAN/CSA-C22.2 No. 601.1, EN 60601-1 and | |
| EN 60601-1-2. Also, any microbiological testing to meet | |
| ISO 10993-X shall be performed. | |
| Substantial Equivalence: | Northgate's IntraMyst Humidification System and |
| Accessories is substantially equivalent in materials, and | |
| intended use to numerous currently marketed devices. | |
| Predicate devices are indicated in Exhibit # 5. | |
| Intended Use: | The Nortech IntraMyst Humidification System is indicated |
| for use as a means of supplying humidity within the intra- | |
| abdominal cavity during diagnostic and / or operative | |
| laparoscopic procedures. |
1
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2004
Mr. Casev Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Road ELGIN IL 60123
Re: K033614
Trade/Device Name: IntraMyst Humidification System Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: 85 HIF Dated: June 1. 2004 Received: June 4, 2004
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 such 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.
2
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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. Bugdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Confidential
510(k) Number (if known):
IntraMyst Humidification System Device Name:
Indications For Use:
The NORTECH IntraMyst Humidification System is indicated for use as a means of supplying humidity within the intra-abdominal cavity during diagnostic and/or operative laparoscopic procedures.
Casey Kerek
Casey Kurek, Regulatory Manager, Northgate Technologies, Inc.
(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)
Nancyc brogelon
(Division Sign-Off)
Division of Reproductive, Ab and Radiological Devic 510(k) Number