(255 days)
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.
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.
The Nortech IntraMyst Humidification System is a Class II device designed to provide continuous or on-demand humidification to the laparoscopic environment. The provided SSS document acts as a 510(k) premarket notification, which is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence, rather than specific performance metrics from a dedicated clinical study for this device.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as demonstrated by similarity to predicate devices) |
|---|---|
| Intended Use: The device must have the same intended use as legally marketed predicate devices. | 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. (This is stated to be substantially equivalent to predicate devices.) |
| Technological Characteristics: The device must have technological characteristics (materials, design, operating principles) that are substantially equivalent to predicate devices. | - Materials: Non-toxic and previously utilized in other devices. - Front Panel Controls: Similar to Northgate's current insufflators. - Controller Functionality: Contains appropriate pneumatics for gas supply and control (100 PSI, 5 LPM), with displays for abdominal pressure, overpressure, gas supply low, mist active, active pressure sense, and fluid dispensed. - Standards Compliance: Will meet UL-2601-1, CAN/CSA-C22.2 No. 601.1, EN 60601-1, EN 60601-1-2. Microbiological testing to meet ISO 10993-X. |
| Safety and Effectiveness: When compared to predicate devices, the new device must not raise different questions of safety and effectiveness. | The document implicitly asserts this by claiming "substantial equivalence in materials, and intended use to numerous currently marketed devices." The compliance with recognized standards (UL, CAN/CSA, EN, ISO) suggests the device's safety and effectiveness will be comparable. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the traditional sense for evaluating device performance against pre-defined criteria. This is a 510(k) submission focused on substantial equivalence, which primarily relies on direct comparison to predicate devices, engineering testing (to meet standards), and possibly bench testing. Therefore:
- Sample Size for Test Set: Not applicable in the context of a clinical performance study. The evaluation likely involved engineering tests and potentially bench tests, but no specific human clinical test set is described.
- Data Provenance: Not applicable in the context of a clinical performance study. The information provided is about the device's design, materials, intended use, and its assertion of substantial equivalence to predicate devices, rather than clinical data from a new study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is a 510(k) submission focusing on substantial equivalence, there is no mention of a human-in-the-loop clinical test set requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laparoscopic insufflator and humidification system, not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm. Its performance would be evaluated through engineering specifications, bench testing, and compliance with standards, not as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a 510(k) submission of this type of device, "ground truth" isn't typically established in the sense of clinical outcomes or expert labels. Instead, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective, and the new device demonstrates equivalence to them through design, materials, and intended use. Performance is implicitly demonstrated by meeting recognized safety and performance standards.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product developed using a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML product developed using a training set.
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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 IntraMystHumidification System Tubing Sets are non-toxic and havebeen previously utilized to manufacture other devices. |
| Description: | Nortech's IntraMyst Humidification System incorporatesfront panel controls that are similar to Northgate's currentInsufflators. The system is designed to provide continuousor on demand humidification to the laparoscopicenvironment. This may reduce the incidence ofpostoperative pain, diminish the likelihood of adhesionformation and reduce laparoscope lens fogging. |
| The controller will contain the appropriate pneumatics forsupplying and controlling the gas to the catheter at 100 PSIand 5 LPM. In addition, the controller will have displaysfor indicating abdominal pressure, overpressure, gas supplylow, mist active, active pressure sense and amount of fluiddispensed. | |
| Northgate Technologies Inc. shall contract the appropriatetesting of the system to meet standards such as UL-2601-1,CAN/CSA-C22.2 No. 601.1, EN 60601-1 andEN 60601-1-2. Also, any microbiological testing to meetISO 10993-X shall be performed. | |
| Substantial Equivalence: | Northgate's IntraMyst Humidification System andAccessories is substantially equivalent in materials, andintended use to numerous currently marketed devices.Predicate devices are indicated in Exhibit # 5. |
| Intended Use: | The Nortech IntraMyst Humidification System is indicatedfor use as a means of supplying humidity within the intra-abdominal cavity during diagnostic and / or operativelaparoscopic procedures. |
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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.
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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
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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
§ 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.