MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215

K033614 · Northgate Technologies, Inc. · HIF · Jul 29, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033614
• Device Name: MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
• Applicant: Northgate Technologies, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jul 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

IntraMyst Humidification System provides continuous or on-demand humidification to laparoscopic environment; intended to reduce postoperative pain, adhesion formation, and laparoscope lens fogging. System includes controller with front panel controls and pneumatics to supply/control gas to catheter at 100 PSI and 5 LPM. Controller features displays for abdominal pressure, overpressure, gas supply low, mist active, active pressure sense, and fluid volume dispensed. Used in clinical settings by physicians during laparoscopic procedures. Output allows clinicians to monitor and manage intra-abdominal gas/humidity levels.

Clinical Evidence

No clinical data. Bench testing performed to meet electrical safety (UL-2601-1, CAN/CSA-C22.2 No. 601.1, EN 60601-1, EN 60601-1-2) and biocompatibility (ISO 10993-X) standards.

Technological Characteristics

Laparoscopic insufflator; pneumatic control system; 100 PSI / 5 LPM output; non-toxic materials; electrical safety per UL-2601-1, CAN/CSA-C22.2 No. 601.1, EN 60601-1, EN 60601-1-2; biocompatibility per ISO 10993-X.

Indications for Use

Indicated for patients undergoing diagnostic or operative laparoscopic procedures requiring intra-abdominal humidification.

Regulatory Classification

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.

Submission Summary (Full Text)

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K033614

## 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<br>Humidification System Tubing Sets are non-toxic and have<br>been previously utilized to manufacture other devices. |
| Description: | Nortech's IntraMyst Humidification System incorporates<br>front panel controls that are similar to Northgate's current<br>Insufflators. The system is designed to provide continuous<br>or on demand humidification to the laparoscopic<br>environment. This may reduce the incidence of<br>postoperative pain, diminish the likelihood of adhesion<br>formation and reduce laparoscope lens fogging. |
| | The controller will contain the appropriate pneumatics for<br>supplying and controlling the gas to the catheter at 100 PSI<br>and 5 LPM. In addition, the controller will have displays<br>for indicating abdominal pressure, overpressure, gas supply<br>low, mist active, active pressure sense and amount of fluid<br>dispensed. |
| | Northgate Technologies Inc. shall contract the appropriate<br>testing of the system to meet standards such as UL-2601-1,<br>CAN/CSA-C22.2 No. 601.1, EN 60601-1 and<br>EN 60601-1-2. Also, any microbiological testing to meet<br>ISO 10993-X shall be performed. |
| Substantial Equivalence: | Northgate's IntraMyst Humidification System and<br>Accessories is substantially equivalent in materials, and<br>intended use to numerous currently marketed devices.<br>Predicate devices are indicated in Exhibit # 5. |
| Intended Use: | The Nortech IntraMyst Humidification System is indicated<br>for use as a means of supplying humidity within the intra-<br>abdominal cavity during diagnostic and / or operative<br>laparoscopic 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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