INSUFLOW DEVICE, MODEL 6198

K063546 · Lexion Medical, LLC · HIF · Jan 10, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K063546
• Device Name: INSUFLOW DEVICE, MODEL 6198
• Applicant: Lexion Medical, LLC
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jan 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lexion Medical Insuflow® device is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.

Device Story

Insuflow® is a single-use accessory for laparoscopic insufflators; it conditions insufflation gas (CO2) by heating, humidifying, and filtering it before delivery into the abdominal cavity. The system comprises a disposable filter/heater/humidifier tubing set and a control module containing safety and control circuits. Gas flows from the insufflator through an in-line filter, enters a cassette containing a heating element and humidification media, and travels through a Luer lock connector to a trocar or needle for patient delivery. Used in clinical settings during laparoscopic procedures; operated by surgical staff. The device aims to mitigate potential adverse effects of cold, dry insufflation gas on the patient.

Clinical Evidence

Bench testing only. Verification testing included system performance tests mapping CO2 gas temperature and humidity characteristics under varying flow rates using sterile water and saline. Electrical safety and EMC testing performed per EN 60601-1-2, EN 55011, EN 61000-3, and EN 61000-4. Biocompatibility assessed per ISO 10993 and FDA G95-1 guidelines. All design and performance requirements were met.

Technological Characteristics

Single-use disposable tubing set with in-line filter, heating element, and humidification media. Includes a control module for safety/control circuits. Connectivity via Luer lock. Biocompatibility per ISO 10993. Electrical safety per EN 60601-1-2, EN 55011, EN 61000-3, and EN 61000-4.

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring gas insufflation. Used as an accessory to an insufflator to condition gas via heating, humidification, and filtration.

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.

Predicate Devices

• Insuflow® Filter Heater/Hydrator Insufflation Gas Conditioner (K970866)

Submission Summary (Full Text)

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K063546

| Date Prepared: | November 22, 2006 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | JAN 10 2007 |
| Submitter: | Lexion Medical, LLC<br>5000 Township Parkway<br>St. Paul, MN 55110 |
| Contact Person: | Duane Lloyd<br>Research and Development<br>Lexion Medical, LLC<br>5000 Township Parkway<br>St. Paul, MN 55110<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Name: | Insuflow® Device, Filter Heater/Hydrator Insufflation Gas<br>Conditioner |
| Classification Name: | Laparoscopic Insufflator |
| Product Code: | HIF |
| Device Class: | II |
| Regulation Number: | 884.1730 |
| Intended Use: | The Lexion Medical Insuflow® device is an accessory to an<br>insufflator intended to heat, humidify and filter a gas stream used<br>for inflation during laparoscopic surgery. |
| Device Description: | The Insuflow® device is a single use device that attaches to the<br>outlet port of an insufflator and is designed to warm and humidify<br>the gas stream prior to insufflation into the abdominal cavity. The<br>Insuflow® device consists of a disposable filter heater/humidifier<br>tubing set and a control module that houses the control and safety<br>circuits for the system.<br><br>Gas from the insufflator flows into the Insuflow® device, through<br>the in-line filter, continues along the tube to enter the Insuflow®<br>device cassette that contains the heating element and<br>humidification media, through a tube that connects via a Luer lock |

:

## 510(k) Summary of Substantial Equivalence

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| | connector to a trocar or insufflation needle, and finally flows into<br>the patient's abdomen. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | Insuflow® Filter Heater/Hydrator Insufflation Gas Conditioner<br>K970866 Decision Date: January 23, 1998 |
| Summary of Studies: | Verification testing included system performance tests designed to<br>map the CO2 gas temperature and humidity characteristics emitted<br>from the Insuflow® under a simulated run of varying flow rates<br>with sterile water and saline. |
| | Electrical safety and EMC testing was performed using applicable<br>guidelines of EN 60601-1-2, EN 55011, EN 61000-3 and EN<br>61000-4. The Insuflow® device met all specified design and<br>performance requirements. |
| Biocompatibility: | The Insuflow® device was assessed for biocompatibility according<br>to guidelines of ISO 10993 - Biological Evaluation of Medical<br>Devices and FDA G95-1 guidelines. All specified<br>biocompatibility requirements were met. |
| Conclusion: | Through the data and information presented, Lexion Medical LLC<br>considers the Insuflow® device to be substantially equivalent to the<br>legally marketed predicate device. |

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## JAN 1 0 2007

Mr. Duane Lloyd Research and Development LEXION Medical, LLC 5000 Township Parkway ST. PAUL MN 55110

Re: K063546

Trade/Device Name: Insuflow® Filter Heater/Hydrator Insufflation Gas Conditioner Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: December 28, 2006 Received: December 29, 2006

Dear Mr. Lloyd:

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 Coosn. 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 affective 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.

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Protecting and Promoting Public Health

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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.

This letter will allow you to begin marketing your device as described in your Section S10(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:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely vours.

Nancy C. Hogdon

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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## Indications for Use

510(k) Number (if known): K063540

Device Name: Insuflow® Filter Heater/Hydrator Insufflation Gas Conditioner

Indications for Use:

The Lexion Medical Insuflow® device is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Office of Device Evaluation (ODE)

David A. Heggem

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number k063546