INSUFLOW

K090456 · Lexion Medical, LLC · HIF · Aug 26, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090456
• Device Name: INSUFLOW
• Applicant: Lexion Medical, LLC
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Aug 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Insuflow® is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.

Device Story

Insuflow is a single-use accessory for laparoscopic insufflators. It receives CO2 gas from a regulated source; passes gas through an in-line filter; directs gas through a cassette containing a heating element and humidification media; and delivers warmed, humidified, and filtered gas into the surgical cavity via a Luer lock connector to a trocar or insufflation needle. Used in OR settings during minimally invasive procedures (thoracoscopic, laparoscopic, endoscopic vein harvesting). Operated by surgeons or surgical staff. Device warms and humidifies gas to mitigate potential adverse effects of cold, dry CO2 insufflation on the surgical cavity. System includes a disposable tubing set and a control module housing safety and control circuits.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison to predicate devices and performance testing.

Technological Characteristics

Single-use disposable filter, heater, and humidifier tubing set with a control module. Connects to standard CO2 insufflator outlet. Provides heating and humidification of gas stream. Class II device (21 CFR 884.1730).

Indications for Use

Indicated for patients undergoing minimally invasive surgery, including thoracoscopic, laparoscopic, and endoscopic vein harvesting procedures, requiring CO2 insufflation of the surgical cavity.

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 (K063546)
• CarbonAid (K052125)

Submission Summary (Full Text)

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K090456

# SECTION 2. SUMMARY AND CERTIFICATION

## A. 510(K) SUMMARY

## Summary of Safety and Effectiveness

AUG 2 6 2009

In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness for Insuflow

| SUBMITTER'S NAME: | LEXION Medical LLC |
|---------------------|---------------------------------------------|
| ADDRESS: | 5000 Township Parkway<br>St. Paul, MN 55110 |
| CONTACT PERSON: | Bernard (Bud) Horwath |
| TELEPHONE NUMBER: | 651-361-8041 |
| FAX NUMBER: | 651-351-8001 |
| DATE OF SUBMISSION: | 18 February 2009 |

#### 1. Identification of device

Proprietary Name: Insuflow® Common Name: Laparoscopic Insufflator Gas Conditioner Classification Status: Class II per regulations 884.1730 Product Code: HIF

#### 2. Equivalent devices

LEXION Medical believes that Insuflow® is substantially equivalent to the following devices:

Insuflow®, K063546 CarbonAid, K052125

Insuflow is the same gas conditioner insufflator accessory device as cleared under 510(k) K063546 and has essentially the same intended use as the predicate devices.

#### 3. Description of the Device

The Insuflow device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the cardiothoracic, vascular or abdominal surgical cavity. The Insuflow device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system.

Regulated CO2 gas flows into the Insuflow® device, through the in-line filter, continues along the tube to enter the Insuflow® device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to anno a insufflation needle/trocar and finally flows into the patient's surgical cayity over and finally

> LEXION Medical Insuflow® 510k

> > Confidential

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#### 4. Intended use

Insuflow is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.

#### న. Technological characteristics, comparison to predicate device.

Technically, the Insuflow is identical to the Insuflow® cleared for market in 510(k) K063546 and essentially equivalent to the other predicate. The indications for use for the Insuflow are patterned after the predicate devices and supported by an extensive collection of literature references.

#### 6. Discussion of performance testing.

Extensive performance testing has been conducted to assure that the Insuflow performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and are summarized in Section 5.

#### 7. Conclusion

Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXION Medical that Insuflow is substantially equivalent to devices already on the market being used for these applications (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

### LEXION Medical Insuflow® 510k

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Confidential

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Insuflow®

## (1) Gas Conditioning Device (1) 10mL Luer Lock Syringe

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Intended Use: Insuflow® is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.

CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician.

Image /page/2/Picture/5 description: The image contains two symbols. The first symbol is a circle with a number 2 inside, and a diagonal line crossing out the number. The second symbol is a triangle with the text 'ST' inside.

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Patent 5,411,474 and Patent 6,068,609

Exic

LEXION Medical 5000 Township Pkwy St. Paul, MN 55110 USA Toll Free Customer Service: (877) 9-LEXION Email: [e-mail]

P/N: #### (rev. A)

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Bernard Horwath Regulatory Consultant LEXION Medical, LLC 5000 Township Parkway ST PAUL MN 55110

Re: K090456

AUG 2 6 2009

Trade/Device Name: Insuflow® Regulation Number: 21 CFR §884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: August 5, 2009 Received: August 6, 2009

Dear Mr. Horwath:

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 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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrh/industry/support/index.html.

Sincerely yours,

Lamme M. Mouk

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## A. INDICATIONS FOR USE

K090456 510(k) Number

Device Name: Insuflow®

### Indications for Use:

Insuflow is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.

(Please do not write below this line - continue on another page if needed)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Over the Counter Use on J sa.

10 300 2017 11/11/2017 10:00 2016 300 2017 17 000 2017 11/07 1

**LEXION Medical**
Insuflow® 510k

Prescription Use

(Per 21 CFR 801,109)

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Confidential