INSUFLOW DEWHEART

K091366 · Lexion Medical, LLC · HIF · Sep 3, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K091366
• Device Name: INSUFLOW DEWHEART
• Applicant: Lexion Medical, LLC
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Sep 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.

Device Story

Insuflow® DewHeart™ is a single-use blower/mister device attaching to an Insuflow controller with a regulated CO2 source. It processes CO2 gas by passing it through an in-line filter and a cassette containing a heating element and humidification media. The conditioned gas is delivered via a nozzle/wand for directional localization into the patient's surgical cavity. Used in cardiovascular surgery, the device is operated by clinical staff to improve surgical visibility and mitigate air embolism risk. The system includes a disposable tubing set and a control module housing safety and control circuits.

Clinical Evidence

Bench testing only. Performance testing was conducted to ensure compliance with specifications and applicable standards; details were previously provided in K063546.

Technological Characteristics

Single-use blower/mister system. Components include an in-line filter, heating element, and humidification media cassette. Connects to an Insuflow controller for regulated CO2 gas input. Features a nozzle/wand for directional gas delivery. Includes a control module for system safety and control circuits.

Indications for Use

Indicated for use in cardiovascular surgical procedures to heat, humidify, and filter CO2 gas for introduction into 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)
• CTS Blower Mister (K983135)

Submission Summary (Full Text)

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# SEP - 3 2009

1091366

# SECTION 2. SUMMARY AND CERTIFICATION

## A. 510(K) SUMMARY

### Summary of Safety and Effectiveness

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

| SUBMITTER'S NAME: | LEXION Medical LLC |
|---------------------|-----------------------|
| ADDRESS: | 5000 Township Parkway |
| | St. Paul, MN 55110 |
| CONTACT PERSON: | Bernard (Bud) Horwath |
| TELEPHONE NUMBER: | 651-361-8041 |
| FAX NUMBER: | 651-351-8001 |
| DATE OF SUBMISSION: | 1 May 2009 |

#### 1. Identification of device

Proprietary Name: Insuflow DewHeart™ Common Name: Blower/Mister Gas Conditioner Classification Status: Class II per regulations 880.5475 Product Code FOH

Class II per regulations 884.1730 Product Code HIF

#### 2. Equivalent devices

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

Insuflow®, K063546

CarbonAid, K052125

CTS Blower Mister, K983135

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

#### Description of the Device 3.

The Insuflow DewHeart™ device is a single use blower/mister device that attaches to the outlet port of the Insuflow controller with regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to introduction into the cardiovascular cavity. The Insuflow DewHeart™ 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® DewHeart™ device, through the in-line filter, continues along the tube to enter the Insuflow® DewHeart™ device cassette that contains the heating element and humidification media, through a nozzle/wand for directional. localization of a CO2 gas stream entry into the patient's surgical cavity of C ( ) gas strem home ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham ham

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#### 4. Intended use

The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.

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

Technically, the Insuflow® DewHeart™ is the same as the Insuflow® cleared for market in 510(k) K063546 and essentially equivalent to the other two predicates. The indications for use for the Insuflow® DewHeart™ 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 DewHeart™ performs in accordance with its specifications and applicable standards. Details of the Insuflow 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® DewHeart™ 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.

### Confidential

S Pricede of the reading starter of the comments of the many the submit and the subject of the subject of

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP - 3 2009

Lexion Medical, LLC c/o Mr. Bernard Horwath Consultant to Lexion Medical, LLC 5000 Township PKWY St. Paul, MN 55110

Re: K091366

Trade/Device Name: Insuflow Dewheart Regulation Number: 21 CFR 884.1730 Regulation Name: Jet. Lavage, Insufflator, laparoscopic Regulatory Class: Class II (two) Dated: August 27, 2009 Received: August 28, 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.

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Page 2 - Mr. Bernard Horwath

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 (reporting of medical 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

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Sincerely vours.

Dana R. Verner

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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

# A. INDICATIONS FOR USE

510(k) Number_K091366

Device Name: Insuflow® DewHeart™

### Indications for Use:

The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.

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### Confidential

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