INSUFLOW SYNERGY PORT

K120640 · Lexion Medical, LLC · HIF · Jul 18, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120640
• Device Name: INSUFLOW SYNERGY PORT
• Applicant: Lexion Medical, LLC
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jul 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

Insuflow Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

Device Story

Insuflow Synergy™ Port is a gas conditioning and access device for minimally invasive surgery. It connects to an external CO2 insufflator; it warms, humidifies, and filters the CO2 gas stream before delivery into the surgical cavity. The device features a disposable component (filter, heater/humidifier, tubing, and path-of-entry access port) and a reusable control module for safety and heating circuits. The access port includes a working channel with duckbill and tool seals for instrument entry; available in single or dual-lumen configurations. Used in OR settings by surgeons; the device maintains surgical cavity pneumoperitoneum while providing conditioned gas to potentially reduce patient discomfort or tissue desiccation. The healthcare provider monitors the insufflation process via the insufflator interface.

Clinical Evidence

Bench testing only. Performance testing included flow/pressure characterization, gas temperature and humidity characterization, insertion/removal testing, and seal leak integrity testing. Biocompatibility testing was conducted per ISO 10993-1.

Technological Characteristics

Disposable gas conditioning device with filter, heater/humidifier, and path-of-entry access port. Reusable control module for safety/heating circuits. Single or dual-lumen configurations with duckbill and tool seals. Biocompatibility per ISO 10993-1. Gas conditioning via integrated heating element and humidification media.

Indications for Use

Indicated for patients undergoing thoracic, abdominal, or gynecologic minimally invasive endoscopic surgery requiring CO2 insufflation and instrument access.

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

• SurgiQuest Trocar with integrated Insufflator (K103692)
• Insuflow (K090456)
• EndoPath Xcel Trocar (K032676)

Submission Summary (Full Text)

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K|20640

# SECTION 2. SUMMARY AND CERTIFICATION

## A. 510(K) SUMMARY

## Summary of Safety and Effectiveness

· JUL 18 2012

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

| SUBMITTER'S NAME: | LEXION Medical LLC |
|---------------------|-----------------------|
| ADDRESS: | 545 Atwater Cr. |
| | St. Paul, MN 55103 |
| CONTACT PERSON: | Bernard (Bud) Horwath |
| TELEPHONE NUMBER: | 651-361-8041 |
| FAX NUMBER: | 651-351-8001 |
| DATE OF SUBMISSION: | 27 Feb 2012 |

#### 1. Identification of device

Proprietary Name: Insuflow® Synergy™ Port Common Name: Gas Conditioner Insufflator Device with integral path of entry device Classification Status: Class II per regulations 884.1730, Product Code: HIF Class II per regulations 876.1500, Product Code: GCJ

#### 2. Equivalent devices

LEXION Medical believes that Insuflow Synergy™ Port is substantially equivalent to the following devices:

SurgiQuest Trocar with integrated Insufflator, K103692 Insuflow®, K090456 EndoPath Xcel Trocar, K032676

Insuflow® Synergy™ Port is a similar gas conditioner insufflator accessory device as Insuflow cleared under 510(k) K090456 with an integral path of entry access port device similar to the predicate trocar device. The Insuflow Synergy™ Port has the same integrated intended use as the predicate devices.

#### 3. Description of the Device

The Insuflow Synergy™ Port (Dual and Single Lumen) is a gas conditioning 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 via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ Port consists of a disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the svstem.

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Regulated CO2 gas flows into the Insuflow® Synergy™ Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity.

The integral path of entry access device is designed and constructed similarly to the predicate trocar device with a sealed instrument access lumen. The Insuflow® Synergy™ Port (Dual and Single Lumen) has a dual-lumen or single-lumen path of entry access device configuration for conditioned gas delivery. Both configurations have a working channel with duckbill and tool seals for instrument entry into the surgical cavity. The single lumen device delivers conditioned insufflation gas through the working channel while the dual lumen configuration has a second outer lumen channel for conditioned gas delivery.

#### 4. Intended use

Insuflow Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat. humidify, filter and introduce a CO> gas stream for insufflation of the surgical cavity.

#### Technological characteristics, comparison to predicate device. 5.

Technically, the Insuflow Synergy™ Port gas conditioning technology is similar to the Insuflow® cleared for market in 510(k) K090456; the devices perform a similar gas conditioning function with minor design configuration and material changes. The Insuflow Synergy™ Port path of entry access device is essentially equivalent to the trocar predicate; the Insuflow Synergy™ Port however is configured in single and dual lumen configurations, while the predicate has only a single lumen configuration. The indications for use for the Insuflow Synergy™ Port are patterned after and essentially the same as the predicate devices.

#### 6. Discussion of performance testing.

Extensive performance testing has been conducted to assure that the Insuflow Synergy™ Port (Dual and Single Lumen) performs in accordance with its specifications and applicable standards. Flow/pressure performance, gas temperature and humidity characterization, insertion/removal testing, and seal leak integrity testing were successfully completed. In addition, biocompatibility testing per ISO 10993-1 was successfully conducted.

#### 7. Conclusion

Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXIQN Medical that Insuflow Synergy™ Port (Dual and Single Lumen) 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.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

### 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

### JUL 18 2012

Re: K120640

> Trade/Device Name: Insuflow® Synergy Port Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, GCJ Dated: July 11, 2012 Received: July 12, 2012

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 for abo stated in the 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 or any I 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

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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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Evans

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ______K120640/S2

Insuflow® Synergy Port Device Name:

### Indications For Use:

Insuflow® Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hhluu

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number_ K 120640

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