INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT

K140263 · Lexion Medical, LLC · HIF · Mar 5, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K140263
• Device Name: INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
• Applicant: Lexion Medical, LLC
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Mar 5, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Insuflow Synergy™ Port (5 mm) and Insuflow® Synergy™ XL Port (8 mm, 10mm and 12mm) have 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

Gas conditioning device for minimally invasive surgery; attaches to CO2 insufflator. System comprises sterile, disposable single-use component (filter, heater/humidifier, tubing, path-of-entry access port) and reusable control module. CO2 gas flows through filter, heater/humidifier, and dual-lumen access port into surgical cavity. Access port includes duckbill/tool seals for instrument entry and separate lumen for gas delivery. Obturator features transparent optical window for endoscopic visualization during insertion. Used by surgeons in OR to maintain surgical cavity insufflation while providing conditioned (heated/humidified) gas to reduce potential tissue desiccation/hypothermia. Output is physical delivery of conditioned gas and instrument access channel.

Clinical Evidence

Bench testing only. Performance testing included flow/pressure characterization and insertion/removal testing for dual-lumen models. Seal leak integrity and gas conditioning (temperature/humidity) data leveraged from predicate devices.

Technological Characteristics

Dual-lumen access port; disposable filter, heater/humidifier, and tubing; reusable control module. Features transparent optical window on obturator for endoscopic visualization. Dual-lumen configuration with thinner inner lumen wall. Gas conditioning via integrated heating element and humidification media.

Indications for Use

Indicated for patients undergoing thoracic, abdominal, or gynecologic minimally invasive endoscopic surgical procedures 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

• Insuflow Synergy™ XL Port (K120640)
• SurgiQuest AirSeal (K121336)

Reference Devices

• EndoPath trocar devices
• SurgiQuest trocar devices

Submission Summary (Full Text)

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140263 age 1 of 3

#### 510(k) Summary 5.0

Insuflow® Synergy™ and Insuflow® Synergy™ XL Port

January 31, 2014 (revised February 27, 2014) Date Prepared:

- Lexion Medical, LLC Submitter: 545 Atwater Circle St. Paul, MN 55103 Telephone: [phone] Fax: [phone]
Mr. Bernard Horwath Contact: Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127 Telephone: [phone]

Proprietary Name Modified Device: Insuflow Synergy™ Port (5 mm) and Insuflow® Synergy™ XL Port (8 mm, 10mm and 12mm)

Common/Usual Name: Gas Conditioner Insufflator Device with integral path of entry device

Classification Name: Class II per regulations 884.1730, Product Code: HIF Class II per regulations 876.1500, Product Code: GCJ

Establishment Registration Number: 2135348

## Predicate Devices:

LEXION Medical believes that the modified Insuflow Synergy™ and Synergy™ XL Port devices are substantially equivalent to the following devices:

-
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Insuflow" Synergy™ XL Port, K.1206440 Synergy
-
- SurgiQuest AirSeal, K121336

## Description:

The Insuflow® Synergy™ and Synergy™ XL Port devices are gas conditioning devices that
attach to the outlet port of an insufflator or other regulated CO2 source and are design and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow® Synergy™ XL Port consist of a
sterile, 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 system.

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The technology for gas conditioning and path of entry for the modified devices are the same as e predicate Insuflow Synergy™ marketed devices. Regulated CO2 gas flows into the nsuflow Synergy™ and Synergy™ XL Port, through the in-line filter, continues along the ubing to enter the path of entry access device that contains the heating element and umidification media, and through the path of entry access device lumen for delivery into the atient's surgical cavity.

be modifications included in this Special 510fk) include the following:

- Adding an 8 mm size path of entry access device to the Insuflow® Synergy™ family. Sizes now available are 5 mm, 8 mm, 10 mm and 12 mm.
- All access devices will be in a dual lumen configuration with a thinner inner lumen wall design that results in a smaller overall outer lumen diameter.

e integral path of entry access device in the modified Insuflow® Synergy™ and Synergy™ XL ort is designed and constructed similarly to the predicate Insuflow® Synergy™ and Synergy™ KL Port devices but an additional 8 mm access device configuration is being added, just as the predicate EndoPath and SurgiQuest trocar devices. The modified Insuflow Synergy™ (5 mm) and Synergy™ XL Port devices (8 mm, 10 mm, and 12 mm) now feature a dual lumen configuration only. The predicate Insuflow® Synergy™ Port (5 mm) came in single and dual lumen configurations and the predicate Insuflow Synergy™ XL Port (10 mm and 12 mm) had nly a single-lumen working channel configuration for conditioned gas delivery and instrument entry. The modified dual lumen configuration has an inner lumen wall thickness thinner than in the predicate design which results in a smaller overall outer lumen diameter. The dual lumen access device has an inner lumen working channel with duckbill and tool seals for instrument ntry into the surgical cavity and delivers conditioned insufflation gas through the outer lumen channel.

As in the predicates, the obturator for the proposed Insuflow® Synergy™ (5 mm) and Synergy™ (8 mm, 10 mm, and 12 mm) Port devices has a transparent optical window at the distal end, ich when used with an endoscope, provides visibility of individual tissue layers during insertion.

#### ndications for Use:

he modified Insuflow Synergy™ Port (5 mm) and the Insuflow® Synergy™ XL Port (8 mm, 10 nm, and 12 mm) have the same intended use as the Insuflow Synergy™ and Synergy™ 3 Port predicate devices. The intended use of the modified device, as described in the labeling, has ot changed as a result of the modifications.

ow Synergy™ Port (5 mm) and Insuflow® Synergy™ XL Port (8 mm, 10mm and 12mm) applications in thoracic, abdominal and gynecologic minimally invasive endoscopic urgical 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.

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

The modified Insuflow Synergy™ (5 mm) and Synergy™ XL Port (8 mm, 10 mm and 12 mm) utilize the same gas conditioning technology and path of entry access port technology as the predicate Insuflow® Synergy™ Port (5 mm) cleared under 510(k) K120640 and the Insuflow® Synergy™ XL Port (10 mm and 12 mm) cleared under 510(k) K132204. All of the modified devices perform the same gas conditioning function as the predicates with minor design configuration changes. The new Insuflow Synergy™ XL Port (8 mm) path of entry access device is technically equivalent to the predicate Insuflow® Synergy™ and Synergy™ XL Port devices but is configured for 8 mm surgical tools, just as the predicate EndoPath and SurgiQuest trocar devices. The modified Insuflow Synergy™ and Synergy™ XL Port devices are configured in the dual lumen configuration while the predicate Insuflow Synergy™ Port (5 mm) is configured in single and dual lumen configurations and the predicate Insuflow Synergy™ XL Port (10 mm and 12 mm) devices have only a single lumen configuration. All materials in the modified Insuflow Synergy™ devices are the same as the predicate Insuflow® Synergy™ devices.

The obturators for the modified Insuflow Synergy™ and Synergy™ XL Port use the same technology and materials as the predicates with a transparent optical window at the distal end, which when used with an endoscope, provides visibility of individual tissue layers during insertion.

#### Discussion of performance testing.

The risk analysis and resulting performance testing have been conducted to assure that the modified Insuflow® Synergy™ and Insuflow® Synergy™ XL Port devices perform in accordance with specifications and applicable standards. All of the modified devices utilize the same exact design/parts as the predicates for gas conditioning and sealing. As a result, the existing testing for gas temperature and humidity characterization and seal leak integrity testing previously submitted applies directly to these devices. Since the lumen designs were changing, flow/pressure performance and insertion/removal testing were repeated and successfully completed for the modified Insuflow® Synergy™ (5 mm) and Synergy™ XL (8 mm,10 mm and 12 mm) Port dual lumen models. As a result, the risk analysis and applicable testing were successfully conducted to confirm that the Insuflow" Synergy™ and Synergy™ XL dual lumen configuration changes do not substantially affect their performance.

#### Conclusion:

Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXION Medical that the modified Insuflow Synergy™ Port (5 mm) and the Insuflow Synergy™ XL Port (8 mm, 10 mm and 12 mm) devices are substantially equivalent to devices already on the market being used for these applications (cleared by the 510(k) process) and present no new concerns about safety and effectiveness.

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Public Health Service

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

March 5, 2014

LEXION Medical, LLC % Bernard Horwath Regulatory Consultant HRG 4486 Timberline Court Vadnais Heights, MN 55127

Re: K140263

Trade/Device Name: Insuflow® Synergy™ and Insuflow® Synergy™ XL Port Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, GCJ Dated: January 31, 2014 Received: February 3, 2014

Dear Bernard 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. Ilisting 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 fabeling 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.

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#### Page 2 - Bernard Horwath

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Sincerely yours,

# Herbert P. Lerner -S

for

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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510(k) Number (if known): K140263

## Insuflow Synergy™ and Insuflow Synergy™ XL Port:

Indications for Use:

Insuflow Synergy™ Port (5 mm) and Insylow® Synergy™ XL Port (8 mm, 10mm and 12mm) have 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 X (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 Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2014.03.05 15:54:19 -05'00'

Lexion Medical Insuflow® Synergy™ and Synergy™ XL Port Special 510(k)