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.

Device Description

The Insuflow® Synergy™ and Insuflow® 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.

AI/ML Overview

The Insuflow® Synergy™ and Synergy™ XL Port devices and their modifications involve design changes to existing gas conditioning and path of entry devices used in minimally invasive surgery.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with specific performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the modified devices perform in accordance with specifications and applicable standards, and are "substantially equivalent" to predicate devices. The performance testing focuses on ensuring that the changes do not negatively impact the established functionalities of the original devices.

Acceptance Criteria (Implied)	Reported Device Performance
Gas Conditioning Functionality (Temperature and Humidity)	The document states: "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." This implies the modified devices meet the same performance as the predicate devices for gas temperature and humidity. No specific quantifiable metrics are provided in this summary, but it's asserted that prior testing for the predicates covers these aspects.
Seal Leak Integrity	Similar to gas conditioning, the document states: "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." This indicates the modified devices maintain the same seal leak integrity as the predicate devices. No specific quantifiable metrics are provided here.
Flow/Pressure Performance	The document states: "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." While no specific pass/fail criteria or measurements are provided, the claim is that they were "successfully completed," implying they met the required performance for the new lumen designs.
Insertion/Removal Performance	The document states: "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." Similar to flow/pressure, no specific metrics are given, but the successful completion implies the devices perform adequately during insertion and removal, despite the thinner inner lumen wall and smaller overall outer lumen diameter in the dual lumen configuration.
Overall Safety and Effectiveness	The ultimate 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... and present no new concerns about safety and effectiveness." This broad criterion is met by demonstrating equivalence through the aforementioned performance tests and comparison to predicates. No specific metrics are provided for "safety and effectiveness" beyond the functional performance.

Study Details

The provided text describes a submission for a Special 510(k), which is typically used for modifications to a legally marketed device that do not significantly affect its safety or effectiveness. As such, the "study" is primarily a performance testing regimen to validate the design changes rather than a large-scale clinical trial or comparative effectiveness study.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of units. The testing was conducted for "the modified Insuflow® Synergy™ (5 mm) and Synergy™ XL (8 mm, 10 mm and 12 mm) Port dual lumen models." This implies that representative samples of each modified size/configuration were tested.
- Data Provenance: The testing was conducted by the manufacturer, LEXION Medical, LLC, as part of their risk analysis and product development. This would be retrospective in the sense that it's laboratory/bench testing performed after the design changes were implemented, but before market introduction of the modified device. The country of origin for the data is not specified, but the submitter is based in St. Paul, MN, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of device modification and performance testing (bench testing for flow, pressure, and mechanical integrity) does not typically involve human expert "ground truth" establishment in the way an imaging AI algorithm would. The "ground truth" is defined by engineering specifications and physical measurements.
Adjudication method for the test set:
- None. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments, such as interpreting medical images. For physical device performance testing, objective measurements against engineering specifications are used, removing the need for expert adjudication in this context.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not applicable as this device is a surgical instrument (gas conditioner and port) and not an AI-powered diagnostic or assistive tool for image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Yes (in a different context). The device itself is a standalone medical device that performs its function without a human "in the loop" for its primary operation (gas conditioning, port access). It's not an AI algorithm. The performance tests described (flow/pressure, insertion/removal) are standalone tests of the device's physical and functional properties.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance testing is based on engineering specifications and measurable physical properties. For example, the "ground truth" for flow/pressure performance would be the required flow rates and pressure tolerances as defined by the device design and relevant industry standards. For insertion/removal, it would relate to acceptable forces, ease of use, and lack of damage.
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth established for it in this context.

Summary

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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: 651-855-1447 Fax: 651-636-1671
Mr. Bernard Horwath Contact: Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127 Telephone: 651- 231-1761

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:

nang oquare and the and the article of noon
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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)

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.