PneuVIEW® XE VeryClear™ Gas Evacuation Cannula has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke and plume generated during minimally invasive surgery from the surgical cavity to aid visualization.

Device Description

The PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Port) is an integral path of entry access port device with smoke evacuation mechanism intended for use in the surgical cavity during minimally invasive surgery. The PneuVIEW® XE VeryClear™ is a disposable single use device consisting of a path of entry access port device with filter and tubing with a multi-position stopcock valve. The PneuVIEW® XE VeryClear™ can be connected to a vacuum source for smoke evacuation. The integral path of entry access port device is designed and constructed similarly to the ' predicate Insuflow Synergy™ Port access device with a sealed instrument access lumen. Just as the Insuflow® Synergy™ Port, the PneuVIEW® XE VeryClear™ has a dual-lumen or single-lumen path of entry access device 5 mm configuration for surgical instrument manipulation and smoke evacuation.

AI/ML Overview

The provided text describes the PneuVIEW® XE VeryClear™ Gas Evacuation Cannula and its 510(k) summary, aiming to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics in the format requested.

The sections "Discussion of performance testing" and "Conclusion" broadly state that "Extensive performance testing has been conducted to assure that the PneuVIEW® XE VeryClear™ performs in accordance with its specifications and applicable standards. Flow/pressure performance and seal leak integrity testing were successfully completed. Since the access port device is the same size and configuration as the Insuflow Synergy™ Port 5 mm device, the insertion/removal testing previously submitted is directly applicable. In addition, biocompatibility per ISO 10993-1 was demonstrated."

This summary is insufficient to populate the requested table and answer the specific questions regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies for an AI/device performance evaluation. The document focuses on demonstrating substantial equivalence to existing devices rather than a standalone performance study with quantifiable acceptance criteria against a defined ground truth.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer based on the limited information and what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Flow/Pressure Performance	Successfully completed (implied to meet specifications/standards)
Seal Leak Integrity	Successfully completed (implied to meet specifications/standards)
Insertion/Removal Testing	Directly applicable from predicate device (Insuflow Synergy™ Port 5 mm device) due to same size and configuration.
Biocompatibility	Demonstrated per ISO 10993-1 (meets standard)
Intended Use	Functions for establishing path of entry and evacuating smoke/plume in minimally invasive surgery.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: Not specified in the provided text.
Data Provenance: Not specified. The studies are referred to as "performance testing," but details on retrospective/prospective nature or country of origin are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. The testing appears to be engineering/laboratory-based performance testing rather than expert-reviewed clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided and is not applicable to the type of performance testing described (flow/pressure, leak integrity, biocompatibility).

5. 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 MRMC study was mentioned. This device is a physical medical device (cannula with smoke evacuation), not an AI diagnostic or assistance system. Therefore, this question is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This device is not an algorithm. This question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the physical tests:
- Flow/Pressure: Likely objective measurements against engineering specifications or established standards.
- Seal Leak Integrity: Objective measurements against engineering specifications or established standards.
- Biocompatibility: Conformance to ISO 10993-1, which involves standard materials testing.
- Insertion/Removal: Assumed based on equivalence to predicate device's prior testing, implying similar objective mechanical performance.
No clinical "ground truth" (like pathology or outcomes data) is mentioned as part of the performance testing for this device's 510(k). The focus is on physical and material properties.

8. The sample size for the training set:

This device is not an AI algorithm, so there is no training set in the AI sense. This question is not applicable.

9. How the ground truth for the training set was established:

This device is not an AI algorithm, so there is no training set or ground truth for it in that context. This question is not applicable.

Summary

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SECTION 1. 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 PneuVIEW® XE VeryClear™ Gas Evacuation Cannula.

SUBMITTER'S NAME:	LEXION Medical LLC
ADDRESS:	545 Atwater Cr.
	St. Paul, MN 55103
CONTACT PERSON:	Bernard (Bud) Horwath
	Consultant to LEXION Medical
ADDRESS:	4486 Timberline CT
	Vadnais Heights, MN 55127
TELEPHONE NUMBER:	651-231-1761
FAX NUMBER:	651-636-1671
DATE OF SUBMISSION:	12 July 2013

SEP 2 0 2013

1. Identification of device

Proprietary Name: PneuVIEW® XE VeryClear™ Gas Evacuation Cannula Common Name: Path of entry access port device and smoke evacuation system Classification Status: Class II per regulations 876.1500, Product Code: GCJ Class I per regulation 876.1500, Product Code: FCZ

2. Equivalent devices

LEXION Medical believes that PneuVIEW® XE VeryClear™ Gas Evacuation Cannula is substantially equivalent to the following devices:

SurgiQuest Trocar with Integrated Insufflator, 510(k) K103692 PneuVIEW®XE Smoke Evacuation System, 510(k) exempt Insuflow SynergyTM Port, 510(k) K120640

PneuVIEW® XE VeryClear™ Gas Evacuation Cannula is an accessory device with an integral path of entry access port device with smoke evacuation mechanism similar to the predicate devices. The PneuVIEW® XE VeryClear™ has the same intended use as the predicate devices.

3. Description of the Device

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device with filter and tubing with a multi-position stopcock valve. The PneuVIEW® XE VeryClear™ can be connected to a vacuum source for smoke evacuation.

The integral path of entry access port device is designed and constructed similarly to the ' predicate Insuflow Synergy™ Port access device with a sealed instrument access lumen. Just as the Insuflow® Synergy™ Port, the PneuVIEW® XE VeryClear™ has a dual-lumen or single-lumen path of entry access device 5 mm configuration for surgical instrument manipulation and smoke evacuation.

4. Intended use

Technological characteristics, comparison to predicate device. న్.

Technically, the PneuVIEW® XE VeryClear™ path of entry access port device is essentially equivalent to the Insuflow Synergy™ Port access device predicate with minor design configuration and material colorant differences. The smoke evacuation system is also essentially the same as the PneuVIEW® XE Smoke Evacuation System, with tubing and valves that are connected to a vacuum source for smoke removal. In addition, the SurgiQuest Trocar with Integrated Insufflator is also a combination of devices featuring an access port and smoke evacuation capabilities, just as the PneuVIEW® XE VeryClear™. The indications for use for the PneuVIEW® XE VeryClear™ 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 PneuVIEW® XE VeryClear™ performs in accordance with its specifications and applicable standards. Flow/pressure performance and seal leak integrity testing were successfully completed. Since the access port device is the same size and configuration as the Insuflow Synergy™ Port 5 mm device, the insertion/removal testing previously submitted is directly applicable. In addition, biocompatibility per ISO 10993-1 was demonstrated.

7. Conclusion

Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXION Medical that PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Port) 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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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 20, 2013

Lexion Medical, LLC % Mr. Bernanrd Horwath Regulatory Consultant 4486 Timberline Court Vadnais Heights, Minnesota 55127

Re: K132203

Trade/Device Name: PneuVEIW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Ports) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, HIF Dated: July 12, 2013 Received: July 23, 2013

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. 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

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Page 2 - Mr. Bernanrd Horwath

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 (OS) 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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A. INDICATIONS FOR USE

510(k) Number

Device Name: PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Ports)

Indications for Use:

X Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Holtally signed by Long H. Chen -A
ONL caUS, D=U.S. Government, ou=a Long H. Chen -A 1300369056 07747 19

(Division Sign-off) for MXM Division of Surgical Devices 510(k) Number: K132203

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.