The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

The Insuflow® Port (5 mm, 8 mm, 10mm and 12mm) devices 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 Lexion AP50/30 Insufflator is a microprocessor controlled CO2 (carbon dioxide) insufflator with multiple operating modes. The insufflator instrumentation is intended for hospital use for Standard/High Flow, Pediatric, and Bariatric laparoscopic procedures used in conjunction with a laparoscope to fill and distend a peritoneal cavity with gas, and for Vessel Harvesting procedures used to create a cavity along the saphenous vein and/or the radial artery during an endoscopic vessel harvesting procedure.

The device incorporates the following major components and features: a metal housing, a world power supply, pressure reducers, a venting system, a gas heater control and a touch screen user interface with various settings and display elements. The software operation includes system checks, user interface, setting adjustments, warning/error messages and service info. The device is equipped with a continuous pressure measurement mode that conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. The AP50/30 Insufflator is designed with several alarms/warnings to inform the operator in case of an overpressure or other malfunctions. The device is to be used with specially designed single-use tubing sets, the Insuflow Port, in order to utilize the full capabilities of continuous pressure measurement and gas heating and humidification. (The insufflator can also accept other tubing sets for gas deliver only.)

The Insuflow® Port (5, 8, 10, 12 mm) devices are gas conditioning/access port devices that attach to the outlet of the AP50/30 Insufflator and are 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 Port consists of an ethylene oxide sterilized, disposable single use tubing set and a path of entry access port device which contains the pressure sensors, a filter, and gas heater/humidifier. The access port device materials are intended for patient contact of less than 24 hours. The Insuflow® Port is connected to the AP50/30 Insufflator via a plug connector cable, which controls the pressure sensing, gas heating and safety circuits for the system.

The technology for gas conditioning and path of entry for the modified port devices is the same as the predicate Insuflow® Synergy™ Port marketed devices. Regulated CO2 gas from the AP50/30 Insufflator flows into the Insuflow® 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Lexion AP50/30 Insufflator with Insuflow® Port. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study or standalone algorithm evaluation in the way one would for an AI/ML medical device.

The "acceptance criteria" discussed here are primarily in the context of demonstrating equivalence to a predicate device, focusing on functional specifications and safety standards rather than diagnostic performance metrics (like sensitivity, specificity, AUC) typically found in AI/ML device submissions. There is no mention of an AI/ML component in this device.

Therefore, the requested information elements (1-9) which are typically relevant for AI/ML medical device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this 510(k) submission.

However, I can extract the information relevant to how this specific device (a CO2 insufflator) demonstrates its performance and safety, framed within the context of a 510(k) submission:

Demonstrating Performance and Safety for the Lexion AP50/30 Insufflator with Insuflow® Port (Non-AI/ML Device)

The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, the Stryker/WOM 45L CORE Insufflator and Lexion Insuflow® Synergy™ Ports. The "acceptance criteria" are implied by meeting or having comparable performance to these predicates and adhering to relevant safety standards.

1. A table of acceptance criteria and the reported device performance:

Since this is not an AI/ML device, the "acceptance criteria" are functional specifications and comparative performance to predicates. There isn't a direct "acceptance criterion" table in the AI/ML sense, but rather a comparison table of key performance specifications between the proposed device and its predicate.

Key Performance Specs	AP50/30 Insufflator (Proposed Device)	45L CORE Insufflator (Predicate Device)	Comparison
Insufflator Indications for Use	The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.	The 45L CORE Insufflator F114 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application, the low flow application and the bariatric application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the 45L CORE Insufflator F 114 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.	Different; the differences between the subject and predicate indications statements are minor and do not alter the intended use
Operating Modes	Standard/High Flow, Pediatric, Bariatric and Vessel Harvesting	Standard/High Flow, Pediatric, Bariatric and Vessel Harvesting	Same
Max Gas Flow	20 lpm (Pediatric)45 lpm (High Flow)50 lpm (Bariatric)10 lpm (Vessel Harvest)	20 lpm (Pediatric)40 lpm (High Flow)45 lpm (Bariatric)10 lpm (Vessel Harvest)	Different; the flow rate of the subject device in bariatric and high flow is higher than the predicate; these differences do not raise different questions of safety and effectiveness.
Pressure Range	1-20mmHg (Pediatric/Vessel Harvest)1-30mmHg (High Flow/Bariatric)	1-20mmHg (Pediatric/Vessel Harvest)1-30mmHg (High Flow/Bariatric)	Same
Intra-abdominal Max Pressure	30 mmHg (High Flow/Bariatric)20 mmHg (Pediatric/Vessel Harvest)	30 mmHg (High Flow/Bariatric)20 mmHg (Pediatric/Vessel Harvest)	Same
Maximum Supply Pressure	65 mm Hg in Bariatric, High Flow, Pediatric and Vessel Harvest modes and 60 mm Hg in Veress mode	70 mm Hg for Bariatric mode, 65 mm Hg for High Flow mode and 60 mm Hg in Veress mode	Different; the subject device maximum supply pressure is lower for bariatric setting. This difference does not raise different questions of safety and effectiveness.
Adjustable Values	Pressure: 1-30 mmHgFlow: 1-50 lpm	Pressure: 1-30 mmHgFlow: 1-45 lpm	Different; the flow rate of the subject device is higher than the predicate; this differences does not raise different questions of safety and effectiveness
Pneumo Pressure Control	Constantly held based upon pressure sensors in Insuflow Port or standard insufflation using pressure sensing in the insufflator	Constantly held based upon real time pressure sensing tube or standard insufflation using pressure sensing in the insufflator	Same
User Interface	Touch screen	Touch screen	Same
Power	100-240 V	100-240 V	Same
Touch Screen Menus (Menu Options)	Configuration Menus:- First Nominal Pressure (15mmHg high flow/bariatric, 10mmHg vessel harvesting, 8mmHg pediatric)- Venting Valve Status with Veress insufflation on or off, Venting system on or off- Venting Pressure Limit: set at 3mmHg (cannot be changed)- Venting Response time: set at 3 sec (cannot be changed)- Gas Supply: House or Bottle- Alarm Volume: set between Level 1-3- Gas Flow Rates: Quick set rate 1-3 (3, 20, 45 LPM high flow; 3, 25, 50 LPM bariatric; 1.0, 4.0, 10.0 LPM vessel harvesting; 0.1 LPM pediatric)- Maximum Nominal Pressure: setting range 5-30 mmHg for bariatric and high flow; 5-20 mmHg for vessel harvesting and pediatric- Flow Safety Limit: Limit On or Off- Warning Signal Occlusion: Signal On or Off- Language: English, Spanish	Configuration Menus:- First Nominal Pressure (15mmHg high flow/bariatric, 10mmHg vessel harvesting, 8mmHg pediatric)- Venting Valve Status with Veress insufflation on or off, Venting system on or off- Venting Pressure Limit: between 2-5 mmHg- Venting Response time: between 2-5 sec- Gas Supply: House or Bottle- Alarm Volume: set between Level 1-3- Gas Flow Rates: Quick set rate 1-3 (3, 20, 40 LPM high flow; 5, 25, 45 LPM bariatric; 1.0, 4.0, 10.0 LPM vessel harvesting; 0.1 LPM pediatric)- Maximum Nominal Pressure: setting range 5-30 mmHg for bariatric and high flow; 5-20 mmHg for vessel harvesting and pediatric- Flow Safety Limit: Limit On or Off- Warning Signal Occlusion: Signal On or Off- Language: English, Spanish	Different; Pressure limits for venting are preset in the subject device, while they can be adjusted in the predicate. Gas flow rates differ to reflect differences in flow range. These differences do not raise different questions of safety and effectiveness.
Error Warnings	Check gas supply, low supply gas pressure, overpressure, venting system active, overpressure/venting system active, occlusion, contamination, contamination/call for service, gas heater/call for service, error message/call for service, device temperature error/turn off device, venting valve non-functioning, continuous pressure sensing deactivated/call for service, flow safety limit, safety limit, valve non-functioning/call for service	Check gas supply, low supply gas pressure, overpressure, venting system active, overpressure/venting system active, occlusion, contamination, contamination/call for service, gas heating defective/call for service, gas temperature >42C, error message/call for service, device temperature error/turn off device, venting valve defective, RTP defective	Different; the minor differences do not raise different questions of safety and effectiveness
Gas Conditioning	Heat and humidify	Heat	Different; the subject device includes humidification with the use of the Insuflow port; this difference does not raise different questions of safety and effectiveness
Tubing Sets	Custom, sterile, single use Insuflow Port	Custom, sterile, single use	Same

2. Sample size used for the test set and the data provenance:

Test Sample Size: Not applicable. Performance was demonstrated through bench testing and adherence to electrical safety and EMC standards.
Data Provenance: Not applicable. The "data" are results from engineering bench tests and compliance assessments to recognized standards, not from a dataset of patient images or clinical outcomes.

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):

Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant to this device's safety and performance assessment. Assessments were made against engineering specifications and predicate device performance.

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

Not applicable. There was no need for expert adjudication in the context of this device's evaluation.

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. This is not an AI-assisted device, so an MRMC study is not relevant.

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

Not applicable. This device does not have a "standalone algorithm" in the AI/ML sense. Its performance is evaluated as an integrated system (insufflator and port). Bench testing focused on its functional performance (e.g., maintaining set pressure, flow rates, handling leaks, overpressure events).

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

The "ground truth" for this device's performance evaluation refers to established engineering specifications, international safety standards (e.g., IEC 60601 series), and the demonstrated performance of the predicate devices during comparative bench testing. For biocompatibility, the ground truth was adherence to ISO 10993 standards and the results of specified biological tests (cytotoxicity, irritation, sensitization, acute systemic toxicity).

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of AI/ML. Software validation was performed according to FDA guidance for software in medical devices, but this refers to traditional software engineering validation, not AI model training.

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

Not applicable. See point 8.

Summary

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November 14, 2017

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

Re: K170799

Trade/Device Name: Lexion AP50/30 Insufflator with Insuflow Port Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF. GCJ. OSV Dated: October 13, 2017 Received: October 16, 2017

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, 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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the text "Benjamin R. Fisher -S". The text is written in a simple, sans-serif font and is horizontally aligned. The background of the image is a light blue color.

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) K170799

Device Name Lexion AP50/30 Insufflator with Insuflow Port

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Lexion AP50/30 Insufflator with Insuflow® Port

Date Prepared:	November 7, 2017
Submitter:	Lexion Medical, LLC545 Atwater CircleSt. Paul, MN 55103Telephone: 651-855-1447Fax: 651-636-1671
Contact:	Mr. Bernard HorwathRegulatory Affairs Consultant4486 Timberline CtVadnais Heights, MN 55127Telephone: 651- 231-1761

Device Name: Lexion AP50/30 Insufflator with Insuflow® Port

Common/Usual Name: Carbon dioxide insufflator for laparoscopic insufflation and endoscopic vessel harvesting (AP50/30), and gas conditioner path of entry device (Insuflow Port)

Classification Name/Code: Class II per regulations 884.1730, Laparoscopic Insufflator Product Code: HIF=Insufflator, laparoscopic Class II per regulations 884.1730, Laparoscopic Insufflator Product Code: OSV=Insufflator, endoscopic vessel harvesting Class II per regulations 876.1500, Endoscope and Accessories Product Code: GCJ=Laparoscope, general and plastic surgery

Predicate Devices:

LEXION Medical believes that the AP50/30 Insufflator with Insuflow® Port devices is substantially equivalent to the following devices:

Primary Predicate: Stryker/WOM 45L CORE Insufflator F114, K063367
WOM Insufflator 50L FM134, K153513
Lexion Insuflow® Synergy™ Port and Synergy™ XL Port, K140263 ●

None of the cited predicate devices have been subject to a design-related recall.

Description:

The device incorporates the following major components and features: a metal housing, a

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world power supply, pressure reducers, a venting system, a gas heater control and a touch screen user interface with various settings and display elements. The software operation includes system checks, user interface, setting adjustments, warning/error messages and service info. The device is equipped with a continuous pressure measurement mode that conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. The AP50/30 Insufflator is designed with several alarms/warnings to inform the operator in case of an overpressure or other malfunctions. The device is to be used with specially designed single-use tubing sets, the Insuflow Port, in order to utilize the full capabilities of continuous pressure measurement and gas heating and humidification. (The insufflator can also accept other tubing sets for gas deliver only.)

Indications for Use:

The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

Technological characteristics, comparison to predicate devices.

AP50/30

The Lexion AP50/30 Insufflator is substantially equivalent to the Stryker/WOM 45L Core Insufflator (K063367) in terms of indications for use, operating mode, basic features, and custom tubing sets. Both insufflators have the same intended use and are used for the same indications. The AP50/30 Insufflator and the predicate device 45L Core Insufflator are CO2 insufflators intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. In addition, both the proposed device and the predicate device are designed with Standard/High Flow, Pediatric and Bariatric operating modes that are indicated to fill and distend a peritoneal cavity with

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gas during a laparoscopic procedure. Both insufflators also incorporate a Vessel Harvesting operating mode that is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

The AP50/30 Insufflator and the predicate 45L Core Insufflator use the same basic operating principles and incorporate the same basic design technology. Both are microprocessor controlled CO2 insufflators that consist of similar major components and incorporate the same type of features, including continuous pressure measurement. In addition, both the proposed device and the predicate device 45L Core Insufflator are to be used with specially designed sterile, single-use tube sets. The following table provides a comparison of key performance specs for the two insufflators.

KeyPerformanceSpecs	AP50/30 Insufflator	45L CORE Insufflator	Comparison
InsufflatorIndications forUse	The AP50/30 Insufflator is aCO2 insufflator intended foruse during diagnostic and/ortherapeutic endoscopicprocedures to distend a cavityby filling it with gas. TheStandard/High Flow, Pediatricand Bariatric operating modesof the device are indicated tofill and distend a peritonealcavity with gas during alaparoscopic procedure. ThePediatric operating mode isspecifically indicated forpediatric laparoscopicprocedures. The VesselHarvesting operating mode isindicated for use duringendoscopic vessel harvestingprocedures to create a cavityalong the saphenous vein orradial artery.	The 45L CORE InsufflatorF114 is a CO2 insufflatorintended for use in diagnosticand/or therapeutic endoscopicprocedures to distend a cavityby filling it with gas. The highflow application, the low flowapplication and the bariatricapplication of the device areeach indicated for use infacilitating the use of alaparoscope by filling theperitoneal cavity with gas todistend it. The low flowapplication of the device isindicated for pediatric use. Thevessel harvesting application ofthe 45L CORE Insufflator F114 is indicated for use duringendoscopic vessel harvestingprocedures to create a cavityalong the saphenous vein and/orradial artery during endoscopicvessel harvesting procedures.	Different; thedifferences betweenthe subject andpredicate indicationsstatements are minorand do not alter theintended use
Operating Modes	Standard/High Flow, Pediatric,Bariatric and VesselHarvesting	Standard/High Flow, Pediatric,Bariatric and Vessel Harvesting	Same
Max Gas Flow	20 lpm (Pediatric)45 lpm (High Flow)50 lpm (Bariatric)10 lpm (Vessel Harvest)	20 lpm (Pediatric)40 lpm (High Flow)45 lpm (Bariatric)10 lpm (Vessel Harvest)	Different; the flowrate of the subjectdevice in bariatricand high flow ishigher than thepredicate; thesedifferences do notraise different
KeyPerformanceSpecs	AP50/30 Insufflator	45L CORE Insufflator	Comparison
Pressure Range	1-20mmHg (Pediatric/VesselHarvest)1-30mmHg (HighFlow/Bariatric)	1-20mmHg (Pediatric/VesselHarvest)1-30mmHg (HighFlow/Bariatric)	Same
Intra-abdominalMax Pressure	30 mmHg (HighFlow/Bariatric)20 mmHg (Pediatric/VesselHarvest)	30 mmHg (HighFlow/Bariatric)20 mmHg (Pediatric/VesselHarvest)	Same
Maximum SupplyPressure	65 mm Hg in Bariatric, HighFlow, Pediatric and VesselHarvest modes and 60 mmHg in Veress mode	70 mm Hg for Bariatricmode, 65 mm Hg for HighFlow mode and 60 mm Hg inVeress mode	Different; thesubject devicemaximum supplypressure is lowerfor bariatric setting.This differencedoes not raisedifferent questionsof safety andeffectiveness.
AdjustableValues	Pressure: 1-30 mmHgFlow: 1-50 lpm	Pressure: 1-30 mmHgFlow: 1-45 lpm	Different; the flowrate of the subjectdevice is higher thanthe predicate; thisdifferences does notraise differentquestions of safetyand effectiveness
Pneumo PressureControl	Constantly held based uponpressure sensors in InsuflowPort or standard insufflationusing pressure sensing in theinsufflator	Constantly held based upon realtime pressure sensing tube orstandard insufflation usingpressure sensing in theinsufflator	Same
User Interface	Touch screen	Touch screen	Same
Power	100-240 V	100-240 V	Same
Touch ScreenMenus (MenuOptions)	Configuration Menus:- First Nominal Pressure15mmHg (high flow)15mmHg (bariatric)10mmHg (vessel harvesting)8mmHg (pediatric)- Venting Valve Statuswith Veress insufflation onor off, Venting system on oroff- Venting Pressure Limit: set at	Configuration Menus:- First Nominal Pressure15mmHg (high flow)15mmHg (bariatric)10mmHg (vessel harvesting)8mmHg (pediatric)- Venting Valve Statuswith Veress insufflation onor off, Venting system on oroff- Venting Pressure Limit: set	Different; Pressurelimits for venting arepreset in the subjectdevice, while theycan be adjusted in thepredicate. Gas flowrates differ to reflectdifferences in flowrange. Thesedifferences do notraise different
KeyPerformanceSpecs	AP50/30 Insufflator	45L CORE Insufflator	Comparison
	3mmHg (cannot be changed)- Venting Response time:set at 3 sec (cannot bechanged)- Gas Supply: House or Bottle- Alarm Volume: set betweenLevel 1-3- Gas Flow Rates: Quick setrate 1-33, 20, 45 LPM (high flow)3, 25, 50 LPM(bariatric)1.0, 4.0, 10.0 LPM (vesselharvesting)0.1 LPM (pediatric)- Maximum Nominal Pressure:setting range 5-30 mmHg forbariatric and high flowsetting range of 5-20 mmHgfor vessel harvesting andpediatric- Flow Safety Limit: Limit Onor Off- Warning Signal Occlusion:Signal On or Off- Language: English, Spanish	between 2-5 mmHg- Venting Response time:between 2-5 sec- Gas Supply: House or Bottle- Alarm Volume: set betweenLevel 1-3- Gas Flow Rates: Quick setrate 1-33, 20, 40 LPM (high flow)5, 25, 45 LPM(bariatric)1.0, 4.0, 10.0 LPM (vesselharvesting)0.1 LPM (pediatric)- Maximum Nominal Pressure:setting range 5-30 mmHg forbariatric and high flowsetting range of 5-20 mmHgfor vessel harvesting andpediatric- Flow Safety Limit: Limit Onor Off- Warning Signal Occlusion:Signal On or Off- Language: English, Spanish	questions of safetyand effectiveness.
Error Warnings	Check gas supply, low supplygas pressure, overpressure,venting system active,overpressure/venting systemactive, occlusion,contamination,contamination/call for service,gas heater/call for service, errormessage/call for service,device temperature error/turnoff device, venting valve non-functioning, continuouspressure sensingdeactivated/call for service,flow safety limit, safety limit,valve non-functioning/call forservice	Check gas supply, low supplygas pressure, overpressure,venting system active,overpressure/venting systemactive, occlusion,contamination,contamination/call for service,gas heating defective/call forservice, gas temperature >42C,error message/call for service,device temperature error/turnoff device, venting valvedefective, RTP defective	Different; the minordifferences do notraise differentquestions of safetyand effectiveness
Gas Conditioning	Heat and humidify	Heat	Different; the subjectdevice includeshumidification withthe use of theInsuflow port; this
KeyPerformanceSpecs	AP50/30 Insufflator	45L CORE Insufflator	Comparison
			difference does notraise differentquestions of safetyand effectiveness
Tubing Sets	Custom, sterile, single useInsuflow Port	Custom, sterile, single use	Same

Comparison Table: Key Performance Specs

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The technical differences between the proposed Lexion AP50/30 Insufflator and the predicate Stryker/WOM 45L Core Insufflator include the following:

The housing of the proposed AP50/30 Insufflator is slightly smaller in dimensions and lighter in weight.
The maximum flow rate in the Bariatric operating mode has been increased from 45 1/min to 50 l/min in the AP50/30 Insufflator.
Continuous pressure measurement is provided by sensors in the Insuflow® Port while the . predicate device 45L Core Insufflator utilizes a real time pressure sensing tube.
. The AP50/30 Insufflator provides heated, humidified CO2 via the Insuflow® Port while the 45L Core Insufflator provides just heated CO2.
There are minor differences in configuration menus and settings, highlighted above. .

The differences in the technological characteristics of the proposed AP50/30 Insufflator and the predicate 45L Core Insufflator do not raise different questions of safety and effectiveness. The the maximum flow rate to 50 1/min for the AP50/30 Insufflator is identical to the secondary predicate WOM Insufflator 50L FM134 (K153513).

Insuflow® Port

The modified Insuflow® Port (5 mm, 8 mm, 10 mm, and 12 mm) devices have intended use as the Insuflow® Synergy™ and Synergy™ XL Port predicate devices. The intended use of the modified device, as described in the labeling, has not changed as a result of the AP50/30 modifications.

The modified Insuflow® Port (5 mm, 8 mm, 10 mm and 12 mm) devices utilize the same gas conditioning technology and path of entry access port technology as the predicate Insuflow Synergy™ Port (5 mm) and the Insuflow® Synergy™ XL Port (8 mm, 10 mm and 12 mm) cleared under 510(k) K140263. All of the modified devices have the same port configuration, design and materials as the predicates. All of the Insuflow® Ports perform the same gas heating/humidification conditioning function as the predicates with minor design changes to accommodate the pressure sensors added to the circuitry. The lumen configurations, dimensions and materials of the Insuflow Port path of entry access device are equivalent to the predicate Insuflow® Synergy™ XL Port devices.

Discussion of performance testing.

A risk analysis and resulting performance testing have been conducted to assure that the AP50/30 Insufflator with the Insuflow® Port devices perform in accordance with specifications and applicable

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standards. Design verification testing of the AP50/30 Insufflator demonstrates that the device performs as intended, and that performance of the device is comparable to that of the predicate.

Electrical safety and electromagnetic compatibility testing was successfully performed by independent laboratories in accordance with the following standards:

IEC 60601-1:2014 Ed 3- Medical Electrical Equipment Part 1: General . Requirements for Basic Safety and Essential Performance
IEC 60601-1-2:2014 Medical Electrical Equipment Part 1 -2: General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

The software used in the AP50/30 Insufflator was determined to have a major level of concern, and was developed and successfully validated in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005.

Comparative bench testing was performed to demonstrate that the performance of the AP50/30 Insufflator is substantially equivalent to that of the predicate device Stryker/WOM 45L Core Insufflator. The comparative bench test included the following tests: set pressure, compensation of small and large leakages, overpressure, and pressurement/control. The test results demonstrate that the performance of the proposed AP50/30 device related to reaching the set pressure, compensation of small and large leakages, pressurement/control and overpressure are comparable to the performance of the predicate device 45L Core Insufflator.

For the Insuflow® Port devices, the subject devices utilize the same design and materials as the predicate for gas conditioning, port access and sealing. The only difference is the addition of the pressure sensors on the subject device circuitry. Per FDA's biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," issued June 16, 2016, testing of the Insuflow device as an external communicating device with contact duration of less than 24 hours was conducted and included cytotoxicity, irritation, sensitization potential, and acute systemic toxicity per ISO 10993-5:2009(R)2014, ISO 10993-10:2010/(R)2014, and ISO 10993-11:2006/(R)2010 respectively. Analysis and testing of the sensor materials exposed to the gas flow demonstrated acceptable biocompatibility per ISO 10993-1. Because there was no change in device dimensions, the existing test data for insertion/removal testing, seal leak integrity testing and ETO sterilization previously provided in the predicate submission can be leveraged to support the safety and effectiveness of the subject device. Since the AP50/30 Insufflator now controls the heating and humidification of the Insuflow® Port device, gas temperature and humidity characterization and flow/pressure performance testing was successfully conducted to assure compliance to specification.

Conclusion:

The subject and predicate devices have the same intended use. As identified above, there are several technological differences between the subject and predicate devices. None of these differences alter the intended use of the subject device from that of the predicate, or raise different questions of safety and effectiveness. Performance testing conducted on the subject device demonstrate that the subject device is as safe and effective as the predicate. Therefore, the AP50/30 Insufflator with Insuflow Port is substantially equivalent to the predicate devices.

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.