Who is the manufacturer of AP50/30 Insufflator with Insuflow Port?

Lexion Medical, LLC filed the 510(k) submission for AP50/30 Insufflator with Insuflow Port (K191780).

What is the FDA product code for AP50/30 Insufflator with Insuflow Port?

HIF. It is classified under 21 CFR 884.1730 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for AP50/30 Insufflator with Insuflow Port?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AP50/30 Insufflator with Insuflow Port?

AP50/30 Insufflator with Insuflow Port (K170799); PNEUMOCLEAR Insufflator (K170784).

Who can help prepare an FDA 510(k) submission like AP50/30 Insufflator with Insuflow Port?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AP50/30 Insufflator with Insuflow Port

K191780 · Lexion Medical, LLC · HIF · Aug 28, 2019 · Obstetrics/Gynecology

Device Facts

Record ID	K191780
Device Name	AP50/30 Insufflator with Insuflow Port
Applicant	Lexion Medical, LLC
Product Code	HIF · Obstetrics/Gynecology
Decision Date	Aug 28, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1730
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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 TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery. 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 Story

Microprocessor-controlled CO2 insufflator; hospital use; provides gas for cavity distension during laparoscopic, vessel harvesting, and TAMIS procedures. Inputs: CO2 gas supply; pressure sensor data from Insuflow® Port or internal sensors. Operation: system monitors cavity pressure vs. pre-set nominal pressure; controls gas flow, heating, and humidification via Insuflow® Port. Output: warmed/humidified CO2 gas stream; visual/auditory alarms for overpressure, occlusion, or malfunction. Operated by clinicians; touch screen interface for mode selection and parameter adjustment. Benefits: maintains stable cavity pressure; reduces patient discomfort via gas conditioning. Hardware includes metal housing, power supply, pressure reducers, venting system, and heater control.

Clinical Evidence

Bench testing only. Evaluated set pressure, flow, leakage compensation, overpressure, and pressure control. Results confirm performance in TAMIS mode is comparable to predicate PNEUMOCLEAR; software changes did not impact performance of previously cleared modes.

Technological Characteristics

Microprocessor-controlled CO2 insufflator; touch screen interface; metal housing. Connectivity: plug connector cable for Insuflow® Port (pressure sensing/heating/safety circuits). Sterilization: ethylene oxide (tubing/port). Standards: IEC 60601-1:2014, IEC 60601-1-2:2014. Software: Major level of concern.

Indications for Use

Indicated for patients undergoing diagnostic/therapeutic endoscopic procedures requiring cavity distension via CO2 gas, including laparoscopic procedures (Standard/High Flow, Pediatric, Bariatric), endoscopic vessel harvesting (saphenous vein/radial artery), and trans anal minimal invasive surgery (TAMIS) for rectum/colon distension.

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

AP50/30 Insufflator with Insuflow Port (K170799)
PNEUMOCLEAR Insufflator (K170784)

Related Devices

K060723 — 40 L HIGH FLOW INSUFFLATOR F113 · W.O.M. World of Medicine AG · May 25, 2006
K063367 — 45L CORE INSUFFLATOR, MODEL F114 · W.O.M. World of Medicine AG · May 23, 2007
K201361 — PNEUMOCLEAR · W.O.M. World of Medicine GmbH · Jul 29, 2020
K153513 — Insufflator 50L FM134 · W.O.M. World of Medicine GmbH · Mar 4, 2016
K222812 — Insufflator · Scivita Medical Technology Co., Ltd. · May 16, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 28, 2019 Lexion Medical LLC % Bernard Horwath Regulatory Consultant HRG 4486 Timberline Ct Vadnais Heights, MN 55127 Re: K191780 > Trade/Device Name: AP50/30 Insufflator with Insuflow® Port Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, OSV, GCJ Dated: July 1, 2019 Received: July 2, 2019 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Sharon Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191780 Device Name AP50/30 Insufflator with Insuflow® Port #### Indications for Use (Describe) 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 TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans and minimal invasive surgery. 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. | Type of Use (Select one or both, as applicable) | |----------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## AP50/30 Insufflator with Insuflow® Port | Date Prepared: | August 27, 2019 | |----------------|-------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Lexion Medical, LLC 545 Atwater Circle St. Paul, MN 55103 Telephone: 651-855-1447 Fax: 651-636-1671 | | Contact: | Mr. Bernard Horwath Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127 Telephone: 651- 231-1761 | Device Name: 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 proposed AP50/30 Insufflator with Insuflow® Port devices is substantially equivalent to the following devices: - Primary Predicate: AP50/30 Insufflator with Insuflow Port, K170799 - . Secondary Predicate: PNEUMOCLEAR Insufflator, K170784 None of the cited predicate devices have been subject to a design-related recall. # 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; for trans anal minimal invasive surgery (TAMIS) to fill and distend the rectum and colon using CO2 gas; and for Vessel {4}------------------------------------------------ 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 controls the 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 singleuse 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. 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. ## 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 TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery. 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. ## Technological characteristics, comparison to predicate devices. AP50/30 {5}------------------------------------------------ The proposed Lexion AP50/30 Insufflator is similar to the predicate devices in that they are all CO2 insufflators intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The proposed Lexion AP50/30 Insufflator is similar in technology to the primary predicate, the previously cleared Lexion AP50/30 Insufflator (K170799), in terms of operating mode, design, basic features, and custom tubing sets. The only change is the addition of the TAMIS mode of operation. As a result, the indications for use and the software design have been modified to incorporate the TAMIS mode. Concerning the TAMIS mode, the proposed Lexion AP50/30 Insufflator has the same indications for use as the secondary predicate, the PNEUMOCLEAR Insufflator (K170784), which is also indicated to fill and distend the rectum and colon using CO2 gas during trans rectal minimally invasive surgery. The following table compares the key performance specifications for the proposed AP50/30 Insufflator and the current AP50/30 Insufflator, demonstrating that the only change from the primary predicate is the addition of the TAMIS mode with appropriate specs. | Key Performance Specs | AP50/30 Insufflator With TAMIS | AP50/30 Insufflator K170799 | 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 TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery. | 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. | Same intended use. The only difference between the proposed and predicate indications statements is the addition of the TAMIS mode. Addition of the TAMIS mode does not alter the intended use. | | Key Performance Specs | AP50/30 Insufflator With TAMIS | AP50/30 Insufflator K170799 | Comparison | | Operating Modes | Standard/High Flow, Pediatric, Bariatric, Vessel Harvesting, and TAMIS | Standard/High Flow, Pediatric, Bariatric and Vessel Harvesting | The proposed device has the addition of the TAMIS mode | | Max Gas Flow | 20 lpm (Pediatric) 45 lpm (High Flow) 50 lpm (Bariatric) 10 lpm (Vessel Harvest) 40 lpm (TAMIS) | 20 lpm (Pediatric) 45 lpm (High Flow) 50 lpm (Bariatric) 10 lpm (Vessel Harvest) | All max gas flows are the same for existing modes; only difference is the addition of TAMIS | | Pressure Range | 1-20mmHg (Pediatric/Vessel Harvest) 1-30mmHg (High Flow/Bariatric) 1-20 mmHg (TAMIS) | 1-20mmHg (Pediatric/Vessel Harvest) 1-30mmHg (High Flow/Bariatric) | All pressure ranges are the same for existing modes; only difference is the addition of TAMIS | | Intra-abdominal Max Pressure | 30 mmHg (High Flow/Bariatric) 20 mmHg (Pediatric/Vessel Harvest) 20 mmHg (TAMIS) | 30 mmHg (High Flow/Bariatric) 20 mmHg (Pediatric/Vessel Harvest) | All max gas pressures are the same for existing modes; only difference is the addition of TAMIS | | Maximum Supply Pressure | 65 mm Hg in Bariatric, High Flow, Pediatric, Vessel Harvest and TAMIS modes and 60 mm Hg in Veress mode | 65 mm Hg in Bariatric, High Flow, Pediatric and Vessel Harvest modes and 60 mm Hg in Veress mode | The max supply pressure is the same for TAMIS as the existing modes. | | Adjustable Values | Pressure: 1-30 mmHg Flow: 1-50 lpm | Pressure: 1-30 mmHg Flow: 1-50 lpm | Same | | 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 pressure sensors in Insuflow Port 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) 15mmHg (bariatric) 10mmHg (vessel harvesting) 8mmHg (pediatric) 15mmHg (TAMIS) - Venting Valve Status with Veress insufflation on or off, Venting system on or off | Configuration Menus: - First Nominal Pressure 15mmHg (high flow) 15mmHg (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 | The proposed device is the same, except the addition of the TAMIS mode | | Key Performance Specs | AP50/30 Insufflator With TAMIS | AP50/30 Insufflator K170799 | Comparison | | | - 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) 5, 20, 40 LPM (TAMIS) - Maximum Nominal Pressure: setting range 5-30 mmHg for bariatric and high flow setting range of 5-20 mmHg for vessel harvesting, pediatric and TAMIS - Flow Safety Limit: Limit On or Off - Warning Signal Occlusion: Signal On or Off - Language: English, Spanish | - 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 setting range of 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 | | | 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 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 | Same | | Gas Conditioning | Heat and humidify | Heat and humidify | Same | | Key Performance Specs | AP50/30 Insufflator With TAMIS | AP50/30 Insufflator K170799 | Comparison | | Tubing Sets | Custom, sterile, single use Insuflow Port | Custom, sterile, single use Insuflow Port | Same | # Primary Predicate Comparison Table: Kev Performance Specs {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Concerning the TAMIS mode the proposed Lexion AP50/30 Insufflator has similar technological characteristics to the PNEUMOCLEAR device, as shown in the table below. | Key Performance Specs | AP50/30 Insufflator With TAMIS | PNEUMOCLEAR K170784 | 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 TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery. | The device PNEUMOCLEAR™ is a insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow 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 indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimally invasive surgery. | TAMIS indication is the same | | Operating Modes | Standard/High Flow, Pediatric, Bariatric, Vessel Harvesting, and TAMIS | Standard/High Flow, Pediatric, Bariatric, Vessel Harvesting, and TAMIS | TAMIS mode is the same | | Max Gas Flow | 20 lpm (Pediatric) 45 lpm (High Flow) 50 lpm (Bariatric) 10 lpm (Vessel Harvest) | 20 lpm (Pediatric) 45 lpm (High Flow) 50 lpm (Bariatric) 10 lpm (Vessel Harvest) | Same | | Key Performance Specs | AP50/30 Insufflator With TAMIS | PNEUMOCLEAR K170784 | Comparison | | Pressure Range | 40 lpm (TAMIS) 1-20mmHg (Pediatric/Vessel Harvest) 1-30mmHg (High Flow/Bariatric) 1-20 mmHg (TAMIS) | 40 lpm (TAMIS) 1-20mmHg (Pediatric/Vessel Harvest) 1-30mmHg (High Flow/Bariatric) 1-20 mmHg (TAMIS) | Same | | Intra-abdominal Max Pressure | 30 mmHg (High Flow/Bariatric) 20 mmHg (Pediatric/Vessel Harvest) 20 mmHg (TAMIS) | 30 mmHg (High Flow/Bariatric) 20 mmHg (Pediatric/Vessel Harvest) 20 mmHg (TAMIS) | Same | | Maximum Supply Pressure | 65 mm Hg in Bariatric, High Flow, Pediatric, Vessel Harvest and TAMIS modes and 60 mm Hg in Veress mode | 65 mm Hg in Bariatric, High Flow, Pediatric, Vessel Harvest and TAMIS modes and 60 mm Hg in Veress mode | Same | # Secondary Predicate Comparison Table: Key TAMIS Mode Performance Specs {9}------------------------------------------------ Overall, the differences in technological characteristics between the subject device and the primary and secondary predicate devices do not raise different questions of safety and effectiveness. # Insuflow® Port There are no changes in the Insuflow® Port (5 mm, 8 mm, 10 mm, and 12 mm) devices as compared to the predicate K170799. ## Discussion of performance testing. A risk analysis and resulting performance testing were conducted to assure that the proposed AP50/30 Insufflator with the Insuflow® Port devices perform in accordance with specifications and applicable standards. The AP50/30 hardware remains unchanged from the predicate. The addition of the TAMIS mode was via software changes, therefore, the design verification testing focused on software verification and insufflator performance testing. Design verification testing of the AP50/30 Insufflator demonstrated that the proposed device performs as intended, and that the performance of the device is comparable to that of the predicates. 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. {10}------------------------------------------------ Comparative bench testing was performed to demonstrate that the performance of the proposed AP50/30 Insufflator is substantially equivalent to that of the predicate devices. The comparative bench test included the following tests: set pressure, flow, compensation of small and large leakages, overpressure, and pressure measurement/control. The test results demonstrate that the performance of the proposed AP50/30 device related to TAMIS mode operation, including attaining the set pressure, flow, compensation of small and large leakages, pressure measurement/control and overpressure are comparable to the performance of the predicate PNEUMOCLEAR Insufflator. In addition, the necessary changes to the software for TAMIS mode have not affected the AP50/30 Insufflator performance specifications for previously cleared operating modes. All other testing, including electrical safety and electromagnetic compatibility testing per IEC 60601-1:2014 and IEC 60601-1-2:2014. that was successfully performed on the predicate K170799 AP50/30 Insufflator was leveraged to support the safety and effectiveness of the proposed AP50/30 Insufflator, as there were no associated changes in hardware with the addition of the TAMIS mode. #### Conclusion: The proposed AP50/30 Insufflator device has the same intended use as the cleared insufflator predicates. As identified above, the technological specifications are similar between the proposed device and predicate devices, and the differences in technological characteristics do not raise different questions of safety and effectiveness. Performance testing conducted on the proposed device demonstrates that the subject device is as safe and effective as the predicates. Therefore, the proposed AP50/30 Insufflator with Insuflow® Port is substantially equivalent to the predicate devices.