(57 days)
Not Found
No
The description focuses on microprocessor control, pressure measurement, and safety features, with no mention of AI or ML algorithms for decision-making or data analysis.
Yes
The device is described as being used during "diagnostic and/or therapeutic endoscopic procedures" to distend a cavity. The "Intended Use" explicitly states its therapeutic application.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures."
No
The device description clearly outlines multiple hardware components including a metal housing, power supply, pressure reducers, venting system, gas heater control, and a touch screen user interface. While it mentions software operation, it is integral to the function of the physical insufflator device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas." This involves direct interaction with the patient's body cavity during a procedure, not the examination of specimens derived from the human body.
- Device Description: The description details a device that delivers CO2 gas into a body cavity and manages pressure. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
The device is a surgical insufflator used to create space within the body for endoscopic procedures. This falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HIF, OSV, GCJ
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; for trans anal minimal invasive surgery (TAMIS) to fill and distend the rectum and colon using CO2 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity, saphenous vein, radial artery, rectum and colon
Indicated Patient Age Range
The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. (for pediatric patients) Not specified for other modes as an age range.
Intended User / Care Setting
hospital use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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.
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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.