(217 days)
Not Found
No
The description mentions a "micro-processor-controlled insufflation and smoke evacuation unit" and "Software was validated per Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005." This indicates standard software control, not AI/ML. There are no mentions of AI, ML, deep learning, training data, or test data related to AI/ML algorithms.
Yes
The device is described as intended for use in "therapeutic endoscopic and laparoscopic procedures," which directly indicates its role in treatment.
No
The device is an insufflator designed to distend body cavities and evacuate surgical smoke for diagnostic and therapeutic procedures. It does not perform diagnostic functions itself, but rather facilitates procedures where diagnostic (or therapeutic) activities may occur.
No
The device description explicitly states it consists of a "micro-processor-controlled insufflation and smoke evacuation unit" and a "disposable tube set," which are physical hardware components. It also mentions being powered by AC and using compressed gas supplies.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, colon or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke." This describes a device used during a medical procedure to facilitate visualization and manipulation, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description focuses on the mechanical function of insufflating a body cavity with gas and evacuating smoke. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. The device's function is purely procedural.
Therefore, the EVA15 Insufflator is a medical device used in surgical procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, colon or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
Product codes (comma separated list FDA assigned to the subject device)
HIF
Device Description
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflation is intended to use in hospital. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.
There are 3 operating modes:
- Flow Mode (1) delivers a fixed flow, settable between 0 and 15 standard liters per ● minute (SLPM)
- . Pressure Modes (2) -
- Intermittent Pressure Insufflation a pressure is targeted, but the flow delivered o in targeting that pressure is capped at 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- Continuous Pressure Insufflation a pressure is targeted, but the flow delivered o in targeting that pressure is capped at 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).
The tubeset is a sterile, single-use product. The tubeset is made of PVC and polyethylene. The A VA 15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, colon or thoracic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following data were provided in support of the substantial equivalence determination:
Bench Testing:
- Static condition: Pressure and flow delivery accuracy; the device was demonstrated to meet predefined acceptance criteria regarding pressure and flow.
- Dynamic condition:
- Simulated leak; the device was demonstrated to meet predefined acceptance criteria under simulated leak conditions.
- Smoke evacuation; the device was demonstrated to meet predefined acceptance criteria regarding smoke evacuation.
- Efficiency of Smoke Evacuation Filter; the device was demonstrated to meet predefined acceptance criteria regarding the smoke evacuation filter.
Software was validated per Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Electrical / EMC:
- Electrical Safety: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) IEC 60601-1-8: 2012. The device was demonstrated to meet the requirements of the standard.
- EMC: IEC 60601-1-2:2014. The device was demonstrated to meet the requirements of the standard.
Sterility and Aging Effect:
- Sterilization of the tubeset is via EtO and was validated per ISO 11135:2014/Amd.1:2018 Annex E, Half cycle approach.
- Testing to ISO 10993-7:2008/Amd 1:2019, ASTM D4169-16, ASTM F1886 (visual inspection), ASTM F2096 (leak detection), ASTM F88 (seal strength) and ASTM F-1980-16 (aging) supported a shelf-life of 1 year.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
July 23, 2020
Palliare Ltd. % Paul Dryden Consultant Palliare Ltd c/o ProMedic. LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704
Re: K193520
Trade/Device Name: EVA15 Insufflator Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: June 23, 2020 Received: June 25, 2020
Dear Paul Dryden:
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Jason R. Roberts, Ph.D. Acting Assistant 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
3
510(k) Summary
| Submitter: | Palliare Ltd.
Galway Business Park, Dangan
Galway H91 P2DK, Ireland |
|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Official Contact: | John O'Dea, Ph.D., Director
Tel: +353-91-516362
Email: jodea@palliare.com |
| Contact Person name: | Paul Dryden
ProMedic, LLC
131 Bay Point Dr NE
St. Petersburg, FL 33704 |
| Date Prepared: | July 21, 2020 |
| Proprietary or Trade Name:
Regulation number:
Regulation Name:
Regulatory Class:
Product Code: | EVA15 Insufflator
21 CFR 884.1730
Laparoscopic Insufflator
Class II
HIF |
| Predicate Device: | K172516 - SurgiQuest AirSeal iFS System |
The predicate devices has no been subject to a design-related recall.
Device Description: The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflation is intended to use in hospital. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.
There are 3 operating modes:
- Flow Mode (1) delivers a fixed flow, settable between 0 and 15 standard liters per ● minute (SLPM)
- . Pressure Modes (2) -
- Intermittent Pressure Insufflation a pressure is targeted, but the flow delivered o in targeting that pressure is capped at 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- Continuous Pressure Insufflation a pressure is targeted, but the flow delivered o in targeting that pressure is capped at 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).
The tubeset is a sterile, single-use product. The tubeset is made of PVC and polyethylene. The A VA 15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic
4
circuitry for insufflation and smoke evacuation, respectively.
Principle of Operation: The operating principle employs 2 methods.
A) A digital insufflation pressure regulation system using compressed CO2 gas to deliver CO2 into the patient cavity to be insufflated at the direction and control of the physician; and
B) The use of a venturi method to create a vacuum to evacuate any smoke created during the procedure.
Indications for Use:
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, colon or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
Comparison of Technological Characteristics of the subject and predicate devices are presented in Table 1 below.
5
| Table 1 - Comparison - Subject vs. Predicate | |||
|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- |
| | Subject Device: EVA15 Insufflator
(K193520) | Predicate Device: SurgiQuest AirSeal iFS System
(K172516) | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Manufacturer | Palliare Ltd. | SurgiQuest Inc. (Acquired by ConMed Co. in 2015) | |
| Classification | 21 C.F.R. § 884.1730 (Laparoscopic
Insufflator), Product Code HIF | 21 C.F.R. § 884.1730 (Laparoscopic Insufflator),
Product Code HIF, GCJ | Same |
| Fundamental
scientific
technology | Digital insufflation pressure
regulation system using compressed
CO2 gas. Venturi smoke evacuation. | Digital insufflation pressure regulation system using
compressed CO2 gas
Smoke evacuation using custom trocar generating
negative pressure | Similar |
| Patient connection | Standard Trocar luer connection | Customized trocar | Similar - each connects
to cavity using a trocar |
| Indications for Use | The EVA15 Insufflator is intended for
use in diagnostic and/or therapeutic
endoscopic and laparoscopic
procedures to distend the abdomen,
colon or thoracic cavity with up to 15
mmHg pressure, by filling it with gas
and to evacuate surgical smoke. | The SurgiQuest AirSeal® iFS System is intended for use
in diagnostic and/or therapeutic endoscopic procedures
to distend a cavity by filling it with gas, to establish and
maintain a path of entry for endoscopic instruments and
to evacuate surgical smoke.
It is indicated to facilitate the use of various
thoracoscopic and laparoscopic instruments by filling
the abdominal or thoracic cavity with gas to distend it,
by creating and maintaining a gas sealed obstruction-
free instrument path and by evacuating surgical smoke.
This instrument can also be used to insufflate the rectum
and colon to facilitate endoscopic observation, diagnosis
and treatment. The trocar of the AirSeal® iFS System is
indicated for use with or without visualization. | Similar except the
subject device does not
include a trocar. |
| | Subject Device: EVA15 Insufflator | Predicate Device: SurgiQuest AirSeal iFS System
(K172516) | Comparison |
| Gas Delivery
Modes | Fixed Flow
Intermittent Pressure (Standard)
Insufflation
Continuous Pressure Insufflation | Intermittent Pressure (Standard and Smoke Evac Modes)
Insufflation
Continuous Pressure Insufflation (Airseal Mode) | Similar
Subject device also has
a fixed flow mode |
| Smoke Evacuation | Available in all modes. Operates
continuously or may be activated
on/off using foot pedal. | Available in Airseal (continuous pressure) and Smoke
Evacuation modes. Operates continuously. | Similar |
| Flow Range | 0-40 SLPM | 0-40 SLPM | Same |
| Pressure Range | 7-15 mmHg | 5-20 mmHg | Similar
Subject device has a
smaller range |
| Accessories | Tubeset | Tubeset, Custom Trocar | Similar |
| Dimensions | 160x130x330mm | 420x220x470mm | Similar
Subject is smaller |
| Weight | 5.5kg | 26.0kg | Similar
Subject is smaller |
| Power Source | AC 100-240V | AC 100/115/230V | Similar |
| Tubeset
Sterilization | EtO | EtO | Same |
| User Interface | Membrane Panel | Touchscreen | Similar |
6
Discussion of Differences
The differences in technological characteristics do not raise different questions of safety and effectiveness when compared to the predicate.
7
Summary of Non-clinical Performance Testing
The subject devices comply with voluntary standards for electrical safety, and electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
Bench
- . Static condition
- Pressure and flow delivery accuracy; the device was demonstrated to meet o predefined acceptance criteria regarding pressure and flow
- Dynamic condition ●
- o Simulated leak; the device was demonstrated to meet predefined acceptance criteria under simulated leak conditions
- Smoke evacuation; the device was demonstrated to meet predefined acceptance o criteria regarding smoke evacuation
- . Efficiency of Smoke Evacuation Filter; the device was demonstrated to meet predefined acceptance criteria regarding the smoke evacuation filter
Software was validated per Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Electrical / EMC
- . Electrical Safety
- o IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) IEC 60601-1-8: 2012 o
The device was demonstrated to meet the requirements of the standard.
- EMC
- IEC 60601-1-2:2014 o
The device was demonstrated to meet the requirements of the standard.
Sterility and Aging Effect
Sterilization of the tubeset is via EtO and was validated per ISO 11135:2014/Amd.1:2018 Annex E, Half cycle approach. In addition, testing to ISO 10993-7:2008/Amd 1:2019, ASTM D4169-16, ASTM F1886 (visual inspection), ASTM F2096 (leak detection), ASTM F88 (seal strength) and ASTM F-1980-16 (aging) supported a shelf-life of 1 year.
Substantial Equivalence Conclusion
The performance testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.