(227 days)
No
The description mentions a "micro-processor-controlled" unit, which is standard for many medical devices and does not inherently indicate AI/ML. There are no mentions of AI, ML, deep learning, image processing, or any related concepts. The performance studies focus on basic device functionality and safety standards, not AI/ML performance metrics.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures."
No
The device is an insufflator designed to distend body cavities with gas and evacuate surgical smoke during endoscopic and laparoscopic procedures. Its function is to facilitate these procedures, not to diagnose a condition. While it is used in "diagnostic and/or therapeutic endoscopic and laparoscopic procedures," its role is as a tool within those procedures rather than a diagnostic one itself.
No
The device description explicitly states it consists of a "micro-processor-controlled insufflation and smoke evacuation unit" and a "disposable tube set," indicating it includes significant hardware components beyond just software.
Based on the provided information, the EVA15 Insufflator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to distend body cavities with gas and evacuate surgical smoke during endoscopic and laparoscopic procedures. This is a therapeutic and diagnostic procedure performed directly on the patient's body, not on samples taken from the body.
- Device Description: The device description confirms its function in insufflating body cavities and evacuating smoke. It's an active medical device used in an operating room or endoscopic suite.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, the EVA15 Insufflator is a medical device used in surgical and diagnostic procedures performed in vivo (within the living body), not 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, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
Product codes
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 instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit, and (2) a disposable tube set.
The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25 mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas 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, rectum, colon, esophagus, stomach or thoracic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room or endoscopy suite.
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)
Performance testing of the insufflator has demonstrated the ability to activate and de-activate smoke evacuation when electrosurgical energy is switched on and off. including testing to IEC 60601-1:2005/AMD1:2012 / AMD 2:2020 (Edition 3.2) - Medical Electrical Equipment - Part 1: General Requirements For Safety and IEC 60601-1-2:2014 / A1:2020 (Edition 4.1) – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K222901 - Palliare EVA15
Reference Device(s)
K131402 – Buffalo Filter VISICLEAR
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 2, 2024
Palliare Ltd. % Paul Dryden President ProMedic Consulting LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K232902
Trade/Device Name: EVA15 insufflator Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: April 24, 2024 Received: April 24, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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 Roberts -S
Jason R. Roberts, Ph.D. 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
3
| Date Prepared: | 2-May-24 |
|---|---|
| Official Contact: | John O'Dea, Ph.D., CEO |
| Palliare Ltd. | |
| Galway Business Park, | |
| Dangan Galway H91 P2DK, Ireland | |
| Telephone - +353-91-516362 | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | EVA15 Insufflator |
| Common/Usual Name: | CO2 insufflator |
| Regulation Number: | 21 CFR 884.1730 |
| Regulation Name: | Laparoscopic insufflator |
| Product Code: | HIF |
| Predicate Device: | K222901 - Palliare EVA15 |
| Reference Device: | K131402 – Buffalo Filter VISICLEAR |
Modifications:
We have provided an accessory, Auto-Evac, as an alternative to the pneumatic foot pedal used by the predicate - K222901 to activate and de-activate the EVA15 smoke evacuation functionality.
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 instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit, and (2) a disposable tube set.
The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25 mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic 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. Smoke evacuation in the predicate is activated/deactivated by sequentially pressing a pneumatic foot-pedal. AutoEvac comprises a battery-operated pneumatic pump along with an antenna to detect when an electrical energy system has been activated. Using the same pneumatic connection as used in the predicate, when energy is activated the pump turns on, causing the smoke evacuator to switch on, and when energy is de-activated the pump turns off up to 5 seconds later which turns off the smoke evacuator.
Indications for Use:
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
4
Patient Population:
Patients undergoing laparoscopic or endoscopic procedures in which insufflation may be helpful.
Environments of use:
Operating room or endoscopy suite.
Table 1 is a comparison - Subject Device vs. the Predicate, K222901 - Palliare EVA15.
Substantial Equivalence Discussion
The EVA15 insufflator has the identical intended use and indications, technological characteristics, and principles of operation as the predicate Palliare EVA15, K222901. There has been no change to the EVA15 system, but an additional accessory is made available to activate/de-activate smoke evacuation.
Intended Use/ Indications for Use
Unchanged from the predicate
Technological Characteristics
The modification does not change the technological characteristics of the EVA 15 insufflator and smoke evacuation system. The AutoEvac accessory provides an alternative means of turning on and off smoke evacuation. Both AutoEvac and the foot pedal accessories activate/deactivate smoke evacuation using the same pneumatic tube. The AutoEvac accessory does not employ software.
Principles of Operation
The EVA 15 Insufflator principle of operation remains unchanged to the predicate.
Non-clinical Testing
Performance testing of the insufflator has demonstrated the ability to activate and de-activate smoke evacuation when electrosurgical energy is switched on and off. including testing to IEC 60601-1:2005/AMD1:2012 / AMD 2:2020 (Edition 3.2) - Medical Electrical Equipment - Part 1: General Requirements For Safety and IEC 60601-1-2:2014 / A1:2020 (Edition 4.1) – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Substantial Equivalence Conclusion
The EVA15 with the AutoEvac accessory has the same intended use, indications, technological characteristics and principles of operation as the predicate.
This difference does not raise different questions of safety or effectiveness as compared to the predicate device because smoke evacuation is activated/de-activated using the same pneumatic principle.
The AutoEvac accessory uses energy sensing to activate and de-activate smoke evacuation in a similar manner to the reference device, Buffalo Filter Visiclear - K131402, which has an accessory called the EZLink automatic activation device. The results of non-clinical performance testing demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination.
5
| | Subject Device:
EVA15 Insufflator with AutoEvac | Predicate:
EVA15 Insufflator - K222901 | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Palliare | Palliare | |
| Classification | 21 C.F.R. § 884.1730 (Laparoscopic Insufflator)
Product Code HIF (Class II) | 21 C.F.R. § 884.1730 (Laparoscopic Insufflator)
Product Code HIF (Class II) | 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. Venturi smoke evacuation. | Same |
| Patient
connection | Standard Trocar luer connection | Standard Trocar luer connection | Same |
| Indications for
Use | The EVA15 Insufflator is intended for use in diagnostic
and/or therapeutic endoscopic and laparoscopic
procedures to distend the abdomen, rectum, colon,
esophagus, stomach or thoracic cavity with up to 25
mmHg pressure, by filling it with gas and to evacuate
surgical smoke. | The EVA15 Insufflator is intended for use in diagnostic
and/or therapeutic endoscopic and laparoscopic
procedures to distend the abdomen, rectum, colon,
esophagus, stomach or thoracic cavity with up to 25
mmHg pressure, by filling it with gas and to evacuate
surgical smoke. | Same |
| Gas Deliverv
Modes | Intermittent Pressure (Standard) Insufflation
Continuous Pressure Insufflation | Intermittent Pressure (Standard) Insufflation
Continuous Pressure Insufflation | Same |
| Smoke
Evacuation | Available in all modes. Operates continuously or may be
activated on/off using foot pedal or automatically using
the AutoEvac accessory. | Available in all modes. Operates continuously or may be
activated on/off using foot pedal. | Alternative accessory
provided for automatic
activation and deactivation
of smoke evacuation |
| Technology of
energy sensing | Activates which surgical energy is sensed | Not available, but use of a reference
Buffalo Filter Visiclear - K131402 EZLink automatic
activation device when surgical energy is sensed. | Buffalo Filter Visiclear -
K131402 EZLink
automatic activation
device when surgical
energy is sensed. |
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K232902 Page 4 of 4
510(k) Summary Page 4 of 4
| Subject Device: | Predicate: | Comparison | |
|---|---|---|---|
| EVA15 Insufflator | EVA15 Insufflator - K222901 | ||
| Flow Range | 0-40 SLPM | 0-40 SLPM | Same |
| Pressure Range | Up to 25 mmHg | Up to 25 mmHg | Same |
| Accessories | Tubeset | Tubeset | Same |
| Use limitation of | |||
| tube set | 48 hours due to ID Chip | 48 hours due to ID Chip | Same |
| Dimensions | 160x130x330mm | 160x130x330mm | Same |
| Weight | 5.5kg | 5.5kg | Same |
| Power Source | 100-240V | 100-240V | Same |
| Tubeset | |||
| Sterilization | EtO | EtO | Same |
| User Interface | Membrane Panel | Membrane Panel | Same |
| Testing | IEC 60601-1 Electrical safety | ||
| IEC 60601-1-2 - - EMC | Similar | Similar |
7
Indications for Use
510(k) Number (if known) K232902
Device Name EVA15 Insufflator
Indications for Use (Describe)
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
| 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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