(126 days)
No
The description focuses on micro-processor control for basic functions like pressure regulation and smoke evacuation, with no mention of AI/ML terms or capabilities.
Yes
The device is used to distend body cavities and evacuate surgical smoke during procedures, which contributes to the treatment or diagnosis of a condition.
No
The EVA 15 Insufflator is used to distend body cavities and evacuate surgical smoke during diagnostic and therapeutic endoscopic and laparoscopic procedures. Its function is to facilitate the use of other endoscopic instruments, not to directly produce a diagnosis.
No
The device description explicitly states it consists of a micro-processor-controlled insufflation and smoke evacuation unit and a disposable tube set, indicating the presence of hardware components beyond just software.
Based on the provided information, the EVA 15 Insufflator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to distend body cavities (abdomen, rectum, colon, etc.) with gas and evacuate surgical smoke during diagnostic and therapeutic endoscopic and laparoscopic procedures. This is a physiological manipulation of the body, not an examination of samples taken from the body.
- Device Description: The device description focuses on the mechanical and pneumatic functions of insufflation and smoke evacuation. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis based on sample analysis
In summary, the EVA 15 Insufflator is a medical device used to facilitate surgical and diagnostic procedures by physically altering the body cavity. It does not perform any in vitro analysis of biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The EVA15 Insufflator is intended for use in diagnostic 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, FCX
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 EVA 15 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 25mmHg 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, thoracic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room or endoscopic suite. Physician
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 in the revised pressure range demonstrated that the subject device met its acceptance criteria, the same acceptance criteria as applied to the predicate. Testing included:
- Static condition .
- Pressure accuracy .
- Dynamic condition ●
- Simulated leak
- Smoke evacuation
The addition of the ID Chipset to the disposable tubeset connector is to ensure that the correct tubeset is used and to limit the time the disposable tubeset may be used. Software verification and validation was performed to test that the EVA 15 insufflator could read the connector chip correctly to determine the presence of the chipset and the identity of the tubeset. Verification of the spring pressure relief valve performance was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
January 27, 2023
Palliare Ltd. % Paul Dryden President/Consultant for Strata ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704
Re: K222901
Trade/Device Name: EVA15 Insufflator Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, FCX Dated: December 20, 2022 Received: December 20, 2022
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 (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,
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
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Indications for Use
510(k) Number (if known) K22901
Device Name EVA15 Insufflator
Indications for Use (Describe)
The EVA 15 Insufflator is intended for use in diagnostic 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Page 1 of 4
| Date Prepared: | 26-Jan-23 |
|---|---|
| Palliare Ltd. | |
| Galway Business Park, Dangan | |
| Galway H91 P2DK, Ireland | |
| Tel - +353-91-516362 | |
| Official Contact: | John O'Dea, Ph.D., Director |
| 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, FCX |
| Predicate Device: | K202799 - Palliare EVA15 |
| Common/Usual Name: | CO2 insufflator |
| Regulation Number: | 21 CFR 884.1730 |
| Regulation Name: | Laparoscopic insufflator |
| Product Code: | HIF, FCX |
Modification:
Updated maximum pressure delivered to 25 mmHg, the ability to select two insufflation pressures and select using the foot pedal, and a chip identifier in the tubeset connectors.
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 EVA 15 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 25mmHg 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.
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
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510(k) Summary Page 2 of 4
cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
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, K202799 - Palliare EVA15.
Substantial Equivalence Discussion
The EVA15 insufflator has the same general intended use and indications, technological characteristics, and principles of operation as the predicate Palliare EVA 15, K202799.
Intended Use/ Indications for Use
The proposed modifications to the indications for use are to extend the pressure delivery range from 15 mmHg to 25 mmHg
Technological Characteristics
The modification does not change the technological characteristics.
Principles of Operation
The EVA15 Insufflator principle of operation remains unchanged to the predicate.
Non-clinical Testing
Performance testing of the insufflator in the revised pressure range demonstrated that the subject device met its acceptance criteria, the same acceptance criteria as applied to the predicate. Testing included:
- Static condition .
- Pressure accuracy .
- Dynamic condition ●
- Simulated leak
- Smoke evacuation
The addition of the ID Chipset to the disposable tubeset connector is to ensure that the correct tubeset is used and to limit the time the disposable tubeset may be used. Software verification and validation was performed to test that the EVA 15 insufflator could read the connector chip correctly to determine the presence of the chipset and the identity of the tubeset. Verification of the spring pressure relief valve performance was performed.
Substantial Equivalence Conclusion
The EVA15 with the modified performance and addition of the ID chip in the tubeset remain to have the same intended use and similar indications, technological characteristics and principles of operation.
This difference does not present different questions of safety or effectiveness than the predicate device because CO2 is delivered to the surgical field at a maximum 25 mmHz, which is lower than other marketed devices e.g., K153513 - World of Medicine Model FM134, and smoke is evacuated without loss of cavity pressure as with the currently cleared EVA15- K202799. The results of non-clinical performance testing demonstrate that the subject device is as safe and effective as the predicate. Thus, the EVA15 Insufflator is substantially equivalent to the Palliare EVA 15, cleared under K202799.
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Table 1 – Comparison – Subject vs. Predicate
| | Proposed Device: EVA15 Insufflator | Predicate:
EVA15 Insufflator - K202799 | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer | Palliare | Palliare | Same |
| Classification | 21 C.F.R. § 884.1730 ( Laparoscopic Insufflator )
Product Code HIF, FCX (Class II) | 21 C.F.R. § 884.1730 ( Laparoscopic Insufflator )
Product Code HIF, FCX (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 EVA 15 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 EVA 15 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 15 mmHg pressure, by filling it
with gas and to evacuate surgical smoke. | Similar except extension of
pressure range |
| Gas Delivery
Modes | Intermittent Pressure (Standard) Insufflation
Continuous Pressure Insufflation | Fixed Flow
Intermittent Pressure (Standard) Insufflation
Continuous Pressure Insufflation | Fixed flow not offered in
proposed product |
| Smoke
Evacuation | Available in all modes. Operates continuously
or may be activated on/off using foot pedal. | Available in all modes. Operates continuously or
may be activated on/off using foot pedal. | Same |
| Flow Range | 0-40 SLPM | 0-40 SLPM | Same |
| Pressure Range | Up to 25 mmHg | 7-15 mmHg | Different but similar to the
reference K153515 |
| Accessories | Tubeset | Tubeset | Same as cleared under
K193520 and K202922
except for addition of ID Chip |
| Use limitation
of tube set | 48 hours due to ID Chip | Labeling was disposable but nothing prevented
continued use | Addition of ID chip |
| | Proposed Device: EVA15 Insufflator | Predicate:
EVA15 Insufflator - K202799 | Comparison |
| 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 |
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