(30 days)
Not Found
No
The description mentions a "micro-processor-controlled insufflation flow control system," which indicates automation and control, but not necessarily AI/ML. There are no mentions of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML in the provided text. The performance studies focus on flow accuracy and switch-off time, which are standard metrics for insufflators and do not suggest AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" states that the device is intended for use in "therapeutic endoscopic procedures" and "to distend the gastrointestinal tract by filling it with gas" which facilitates the introduction of various endoscopic instruments.
No
The device is an insufflator used to distend the gastrointestinal tract during diagnostic and/or therapeutic endoscopic procedures. It facilitates the introduction of endoscopic instruments but does not perform diagnostic functions itself.
No
The device description explicitly states it is a hardware device consisting of a micro-processor-controlled insufflation flow control system, powered by AC, and uses a compressed gas supply.
Based on the provided information, the EVA5 Insufflator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "distend the gastrointestinal tract by filling it with gas" during endoscopic procedures. This is a therapeutic or diagnostic procedure performed directly on the patient, not a test performed on a sample taken from the patient outside the body.
- Device Description: The description focuses on the mechanical function of insufflating a body cavity with gas. It does not mention any analysis of biological samples or substances.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information about a patient's health status based on sample analysis
The EVA5 Insufflator is a medical device used to facilitate a medical procedure, but it does not perform in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.
Product codes (comma separated list FDA assigned to the subject device)
FCX
Device Description
The EVA5 insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. It is indicated to facilitate the introduction of various endoscopic instruments by filling the alimentary canal with gas to distend it. The EVA5 Insufflator is used in an operating room or endoscopic suite. It consists of the following major component (1) a micro-processor-controlled insufflation flow control system.
The EVA5 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate the alimentary canal via an endoscope. The EVA5 is powered by AC and uses a compressed 50 psi CO2 gas supply to supply the pneumatic circuitry for insufflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Patient undergoing endoscopic procedures in which insufflation may be helpful.
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)
Non-clinical Testing
Performance testing of the insufflator demonstrated that the subject device met its acceptance criteria, which are similar to the predicate (±0.3 SLPM (EVA5) versus ±1 SLPM (EVA15) specifications).
Testing included:
- Flow accuracy ●
- . Switch-off time accuracy
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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March 24, 2023
Palliare Ltd. % Paul Dryden Consultant Palliare Ltd. c/o ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K230474
Trade/Device Name: EVA5 Insufflator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FCX Dated: February 21, 2023 Received: February 22, 2023
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. 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,
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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) K230474
Device Name
EVA5 Insufflator
Indications for Use (Describe)
The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.
| 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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Date Prepared:
14-Mar-23
K230474 Page 1 of 5
| Palliare Ltd.
Galway Business Park,
Dangan Galway H91 P2DK,
| Ireland | |
|---|---|
| Official Contact: | John O'Dea, Ph.D., CEO |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | EVA5 Insufflator |
| Classification Panel: | Gastroenterology/ Urology |
| Regulatory Class: | Class II |
| Common/Usual Name: | |
| Regulation Number: Product | |
| Code: | CO2 insufflator |
| 21 CFR 876.1500 | |
| FCX – Insufflator, Automatic Carbon-Dioxide | |
| For Endoscope | |
| Primary Predicate Device: | |
| Common/Usual Name: | |
| Regulation Number: Product | |
| Code: | K193520 – Palliare EVA15 |
| CO2 insufflator | |
| 21 CFR 876.1730 | |
| HIF – Insufflator, Automatic Carbon-Dioxide For | |
| Endoscope | |
| Secondary Predicate Device: | |
| Common/Usual Name: | |
| Regulation Number: Product | |
| Code: | K222901 – Palliare EVA15 |
| CO2 insufflator | |
| 21 CFR 876.1730 | |
| HIF and FCX – Insufflator, Automatic Carbon- | |
| Dioxide For Endoscope |
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Device Description:
The EVA5 insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. It is indicated to facilitate the introduction of various endoscopic instruments by filling the alimentary canal with gas to distend it. The EVA5 Insufflator is used in an operating room or endoscopic suite. It consists of the following major component (1) a micro-processor-controlled insufflation flow control system.
The EVA5 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate the alimentary canal via an endoscope. The EVA5 is powered by AC and uses a compressed 50 psi CO2 gas supply to supply the pneumatic circuitry for insufflation.
Principle of Operation:
EVA5 employs a proportional flow control solenoid in series with a flow sensor which provides flow feedback. The flow delivery pneumatics are identical to those used in the predicate K193520.
Indications for Use:
The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.
Patient Population:
Patient undergoing 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 Primary Predicate, K193520 and Secondary Predicate K222901 - Palliare EVA 15.
Substantial Equivalence Discussion
The EVA5 insufflator has a narrowed intended use and indications, and the same technological characteristics, and principles of operation as the predicate Palliare EVA 15, K193520.
Intended Use/ Indications for Use
The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas. The proposed modifications to the indications for use are essentially a restricted subset of the which the predicate Palliare EVA15 Insufflator, K193520, was cleared.
Modification:
The primary predicate K193520 had the following indications and intended uses.
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, bv filling it with gas and to evacuate surgical smoke.
5
The insufflator offered both fixed flow and pressure endoscopic and laparoscopic insufflation modalities and smoke evacuation (cleared with HIF Procode)
The secondary predicate K222901 had the following indications and intended uses.
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 insufflator offers only pressure insufflation and smoke evacuation (cleared with HIF and FCX Product Codes)
The EVA5 insufflator offers only fixed flow insufflation and no smoke evacuation, thus the appropriate ProCode would be FCX.
Technological Characteristics
The modification does not change the technological characteristics. See Table 1 below on page 4 of 5 and page of 5 of 5.
Principles of Operation
The EVA5 Insufflator principle of operation for flow delivery is identical to the predicates K193520 and K222901.
Non-clinical Testing
Performance testing of the insufflator demonstrated that the subject device met its acceptance criteria, which are similar to the predicate (±0.3 SLPM (EVA5) versus ±1 SLPM (EVA15) specifications).
Testing included:
- Flow accuracy ●
- . Switch-off time accuracy
Substantial Equivalence Conclusion
The EVA5 with the modified indications represents a restricted subset of the intended use and has similar indications, technological characteristics and principles of operation as the predicate K193520.
This difference does not present different questions of safety or effectiveness than the predicate device because K193520 offered a fixed flow mode. EVA5 delivers a subset of the flow range cleared in K193520 Thus, the fixed flow mode of insufflation offered in the EVA5 Insufflator is substantially equivalent to that offered in the Palliare EVA 15, cleared under K193520.
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Table 1 – Comparison – Subject vs. Predicates
| | Proposed Device:
EVA5 Insufflator | Primary Predicate:
EVA15 Insufflator -
K193520 | Secondary Predicate:
EVA15 Insufflator -
K222901 | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Palliare | Palliare | Palliare | |
| Classification | 21 C.F.R. § 876.1500
(Endoscopic Insufflator),
Product Code
FCX | 21 C.F.R. § 884.1730
(Laparoscopic Insufflator),
Product Code
HIF | 21 C.F.R. § 884.1730
(Laparoscopic Insufflator),
Product Code
HIF and FCX | The predicate has the insufflator intended use
that is under FCX, but the FDA clearance did
not include FCX. However, the secondary
predicate K222901 includes the FCX Code |
| Fundamental
scientific
technology | Digital insufflation flow
regulation system using
compressed CO2 gas. | Digital insufflation flow
regulation and pressure
regulation system using
compressed CO2 gas.
Venturi smoke evacuation. | Digital insufflation
pressure regulation system
using compressed CO2 gas.
Venturi smoke evacuation. | Functionality of K193520 has been split into
two devices - a pressure insufflator and a flow
insufflator |
| Patient
connection | Endoscope connection | Standard Trocar luer
connection or endoscope
connection | Standard Trocar luer
connection or endoscope
connection | K193520 and K222901 can connect to
endoscope |
| Indications
for Use | The EVA5 Insufflator is
intended for use in
diagnostic and/or
therapeutic endoscopic
procedures to distend the
gastrointestinal tract by
filling it with gas. | 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 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. | Proposed device has IFU which are a subset of
K193520 IFU but describing the anatomical
location more generally |
| | Proposed Device:
EVA5 Insufflator | Primary Predicate:
EVA15 Insufflator -
K193520 | Secondary Predicate:
EVA15 Insufflator -
K222901 | Comparison |
| Gas Delivery
Modes | Fixed Flow | Fixed Flow
Intermittent Pressure
(Standard) Insufflation
Continuous Pressure
Insufflation | Intermittent Pressure
(Standard) Insufflation
Continuous Pressure
Insufflation | Proposed device has Fixed Flow which are a
subset of K193520 features |
| Smoke
Evacuation | N/A | 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. | Proposed device does not have Smoke Evac
(not required in Endoscopic applications) |
| Flow Range | 0-4 SLPM | 0-40 SLPM | 0-40 SLPM | Proposed device has flow range which is a
subset of K193520 and K222901 |
| Pressure
Range | N/A | 7-15 mmHg | 7-25 mmHg | Proposed device does not offer pressure
insufflation |
| Accessories | None | Tubesets | Tubesets | EVA15 works with any commercial water
bottle tubeset |
| Dimensions | 160x130x330mm | 160x130x330mm | 160x130x330mm | Same |
| Weight | 5.0kg | 5.5kg | 5.5kg | Lighter on account of no smoke evacuation
pneumatics |
| Power Source | 100-240V | 100-240V | 100-240V | Same |
| User Interface | Membrane Panel | Membrane Panel | Membrane Panel | Same |
| Automatic
Switch-off
time | 30, 60, 90, 120 minutes | N/A | N/A | A user feature |
7