(30 days)
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 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.
The EVA5 Insufflator is a medical device intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas. The document provides information regarding its non-clinical testing to demonstrate substantial equivalence to its predicate devices.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (EVA5) | Predicate Device (EVA15) Specification (K193520) |
|---|---|---|
| Flow accuracy | ±0.3 SLPM | ±1 SLPM |
| Switch-off time accuracy | Met acceptance criteria | Not explicitly stated (N/A in table) |
2. Sample Size and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is non-clinical, focusing on the device's technical specifications.
3. Number of Experts and Qualifications
This information is not provided as the described testing is non-clinical performance testing of the device's mechanical and electronic functions, not human interpretation of medical images or data.
4. Adjudication Method
This information is not applicable as the testing described is non-clinical performance testing, not involving human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The EVA5 Insufflator is a mechanical device, and its performance is evaluated based on technical specifications rather than human reader accuracy.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm (the insufflator's flow control system). The "Non-clinical Testing" section states: "Performance testing of the insufflator demonstrated that the subject device met its acceptance criteria..." This refers to the device's intrinsic mechanical/electronic performance.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance testing would be the precise, calibrated measurements of flow rate and timing. These would be established using validated testing equipment and methodologies.
8. Sample Size for the Training Set
This information is not applicable. The EVA5 Insufflator is a hardware device with a micro-processor-controlled insufflation flow control system. It is not an AI/ML algorithm that is "trained" on a large dataset in the conventional sense. Its "training" or calibration would occur during its manufacturing and quality control processes based on engineering specifications.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and "ground truth" for a training set is not directly applicable to a hardware device like an insufflator. The device's operational parameters are designed and calibrated based on engineering principles and established medical device standards. The "ground truth" for its performance would be defined by these engineering specifications and validated through rigorous testing against calibrated measuring instruments.
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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
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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
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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 DrydenProMedic, LLC |
| Proprietary or Trade Name: | EVA5 Insufflator |
| Classification Panel: | Gastroenterology/ Urology |
| Regulatory Class: | Class II |
| Common/Usual Name:Regulation Number: ProductCode: | CO2 insufflator21 CFR 876.1500FCX – Insufflator, Automatic Carbon-DioxideFor Endoscope |
| Primary Predicate Device:Common/Usual Name:Regulation Number: ProductCode: | K193520 – Palliare EVA15CO2 insufflator21 CFR 876.1730HIF – Insufflator, Automatic Carbon-Dioxide ForEndoscope |
| Secondary Predicate Device:Common/Usual Name:Regulation Number: ProductCode: | K222901 – Palliare EVA15CO2 insufflator21 CFR 876.1730HIF 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.
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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 CodeFCX | 21 C.F.R. § 884.1730(Laparoscopic Insufflator),Product CodeHIF | 21 C.F.R. § 884.1730(Laparoscopic Insufflator),Product CodeHIF and FCX | The predicate has the insufflator intended usethat is under FCX, but the FDA clearance didnot include FCX. However, the secondarypredicate K222901 includes the FCX Code |
| Fundamentalscientifictechnology | Digital insufflation flowregulation system usingcompressed CO2 gas. | Digital insufflation flowregulation and pressureregulation system usingcompressed CO2 gas.Venturi smoke evacuation. | Digital insufflationpressure regulation systemusing compressed CO2 gas.Venturi smoke evacuation. | Functionality of K193520 has been split intotwo devices - a pressure insufflator and a flowinsufflator |
| Patientconnection | Endoscope connection | Standard Trocar luerconnection or endoscopeconnection | Standard Trocar luerconnection or endoscopeconnection | K193520 and K222901 can connect toendoscope |
| Indicationsfor Use | The EVA5 Insufflator isintended for use indiagnostic and/ortherapeutic endoscopicprocedures to distend thegastrointestinal tract byfilling it with gas. | The EVA15 Insufflator isintended for use indiagnostic and/ortherapeutic endoscopic andlaparoscopic procedures todistend the abdomen, colonor thoracic cavity with up to15 mmHg pressure, byfilling it with gas and toevacuate surgical smoke. | The EVA15 Insufflator isintended for use indiagnostic and/ortherapeutic endoscopic andlaparoscopic procedures todistend the abdomen,rectum, colon, esophagus,stomach or thoracic cavitywith up to 25 mmHgpressure, by filling it withgas and to evacuatesurgical smoke. | Proposed device has IFU which are a subset ofK193520 IFU but describing the anatomicallocation more generally |
| Proposed Device:EVA5 Insufflator | Primary Predicate:EVA15 Insufflator -K193520 | Secondary Predicate:EVA15 Insufflator -K222901 | Comparison | |
| Gas DeliveryModes | Fixed Flow | Fixed FlowIntermittent Pressure(Standard) InsufflationContinuous PressureInsufflation | Intermittent Pressure(Standard) InsufflationContinuous PressureInsufflation | Proposed device has Fixed Flow which are asubset of K193520 features |
| SmokeEvacuation | N/A | Available in all modes.Operates continuously ormay be activated on/offusing foot pedal. | Available in all modes.Operates continuously ormay be activated on/offusing 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 asubset of K193520 and K222901 |
| PressureRange | N/A | 7-15 mmHg | 7-25 mmHg | Proposed device does not offer pressureinsufflation |
| Accessories | None | Tubesets | Tubesets | EVA15 works with any commercial waterbottle tubeset |
| Dimensions | 160x130x330mm | 160x130x330mm | 160x130x330mm | Same |
| Weight | 5.0kg | 5.5kg | 5.5kg | Lighter on account of no smoke evacuationpneumatics |
| Power Source | 100-240V | 100-240V | 100-240V | Same |
| User Interface | Membrane Panel | Membrane Panel | Membrane Panel | Same |
| AutomaticSwitch-offtime | 30, 60, 90, 120 minutes | N/A | N/A | A user feature |
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§ 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.