(256 days)
The INSPIRA™ ART100 system is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting six hours or less.
The INSPIRA™ ART100 system is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The INSPIRA™ ART100 system consists of the following components: Controller Unit, Pump Drive Unit, Manual Pump Drive Unit, Blood Flow and Bubble Detection Sensor, Temperature Sensor, Cable adapters for Pressure Sensors, Cable adapters for Temperature Sensor, Oxygenator and Pump Drive Holders. The system is compatible with a Non-Roller Centrifygal Pump (Capiox iCP Centrifyqal Pump). The Inspira Pump Drives are magnetically coupled exclusively with the Capiox iCP Centrifugal Pump, designed and manufactured by Terumo Cardiovascular Systems Corporation, and can be supplied by Inspira. The INSPIRA™ ART100 system is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors, pressure sensors, supplied by hospital users or other manufacturers.
The provided text describes a 510(k) premarket notification for the INSPIRA™ ART100 device. While it details the device's technological characteristics, intended use, and comparison to a predicate device, it does not include specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) or a detailed study proving the device meets these criteria in the context of an AI/human-in-the-loop system.
The device, Inspira Art100, is a cardiopulmonary bypass pump speed control system. The testing performed is related to ensuring the device functions as intended and meets safety standards, rather than evaluating specific clinical performance metrics typical of AI/ML-driven diagnostic or prognostic devices.
Therefore, many of the requested details about acceptance criteria and performance studies for an AI device cannot be extracted from this document.
However, I can extract information regarding non-clinical tests performed to demonstrate safety and effectiveness for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "All testing met predetermined acceptance criteria." However, the specific acceptance criteria and detailed reported performance values for each non-clinical test are not explicitly provided in a table format. The reported performance is implicitly that the device passed these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification and Validation | Met predetermined acceptance criteria. |
| Functional Design Verification and Validation | Met predetermined acceptance criteria. |
| Electrical Safety, EMI/EMC | Met predetermined acceptance criteria and certified by accredited third-party laboratories to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8. |
| Interoperability Evaluation (with accessories/compatible devices) | Met predetermined acceptance criteria. |
| Reliability Testing | Met predetermined acceptance criteria. |
| Simulated Use Testing | Met predetermined acceptance criteria. |
| Cleaning Validation | Met predetermined acceptance criteria. |
| Packaging and Shipping Testing | Met predetermined acceptance criteria and certified to ASTM D4332-22, ASTM D4169-22. |
| Usability/Human Factors | Completed human factors validation study in accordance with IEC 62366-1, ISO 14971, and FDA guidance. All residual use-error risks evaluated and minimized; overall residual risk acceptable. |
| Risk Management | In accordance with ISO 14971:2019. |
| Software Life Cycle Processes | In accordance with IEC 62304:2006/AMD 1:2015. |
| Battery Safety/Transport | Certified to IEC / UL 62133-2:2020 Ed.1 / CSA C22.2 and UN38.3. |
2. Sample size used for the test set and the data provenance: Not applicable. The tests performed are non-clinical, bench, and simulated use tests for a pump speed control device, not a diagnostic or prognostic AI system using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI models (e.g., disease presence) is not relevant for the type of device and testing described. Expert involvement would be in the design, testing, and validation of the device's engineering and safety aspects.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, this type of study was not done. The device is a cardiopulmonary bypass pump speed control system, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes standalone device testing (bench tests) for its functional and safety performance, but not in the context of an AI algorithm vs. human performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests described, "ground truth" refers to engineering specifications, performance standards (e.g., for pump speed, flow rate accuracy), and compliance with recognized industry standards (e.g., IEC, ISO, ASTM).
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established: Not applicable.
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May 24, 2024
Inspira Technologies Oxy B.H.N Ltd. % Fernando Aguel Vice President, Heart Failure & Circulatory Support Regulatory Affairs MCRA 803 7th Street NW, 3rd Floor Washington, District of Columbia 20005
Re: K232788
Trade/Device Name: Inspira Art100 Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II Product Code: DWA Dated: April 22, 2024 Received: April 22, 2024
Dear Fernando Aguel:
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" (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).
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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 medical devices and radiation-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,
Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232788
Device Name INSPIRA ART100
Indications for Use (Describe)
The INSPIRA ART100 system is intended for use in an extra corporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
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
Inspira Technologies Oxy B.H.N. Ltd.'s INSPIRA™ ART100 Device
1. 510(k) Owner's Information:
| Applicant's name: | Inspira Technologies Oxy B.H.N. Ltd.2 Ha-Tidhar St.,Ra'anana, 4366504, Israel | |
|---|---|---|
| Contact Person: | Dganit Litinsky, VP RATel. 972-9-9664488+dganit@inspirao2.com | |
| Date Prepared: | September 11, 2023 | |
| 2. Device Name | ||
| Trade Name: | INSPIRA™ ART100 | |
| Common Name: | Control, Pump Speed, Cardiopulmonary Bypass | |
| Classification: | Product Code: | DWA |
| Regulation No:Class: | 21 C.F.R. §870.4380Class: II, Cardiopulmonary bypass pumpspeed control | |
| Classification Panel: | Cardiovascular |
3. Predicate Device:
RotaFlow Centrifugal Pump System, cleared under K991864
4. Device Description:
The INSPIRA™ ART100 system is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures.
The INSPIRA™ ART100 system consists of the following components:
-
- Controller Unit
-
- Pump Drive Unit
-
- Manual Pump Drive Unit
-
- Blood Flow and Bubble Detection Sensor
-
- Temperature Sensor
-
- Cable adapters for Pressure Sensors
-
- Cable adapters for Temperature Sensor
-
- Oxygenator and Pump Drive Holders
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The system is compatible with a Non-Roller Centrifygal Pump (Capiox iCP Centrifyqal Pump). The Inspira Pump Drives are magnetically coupled exclusively with the Capiox iCP Centrifugal Pump, designed and manufactured by Terumo Cardiovascular Systems Corporation, and can be supplied by Inspira.
The INSPIRA™ ART100 system is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors, pressure sensors, supplied by hospital users or other manufacturers. Those disposables are currently not supplied by Inspira as part of the system.
5. Intended Use / Indications for Use
The INSPIRA™ ART100 System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting six hours or less.
Contraindications
The INSPIRA™ ART100 system is contraindicated for use in a transport environment (aircraft, ambulance, etc.).
Contraindications of the disposables, as stated in their respective Instructions for Use, must be taken into account.
6. Intended Users
The INSPIRA™ ART100 system is designed for use by licensed physicians and perfusionists to perform cardiopulmonary bypass procedures. Trained specialists, surgical nurses and physician assistants may assist in the setup of the equipment and preparation of patients.
7. Intended Patient Population and Intended Part of Body
The device is intended to be used for patients needing cardiopulmonary bypass. Suitability of the device for specific patients is determined by licensed and trained physicians and specialists.
8. Intended Use Environment
The INSPIRA™ ART100 system is intended to be used in an operating room, and placed outside a sterile field.
The device is supplied non-sterile.
9. Technological Characteristics
The intended use and technological characteristics are compared with one predicate, legally marketed device and one reference device in the table below.
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| Product Nameand Model | INSPIRA™ ART100 | Rotaflow®Centrifugal PumpSystem (Predicate) | Anivia SG1000Pump Console(Reference) | Comparison/Notes |
|---|---|---|---|---|
| Manufacturer | Inspira TechnologiesOxy B.H.N. Ltd. | Getinge MaquetCardiopulmonaryAG, Germany | APMTD Inc. USA | N/A |
| FDA 510(k)number | K232788 | K991864 | K221491K230698 | N/A |
| Indications forUse | The INSPIRA™ART100 Systemis intended for use inan extracorporealperfusion circuit topump blood duringshort durationcardiopulmonarybypass procedureslasting six hours orless. | The RotaFlowCentrifugalPump System isintended for use inan extracorporealperfusion circuit topump blood duringshort durationcardiopulmonarybypass procedureslasting six hours orless. | The AniviaSG1000Pump Console isintended to pumpblood through theextracorporealbypasscircuit forextracorporealsupport forperiodsappropriate tocardiopulmonarybypass(up to 6 hours). | Same aspredicate |
| FDAClassificationCodes | Class II, CFR870.4380,DWA,Cardiopulmonarybypass pump speedcontrol | Class II, CFR870.4360, KFMPump, Blood,CardiopulmonaryBypass, Non-RollerType | Class II, CFR870.4380,DWA,Cardiopulmonarybypass pumpspeedcontrol | Same asreference |
| Duration of Use | Up to 6 hours | Up to 6 hours | Up to 6 hours(limited bydisposables, notlimited byConsole electro-mechanicalmodules) | Same aspredicate. |
| Intended Use | Pump Speed Control,CPB Machine Console(not including sterile,blood-contactingaccessories) | Pump SpeedControl, CPBMachine Console(bundled with sterile,blood-contactingaccessories, outsidethe scope of thisapplication) | Pump SpeedControl, CPBMachine Console(not includingsterile, blood-contactingaccessories) | Same asreference. |
| Intended Users | Cardiopulmonaryphysicians,perfusionists, trainedphysician assistants | Cardiopulmonaryphysicians,perfusionists, trainedphysician assistants | Cardiopulmonaryphysicians,perfusionists,trained physicianassistants | Same aspredicate. |
| Intended Patients | As prescribed bycardiopulmonaryspecialists | As prescribed bycardiopulmonaryspecialists | As prescribed bycardiopulmonaryspecialists | Same aspredicate. |
| Product Nameand Model | INSPIRA™ ART100 | Rotaflow®Centrifugal PumpSystem (Predicate) | Anivia SG1000Pump Console(Reference) | Comparison/Notes |
| Identification ofDisposableCentrifugal PumpHeadsCompatible withSystem Console | TerumoCardiovascularSystem Corporation,Capiox iCPCentrifugal Pump | RotaFlow® RF-32centrifugal pumpheads | Medtronic BPX-80, BP-50centrifugal pumpheads (w/ PumpDriver ModuleSG1000-PDM-001)RotaFlow® RF-32 centrifugalpump heads (w/Pump DriverModule SG1000-PDM-002)Medtronic AffinityCPAP40,BBAP40,centrifugal pumpheads (w/ PumpDriver ModuleSG1000-PDM-003)LivaNovaRevolution®Catalogue No.050300700,050300000centrifugal pumpheads (w/ PumpDriver ModuleSG1000-PDM-004) | Same aspredicate andreference.INSPIRAART100 isfollowingAniviaSG1000precedent forclearingconsole withpump headfrom differentmanufacturer |
| Centrifugal PumpDriver | Non-contact,magnetically coupled | Non-contact,magneticallycoupled | Non-contact,magneticallycoupled | Same aspredicate. |
| RegulationControl Functions | • Speed RegulationMechanical Knob andTouch Display | • Speed Regulation• Flow Regulation(Stability)Mechanical Knob | • SpeedRegulation• Flow Regulation(Stability)Mechanical Knoband TouchDisplay | No FlowRegulation –Difference hasno impact onsafety oreffectiveness. |
| Components | • Controller• Pump Drive• Emergency ManualPump Drive. | • Rotaflow Console• Pump Drive.• EmergencyManual Pump Drive | • Touch screencontrol anddisplay panel | Same aspredicate. |
| Product Nameand Model | INSPIRA™ ART100 | Rotaflow®Centrifugal PumpSystem (Predicate) | Anivia SG1000Pump Console(Reference) | Comparison/Notes |
| • Flow and BubbleSensor• Integrated twoBackup Batteries• Adjustable SupportHolders | • Integrated flow andbubble sensors inthe drive unit• Integrated batterybackup• Adjustable SupportArm. | • Pump DriverModule• EmergencyHandcrank• Flow BubbleSensor• Backup BatteryModule• Mobile cart withadjustableSupport Arm(optionalaccessory)• Backup PumpDriver Module | ||
| Pump Speed(RPM) | 0 - 3600 | 0-5000 | 0 - 45000 - 50000 - 40000 - 3500 | CentrifugalPumpDependent.Difference hasno impact onsafety oreffectiveness. |
| Visual andAuditory Alarmson AbnormalConditions | Yes, preset limits:Speed Rate, BackFlow, Bubble,Pressure,Temperature. | Yes, preset limits | Yes, preset limits:Speed, FlowRate, Back Flow,Bubble,Pressure,Temperature | Same aspredicate. |
| Blood Flow Rate(L/min) | Dependent onexternal circuit, up to0-8 L/min | Dependent onexternal circuit, up to0-9.9 L/min | Dependent onexternal circuit,up to 0 - 9.9L/min | CentrifugalPumpDependent.Difference hasno impact onsafety oreffectiveness. |
| Interface to BloodFlow Sensor | Yes (Qty 1) | Yes (Qty 1) | Yes (Qty 1) | Same aspredicate. |
| Air BubbleDetector | Yes (Qty 1),integrated with BloodFlow Sensor. | Yes (Qty 1) | Yes (Qty 1),integrated withBlood FlowSensor. | Same asreference. |
| Blood Flow andBubble DetectorSensorTechnology | Non-contact,ultrasound Clamp-Onaround blood tube. | Non-contact,ultrasound Clamp-On.around bloodtube | Non-contact,ultrasoundClamp-Onaround bloodtube | Same aspredicate. |
| Product Nameand Model | INSPIRA™ ART100 | Rotaflow®Centrifugal PumpSystem (Predicate) | Anivia SG1000Pump Console(Reference) | Comparison/Notes |
| PressureSensors | Yes (Qty 3, external),previously 510(k)cleared accessoriesmanufactured by thirdparties. | N/A | Yes (Qty 2,external),previously 510(k)clearedaccessoriesmanufactured bythird parties | Difference hasno impact onsafety oreffectiveness. |
| TemperatureSensors | Yes (Qty 1, external) | N/A | Yes (Qty 2,external),previously 510(k)clearedaccessoriesmanufactured bythird parties. | Difference hasno impact onsafety oreffectiveness |
| Power Input | 100-240 VAC50 — 60 Hz4.0A - 1.8A410 W | Factory Set100/115/230/240 VAC 2A / 1A | Universal 90-264VAC/50 — 60 Hz2.5A / 1.3A up to250 W | Difference hasno impact onsafety oreffectiveness. |
| Backup Battery | Li lon | NiCad | LiFePO4 | Difference hasno impact onsafety oreffectiveness. |
| Backup BatteryCapacity | 28.8 V 9.8 Ah, 282WH,2 hours, at 3600RPM, 8 L/min4 hours, at 2900RPM, 8 L/min | 24 VDC, 5 AH, 120WH1.5 hours, at 5 L/min | 25.6 VDC, 12AH, 307 WH,minimum 1 hour,up to 3 hoursdepending onspeed and flow | Difference hasno impact onsafety oreffectiveness. |
| Backup Pump | Yes, hand-crank | Yes, hand-crank | Yes, backupelectrical PumpDriver Module onstandby, andhand-crank | Same aspredicate. |
| Pump MotorTechnology | Brushless DC motor | Brushless DC motor | Brushless DCmotor | Same aspredicate. |
| Display Screen | 13.3" FHD ColorTFT-LCD | None | 31 cm (12.1") | Difference hasno impact onsafety oreffectiveness. |
| Dimensions,Display & ControlModule | 33.00 cm W x 23.4cm H x 44.8 cm D | 18 x 39 x 24 cm | 14 cm W x 15 cmH x 9 cm D | Difference hasno impact onsafety oreffectiveness. |
| Weight, Display &Control | 12 kg - includingbackup battery | 14.4 kg includingbackup battery | 3.3 kg - Display& Control Module | Difference hasno impact on |
| Product Nameand Model | INSPIRA™ ART100 | Rotaflow®Centrifugal PumpSystem (Predicate) | Anivia SG1000Pump Console(Reference) | Comparison/Notes |
| Difference has noimpact on safety andeffectiveness. | 4 kg - BackupBattery Module | safety oreffectiveness. | ||
| Automatic PumpStop intervention | Yes, at bubblesdetection.Indicated on screenvia an Alarm andicon. | Yes, at bubblesdetection (In SpeedRegulationoperation)Indicated via LED. | N/A | Same aspredicate. |
| OperationTemperatureRelative HumidityPressure | 10-35°C15-90%70-106kPa | 10-40°C15-95%66-106kPa | N/A | Difference hasno impact onsafety oreffectiveness. |
| StorageTemperatureRelative HumidityPressure | (-20)-55°C10-90%50-106kPa | (-18)-45°C10-96%66-106kPa | N/A | Difference hasno impact onsafety oreffectiveness. |
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Centrifugal Pump Specifications (Compatible Device)
| Product Name andModel | INSPIRA™ ART100 | Capiox iCPCentrifugal Pump withXcoating™(Compatible Device) | Comparison/Notes |
|---|---|---|---|
| Manufacturer | Inspira Technologies OxyB.H.N. Ltd. | Terumo CardiovascularSystems Corporation | N/A |
| FDA 510(k)number | K232788 | K200091 | N/A |
| Indications for Use | The INSPIRA™ ART100Systemis intended for use in anextracorporeal perfusioncircuit to pump blood duringshort durationcardiopulmonary bypassprocedures lasting six hoursor less. | The Capiox iCPCentrifugal Pump withXcoating™ is a sterile,single use device, usedas an extracorporealblood pump for use incardiopulmonary bypassprocedures for up to 6hours. | N/A |
| FDAClassificationCodes | Class II, CFR 870.4380,DWA,Cardiopulmonarybypass pump speedcontrol | Class II, CFR 870.4360,KFM Pump, Blood,CardiopulmonaryBypass, Non-Roller Type | N/A |
| Duration of Use | Up to 6 hours | Up to 6 hours | Same asCompatibleDevice |
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| Product Name andModel | INSPIRA™ ART100 | Capiox iCPCentrifugal Pump withXcoating™(Compatible Device) | Comparison/Notes |
|---|---|---|---|
| Centrifugal PumpDriver | Non-contact, magneticallycoupled | Non-contact,magnetically coupled | Same asCompatibleDevice |
| Pump Speed (RPM) | 0 - 3600 | 0 - 3600 | Same asCompatibleDevice |
| Blood Flow Rate(L/min) | Dependent on external circuit,up to 0-8 L/min | up to 0-8 L/min | Same asCompatibleDevice |
The technological characteristics of the INSPIRA™ ART100 system are substantially the same as predicate device and where there are minor differences they do not raise different questions of safety and effectiveness.
The geometry and design parameters are consistent with the device's intended use as an electromechanical pump driver and controller in cardiopulmonary bypass procedures.
- A. Pump Drive Module is based on a brushless DC motor, motor control electronics, and a contactless magnetic coupler driving a detachable one-time use centrifuqal pump.
- B. Manual Pump Drive is based on a transmission gear, connected from the "low gear side" to a crank handle, and from the "fast gear side" to a contactless magnetic coupler driving a detachable one-time use centrifygal pump.
- C. Display & Control Module is based on a touch screen, a rotary knob, control electronics, isolated electronic signal interface for external sensors (accessories), and a medical grade AC-to-DC power supply.
- D. Blood Flow Bubble Sensor Module is clamp-on non-contact ultrasonic flow meter, compatible with commonly used plastic blood tubes of specified diameters and material.
- E. Two Backup Battery Modules are based on lithium ion that can provide at least 2 to 5 hours (load dependent) of backup power in case of brief power outage of the AC power line, or for supporting transport within a hospital.
- F. The INSPIRA™ ART100 system may be used with the following previously 510(k) cleared devices, supplied by hospital users:
- Blood pressure sensors, supplied sterile, Biometrix Ltd., Art-Line™ . Disposable Pressure Transducer Set, as listed in the Instructions for Use.
9.1 Biocompatibility
Not applicable. The INSPIRA™ ART100 system does not contain any blood contacting or patient contacting devices. The INSPIRA™ ART100 is labeled for use with the Terumo Capiox iCP Centrifugal Pump with Xcoating™, previously cleared by the FDA in K200091.
9.2 Sterility and Shelf-Life
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Not applicable. The INSPIRA™ ART100 system and accessories are provided nonsterile and have been tested with sterile, one-time use accessories/compatible devices specified in the Instructions for Use.
9.3 Non-Clinical Tests
The INSPIRA™ ART100 system performance characteristics were demonstrated through system bench testing, mechanical testing, electrical safety and electromagnetic interference and compatibility testing, software testing, reliability, and usability testing.
The following performance tests were conducted on the INSPIRA™ ART100 system to support the determination of substantial equivalence:
- Software verification and validation testing ●
- Functional design verification and validation testing ●
- . Electrical safety, electromagnetic interference and compatibility (EMI/EMC) testing
- Interoperability evaluation with specified accessories/compatible devices
- Reliability testing
- Simulated use testing ●
- Cleaning validation ●
- Packaging and shipping testing
All testing met predetermined acceptance criteria.
The INSPIRA™ ART100 system was also tested and certified by accredited third party laboratories to meet the following consensus standards:
- . IEC 60601-1:2020 (ed. 3.2) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:202020 (ed. 4.1) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- . IEC 60601-1-8:2020 (ed. 2.2) Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- IEC 62366-1:2020 (ed. 1.1) Medical devices Part 1: Application of usability . engineering to medical devices.
- IEC 60601-1-6: 2020 (ed. 3.2) Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
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- . ISO 14971:2019 (ed 3.0) Medical devices - Application of risk management to medical devices
- . IEC 62304:2006/AMD 1: 2015 (ed. 1.1) Medical device software - Software life cycle processes.
- IEC / UL 62133-2:2020 Ed.1 / CSA C22.2 Secondary cells and batteries . containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
- . UN38.3, Seventh Edition United Nations Manual of Tests and Standards for the Transport of Dangerous Goods - Section 38.3 of Part 3 - Certification of Lithium Metal and Lithium-lon Batteries.
- . ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing.
- . ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems, Assurance Level I, According to DC 2.
- ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
9.4 Animal Tests - Not Applicable
9.5 Clinical Tests - Not Applicable
9.6 Human Factors Testing
The INSPIRA™ ART100 System has completed a human factors validation study, in accordance with IEC 62366-1, ISO 14971 and FDA's latest guidance 'Applying Human Factors and Usability Engineering to Medical Devices.' All residual use-error risks were evaluated and minimized, and benefit/risk considerations were taken, to support the conclusion that no further changes to the user interface are necessary for safe device use and that the overall residual risk is acceptable. Inspira has concluded that the INSPIRA™ ART100 System is as safe and effective for the intended users, uses, and use environments as the predicate.
9.7 Labeling
The labeling includes instructions on circuit setup, explanation of the hardware and software user interface, visual and auditory alarms, maintenance during a procedure, precautions and warnings, troubleshooting guide, and performance characteristics relevant to compatibility among different devices and accessories in the circuit.
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10. Conclusion
Based on the above comparisons of intended use, intended users, use environment, indications for use, operating principles, technological characteristics, performance test data, and compliance with the listed consensus standards, the INSPIRA™ ART100 is substantially equivalent to, and as safe and effective as the predicate device, the RotaFlow Centrifugal Pump System device previously cleared under K991864.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).