INSPIRA ART100

K232788 · Inspira Technologies Oxy B.H.N. , Ltd. · DWA · May 24, 2024 · Cardiovascular

Device Facts

• Record ID: K232788
• Device Name: INSPIRA ART100
• Applicant: Inspira Technologies Oxy B.H.N. , Ltd.
• Product Code: DWA · Cardiovascular
• Decision Date: May 24, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4380
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The INSPIRA ART100 is an electromechanical pump console for cardiopulmonary bypass (CPB). It functions as a controller for a non-contact, magnetically coupled centrifugal pump (e.g., Terumo Capiox iCP). The system includes a controller unit, pump drive, manual emergency drive, and sensors for blood flow, bubbles, pressure, and temperature. It is operated by physicians and perfusionists in an operating room. The device provides speed regulation via a touch screen and rotary knob. It monitors parameters and triggers visual/auditory alarms for speed, backflow, bubbles, pressure, and temperature. In the event of bubble detection, the system can automatically stop the pump. It includes battery backup and a manual hand-crank for emergency operation. The device does not contact blood directly; it interfaces with sterile, third-party disposables. By providing precise pump control and monitoring, it assists in maintaining extracorporeal circulation, supporting the patient during cardiac procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software verification/validation, functional design verification, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), alarm system testing (IEC 60601-1-8), usability engineering (IEC 62366-1), and human factors validation.

Technological Characteristics

Electromechanical pump controller; brushless DC motor; contactless magnetic coupling; 13.3" FHD TFT-LCD touch screen; rotary knob; ultrasonic clamp-on flow/bubble sensor; Li-ion backup batteries. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62366-1, IEC 62304, and ISO 14971. Non-sterile, non-patient contacting.

Indications for Use

Indicated for patients requiring cardiopulmonary bypass during procedures lasting 6 hours or less. Contraindicated for use in transport environments (aircraft, ambulance, etc.).

Regulatory Classification

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.

Predicate Devices

• RotaFlow Centrifugal Pump System (K991864)

Reference Devices

• Anivia SG1000 Pump Console (K221491, K230698)
• Capiox iCP Centrifugal Pump with Xcoating (K200091)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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).

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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.<br>2 Ha-Tidhar St.,<br>Ra'anana, 4366504, Israel | |
|-------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Dganit Litinsky, VP RA<br>Tel. [phone]+<br>[e-mail] | |
| 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:<br>Class: | 21 C.F.R. §870.4380<br>Class: II, Cardiopulmonary bypass pump<br>speed 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:

- 1. Controller Unit
- 2. Pump Drive Unit
- 3. Manual Pump Drive Unit
- 4. Blood Flow and Bubble Detection Sensor
- 5. Temperature Sensor
- 6. Cable adapters for Pressure Sensors
- 7. Cable adapters for Temperature Sensor
- 8. Oxygenator and Pump Drive Holders

{4}------------------------------------------------

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.

{5}------------------------------------------------

| Product Name<br>and Model | INSPIRA™ ART100 | Rotaflow®<br>Centrifugal Pump<br>System (Predicate) | Anivia SG1000<br>Pump Console<br>(Reference) | Comparison/<br>Notes |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inspira Technologies<br>Oxy B.H.N. Ltd. | Getinge Maquet<br>Cardiopulmonary<br>AG, Germany | APMTD Inc. USA | N/A |
| FDA 510(k)<br>number | K232788 | K991864 | K221491<br>K230698 | N/A |
| Indications for<br>Use | The INSPIRA™<br>ART100 System<br>is intended for use in<br>an extracorporeal<br>perfusion circuit to<br>pump blood during<br>short duration<br>cardiopulmonary<br>bypass procedures<br>lasting six hours or<br>less. | The RotaFlow<br>Centrifugal<br>Pump System is<br>intended for use in<br>an extracorporeal<br>perfusion circuit to<br>pump blood during<br>short duration<br>cardiopulmonary<br>bypass procedures<br>lasting six hours or<br>less. | The Anivia<br>SG1000<br>Pump Console is<br>intended to pump<br>blood through the<br>extracorporeal<br>bypass<br>circuit for<br>extracorporeal<br>support for<br>periods<br>appropriate to<br>cardiopulmonary<br>bypass<br>(up to 6 hours). | Same as<br>predicate |
| FDA<br>Classification<br>Codes | Class II, CFR<br>870.4380,<br>DWA,<br>Cardiopulmonary<br>bypass pump speed<br>control | Class II, CFR<br>870.4360, KFM<br>Pump, Blood,<br>Cardiopulmonary<br>Bypass, Non-Roller<br>Type | Class II, CFR<br>870.4380,<br>DWA,<br>Cardiopulmonary<br>bypass pump<br>speed<br>control | Same as<br>reference |
| Duration of Use | Up to 6 hours | Up to 6 hours | Up to 6 hours<br>(limited by<br>disposables, not<br>limited by<br>Console electro-<br>mechanical<br>modules) | Same as<br>predicate. |
| Intended Use | Pump Speed Control,<br>CPB Machine Console<br>(not including sterile,<br>blood-contacting<br>accessories) | Pump Speed<br>Control, CPB<br>Machine Console<br>(bundled with sterile,<br>blood-contacting<br>accessories, outside<br>the scope of this<br>application) | Pump Speed<br>Control, CPB<br>Machine Console<br>(not including<br>sterile, blood-<br>contacting<br>accessories) | Same as<br>reference. |
| Intended Users | Cardiopulmonary<br>physicians,<br>perfusionists, trained<br>physician assistants | Cardiopulmonary<br>physicians,<br>perfusionists, trained<br>physician assistants | Cardiopulmonary<br>physicians,<br>perfusionists,<br>trained physician<br>assistants | Same as<br>predicate. |
| Intended Patients | As prescribed by<br>cardiopulmonary<br>specialists | As prescribed by<br>cardiopulmonary<br>specialists | As prescribed by<br>cardiopulmonary<br>specialists | Same as<br>predicate. |
| Product Name<br>and Model | INSPIRA™ ART100 | Rotaflow®<br>Centrifugal Pump<br>System (Predicate) | Anivia SG1000<br>Pump Console<br>(Reference) | Comparison/<br>Notes |
| Identification of<br>Disposable<br>Centrifugal Pump<br>Heads<br>Compatible with<br>System Console | Terumo<br>Cardiovascular<br>System Corporation,<br>Capiox iCP<br>Centrifugal Pump | RotaFlow® RF-32<br>centrifugal pump<br>heads | Medtronic BPX-<br>80, BP-50<br>centrifugal pump<br>heads (w/ Pump<br>Driver Module<br>SG1000-PDM-<br>001)<br>RotaFlow® RF-<br>32 centrifugal<br>pump heads (w/<br>Pump Driver<br>Module SG1000-<br>PDM-002)<br>Medtronic Affinity<br>CPAP40,<br>BBAP40,<br>centrifugal pump<br>heads (w/ Pump<br>Driver Module<br>SG1000-PDM-<br>003)<br>LivaNova<br>Revolution®<br>Catalogue No.<br>050300700,<br>050300000<br>centrifugal pump<br>heads (w/ Pump<br>Driver Module<br>SG1000-PDM-<br>004) | Same as<br>predicate and<br>reference.<br>INSPIRA<br>ART100 is<br>following<br>Anivia<br>SG1000<br>precedent for<br>clearing<br>console with<br>pump head<br>from different<br>manufacturer |
| Centrifugal Pump<br>Driver | Non-contact,<br>magnetically coupled | Non-contact,<br>magnetically<br>coupled | Non-contact,<br>magnetically<br>coupled | Same as<br>predicate. |
| Regulation<br>Control Functions | • Speed Regulation<br>Mechanical Knob and<br>Touch Display | • Speed Regulation<br>• Flow Regulation<br>(Stability)<br>Mechanical Knob | • Speed<br>Regulation<br>• Flow Regulation<br>(Stability)<br>Mechanical Knob<br>and Touch<br>Display | No Flow<br>Regulation –<br>Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Components | • Controller<br>• Pump Drive<br>• Emergency Manual<br>Pump Drive. | • Rotaflow Console<br>• Pump Drive.<br>• Emergency<br>Manual Pump Drive | • Touch screen<br>control and<br>display panel | Same as<br>predicate. |
| Product Name<br>and Model | INSPIRA™ ART100 | Rotaflow®<br>Centrifugal Pump<br>System (Predicate) | Anivia SG1000<br>Pump Console<br>(Reference) | Comparison/<br>Notes |
| | • Flow and Bubble<br>Sensor<br>• Integrated two<br>Backup Batteries<br>• Adjustable Support<br>Holders | • Integrated flow and<br>bubble sensors in<br>the drive unit<br>• Integrated battery<br>backup<br>• Adjustable Support<br>Arm. | • Pump Driver<br>Module<br>• Emergency<br>Handcrank<br>• Flow Bubble<br>Sensor<br>• Backup Battery<br>Module<br>• Mobile cart with<br>adjustable<br>Support Arm<br>(optional<br>accessory)<br>• Backup Pump<br>Driver Module | |
| Pump Speed<br>(RPM) | 0 - 3600 | 0-5000 | 0 - 4500<br>0 - 5000<br>0 - 4000<br>0 - 3500 | Centrifugal<br>Pump<br>Dependent.<br>Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Visual and<br>Auditory Alarms<br>on Abnormal<br>Conditions | Yes, preset limits:<br>Speed Rate, Back<br>Flow, Bubble,<br>Pressure,<br>Temperature. | Yes, preset limits | Yes, preset limits:<br>Speed, Flow<br>Rate, Back Flow,<br>Bubble,<br>Pressure,<br>Temperature | Same as<br>predicate. |
| Blood Flow Rate<br>(L/min) | Dependent on<br>external circuit, up to<br>0-8 L/min | Dependent on<br>external circuit, up to<br>0-9.9 L/min | Dependent on<br>external circuit,<br>up to 0 - 9.9<br>L/min | Centrifugal<br>Pump<br>Dependent.<br>Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Interface to Blood<br>Flow Sensor | Yes (Qty 1) | Yes (Qty 1) | Yes (Qty 1) | Same as<br>predicate. |
| Air Bubble<br>Detector | Yes (Qty 1),<br>integrated with Blood<br>Flow Sensor. | Yes (Qty 1) | Yes (Qty 1),<br>integrated with<br>Blood Flow<br>Sensor. | Same as<br>reference. |
| Blood Flow and<br>Bubble Detector<br>Sensor<br>Technology | Non-contact,<br>ultrasound Clamp-On<br>around blood tube. | Non-contact,<br>ultrasound Clamp-On.<br>around blood<br>tube | Non-contact,<br>ultrasound<br>Clamp-On<br>around blood<br>tube | Same as<br>predicate. |
| Product Name<br>and Model | INSPIRA™ ART100 | Rotaflow®<br>Centrifugal Pump<br>System (Predicate) | Anivia SG1000<br>Pump Console<br>(Reference) | Comparison/<br>Notes |
| Pressure<br>Sensors | Yes (Qty 3, external),<br>previously 510(k)<br>cleared accessories<br>manufactured by third<br>parties. | N/A | Yes (Qty 2,<br>external),<br>previously 510(k)<br>cleared<br>accessories<br>manufactured by<br>third parties | Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Temperature<br>Sensors | Yes (Qty 1, external) | N/A | Yes (Qty 2,<br>external),<br>previously 510(k)<br>cleared<br>accessories<br>manufactured by<br>third parties. | Difference has<br>no impact on<br>safety or<br>effectiveness |
| Power Input | 100-240 VAC<br>50 — 60 Hz<br>4.0A - 1.8A<br>410 W | Factory Set<br>100/115/230/240 V<br>AC 2A / 1A | Universal 90-264<br>VAC/50 — 60 Hz<br>2.5A / 1.3A up to<br>250 W | Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Backup Battery | Li lon | NiCad | LiFePO4 | Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Backup Battery<br>Capacity | 28.8 V 9.8 Ah, 282<br>WH,<br>2 hours, at 3600<br>RPM, 8 L/min<br>4 hours, at 2900<br>RPM, 8 L/min | 24 VDC, 5 AH, 120<br>WH<br>1.5 hours, at 5 L/min | 25.6 VDC, 12<br>AH, 307 WH,<br>minimum 1 hour,<br>up to 3 hours<br>depending on<br>speed and flow | Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Backup Pump | Yes, hand-crank | Yes, hand-crank | Yes, backup<br>electrical Pump<br>Driver Module on<br>standby, and<br>hand-crank | Same as<br>predicate. |
| Pump Motor<br>Technology | Brushless DC motor | Brushless DC motor | Brushless DC<br>motor | Same as<br>predicate. |
| Display Screen | 13.3" FHD Color<br>TFT-LCD | None | 31 cm (12.1") | Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Dimensions,<br>Display & Control<br>Module | 33.00 cm W x 23.4<br>cm H x 44.8 cm D | 18 x 39 x 24 cm | 14 cm W x 15 cm<br>H x 9 cm D | Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Weight, Display &<br>Control | 12 kg - including<br>backup battery | 14.4 kg including<br>backup battery | 3.3 kg - Display<br>& Control Module | Difference has<br>no impact on |
| Product Name<br>and Model | INSPIRA™ ART100 | Rotaflow®<br>Centrifugal Pump<br>System (Predicate) | Anivia SG1000<br>Pump Console<br>(Reference) | Comparison/<br>Notes |
| | Difference has no<br>impact on safety and<br>effectiveness. | | 4 kg - Backup<br>Battery Module | safety or<br>effectiveness. |
| Automatic Pump<br>Stop intervention | Yes, at bubbles<br>detection.<br>Indicated on screen<br>via an Alarm and<br>icon. | Yes, at bubbles<br>detection (In Speed<br>Regulation<br>operation)<br>Indicated via LED. | N/A | Same as<br>predicate. |
| Operation<br>Temperature<br>Relative Humidity<br>Pressure | 10-35°C<br>15-90%<br>70-106kPa | 10-40°C<br>15-95%<br>66-106kPa | N/A | Difference has<br>no impact on<br>safety or<br>effectiveness. |
| Storage<br>Temperature<br>Relative Humidity<br>Pressure | (-20)-55°C<br>10-90%<br>50-106kPa | (-18)-45°C<br>10-96%<br>66-106kPa | N/A | Difference has<br>no impact on<br>safety or<br>effectiveness. |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

# Centrifugal Pump Specifications (Compatible Device)

| Product Name and<br>Model | INSPIRA™ ART100 | Capiox iCP<br>Centrifugal Pump with<br>Xcoating™<br>(Compatible Device) | Comparison/<br>Notes |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Manufacturer | Inspira Technologies Oxy<br>B.H.N. Ltd. | Terumo Cardiovascular<br>Systems Corporation | N/A |
| FDA 510(k)<br>number | K232788 | K200091 | N/A |
| Indications for Use | The INSPIRA™ ART100<br>System<br>is intended for use in an<br>extracorporeal perfusion<br>circuit to pump blood during<br>short duration<br>cardiopulmonary bypass<br>procedures lasting six hours<br>or less. | The Capiox iCP<br>Centrifugal Pump with<br>Xcoating™ is a sterile,<br>single use device, used<br>as an extracorporeal<br>blood pump for use in<br>cardiopulmonary bypass<br>procedures for up to 6<br>hours. | N/A |
| FDA<br>Classification<br>Codes | Class II, CFR 870.4380,<br>DWA,<br>Cardiopulmonary<br>bypass pump speed<br>control | Class II, CFR 870.4360,<br>KFM Pump, Blood,<br>Cardiopulmonary<br>Bypass, Non-Roller Type | N/A |
| Duration of Use | Up to 6 hours | Up to 6 hours | Same as<br>Compatible<br>Device |

{10}------------------------------------------------

| Product Name and<br>Model | INSPIRA™ ART100 | Capiox iCP<br>Centrifugal Pump with<br>Xcoating™<br>(Compatible Device) | Comparison/<br>Notes |
|----------------------------|---------------------------------------------------|-------------------------------------------------------------------------|---------------------------------|
| Centrifugal Pump<br>Driver | Non-contact, magnetically<br>coupled | Non-contact,<br>magnetically coupled | Same as<br>Compatible<br>Device |
| Pump Speed (RPM) | 0 - 3600 | 0 - 3600 | Same as<br>Compatible<br>Device |
| Blood Flow Rate<br>(L/min) | Dependent on external circuit,<br>up to 0-8 L/min | up to 0-8 L/min | Same as<br>Compatible<br>Device |

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

{11}------------------------------------------------

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.

{12}------------------------------------------------

- . 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.

{13}------------------------------------------------

# 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.