(256 days)
No
The summary describes a mechanical blood pump system with sensors and controllers, with no mention of AI or ML capabilities.
Yes.
The device pumps blood in an extracorporeal perfusion circuit during cardiopulmonary bypass, which directly aids in maintaining physiological function during medical procedures, thereby providing therapeutic benefit.
No
The device is a blood pump used in extracorporeal perfusion circuits for cardiopulmonary bypass procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (Controller Unit, Pump Drive Unit, Sensors, Cables, Holders) and describes a physical system for pumping blood, indicating it is not software-only.
Based on the provided information, the INSPIRA™ ART100 system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "pump blood during short duration cardiopulmonary bypass procedures." This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details a system for pumping blood in an extracorporeal circuit, including components like pump drives, sensors, and holders. These are all related to the physical process of circulating blood outside the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVD devices are specifically designed for testing samples to diagnose, monitor, or screen for diseases or conditions.
In summary, the INSPIRA™ ART100 system is a medical device used for a therapeutic procedure (cardiopulmonary bypass), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DWA
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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.
Intended User / Care Setting
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.
The INSPIRA™ ART100 system is intended to be used in an operating room, and placed outside a sterile field.
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)
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 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.
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.
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
§ 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).
0
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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).
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 (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
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)
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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.
2 Ha-Tidhar St.,
Ra'anana, 4366504, Israel | |
|-------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Dganit Litinsky, VP RA
Tel. 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. §870.4380
Class: II, Cardiopulmonary bypass pump
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:
-
- 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
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
and Model | INSPIRA™ ART100 | Rotaflow®
Centrifugal Pump
System (Predicate) | Anivia SG1000
Pump Console
(Reference) | Comparison/
Notes |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inspira Technologies
Oxy B.H.N. Ltd. | Getinge Maquet
Cardiopulmonary
AG, Germany | APMTD Inc. USA | N/A |
| FDA 510(k)
number | K232788 | K991864 | K221491
K230698 | N/A |
| 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. | The RotaFlow
Centrifugal
Pump 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 Anivia
SG1000
Pump Console is
intended to pump
blood through the
extracorporeal
bypass
circuit for
extracorporeal
support for
periods
appropriate to
cardiopulmonary
bypass
(up to 6 hours). | Same as
predicate |
| FDA
Classification
Codes | Class II, CFR
870.4380,
DWA,
Cardiopulmonary
bypass pump speed
control | Class II, CFR
870.4360, KFM
Pump, Blood,
Cardiopulmonary
Bypass, Non-Roller
Type | Class II, CFR
870.4380,
DWA,
Cardiopulmonary
bypass pump
speed
control | Same as
reference |
| Duration of Use | Up to 6 hours | Up to 6 hours | Up to 6 hours
(limited by
disposables, not
limited by
Console electro-
mechanical
modules) | Same as
predicate. |
| Intended Use | Pump Speed Control,
CPB Machine Console
(not including sterile,
blood-contacting
accessories) | Pump Speed
Control, CPB
Machine Console
(bundled with sterile,
blood-contacting
accessories, outside
the scope of this
application) | Pump Speed
Control, CPB
Machine Console
(not including
sterile, blood-
contacting
accessories) | Same as
reference. |
| Intended Users | Cardiopulmonary
physicians,
perfusionists, trained
physician assistants | Cardiopulmonary
physicians,
perfusionists, trained
physician assistants | Cardiopulmonary
physicians,
perfusionists,
trained physician
assistants | Same as
predicate. |
| Intended Patients | As prescribed by
cardiopulmonary
specialists | As prescribed by
cardiopulmonary
specialists | As prescribed by
cardiopulmonary
specialists | Same as
predicate. |
| Product Name
and Model | INSPIRA™ ART100 | Rotaflow®
Centrifugal Pump
System (Predicate) | Anivia SG1000
Pump Console
(Reference) | Comparison/
Notes |
| Identification of
Disposable
Centrifugal Pump
Heads
Compatible with
System Console | Terumo
Cardiovascular
System Corporation,
Capiox iCP
Centrifugal Pump | RotaFlow® RF-32
centrifugal pump
heads | Medtronic BPX-
80, BP-50
centrifugal pump
heads (w/ Pump
Driver Module
SG1000-PDM-
001)
RotaFlow® RF-
32 centrifugal
pump heads (w/
Pump Driver
Module SG1000-
PDM-002)
Medtronic Affinity
CPAP40,
BBAP40,
centrifugal pump
heads (w/ Pump
Driver Module
SG1000-PDM-
003)
LivaNova
Revolution®
Catalogue No.
050300700,
050300000
centrifugal pump
heads (w/ Pump
Driver Module
SG1000-PDM-
004) | Same as
predicate and
reference.
INSPIRA
ART100 is
following
Anivia
SG1000
precedent for
clearing
console with
pump head
from different
manufacturer |
| Centrifugal Pump
Driver | Non-contact,
magnetically coupled | Non-contact,
magnetically
coupled | Non-contact,
magnetically
coupled | Same as
predicate. |
| Regulation
Control Functions | • Speed Regulation
Mechanical Knob and
Touch Display | • Speed Regulation
• Flow Regulation
(Stability)
Mechanical Knob | • Speed
Regulation
• Flow Regulation
(Stability)
Mechanical Knob
and Touch
Display | No Flow
Regulation –
Difference has
no impact on
safety or
effectiveness. |
| Components | • Controller
• Pump Drive
• Emergency Manual
Pump Drive. | • Rotaflow Console
• Pump Drive.
• Emergency
Manual Pump Drive | • Touch screen
control and
display panel | Same as
predicate. |
| Product Name
and Model | INSPIRA™ ART100 | Rotaflow®
Centrifugal Pump
System (Predicate) | Anivia SG1000
Pump Console
(Reference) | Comparison/
Notes |
| | • Flow and Bubble
Sensor
• Integrated two
Backup Batteries
• Adjustable Support
Holders | • Integrated flow and
bubble sensors in
the drive unit
• Integrated battery
backup
• Adjustable Support
Arm. | • Pump Driver
Module
• Emergency
Handcrank
• Flow Bubble
Sensor
• Backup Battery
Module
• Mobile cart with
adjustable
Support Arm
(optional
accessory)
• Backup Pump
Driver Module | |
| Pump Speed
(RPM) | 0 - 3600 | 0-5000 | 0 - 4500
0 - 5000
0 - 4000
0 - 3500 | Centrifugal
Pump
Dependent.
Difference has
no impact on
safety or
effectiveness. |
| Visual and
Auditory Alarms
on Abnormal
Conditions | Yes, preset limits:
Speed Rate, Back
Flow, Bubble,
Pressure,
Temperature. | Yes, preset limits | Yes, preset limits:
Speed, Flow
Rate, Back Flow,
Bubble,
Pressure,
Temperature | Same as
predicate. |
| Blood Flow Rate
(L/min) | Dependent on
external circuit, up to
0-8 L/min | Dependent on
external circuit, up to
0-9.9 L/min | Dependent on
external circuit,
up to 0 - 9.9
L/min | Centrifugal
Pump
Dependent.
Difference has
no impact on
safety or
effectiveness. |
| Interface to Blood
Flow Sensor | Yes (Qty 1) | Yes (Qty 1) | Yes (Qty 1) | Same as
predicate. |
| Air Bubble
Detector | Yes (Qty 1),
integrated with Blood
Flow Sensor. | Yes (Qty 1) | Yes (Qty 1),
integrated with
Blood Flow
Sensor. | Same as
reference. |
| Blood Flow and
Bubble Detector
Sensor
Technology | Non-contact,
ultrasound Clamp-On
around blood tube. | Non-contact,
ultrasound Clamp-On.
around blood
tube | Non-contact,
ultrasound
Clamp-On
around blood
tube | Same as
predicate. |
| Product Name
and Model | INSPIRA™ ART100 | Rotaflow®
Centrifugal Pump
System (Predicate) | Anivia SG1000
Pump Console
(Reference) | Comparison/
Notes |
| Pressure
Sensors | Yes (Qty 3, external),
previously 510(k)
cleared accessories
manufactured by third
parties. | N/A | Yes (Qty 2,
external),
previously 510(k)
cleared
accessories
manufactured by
third parties | Difference has
no impact on
safety or
effectiveness. |
| Temperature
Sensors | Yes (Qty 1, external) | N/A | Yes (Qty 2,
external),
previously 510(k)
cleared
accessories
manufactured by
third parties. | Difference has
no impact on
safety or
effectiveness |
| Power Input | 100-240 VAC
50 — 60 Hz
4.0A - 1.8A
410 W | Factory Set
100/115/230/240 V
AC 2A / 1A | Universal 90-264
VAC/50 — 60 Hz
2.5A / 1.3A up to
250 W | Difference has
no impact on
safety or
effectiveness. |
| Backup Battery | Li lon | NiCad | LiFePO4 | Difference has
no impact on
safety or
effectiveness. |
| Backup Battery
Capacity | 28.8 V 9.8 Ah, 282
WH,
2 hours, at 3600
RPM, 8 L/min
4 hours, at 2900
RPM, 8 L/min | 24 VDC, 5 AH, 120
WH
1.5 hours, at 5 L/min | 25.6 VDC, 12
AH, 307 WH,
minimum 1 hour,
up to 3 hours
depending on
speed and flow | Difference has
no impact on
safety or
effectiveness. |
| Backup Pump | Yes, hand-crank | Yes, hand-crank | Yes, backup
electrical Pump
Driver Module on
standby, and
hand-crank | Same as
predicate. |
| Pump Motor
Technology | Brushless DC motor | Brushless DC motor | Brushless DC
motor | Same as
predicate. |
| Display Screen | 13.3" FHD Color
TFT-LCD | None | 31 cm (12.1") | Difference has
no impact on
safety or
effectiveness. |
| Dimensions,
Display & Control
Module | 33.00 cm W x 23.4
cm H x 44.8 cm D | 18 x 39 x 24 cm | 14 cm W x 15 cm
H x 9 cm D | Difference has
no impact on
safety or
effectiveness. |
| Weight, Display &
Control | 12 kg - including
backup battery | 14.4 kg including
backup battery | 3.3 kg - Display
& Control Module | Difference has
no impact on |
| Product Name
and Model | INSPIRA™ ART100 | Rotaflow®
Centrifugal Pump
System (Predicate) | Anivia SG1000
Pump Console
(Reference) | Comparison/
Notes |
| | Difference has no
impact on safety and
effectiveness. | | 4 kg - Backup
Battery Module | safety or
effectiveness. |
| Automatic Pump
Stop intervention | Yes, at bubbles
detection.
Indicated on screen
via an Alarm and
icon. | Yes, at bubbles
detection (In Speed
Regulation
operation)
Indicated via LED. | N/A | Same as
predicate. |
| Operation
Temperature
Relative Humidity
Pressure | 10-35°C
15-90%
70-106kPa | 10-40°C
15-95%
66-106kPa | N/A | Difference has
no impact on
safety or
effectiveness. |
| Storage
Temperature
Relative Humidity
Pressure | (-20)-55°C
10-90%
50-106kPa | (-18)-45°C
10-96%
66-106kPa | N/A | Difference has
no impact on
safety or
effectiveness. |
6
7
8
9
Centrifugal Pump Specifications (Compatible Device)
| Product Name and
Model | INSPIRA™ ART100 | Capiox iCP
Centrifugal Pump with
Xcoating™
(Compatible Device) | Comparison/
Notes |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Manufacturer | Inspira Technologies Oxy
B.H.N. Ltd. | Terumo Cardiovascular
Systems Corporation | N/A |
| FDA 510(k)
number | K232788 | K200091 | N/A |
| 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. | The Capiox iCP
Centrifugal Pump with
Xcoating™ is a sterile,
single use device, used
as an extracorporeal
blood pump for use in
cardiopulmonary bypass
procedures for up to 6
hours. | N/A |
| FDA
Classification
Codes | Class II, CFR 870.4380,
DWA,
Cardiopulmonary
bypass pump speed
control | Class II, CFR 870.4360,
KFM Pump, Blood,
Cardiopulmonary
Bypass, Non-Roller Type | N/A |
| Duration of Use | Up to 6 hours | Up to 6 hours | Same as
Compatible
Device |
10
| Product Name and
Model | INSPIRA™ ART100 | Capiox iCP
Centrifugal Pump with
Xcoating™
(Compatible Device) | Comparison/
Notes |
|----------------------------|---------------------------------------------------|-------------------------------------------------------------------------|---------------------------------|
| Centrifugal Pump
Driver | Non-contact, magnetically
coupled | Non-contact,
magnetically coupled | Same as
Compatible
Device |
| Pump Speed (RPM) | 0 - 3600 | 0 - 3600 | Same as
Compatible
Device |
| Blood Flow Rate
(L/min) | Dependent on external circuit,
up to 0-8 L/min | up to 0-8 L/min | Same as
Compatible
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
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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.