(435 days)
No
The summary describes a mechanical blood oxygenator with integrated pressure and temperature sensors. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device oxygenates blood and removes carbon dioxide, which directly treats a physiological condition during cardiac surgery.
No
The primary function of the device is to oxygenate and remove carbon dioxide from venous blood during cardiac surgery (a therapeutic function), and it also measures blood pressure and temperature during the procedure (monitoring, not diagnostic).
No
The device description clearly details a physical, hardware-based blood oxygenator with components like hollow fibers, connectors, and a biocompatible coating. It also mentions measuring blood pressure and temperature, which implies hardware sensors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure." This describes a device that directly interacts with blood outside the body for therapeutic and monitoring purposes during a surgical procedure.
- Device Description: The description details how the device functions as a blood oxygenator, facilitating gas exchange between blood and sweep gas. It describes the physical components and how blood flows through the device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is a life-support and monitoring device used during surgery.
- Performance Studies: The performance studies focus on the device's ability to perform its intended function (gas transfer, pressure/temperature measurement, mechanical integrity, etc.), not on the accuracy of a diagnostic test.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
VT75-E1
Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.
Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².
VT75-E2
Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use.
Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.
Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethylpentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.
All the device surfaces in contact with blood are treated with a phosphorylcholinebased biocompatible coating.
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
Paediatric (0.6 m²
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
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September 12, 2024
Qura S.r.1. % Raffaella Tommasini QA&RA Director Spectrum Medical s.r.l. Via di Mezzo, 23 Mirandola, Modena 41037 Italy
Re: K231982
Trade/Device Name: Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ Dated: August 7, 2024 Received: August 7, 2024
Dear Raffaella Tommasini:
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 (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/cdrb/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.
1
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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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
Enclosure
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510(K) SUMMARY
| I. | SUBMITTER |
|---|---|
| Submitter Name: | Spectrum Medical S.r.l. |
| Submitter Address: | Via di Mezzo, 23 41037 Mirandola (MO) Italy |
| Contact Person: | Raffaella Tommasini, QA&RA Director – Spectrum Medical S.r.l. |
| Phone: | +39 0535 1803050 |
| e-mail: | raffaella.tommasini@spectrummedical.com |
| Fax: | +39 0535 1803051 |
| Date Summary Prepared: | December 22th, 2023 |
ll. DEVICE
| Proprietary Name: | Quantum Perfusion Blood Oxygenator VT75-E1 |
|---|---|
| Quantum Perfusion Blood Oxygenator VT75-E2 | |
| Common Name: | Oxygenator |
| Classification Name: | Oxygenator, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DTZ |
| Panel: | Cardiovascular Devices, Office of Health Technology 2 |
| (OHT2) / Division of Health Technology 2 B (Circulatory | |
| Support, Structural and Vascular Devices) |
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III. PREDICATE AND REFERENCE DEVICES
| Predicate Device: | |
|---|---|
| Proprietary Name: | Medos Hilite Pediatric Oxygenator 2400 LT |
| Registered Establishment Name: | GISH BIOMEDICAL INC |
| Regulation Number: | 870.4350 |
| Common Name: | Oxygenator |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510(k) Number: | K090450 |
Reference Device:
| Proprietary Name: | Quantum Perfusion Blood Oxygenators ECC |
|---|---|
| Registered Establishment Name: | Spectrum Medical S.r.l. |
| Regulation Number: | 870.4350 |
| Common Name: | Oxygenator |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510(k) Number: | K203424 |
IV. DEVICE DESCRIPTION
The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.
Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethylpentene (PMP). In this chamber, carbon dioxide moves from the blood to
6
Image /page/6/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum Medical" is written in blue font. A red line in the shape of an EKG reading is placed between the two words.
the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a
single box.
All the device surfaces in contact with blood are treated with a phosphorylcholinebased biocompatible coating.
INTENDED USE / INDICATIONS FOR USE V.
VT75-E1
Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.
Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².
VT75-E2
Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use.
Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².
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Image /page/7/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is in blue, followed by a red heartbeat symbol. The word "Medical" is in blue and follows the heartbeat symbol.
www.spectrummedical.com
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES VI.
| Device | Proposed Device - Quantum Perfusion Blood
Oxygenator
Spectrum Medical S.r.l. | Predicate Device - Medos Hilite Pediatric
Oxygenator 2400 LT
GISH BIOMEDICAL INC | Reference Device -
Quantum Perfusion
Blood Oxygenator ECC
Spectrum Medical
S.r.l. | Device | Proposed Device - Quantum Perfusion Blood
Oxygenator
Spectrum Medical S.r.l. | Predicate Device - Medos Hilite Pediatric
Oxygenator 2400 LT
GISH BIOMEDICAL INC | Reference Device -
Quantum Perfusion
Blood Oxygenator ECC
Spectrum Medical
S.r.l. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Quantum Perfusion Blood Oxygenator VT75-E1
Quantum Perfusion Blood Oxygenator VT75-E2 | Medos Hilite Pediatric Oxygenator 2400
LT | Quantum Perfusion
Blood Oxygenator ECC
VT160-E1
Quantum Perfusion
Blood Oxygenator ECC
VT160-E2
Quantum Perfusion
Blood Oxygenator ECC
VT200-E1
Quantum Perfusion
Blood Oxygenator ECC
VT200-E2 | | | | contact with blood are
treated with a
phosphorylcholine-
based biocompatible
coating. |
| 510(k) Number | K231982 | K090450 | K203424 | Regulation # | 870.4350 | 870.4350 | 870.4350 |
| Device
description | The Quantum Perfusion Blood Oxygenator
(acronym VT-E) diffusion membrane device is
designed to oxygenate blood and remove
carbon dioxide from venous blood during
cardiac surgical procedures requiring
cardiopulmonary bypass for a maximum
duration of 6 hours. | The MEDOS HILITE 2400 LT Hollow Fiber
Oxygenators consist of a hollow fiber
membrane oxygenator and
extracorporeal heat exchanger. The
MEDOS HILITE 2400 LT hollow fibre
membrane consists of a
Polymethylpentene gas plasma tight mat.
The unique mat design increases the
interaction between blood and gas. | The
Quantum
Perfusion
Blood
Oxygenator ECC
(acronym VT-E)
diffusion membrane
device is designed to
oxygenate blood and
remove carbon dioxide | Regulation Name | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary
Bypass Oxygenator |
| Device | Proposed Device - Quantum Perfusion Blood
Oxygenator
Spectrum Medical S.r.l. | Predicate Device – Medos Hilite Pediatric
Oxygenator 2400 LT
GISH BIOMEDICAL INC | Reference Device -
Quantum Perfusion
Blood Oxygenator ECC
Spectrum Medical
S.r.l. | Product Code | DTZ | DTZ | DTZ |
| | Blood enters the oxygenator through the blood
inlet connector, flows through a blood
chamber, touching the outer surface of hollow
fibres membrane; while the sweep gas flows
into the hollow fibre membrane. The hollow
fibres are made of Polymethylpentene (PMP).
In this chamber, carbon dioxide moves from the
blood to the gas compartment, while oxygen
enters into the red blood cells. Then, blood
exits the oxygenator with the desired level of
oxygen content and saturation, and carbon
dioxide content. Sweep gas composition and
flow rate are used to control saturation, and
oxygen and carbon dioxide content of blood at
the outlet of the oxygenator. The device is non-
toxic, non-pyrogenic, sterilized by ethylene
oxide and packaged in a single box. All the
device surfaces in contact with blood are
treated with a phosphorylcholine-based
biocompatible coating. | creating a highly efficient blood
oxygenator. The heat exchanger consists
of a polyester non-porous hollow fiber
configured heat exchanger as the primary
element to affect heat exchange. This
element is encased by a polycarbonate
housing, which directs the blood around
the outside of the fibres while water flow
through the inner lumen of the fibres and
therefore effects heat exchange while
minimizing priming volume. | from venous blood
during cardiac surgical
procedures requiring
cardiopulmonary
bypass for a maximum
duration of 6 hours.
Blood enters the
oxygenator through
the blood inlet
connector, flows
through a blood
chamber, touching the
outer surface of hollow
fibres membrane;
while the sweep gas
flows into the hollow
fibre membrane. The
hollow fibres are made
of Polymethylpentene
(PMP). In this chamber,
carbon dioxide moves from the blood to the | Classification | II | II | II |
| Device | Proposed Device - Quantum Perfusion Blood Oxygenator
Spectrum Medical S.r.l. | Predicate Device – Medos Hilite Pediatric
Oxygenator 2400 LT
GISH BIOMEDICAL INC | Reference Device -
Quantum Perfusion Blood Oxygenator ECC
Spectrum Medical S.r.l. | Indication for
Use | VT75-E1
Quantum Perfusion Blood Oxygenator VT75-E1
is a diffusion membrane oxygenator, designed
to oxygenate and remove carbon dioxide from
venous blood during cardiac surgery requiring
cardiopulmonary bypass and to measure blood
pressure and temperature during the
procedure. The device is limited to 6 hours to
use.
VT75-E2
Quantum Perfusion Blood Oxygenator VT75-E2
is a diffusion membrane oxygenator, designed
to oxygenate and remove carbon dioxide from | The hilite 2400 LT is a hollow fibre
membrane oxygenator is indicated for use
in procedures requiring the
extracorporeal oxygenation of and carbon
dioxide removal from human blood. The
2400 LT is a paediatric oxygenators
intended for use at blood flow rates of 0.5
to 2.4 litres per minute for periods of up to
six hours. | VT200-E1 and VT160-
E1
Quantum Perfusion
Blood Oxygenator ECC
(VT-E1) is a diffusion
membrane
oxygenator, designed
to oxygenate and
remove carbon dioxide
from venous blood
during cardiac surgery
requiring
cardiopulmonary |
| | | | gas compartment,
while oxygen enters
into the red blood cells.
Then, blood exits the
oxygenator with the
desired level of oxygen
content and
saturation, and carbon
dioxide content.
Sweep gas composition
and flow rate are used
to control saturation,
and oxygen and carbon
dioxide content of
blood at the outlet of
the oxygenator. The
device is non-toxic,
non-pyrogenic,
sterilized by ethylene
oxide and packaged in
a single box. All the
device surfaces in | | | | |
8
www.spectrummedical.com
9
SpectrumMedical
10
SpectrumMedical
www.spectrummedical.com
11
SpectrumMedical
| Device | Proposed Device - Quantum Perfusion Blood
Oxygenator
Spectrum Medical S.r.l. | Predicate Device - Medos Hilite Pediatric
Oxygenator 2400 LT
GISH BIOMEDICAL INC | Reference Device -
Quantum Perfusion
Blood Oxygenator ECC
Spectrum Medical
S.r.l. |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | cardiopulmonary bypass and to measure blood
pressure during the procedure. The device is
limited to 6 hours of use. | | blood pressure and
temperature during
the procedure. The
device is limited to 6
hours to use.
VT200-E2 and VT160-
E2
Quantum Perfusion
Blood Oxygenator ECC
(VT-E2) is a diffusion
membrane
oxygenator, designed
to oxygenate and
remove carbon dioxide
from venous blood
during cardiac surgery
requiring
cardiopulmonary
bypass and to measure
blood pressure during
the procedure. The
device is limited to 6
hours of use. |
| Target
population | Paediatric
(0.6 m²