(107 days)
No
The description focuses on the physical function of a heat exchanger for blood temperature management during CPB and does not mention any AI or ML components.
Yes
The device is described as managing the temperature of blood during cardiopulmonary bypass procedures to maintain patient thermoregulation and rewarm blood, which are therapeutic actions.
No
Explanation: The device is a heat exchanger intended to heat/cool blood during cardiopulmonary bypass procedures, managing blood temperature and thermoregulation. Its function is therapeutic and supportive, not diagnostic (i.e., it does not identify or characterize a disease or condition).
No
The device description clearly states it is a "Heat Exchanger" and describes its physical function of managing blood temperature using a heater/cooler system and heat transfer fluid. This indicates a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to heat/cool blood during a cardiopulmonary bypass procedure. This is a therapeutic intervention performed on the patient's body, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description focuses on managing the temperature of circulating blood during surgery. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information. The device's function is purely related to temperature control of blood within the patient's circulatory system during surgery.
Therefore, the Quantum PureFlow Standard Heat Exchanger is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedure up to 6 hours in duration. Devices are intended for adult patients.
Product codes (comma separated list FDA assigned to the subject device)
DTR
Device Description
The subject of the present Special 510(k) is the Quantum PureFlow Standard Heat Exchanger product family for inclusion of three additional variants with respect to the currently cleared (K220110) portfolio.
Quantum PureFlow Standard Heat Exchanger devices are designed to manage the temperature of blood during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.
HX-S devices are designed to:
- keep circulating blood at a specific temperature, depending on the type of surgery being performed;
- maintain blood/patient thermoregulation during the CPB;
- . rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition.
Quantum PureFlow Standard Heat Exchangers have been designed to be powered by heatercooler systems that use
- . Water
or - Glycol-based solution
as Heat Transfer Fluid (HTF).
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
Adult patients.
Intended User / Care Setting
Not Found
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)
NON-CLINICAL TESTING
The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact:
- । update of labeling and Instructions for Use (IFU) according to ISO 15223-1:2021 Medical Devices - Symbols to Be Used with Medical Device Labels, Labelling, And Information to Be Supplied - Part 1: General Requirements [Recognition Nr. 5-134];
- -Performance tests for new REF codes introduced in the portfolio, according to ISO 7199:2016 [Recognition Nr. 3-150].
Animal Study
No animal studies have been performed to support changes object of the present Special 510(k).
CLINICAL TESTING
No clinical data on Quantum PureFlow Standard Heat Exchanger have been included in the current 510(k) submission.
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.
Not Found
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
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).
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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 acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 13, 2023 Quara S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo, 23 Mirandola, Modena 41037 Italy
Re: K223879
Trade/Device Name: Quantum PureFlow Standard Heat Exchanger (HX11W-S2, HX11W-S1M and HX11W-S2M) Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary bypass heat exchanger Regulatory Class: Class II Product Code: DTR Dated: March 15, 2023 Received: March 15, 2023
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Kathleen M. Grunder -S for 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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Indications for Use
510(k) Number (if known) K223879
Device Name
Quantum PureFlow Standard Heat Exchanger (HX11W-S2, HX11W-S1M and HX11W-S2M)
Indications for Use (Describe)
The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedure up to 6 hours in duration. Devices are intended for adult patients.
| 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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Image /page/3/Picture/0 description: The image is a logo for QURA advanced medical solutions. The logo features a stylized human figure with arms outstretched, enclosed within a curved line. To the right of the figure is the word "QURA" in a bold, sans-serif font. Below "QURA" are the words "advanced medical solutions" in a smaller, lighter font.
510(K) SUMMARY
SUBMITTER l.
| Submitter Name: | Qura S.r.l. |
|---|---|
| Submitter Address: | Via di Mezzo, 23 41037 Mirandola (MO) Italy |
| Contact Person: | Raffaella Tommasini, QA&RA Director – Qura s.r.l. |
| Phone: | +39 0535 1803050 |
| e-mail: | raffaella.tommasini@quramed.com |
| Fax: | +39 0535 1803051 |
| Date Summary Prepared: | 23 December, 2022 |
DEVICE II.
| Proprietary Name: | Quantum PureFlow Standard Heat Exchangers (including HX11W-S2, HX11W-S1M and HX11W-S2M, object of present submission) |
|---|---|
| Common Name: | Standard Heat Exchanger |
| Classification Name: | Cardiopulmonary bypass heat exchanger |
| Regulatory Class: | II |
| Product Code: | DTR |
| Panel: | Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
III. PREDICATE DEVICE
| Proprietary Name: | Quantum PureFlow Standard Heat Exchangers |
|---|---|
| Common Name: | Standard Heat Exchanger |
| Classification Name: | Cardiopulmonary bypass heat exchanger |
| Regulatory Class: | II |
| Product Code: | DTR |
| Panel: | Cardiovascular Devices, Office of Health Technology 2 (OHT2) / |
| Division of Health Technology 2 B (Circulatory Support, | |
| Structural and Vascular Devices) | |
| 510(k) Number: | K220110 |
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Image /page/4/Picture/1 description: The image is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure inside of an oval shape on the left side of the image. To the right of the figure is the word "QURA" in a bold, sans-serif font. Below the word "QURA" is the phrase "advanced medical solutions" in a smaller, sans-serif font.
IV. DEVICE DESCRIPTION
The subject of the present Special 510(k) is the Quantum PureFlow Standard Heat Exchanger product family for inclusion of three additional variants with respect to the currently cleared (K220110) portfolio.
Quantum PureFlow Standard Heat Exchanger devices are designed to manage the temperature of blood during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.
HX-S devices are designed to:
- keep circulating blood at a specific temperature, depending on the type of surgery being performed;
- maintain blood/patient thermoregulation during the CPB;
- . rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition.
Quantum PureFlow Standard Heat Exchangers have been designed to be powered by heatercooler systems that use
-
. Water
or -
Glycol-based solution
as Heat Transfer Fluid (HTF).
V. INTENDED USE / INDICATIONS FOR USE
The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Devices are intended for adult patients.
No changes have been made to the devices' intended use with respect to the original K220110 submission.
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Image /page/5/Picture/1 description: The image is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a partial circular shape. The text "QURA" is written in a bold, sans-serif font, with the words "advanced medical solutions" appearing in a smaller font size beneath it. The color scheme is primarily blue.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Additional device models have been introduced in the HX-S product family in order to provide to clinicians/users an additional option to perform cardiopulmonary bypass procedures.
New REF codes introduced in the portfolio for Quantum PureFlow Standard Heat Exchanger product family are aligned with information provided in original submission K220110 in terms of general structure (including packaging), principle of operation, intended use, manufacturing and sterilization processes.
Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices.
Applicable testing activities demonstrated that the proposed device model does not raise any new issues of safety and effectiveness as compared to the currently cleared predicate and reference products.
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact:
- । update of labeling and Instructions for Use (IFU) according to ISO 15223-1:2021 Medical Devices - Symbols to Be Used with Medical Device Labels, Labelling, And Information to Be Supplied - Part 1: General Requirements [Recognition Nr. 5-134];
- -Performance tests for new REF codes introduced in the portfolio, according to ISO 7199:2016 [Recognition Nr. 3-150].
Animal Study
No animal studies have been performed to support changes object of the present Special 510(k).
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Image /page/6/Picture/0 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with multiple arms and legs, enclosed within a partial oval shape. To the right of the figure, the word "QURA" is written in a bold, sans-serif font, with the words "advanced medical solutions" written in a smaller font underneath.
CLINICAL TESTING
No clinical data on Quantum PureFlow Standard Heat Exchanger have been included in the current 510(k) submission.
VIII. CONCLUSIONS
Considering all changes performed on original devices cleared by K220110, it could be stated that devices under evaluation are identical in terms of intended use and applicable medical technique.
Based on the testing activities, technological characteristics and the indications for use, the proposed devices have been demonstrated to be appropriate for their intended use and are considered substantially equivalent to Qura's own original devices.