(265 days)
The Quantum Perfusion Arterial Cannula Graft is designed to the patient through an arterial vessel during cardiopulmonary bypass procedures for periods of maximum 6 hours. The device is equipped with an additional valved access which allows accessing arterial circulation.
The Quantum Perfusion Arterial Cannula Graft is a standalone single use device intended to be used in medical procedures requiring extracorporeal life support. It is designed to infuse blood coming from extracorporeal circuit into the patient's vascular district while being sutured to an arterial vessel.
The device also consists of a 3/8″ barbed connection with a side branch containing a hemostatic valve. Due to this valve, the Quantum Perfusion Arterial Cannula Graft can also act as an additional access for interventional catheterization. This feature allows the clinician to perform a single site access during medical procedures, avoiding multiple site access and thus reducing invasiveness.
The application duration of the Quantum Perfusion Arterial Cannula Graft is 6 hours.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch.
The provided text describes the 510(k) summary for the Quantum Perfusion Arterial Cannula Graft. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria and device performance in the context of an AI-powered diagnostic device, which your questions pertain to.
The device discussed is a physical medical device (an arterial cannula graft) for cardiopulmonary bypass procedures, not an AI/ML-driven software or diagnostic tool. Therefore, the questions regarding AI/ML performance metrics, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable to the information contained in this document.
The document states:
- No clinical data were included to support substantial equivalence.
- No animal studies were performed except for mandatory biocompatibility tests.
- In-vitro testing was performed to demonstrate substantial equivalence and compliance with user needs and safety/effectiveness requirements.
The non-clinical testing included:
- Evaluation of device performances (pressure drop, valve backflow and leakage, graft water entry pressure, suture retention strength, dynamic blood damage, kinking resistance, mechanical integrity) according to specific ISO standards.
- Evaluation of product shelf life and sterility.
- Validation of EtO Sterilization process.
- Packaging Validation tests.
- Biocompatibility testing according to ISO 10993-1:2018.
Conclusion stated in the document:
"Based on the indications for use, technological characteristics and results of non-clinical testing, the Quantum Perfusion Arterial Cannula Graft has been demonstrated to its intended use and is considered substantially equivalent to claimed predicate VASCUTEK CANNULA GRAFT, cleared by K081560."
Since your request is tailored for AI/ML device evaluations, and this document describes a physical medical device, I cannot provide answers to most of your specific questions based on the input provided.
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June 30, 2021
Qura S.r.1. Raffaella Tommasini QA & RA Director Via di Mezzo 23 Mirandola, Modena 41037 Italy
Re: K203057
Trade/Device Name: Quantum Perfusion Arterial Cannula Graft Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: June 1, 2021 Received: June 3, 2021
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
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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,
for Nicole Gillette Acting 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) K203057
Device Name Quantum Perfusion Arterial Cannula Graft
Indications for Use (Describe)
The Quantum Perfusion Arterial Cannula Graft is designed to the patient through an arterial vessel during cardiopulmonary bypass procedures for periods of maximum 6 hours. The device is equipped with an additional valved access which allows accessing arterial circulation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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/2 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a circular design. To the right of the figure, the word "QURA" is written in a bold, sans-serif font. Below "QURA", the words "advanced medical solutions" are written in a smaller, lighter font.
Traditional 510(k) Quantum Perfusion Arterial Cannula Graft 510(k) Summary
510(K) SUMMARY Section 5.0
l. SUBMITTER
| 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: | June 1, 2021 |
II. DEVICE
| Proprietary Name: | Quantum Perfusion Arterial Cannula Graft |
|---|---|
| Common Name: | Arterial Cannula Graft |
| Classification Name: | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DWF |
| Panel: | Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division ofHealth Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
PREDICATE DEVICE lll.
| Trade Name: | VASCUTEK CANNULA GRAFT |
|---|---|
| Registered Establishment Name: | VASCUTEK LTD. |
| Classification Name: | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DWF |
| Panel: | Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division ofHealth Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
| 510(k) Clearance: | K081560 |
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Image /page/4/Picture/2 description: The image contains the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a circular design. To the right of the figure, the word "QURA" is written in bold, blue letters, with the words "advanced medical solutions" written in a smaller font underneath.
Traditional 510(k) Quantum Perfusion Arterial Cannula Graft 510(k) Summary
DEVICE DESCRIPTION IV.
The Quantum Perfusion Arterial Cannula Graft is a standalone single use device intended to be used in medical procedures requiring extracorporeal life support. It is designed to infuse blood coming from extracorporeal circuit into the patient's vascular district while being sutured to an arterial vessel.
The device also consists of a 3/8″ barbed connection with a side branch containing a hemostatic valve. Due to this valve, the Quantum Perfusion Arterial Cannula Graft can also act as an additional access for interventional catheterization. This feature allows the clinician to perform a single site access during medical procedures, avoiding multiple site access and thus reducing invasiveness.
The application duration of the Quantum Perfusion Arterial Cannula Graft is 6 hours.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch.
v. INTENDED USE / INDICATIONS FOR USE
The Quantum Perfusion Arterial Cannula Graft is designed to the patient through an arterial vessel during cardiopulmonary bypass procedures for periods of maximum 6 hours. The device is equipped with an additional valved access which allows accessing arterial circulation.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Quantum Perfusion Arterial Cannula Graft has the same intended use, technological characteristics and operating principle as the predicate device (VASCUTEK CANNULA GRAFT, K081560).
In-vitro performance tests have been performed in order to support claimed substantial equivalence determining that proposed devices do not raise any new issues in terms of product's safety or effectiveness if compared to currently cleared predicate products.
Quantum Perfusion Arterial Cannula Graft can be therefore considered as substantially equivalent to predicate device, according to FDA's Guidance "Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," issued July 28, 2014.
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Image /page/5/Picture/2 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a partial circle. To the right of the figure is the word "QURA" in bold, blue letters. Below "QURA" are the words "advanced medical solutions" in a smaller, lighter font.
Traditional 510(k) Quantum Perfusion Arterial Cannula Graft 510(k) Summary
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
In-vitro testing was performed to demonstrate product substantial equivalence with the predicate device and also to comply with user needs and safety and effectiveness requirements. Testing supplied in the 510(k) Notification includes biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), verification and validation tests.
All testing passed by meeting the established requirements set for the use of Quantum Perfusion Arterial Cannula Graft. The following data were provided:
- Evaluation of devices' performances: -
- O Device pressure drop;
- o Valve backflow and leakage;
- o Graft Water Entry Pressure;
- O Suture retention strength;
- O Dynamic blood damage;
- O Kinking resistance;
- o Mechanical integrity;
and mainly performed according to ISO/DIS 18193, ISO 7198:2016 [Recognition Nr.: 3-144] and ISO 10555-1:2013 + AMD 2017 [Recognition Nr.: 6-408];
- -Evaluation of product shelf life, including product's sterility according to EP/UPS requirements;
- -Validation of the EtO Sterilization process, according to ISO 11135:2014 [Recognition Nr.: 14-452],
- Packaging Validation tests according to ISO 11607-1:2019 [Recognition Nr.: 14-530]; -
- -Biocompatibility of the finished product, according to International Standard ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Animal Study
No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
CLINICAL TESTING
No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate device.
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K203057/S001
Quantum Perfusion Arterial Cannula Graft
Image /page/6/Picture/2 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a circular shape. To the right of the figure is the word "QURA" in a bold, sans-serif font, and below that is the text "advanced medical solutions" in a smaller font.
Traditional 510(k) Quantum Perfusion Arterial Cannula Graft 510(k) Summary
CONCLUSIONS VIII.
Based on the indications for use, technological characteristics and results of non-clinical testing, the Quantum Perfusion Arterial Cannula Graft has been demonstrated to its intended use and is considered substantially equivalent to claimed predicate VASCUTEK CANNULA GRAFT, cleared by K081560.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).