Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

Device Description

All medical devices pertaining to Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal.

Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter.

Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.

Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholinebased biocompatible material.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Qura's Quantum Perfusion Dual Lumen Cannula, which introduces new REF codes (different sizes) and a warning in the Instruction for Use. It does not describe acceptance criteria for an AI/ML powered device or a study involving human readers or sophisticated ground truth establishment.

Therefore, most of the requested information (related to AI/ML device performance, reader studies, type of ground truth, training sets, etc.) cannot be extracted from this document, as it pertains to a medical device's physical and mechanical performance rather than an AI/ML algorithm.

However, I can extract the relevant information regarding the non-clinical testing for this specific medical device submission.

Here's what can be extracted based on the provided text:

Study and Acceptance Criteria Information (as per the provided document's scope):

The document describes the performance data and conclusions for new variants of a Quantum Perfusion Dual Lumen Cannula. The "study" here refers to the non-clinical bench testing conducted to demonstrate product safety and effectiveness for these new variants.

1. A table of acceptance criteria and the reported device performance:

The document mentions "Performance tests for new REF codes introduced in the portfolio, according to applicable Recognized Consensus Standard ISO 18193:2021" specifically, "Evaluation of devices' Pressure Drop." However, the specific acceptance criteria values (e.g., "Pressure drop must be less than X mmHg at Y flow rate") and the reported device performance values are not detailed in this summary. It only states that testing was performed "as per same internal applicable standards/protocols applied for predicate devices (K203067)."

Acceptance Criteria (Specific Values)	Reported Device Performance (Specific Values)
Not specified in the document. (e.g., Pressure Drop < X)	Not specified in the document. (e.g., Achieved Pressure Drop Y)

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The document states "Performance tests for new REF codes introduced in the portfolio..." but does not mention the number of devices tested.
Data Provenance: The tests were conducted by Qura S.r.l. in Italy, as indicated by the submitter's address. The data is likely from retrospective (bench testing) as opposed to clinical (patient) studies, given the "Non-Clinical Testing" section.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the "ground truth" for a physical medical device like a cannula is established through engineering specifications, material properties, and physical performance testing against recognized standards (like ISO 18193:2021). There are no "experts" in the sense of human readers/interpreters establishing ground truth for image analysis or diagnostic tasks.

4. Adjudication method for the test set:

This is not applicable. Adjudication typically refers to resolving discrepancies between human readers or between human and AI interpretations in diagnostic or imaging studies. For physical device performance testing, results are typically objective measurements against engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This document is for a physical medical device (cannula), not an AI/ML-powered diagnostic or assistive device. No MRMC study was conducted or is relevant for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. This describes a physical medical device, not an AI algorithm.

7. The type of ground truth used:

The ground truth for this medical device is based on engineering specifications and performance standards (specifically ISO 18193:2021) for characteristics like "Pressure Drop," as well as material properties and structural integrity.

8. The sample size for the training set:

This is not applicable. This is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established:

This is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

August 18, 2022

Qura S.r.1. Raffaella Tommasini QA & RA Director Via di Mezzo 23 Mirandola, Modena 41037 Italy

Re: K221353

Trade/Device Name: Quantum Perfusion Dual Lumen Cannula 31F-VS, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27-VS, Quantum Perfusion Dual Lumen Cannula 27-V1, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 31F Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: July 19, 2022 Received: July 20, 2022

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.

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

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 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 (QS) 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 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 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}------------------------------------------------

510(k) Number (if known) K221353

Device Name Quantum Perfusion Dual Lumen Cannula 24F

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 24F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CER 801 Subpart C)

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

510(k) Number (if known) K221353

Device Name

Quantum Perfusion Dual Lumen Cannula 24F-V 1

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 24F-V1 is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

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

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

510(k) Number (if known) K221353

Device Name Quantum Perfusion Dual Lumen Cannula 27F

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 27F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

510(k) Number (if known) K221353

Device Name

Quantum Perfusion Dual Lumen Cannula 27F-V 1

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 27F-V1 is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

|X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

510(k) Number (if known) K221353

Device Name

Quantum Perfusion Dual Lumen Cannula 27F-VS

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 27F-VS is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

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

510(k) Number (if known) K221353

Device Name Quantum Perfusion Dual Lumen Cannula 29F

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 29F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

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

510(k) Number (if known) K221353

Device Name

Quantum Perfusion Dual Lumen Cannula 29F-V 1

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 29F-V 1 is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

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

510(k) Number (if known) K221353

Device Name Quantum Perfusion Dual Lumen Cannula 31F

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 31F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

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

510(k) Number (if known) K221353

Device Name

Quantum Perfusion Dual Lumen Cannula 31F-VS

Indications for Use (Describe)

The Quantum Perfusion Dual Lumen Cannula 31F-VS is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

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

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

Image /page/11/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.

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:	May 9th, 2022

DEVICE II.

Proprietary Name:	Quantum Perfusion Dual Lumen Cannula 31F
	Quantum Perfusion Dual Lumen Cannula 27F
	Quantum Perfusion Dual Lumen Cannula 24F
	Quantum Perfusion Dual Lumen Cannula 29F
	Quantum Perfusion Dual Lumen Cannula 24F-V1
	Quantum Perfusion Dual Lumen Cannula 27F-V1
	Quantum Perfusion Dual Lumen Cannula 29F-V1
	Quantum Perfusion Dual Lumen Cannula 27F-VS
	Quantum Perfusion Dual Lumen Cannula 31F-VS
Common Name:	Dual Lumen Cannulae
Classification Name:	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary
	Bypass
Regulatory Class:	II
Product Code:	DWF
Regulation Number:	21 CFR 870.4210
Panel:	Cardiovascular Devices, Office of Health Technology 2 (OHT2) /
	Division of Health Technology 2 B (Circulatory Support,
	Structural and Vascular Devices)

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

Image /page/12/Picture/1 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure within a circular arc, followed by the word "QURA" in a bold, sans-serif font. Below "QURA" are the words "advanced medical solutions" in a smaller, lighter font.

lll. PREDICATE DEVICES

Proprietary Name:	Quantum Perfusion Dual Lumen Cannula 31F
	Quantum Perfusion Dual Lumen Cannula 27F
	Quantum Perfusion Dual Lumen Cannula 24F
Common Name:	Dual Lumen Cannulae
Classification Name:	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary
	Bypass
Regulatory Class:	II
Product Code:	DWF
Regulation Number:	21 CFR 870.4210
Panel:	Cardiovascular Devices, Office of Health Technology 2 (OHT2) /
	Division of Health Technology 2 B (Circulatory Support,
	Structural and Vascular Devices)
510(k) Number:	K203067

DEVICE DESCRIPTION IV.

Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.

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

Image /page/13/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. 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.

V. INTENDED USE / INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The present 510(k) is related to the following modifications to Qura's own legally approved predicate products (Quantum Perfusion Dual Lumen Cannulae product family, cleared by K203067):

Inclusion of new REF Codes in the product family; .
. Introduction of a new warning in Instruction for Use to avoid the insertion of the cannula beyond the last depth marker.

The additional variants with different lengths have been introduced in order to provide to clinicians/users additional options as far as patient sizes are concerned. REF codes introduced in the portfolio are aligned with information provided in original submission K203067 in terms of general structure and materials (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.

The new warning has been introduced in order to mitigate the risk of inserting the cannula too deeply. The portion of the cannula beyond the last depth marker is less flexible than the rest of the cannula and can therefore be subjected to undesirable curve at the insertion point, which can ultimately lead to device damage.

Thus, the devices have the same intended use, principle of operation, and technological characteristics. Applicable testing has demonstrated that the proposed devices do not raise any new issues of safety and effectiveness as compared to the currently cleared predicate products.

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Image /page/14/Picture/0 description: The image shows the logo for Qura advanced medical solutions. The logo features a stylized human figure inside of an oval shape. The text "QURA" is to the right of the figure, and the text "advanced medical solutions" is below the text "QURA".

PERFORMANCE DATA VII.

NON-CLINICAL TESTING

The following activities were performed to demonstrate product safety and effectiveness, considering the proposed changes and related impact:

Update of labeling and Instructions for Use (IFU) according to ISO 15223-1:2016 Medical Devices - Symbols to Be Used with Medical Device Labels, Labelling, And Information to Be Supplied - Part 1: General Requirements [Recognition Nr. 5-117];
Performance tests for new REF codes introduced in the portfolio, according to applicable Recognized Consensus Standard ISO 18193:2021 [Recognition Nr. 3-176]:
- O Evaluation of devices' Pressure Drop;

as per same internal applicable standards/protocols applied for predicate devices (K203067).

The new codes differ from the original ones only regarding the dimensions (French size and length). The general devices' structure, principle of operation, materials and manufacturing processes are the same for all the sizes and therefore data provided in original submission should be considered as still valid and only performance have been verified as affected by the changes.

Animal Study

No animal studies have been performed to support changes object of the present 510(k).

CLINICAL TESTING

No clinical data have been included in the current 510(k) submission.

CONCLUSIONS VIII.

Considering changes performed on original devices cleared by K203067, the 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.

Regulation Number and Section

§ 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).

Re: K221353

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510(K) SUMMARY

SUBMITTER l.

DEVICE II.

lll. PREDICATE DEVICES

DEVICE DESCRIPTION IV.

V. INTENDED USE / INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

PERFORMANCE DATA VII.

NON-CLINICAL TESTING

Animal Study

CLINICAL TESTING

CONCLUSIONS VIII.

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

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