(217 days)
The Arterial Cannulae are intended to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.
The PureFlex Arterial Cannulae intended to be used to cannulate the arterial vessels during cardiopulmonary bypass surgery.
The cannulae consist of a single-lumen wire-reinforced polymer body constructed and a distal tip. The distal tip is available in either a straight or curved shape with a collar or They are offered with or without a connector for attachment to the flange. cardiopulmonary bypass circuit.
The provided text is a 510(k) summary for the PureFlex Arterial Cannulae. It details the device's description, indications for use, technological characteristics, and non-clinical testing. However, it does not describe an AI medical device or a study involving an AI algorithm. Therefore, I cannot extract information related to acceptance criteria for an AI device, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI system.
The document focuses on the substantial equivalence of the PureFlex Arterial Cannulae to a predicate device (Aortic Arch Cannulae K162215) based on physical and performance characteristics, not on software or AI performance.
Below is the information regarding the medical device described in the document, based on the non-AI related testing performed.
1. A table of acceptance criteria and the reported device performance
| Test Name | Acceptance Criteria (Implicit) | Reported Device Performance Statement |
|---|---|---|
| Peak Tensile Force | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Structural Integrity | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Blood Trauma | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Kink Resistance | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Pressure Drop | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Leakage Under Pressure | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Shipping/Packaging | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Biocompatibility | Compliance with ISO 10993-1 and FDA's Guidance for Use of International Standard ISO 10993-1. | "Biocompatibility testing was performed in accordance with ISO 10993-1..." |
| Sterility Assurance Level | SAL of ≤10-6 | "Sterilized with ethylene oxide and have a sterility assurance level (SAL) of ≤10-6" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the "in vitro testing" mentioned (Peak Tensile Force, Structural Integrity, etc.). It also does not explicitly state the provenance of data for these tests. It's safe to assume this data is collected during product development and testing activities by Sorin Group Italia, which is based in Italy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a medical cannulae and the testing described is engineering/performance testing, not diagnostic or clinical interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the type of device and testing described.
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
Not applicable as this is not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is not an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" refers to the established performance specifications and the requirements outlined in relevant standards such as ISO 10555-1 and ISO 10993-1. For biocompatibility, it's compliance with biological safety standards. For sterility, it's achieving the specified Sterility Assurance Level.
8. The sample size for the training set
Not applicable as this is not an AI medical device.
9. How the ground truth for the training set was established
Not applicable as this is not an AI medical device.
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November 16, 2018
Sorin Group Italia S.r.l % Scott Light Senior Manager, Regulatory Affairs LivaNova USA, Inc. 14401 West 65th Way Arvada, Colorado 80004
Re: K180979
Trade/Device Name: PureFlex Arterial Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: October 16, 2018 Received: October 18, 2018
Dear Scott Light:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Fernando Aguel -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name PureFlex Arterial Cannulae
Indications for Use (Describe)
The Arterial Cannulae are intended to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary surgery for periods of up to six 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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510(K) SUMMARY
| SUBMITTER: | Sorin Group Italia86, Via Statale 12 Nord41037 Mirandola (MO) Italy |
|---|---|
| CONTACT PERSON: | Luigi VecchiPhone: 39 0535 29811Fax: 39 0535 25229 |
| DATE PREPARED: | October 16, 2018 |
| DEVICE TRADE NAME: | PureFlex Arterial Cannulae |
| COMMON NAME: | Cardiopulmonary Bypass Vascular Cannulae |
| CLASSIFICATIONNAME: | Catheter, Cannula and Tubing, Vascular,Cardiopulmonary Bypass |
| CLASSIFICATIONCODE: | DWF |
| REGULATIONNUMBER: | 870.4210 |
| PREDICATE DEVICE: | Aortic Arch Cannulae (K162215) |
DEVICE DESCRIPTION:
The PureFlex Arterial Cannulae intended to be used to cannulate the arterial vessels during cardiopulmonary bypass surgery.
The cannulae consist of a single-lumen wire-reinforced polymer body constructed and a distal tip. The distal tip is available in either a straight or curved shape with a collar or They are offered with or without a connector for attachment to the flange. cardiopulmonary bypass circuit.
INDICATIONS FOR USE:
The Arterial Cannulae are intended to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.
TECHNOLOGICAL CHARACTERISTICS:
As for the predicate Aortic Arch Cannulae, the PureFlex Arterial Cannulae consist of a soft flexible body with an encapsulated stainless steel spring for structural support. They are offered with either a straight or curved distal tip with either a collar or flange. The optional proximal connector is available with our without a vent port.
The PureFlex Cannulae and predicate Aortic Arch Cannulae have the same intended use, principles of operation and control mechanisms.
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The PureFlex Arterial Cannulae and predicate Aortic Arch Cannulae are sterile, nonpyrogenic, single use devices. They are sterilized with ethylene oxide and have a sterility assurance level (SAL) of ≤10-6
The PureFlex Cannulae differs from the predicate Aortic Arch Cannulae as follows:
-
- Different materials were selected for the PureFlex for an improved appearance.
-
- The stainless steel spring encapsulated in the body of the PureFlex is shorter to provide a longer clamping area.
-
- The PureFlex Cannulae are offered in French sizes 18, 20, 22 and 24 (6 to 8mm) whereas the predicate Aortic Arch Cannulae are offered in French sizes ranging from 9 to 24 (3 to 8mm).
-
- The geometry of the PureFlex differs slightly from the predicate.
Since pressure and flow are dependent on the size and geometry of the cannulae, graphs are provided in the Instructions for Use.
Non Clinical Testing:
Biocompatibility testing was performed in accordance with ISO 10993-1 considering FDA's Guidance for Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued June 16, 2016. The PureFlex cannulae are categorized as externally communicating, circulating blood, limited contact duration (<24hrs) devices.
IN VITRO TESTING:
Testing was conducted to verify compliance to the product's performance specifications and to demonstrate substantial equivalence to the predicate devices. The testing included relevant sections of ISO 10555-1 "Intravascular catheters - Sterile and singleuse catheters Part 1: General requirements".
The devices met the acceptance criteria for the following tests.
-
- Peak Tensile Force
-
- Structural Integrity
-
- Blood Trauma
-
- Kink Resistance
-
- Pressure Drop
-
- Leakage Under Pressure
-
- Shipping/Packaging
CONCLUSIONS:
The testing performed demonstrates the PureFlex cannulae are substantially equivalent to the predicate Aortic Arch Cannulae (K162215).
§ 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).