(217 days)
No
The summary describes a physical medical device (arterial cannulae) and its intended use and construction. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The testing described is focused on biocompatibility and in vitro performance of the physical device.
No.
The device is used to return arterial blood to the patient during cardiopulmonary surgery, which is a supportive rather than a therapeutic function. It does not treat or cure a disease.
No
This device is described as a perfusion cannula used to return arterial blood during cardiopulmonary surgery, which is a therapeutic function, not a diagnostic one. It does not measure, analyze, or interpret any physiological signs or data to determine a diagnosis.
No
The device description clearly indicates it is a physical medical device (cannulae) made of polymer with a wire-reinforced body and a distal tip, intended for surgical use. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to return arterial blood to the patient during cardiopulmonary surgery. This is a direct interaction with the patient's circulatory system for therapeutic purposes (maintaining blood flow during bypass), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a physical cannula designed to be inserted into arterial vessels. It's a surgical tool for blood circulation, not a reagent, instrument, or system for in vitro examination.
- Lack of IVD Characteristics: There is no mention of analyzing blood or other bodily fluids outside the body, using reagents, or providing diagnostic information.
The device is clearly intended for in vivo use (within the living body) during a surgical procedure.
N/A
Intended Use / 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.
Product codes
DWF
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.
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
Not Found
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
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 (
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for LivaNova. The logo is purple and consists of the word "LivaNova" in a stylized font. Below the logo is the tagline "Health innovation that matters" in a smaller, orange font. The logo is simple and modern, and the tagline is clear and concise.
510(K) SUMMARY
| SUBMITTER: | Sorin Group Italia
86, Via Statale 12 Nord
41037 Mirandola (MO) Italy |
|-------------------------|-----------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: 39 0535 29811
Fax: 39 0535 25229 |
| DATE PREPARED: | October 16, 2018 |
| DEVICE TRADE NAME: | PureFlex Arterial Cannulae |
| COMMON NAME: | Cardiopulmonary Bypass Vascular Cannulae |
| CLASSIFICATION
NAME: | Catheter, Cannula and Tubing, Vascular,
Cardiopulmonary Bypass |
| CLASSIFICATION
CODE: | DWF |
| REGULATION
NUMBER: | 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.
4
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 (