(253 days)
Not Found
No
The device description details a physical cannula and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical performance and compliance with standards.
No.
The device is used for delivering cardioplegic solution and venting the heart during cardiopulmonary bypass surgery, which are supportive functions during a surgical procedure, not a direct treatment or cure for a disease.
No
The device description and intended use state that it is used for delivery of cardioplegic solution and venting during cardiopulmonary bypass surgery, which are therapeutic and supportive functions, not diagnostic.
No
The device description explicitly details physical components made of PVC and stainless steel, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery". This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical device (cannula) used for insertion into the body.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The Aortic root cannulae are intended for use in adult and pediatric patients to cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery for periods of up to six hours.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The R501-R502 Aortic Root Cannula (hereinafter referred to as R501-R502 cannulae) are aortic root cannulae intended to be used to cannulate the aortic root, to vent and to deliver cardioplegic solution during heat bypass operations.
The device is available in two styles: with a vent line ( R502) and without a vent line ( R501). Both models consist of a flexible Polyvinylchloride (PVC) tubing body, a PVC flanged tip and luer connector. The introducer is made of stainless steel with a PVC obturator. The vent line model have an additional feature constituted by a vent line provided as integral part of the device. This attribute makes it possible to vent and also introduce cardioplegic solutions using the same device. These cannulae are available in a range of sizes as per table below:
| Model | Tip size (internal diameter) | Product designation |
|---|---|---|
| R501 (aortic root without vent line) | 1.5 mm | R501-15 |
| 2.0 mm | R501-20 | |
| 2.6 mm | R501-26 | |
| R502 (aortic root with vent line) | 1.5 mm | R502-15 |
| 2.0 mm | R502-20 | |
| 2.6 mm | R502-26 |
The R501-R502 cannulae are a modified version of the currently marketed R501-R502 Aortic Root cannulae (K861310).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aortic root, coronary arteries, heart
Indicated Patient Age Range
Adult and pediatric 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 Performance Data: SORIN GROUP ITALIA S.R.L. has conducted extensive verification and validation testing of the R501-R502 Cannulae, as a cardiopulmonary bypass arterial cannula capable of providing adequate perfusion to the patient during surgery.
The R501-R502 Cannulae complies with all the applicable voluntary standards related to cardiopulmonary bypass arterial cannulae. The device passed all the testing in accordance with national and international standards.
Clinical Performance Data: No clinical testing was conducted in support of the R501-R502 Cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate device, which has been on the market for several vears with proven safety and efficacy of use. The non-clinical testing summarized in this submission supports the substantial equivalence of the subject device with the predicate device when used according to its intended use.
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
§ 870.4210 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
November 17, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sorin Group Italia S.r.1. Luigi Vecchi Director, Regulatory Affairs Via statale 12 Nord, 86 Mirandola, Modena 41037 Italy
Re: K200612
Trade/Device Name: R501 aortic root cannula without vent line. R502 aortic root cannula with vent line Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: October 14, 2020 Received: October 15, 2020
Dear Luigi Vecchi:
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,
for Fernando Aguel 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200612
Device Name R501 Aortic Root Cannula without vent line R502 Aortic Root Cannula with vent line
Indications for Use (Describe)
The Aortic root cannulae are intended for use in adult and pediatric patients to cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery for periods of up to six 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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Section 8 – 510(k) Summary
(in accordance with 21 CFR 807.92)
510(k) Number: K200612
l. Applicant Information
| Applicant: | SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola, MO
41037 Italy |
|--------------------------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Luigi Vecchi
Director, Regulatory Affairs
Tel: +39 0535 29957
e-mail: luigi.vecchi@livanova.com |
| Application Correspondent: | SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola, MO
41047 Italy |
| Contact Person: | Luigi Vecchi
Director, Regulatory Affairs
Tel: +39 0535 29957
e-mail: luigi.vecchi@livanova.com |
| Date Prepared: | February 13th 2020 |
| Subject Device Identification | |
| Proprietary Name: | R501 Aortic Root Cannula without vent line
R502 Aortic Root Cannula with vent line |
| Common/Usual Name: | Cardiopulmonary bypass vascular cannula |
| Classification Name: | Cardiopulmonary bypass vascular catheter,
cannula or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
Traditional 510(k) – R501-R502 Cannulae
ll.
4
lll. Predicate Device
The R501-R502 Aortic Root Cannula is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:
| 510(k) Number: | K861310 |
|---|---|
| Proprietary Name: | R501 Aortic Root Cannula without vent line |
| R502 Aortic Root Cannula with vent line | |
| Common/Usual Name: | Cardiopulmonary bypass vascular cannula |
| Classification Name: | Cardiopulmonary bypass vascular catheter, |
| cannula or tubing | |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
IV. Device Description
The R501-R502 Aortic Root Cannula (hereinafter referred to as R501-R502 cannulae) are aortic root cannulae intended to be used to cannulate the aortic root, to vent and to deliver cardioplegic solution during heat bypass operations
The device is available in two styles: with a vent line ( R502) and without a vent line ( R501). Both models consist of a flexible Polyvinylchloride (PVC) tubing body, a PVC flanged tip and luer connector. The introducer is made of stainless steel with a PVC obturator. The vent line model have an additional feature constituted by a vent line provided as integral part of the device . This attribute makes it possible to vent and also introduce cardioplegic solutions using the same device. These cannulae are available in a range of sizes as per table below:
| Model | Tip size (internal diameter) | Product designation |
|---|---|---|
| R501 (aortic root | ||
| without vent line) | 1.5 mm | R501-15 |
| 2.0 mm | R501-20 | |
| 2.6 mm | R501-26 | |
| R502 (aortic root | ||
| with vent line) | 1.5 mm | R502-15 |
| 2.0 mm | R502-20 | |
| 2.6 mm | R502-26 |
5
The R501-R502 cannulae are a modified version of the currently marketed R501-R502 Aortic Root cannulae (K861310).
V. Indications for Use
The Aortic root cannulae are intended for venting the aortic root for delivery of cardioplegic solution and for rapid and secure perfusion into the coronary arteries during cardiopulmonary surgery for periods of up to six hours.
VI. Summary of Technical Characteristics
The R501-R502 Cannulae have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices.
The R501-R502 Cannulae are provided with a different material of one specific component of the device (the flanged tip): the PVC material used for this component in the R501-R502 Cannulae is without Phthalates while the original PVC material used in the unmodified devices does contain Phthalates
No other design changes have been made to the device. Except for the change of the tip material, the R501-R502 cannulae utilize the same materials as the unmodified cannulae.
The devices are ethylene oxide sterilized and have a non-pyrogenic fluid path. They are for single use only.
VII. Non-Clinical Performance Data
SORIN GROUP ITALIA S.R.L. has conducted extensive verification and validation testing of the R501-R502 Cannulae, as a cardiopulmonary bypass arterial cannula capable of providing adequate perfusion to the patient during surgery.
The R501-R502 Cannulae complies with all the applicable voluntary standards related to cardiopulmonary bypass arterial cannulae. The device passed all the testing in accordance with national and international standards.
VIII. Clinical Performance Data
No clinical testing was conducted in support of the R501-R502 Cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate device, which has been on the market for several vears with proven safety and efficacy of use. The non-clinical testing summarized in this submission supports the substantial equivalence of the subject device with the predicate device when used according to its intended use.
6
IX. Statement of Substantial Equivalence
Based on equivalent intended use and technological characteristics, as well as on equivalent performance testing, the R501-R502 Cannulae can be deemed to be substantially equivalent to its predicate device, the Unmodified R501-R502 Cannulae, cleared under K861310.
The R501-R502 Cannulae, as designed and manufactured, does not raise new questions regarding safety and effectiveness as compared to its predicate device and is determined to be substantially equivalent to its predicate device, the Unmodified R501-R502 Cannulae.