(28 days)
No
The description focuses on mechanical and material properties, temperature/pressure monitoring, and fluid handling. There is no mention of AI/ML terms or functionalities.
No
The device is described as mixing, cooling, warming, and delivering cardioplegic solution, which are actions performed during a medical procedure, not directly treating a disease or condition itself.
No
The device is designed to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution, and to monitor temperature and pressure, trap bubbles, and remove air. Its primary function is therapeutic delivery during cardiac procedures, not diagnosis. While it monitors temperature and pressure, this is for operational control and safety during treatment rather than for diagnosing a patient's condition.
No
The device description clearly outlines physical components such as a heat exchanger, bubble trap, tubing, connectors, valves, and ports, indicating it is a hardware device with potential software control or monitoring, but not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for mixing, cooling, warming, and delivering blood and cardioplegic solution to the patient. This is a therapeutic and supportive function performed in vivo (within the living organism), not a diagnostic test performed in vitro (outside the body, typically on biological samples).
- Device Description: The description details a heat exchanger, bubble trap, tubing, and monitoring ports for temperature and pressure. These components are all consistent with a system designed for direct patient treatment during a surgical procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, etc.) to diagnose a condition, monitor disease progression, or determine treatment response. The monitoring is of the delivered solution's temperature and pressure, which are parameters relevant to the delivery process itself, not a diagnostic assessment of the patient's condition.
Therefore, the SMAR, T® BCD Vanguard™ Blood Cardioplegia System is a medical device used for patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SMAR, T BCD Vanguard Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.
Product codes
DTR
Device Description
The SMAR, T BCD Vanguard System is a cardioplegia heat exchanger with integral bubble trap, available with various tubing ratio configurations connected to the heat exchanger assembly. Surface-modifying materials have been added to the primary blood contact surfaces of the heat exchanger, tubing and connectors to improve the blood compatibility of the system. The product is sterilized by ethylene oxide, is for single use only, and has nonpyrogenic fluid pathways.
The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a temperature monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardionlegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In-Vitro tests were performed to demonstrate that the SMAR-T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).
0
021830
PAGE 1 OF 2
Special 510(k) Pre-Market Notification: SMAR,T® BCD Vanguard™ Blood Cardioplegia System COBE Cardiovascular, Inc.
16
JUL - 2 2002
| SUBMITTER: | COBE Cardiovascular, Inc.
14401 W. 65th Way
Arvada, CO 80004 |
|----------------------|-------------------------------------------------------------------------------------|
| CONTACT PERSON: | Shawn Riedel
Phone:(303) 467-6521
Fax: (303) 467-6525 |
| DATE PREPARED: | 28 May 2002 |
| DEVICE TRADE NAME: | Sorin Biomedica SMARₓT® BCD Vanguard™
Surface Modified Blood Cardioplegia System |
| COMMON/USUAL NAME: | Cardioplegia Heat Exchanger |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Heat Exchanger |
| PREDICATE DEVICE: | Sorin Biomedica BCD Vanguard™ Blood Cardioplegia System |
DEVICE DESCRIPTION:
The SMAR, T BCD Vanguard System is a cardioplegia heat exchanger with integral bubble trap, available with various tubing ratio configurations connected to the heat exchanger assembly. Surface-modifying materials have been added to the primary blood contact surfaces of the heat exchanger, tubing and connectors to improve the blood compatibility of the system. The product is sterilized by ethylene oxide, is for single use only, and has nonpyrogenic fluid pathways.
The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a temperature monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardionlegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.
INDICATIONS FOR USE
The SMAR, T BCD Vanguard Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.
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Page 2 of 2 Special 510(k) Pre-Market Notification: SMAR T® BCD Vanguard" Blood Cardioplegia System COBE Cardiovascular, Inc.
17
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The SMAR.T BCD Vanguard Surface Modified Blood Cardioplegia System has the same intended use as the Sorin BCD Vanguard Blood Cardioplegia System. Unless noted below the , materials, components, design, sterilization and manufacturing processes for the two devices are the same. The new device will be called the Sorin Biomedica SMAR T® BCD Vanguard™ Surface Modified Blood Cardioplegia System.
The changes in the two devices: 1) the SMAR, T BCD Vanguard contains a surface-modifying material. Mimesys which coats the heat exchanger (not including the bubble trap) of the System, 2) Substituting SMAR, T Surface Modified Tubing and Connectors (K981613) for various tubing and connectors within the circuit configurations and 3) Substituting High Impact Polystyrene (HIPS) for PolyEthylene Terephthalate Glycol (PETG) as the packaging material.
In-Vitro tests were performed to demonstrate that the SMAR-T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847).
Truthful and Accurate Statement
A statement attesting to the truthfulness and accuracy of the information contained in this submission is attached as Appendix 5.
Further Information
In the event additional information is required, please contact:
Shawn Riedel Regulatory/Quality Manager COBE Cardiovascular, Inc. 14401 West 65th Way Arvada, Colorado 80004 USA Phone: (303) 467-6521 Fax: (303) 467-6525
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the profiles, creating a symbolic representation of health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
COBE Cardiovascular, Inc. c/o Mr. Shawn Riedel Regulatory/Quality Manager 14401 W. 65th Way Arvada, CO 80004-3599
JUL = 2 2002
Re: K021830
Device Name: Sorin Biomedica SMART® BCD Vanguard™ Surface Modified Blood Cardioplegia System Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary bypass heat exchanger. Regulatory Class: Class II (two) Product Code: DTR Dated: June 3, 2002 Received: June 4, 2002
Dear Mr. Riedel:
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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Shawn Riedel
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
· Sincerely yours,
Donna Dee Tillman, Ph.D.
onna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3
Special 510(k) Pre-Market Notification: SMARy1® BCD Vanguard™ Blood Cardioplegia System COBE Cardiovascular, Inc.
Indications For Use
510(k) Number (If known): K021832
Device Name:
Sorin Biomedica SMAR, T® BCD Vanguard™ Surface Modified Blood Cardioplegia System
Indications For Use:
The SMAR, T® BCD Vanguard™ Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q. Carter
510(k) Number K021830
Image /page/4/Picture/13 description: The image shows the words "Prescription Use" followed by the text "(Per 21 CFR 801.109)". There is a large X drawn over the words "Prescription Use". The text is in a simple, sans-serif font.
OR
Over-The-Counter Use