(19 days)
Not Found
No
The document describes a mechanical system for mixing and delivering fluids, with no mention of AI or ML technologies.
Yes
The device is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution, which are therapeutic actions performed on the patient.
No
The device is described as a system intended to "mix, cool, warm, and deliver oxygenated blood and cardioplegic solution." While it allows for "monitoring of temperature and pressure," its primary functions are therapeutic/supportive (fluid management) rather than diagnostic (identifying a disease or condition).
No
The device description clearly indicates it is a physical system with components like a heat exchanger, bubble trap, and tubing, and the performance studies focus on in-vitro testing of these physical aspects.
Based on the provided information, the CSC14 Blood Cardioplegia System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device's function as mixing, cooling, warming, and delivering oxygenated blood and cardioplegic solution to the patient. This is a direct therapeutic intervention on the patient's circulatory system during a surgical procedure.
- Device Description: The description focuses on the physical components and function of the device in handling and delivering fluids to the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The CSC14 does not perform any analysis or testing of patient specimens. It is a device for preparing and delivering a solution to the patient.
Therefore, the CSC14 Blood Cardioplegia System is a medical device used in a surgical setting for patient treatment, not an IVD.
N/A
Intended Use / Indications for Use
The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for up to 6 hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump through the extension line and appropriate cannula.
Product codes
DTR
Device Description
The CSC14 Blood Cardioplegia System is a sterile device with non-pvrogenic fluid pathways. for single use only, and is not to be resterilized by the user. The device is a heat exchanger with integral bubble trap and various tubing configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
In-vitro tests were performed to demonstrate that the CSC14 Blood Cardioplegia System described in this submission is substantially equivalent to the SORIN CSC 14 Blood Cardioplegia System (K934847). In-vitro testing consisted of heat exchanger efficiency, pressure drop, priming volume, device integrity, connections integrity, sterile barrier integrity, and blood trauma.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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
Special 510(k)-Device Modification: CSC14 Blood Cardioplegia System
19
SEP 1 7 2001
| SUBMITTER: | COBE Cardiovascular, Inc. |
|---|---|
| 14401 W. 65th Way |
510(k) Summary
14401 W. 65th Wav Arvada, CO 80004
CONTACT PERSON: Lynne Leonard Phone: (303) 467-6586 Fax: (303) 467-6429
DATE PREPARED: August 27, 2001
DEVICE TRADE NAME: CSC14 Blood Cardioplegia System
COMMON/USUAL NAME: Cardioplegia Heat Exchanger
CLASSIFICATION NAME: Cardiopulmonary Bypass Blood Heat Exchanger
PREDICATE DEVICE: SORIN BCD Vanguard Blood Cardioplegia System, #K934847
DEVICE DESCRIPTION:
The CSC14 Blood Cardioplegia System is a sterile device with non-pvrogenic fluid pathways. for single use only, and is not to be resterilized by the user. The device is a heat exchanger with integral bubble trap and various tubing configurations.
INDICATIONS FOR USE
The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for up to 6 hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump through the extension line and appropriate cannula.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The CSC14 Blood Cardioplegia System is identical to the SORIN BCD Vanguard Blood Cardioplegia System (K934847) in intended use, method of operation, and fundamental scientific technology. The two devices differ in the geometry and features of the integral bubble trap.
TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE
In-vitro tests were performed to demonstrate that the CSC14 Blood Cardioplegia System described in this submission is substantially equivalent to the SORIN CSC 14 Blood Cardioplegia System (K934847). In-vitro testing consisted of heat exchanger efficiency, pressure drop, priming volume, device integrity, connections integrity, sterile barrier integrity, and blood trauma.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation.
Public Health Service
SEP 1 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynne Leonard Sr. Regulatory Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 8004-3599
Re: K012898
CSC14 Blood Cardioplegia System Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary Bypass Heat Exchangers Regulatory Class: II Product Code: DTR Dated: August 28, 2001 Received: August 29, 2001
Dear Ms. Leonard:
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, listing 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
2
Page 2 - Ms. Lynne Leonard
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty by became (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) I mis letter will and w you'll finding of substantial equivalence of your device to a legally prematicate 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 If you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 8586. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1500. I fine of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Thisolanang oresponsibilities under the Act may be obtained from the Outcr general miormation on your respational 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,
signature
James H. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (If known): KOL2898
CSC14 Blood Cardioplegia System Device Name:
Indications For Use:
The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 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)
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Division of Cardiovascular & Respiratory Devices 510(k) Number Loud 9 K
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
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