(19 days)
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.
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.
The provided text is a 510(k) summary for the CSC14 Blood Cardioplegia System. It describes the device, its intended use, and states that it has been determined substantially equivalent to a predicate device, the SORIN BCD Vanguard Blood Cardioplegia System (K934847).
However, the document does not contain specific acceptance criteria with numerical targets or a detailed study report with device performance against such criteria for the new device. Instead, it relies on demonstrating substantial equivalence to the predicate device through in-vitro tests comparing certain characteristics.
Here is an attempt to structure the information based on the request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria and corresponding performance values for the CSC14 device are not provided in the document, this table can only list the types of tests performed to demonstrate substantial equivalence to the predicate device.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Heat Exchanger Efficiency | Determined to be substantially equivalent to K934847 |
| Pressure Drop | Determined to be substantially equivalent to K934847 |
| Priming Volume | Determined to be substantially equivalent to K934847 |
| Device Integrity | Determined to be substantially equivalent to K934847 |
| Connections Integrity | Determined to be substantially equivalent to K934847 |
| Sterile Barrier Integrity | Determined to be substantially equivalent to K934847 |
| Blood Trauma | Determined to be substantially equivalent to K934847 |
Note: The document states, "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)." This implies that the performance of the CSC14 device in these categories met or was comparable to the performance of the predicate device, which serves as the "acceptance criteria" for substantial equivalence in this context. No specific numerical thresholds or results are given for either device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "In-vitro tests were performed."
- Data Provenance: The tests were "In-vitro," meaning laboratory tests, not clinical data from patients. The location of the testing is not specified, but it would presumably be performed by or for COBE Cardiovascular, Inc. (USA). This is a prospective test for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This point is not applicable to an in-vitro device comparison focused on technical characteristics. Ground truth is not established by human experts in this context; rather, it is determined by engineering measurements and comparisons to a known predicate device's performance.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication described for these in-vitro tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (MRMC) is typically for assessing human reader performance, often with AI assistance, in interpreting medical images or data. The CSC14 Blood Cardioplegia System is a physical medical device, not a diagnostic AI system, so an MRMC study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This question pertains to AI algorithms. The CSC14 Blood Cardioplegia System is a physical device, not an algorithm. The in-vitro tests performed can be considered "standalone" in the sense that they assess the device's physical and functional properties directly, without human intervention in the measurement process, but this is not what is typically meant by "standalone performance" in the context of AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance characteristics of the predicate device (SORIN BCD Vanguard Blood Cardioplegia System, #K934847). The tests were designed to show that the CSC14 device performs similarly in key technical areas (e.g., heat exchanger efficiency, pressure drop, blood trauma).
8. The Sample Size for the Training Set
Not applicable. The CSC14 Blood Cardioplegia System is a physical medical device, not an AI model, and therefore does not have a "training set" in the machine learning sense. The device's design is based on engineering principles and comparison to the predicate.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this physical device.
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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.
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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
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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
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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
ﻟﺬ ﺑﻌ
§ 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).