(90 days)
Not Found
Not Found
No
The device description focuses on mechanical components for fluid delivery and pressure monitoring, with no mention of AI/ML capabilities or data processing beyond simple pressure measurement.
No.
The device is an adapter for delivering cardioplegia solution, which is a drug, and monitoring pressure; it does not directly treat a disease or condition itself.
No
The device is designed to deliver cardioplegia solution and, in some models, monitor pressure during delivery. It does not perform any diagnostic function such as identifying, assessing, or predicting a medical condition.
No
The device description clearly details physical components such as tubing, luers, stopcocks, and a base plate, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Antegrade/Retrograde Perfusion Adapter is a device used to deliver a solution (cardioplegia) directly into the body (aortic root or coronary sinus) during a surgical procedure. It is an in vivo device, meaning it is used within a living organism.
- Lack of Diagnostic Testing: The device does not perform any tests on samples taken from the body. Its function is purely for the delivery of a therapeutic solution and, in one model, monitoring pressure within the body.
Therefore, the device's intended use and function clearly place it outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Antegrade/Retrograde Perfusion Adapter is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus. The Antegrade/Retrograde Perfusion Adapter with Pressure Line is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus while continually monitoring the pressure of the coronary sinus.
Product codes
DWF
Device Description
The Antegrade/Retrogarde Perfusion Adapters are designed to deliver cardioplegia solution to either the coronary sinus or aortic root by the turn of a stopcock and are available with or without a pressure monitoring line. The model with a pressure monitoring line allows for simultaneous monitoring of the coronary sinus pressure while administering cardioplegia solution to either the coronary sinus or aortic root.
In general, a red color-coded tubing with a standard male luer connects to the aortic root cannula's infusion port while a blue color-coded tubing with a standard male luer connects to the coronary sinus cannula's infusion port for delivery of cardioplegia solution. The model provided with a pressure monitoring line is connected to the pressure monitoring outlet of the coronary sinus cannula at one end and the other end is connected to a transducer via a female luerlock connector. An optional male luer-lock swivel adapter is also supplied for this connection. The cardioplegia inlet tubing, which is white color-coded in the pressure monitoring line model, connects to the cardioplegia administration line. The adapter also has a base plate, which allows for either suturing or clamping of the stopcock to the surgical drape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aortic root or coronary sinus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K993818
p1of2
Summary of Safety and Effectiveness
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The California Medical Laboratories, Inc. devices are substantially equivalent to the Baxter Research Medical predicate device. The California Medical Laboratories, Inc. devices have substantially equivalent intended uses as the predicate device. The California Medical Laboratories, Inc. devices have technologic characteristics, which are substantially equivalent to the Baxter Research Medical predicate device.
COMPANY AND CONTACT PERSON
California Medical Laboratories Inc. 2681 Kelvin Avenue Irvine, California 92614
Mehmet Bicakci President
DEVICE NAME
California Medical Laboratories Inc. Antegrade Perfusion Adapter, Antegrade/Retrograde Perfusion Adapter with Pressure Line
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
The claim of substantial equivalence is based upon the following device:
- . Baxter Research Medical. Inc. Cardioplegia Antegrade-Retrograde Solution Infusion with or without Retrograde Pressure Monitoring
DESCRIPTION OF DEVICE
The Antegrade/Retrogarde Perfusion Adapters are designed to deliver cardioplegia solution to either the coronary sinus or aortic root by the turn of a stopcock and are available with or without a pressure monitoring line. The model with a pressure monitoring line allows for simultaneous monitoring of the coronary sinus pressure while administering cardioplegia solution to either the coronary sinus or aortic root.
In general, a red color-coded tubing with a standard male luer connects to the aortic root cannula's infusion port while a blue color-coded tubing with a standard male luer connects to the coronary sinus cannula's infusion port for delivery of cardioplegia solution. The model provided with a pressure monitoring line is connected to the pressure monitoring outlet of the coronary sinus cannula at one end and the other end is connected to a transducer via a female luerlock connector. An optional male luer-lock swivel adapter is also supplied for this connection. The cardioplegia inlet tubing, which is white color-coded in the pressure monitoring line model, connects to the cardioplegia administration line. The adapter also has a base plate, which allows for either suturing or clamping of the stopcock to the surgical drape.
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K993818
p.272
STATEMENT OF INTENDED USE
The Antegrade/Retrograde Perfusion Adapter is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus. The Antegrade Perfusion adapter with Pressure Line is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus while continually monitoring the pressure of the coronary sinus.
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES
The predicate device has the same intended use as stated above.
STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
The California Medical Laboratories, Inc devices have technologic characteristics, which are substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 8 2000
Mr. Mehmet Bicakci President California Medical Laboratories, Inc. 2681 Kelvin Avenue Irvine, CA 92614
Re: K993818
Antegrade/Retrograde Perfusion Adapter (CA-80010) Trade Name: and Antegrade/Retrograde Perfusion Adapter with Pressure Line (CA-81010) II (two) Regulatory Class: DWF Product Code: November 8, 1999 Dated: November 10, 1999 Received:
Dear Mr. Bicakci:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
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Page 2 - Mr. Mehmet Bicakci
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), or for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Rosa R. Capperle
Celia M. Witten, Ph.D., Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
California Medical Laboratories Inc. Antegrade/Retrograde Perfusion Adapters with Device Name: or without a Pressure Line
Indications
The Antegrade/Retrograde Perfusion Adapter is indicated for use to deliver For Use: cardioplegia solution to either the aortic root or coronary sinus. The Antegrade/Retrograde Perfusion Adapter with Pressure Line is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus while continually monitoring the pressure of the coronary sinus.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 801.109
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Per 21 CFR
Lega B. Cooperle
(Division Sign-Off) Division of Cardiovascular, and Neurological Device 510(k) Number
510(k) Notification California Medical Laboratories, Inc.
Page 5
CONFIDENTIAL 11/8/1999