ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
Device Facts
| Record ID | K993818 |
|---|---|
| Device Name | ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE |
| Applicant | California Medical Laboratories, Inc. |
| Product Code | DWF · Cardiovascular |
| Decision Date | Feb 8, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4210 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 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.
Device Story
Device consists of perfusion adapters designed for cardioplegia solution delivery to coronary sinus or aortic root; operated via stopcock. Red color-coded tubing connects to aortic root cannula; blue color-coded tubing connects to coronary sinus cannula. Pressure monitoring model includes additional line connecting to coronary sinus cannula and external transducer via female luer-lock. Base plate allows suturing or clamping to surgical drapes. Used in surgical settings by clinicians to facilitate cardioplegia administration; pressure monitoring model provides real-time coronary sinus pressure data to assist in monitoring during solution delivery. Benefits include controlled, targeted delivery of cardioplegia and integrated pressure monitoring capability.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Perfusion adapter system with stopcock flow control. Features color-coded tubing (red for aortic root, blue for coronary sinus, white for cardioplegia inlet). Includes male/female luer-lock connectors and optional pressure monitoring line for transducer connection. Base plate provided for surgical drape attachment. Non-electronic, mechanical device.
Indications for Use
Indicated for patients undergoing cardiac surgery requiring cardioplegia solution delivery to the aortic root or coronary sinus, with or without concurrent coronary sinus pressure monitoring.
Regulatory Classification
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.
Predicate Devices
- Baxter Research Medical, Inc. Cardioplegia Antegrade-Retrograde Solution Infusion with or without Retrograde Pressure Monitoring
Submission Summary (Full Text)
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K993818
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#### 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
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## 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.
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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.
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CONFIDENTIAL 11/8/1999
