(88 days)
Medtronic DLP Coronary Ostial Perfusion Cannulae
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a perfusion cannula, with no mention of AI or ML technology.
Yes
The device is used to deliver cardioplegic solution during surgery, which is a therapeutic intervention.
No
The device is intended to deliver cardioplegic solution during surgery, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is comprised of physical components like plastic, stainless steel, and silicone, and is a physical cannula. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery." This describes a device used in vivo (within the body) for a surgical procedure.
- Device Description: The description details a physical device (cannulae) used to deliver a substance into the body.
- 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. This device does not perform any such function.
The information provided clearly indicates a surgical instrument used directly on a patient during a procedure, not a device for testing samples in a lab.
N/A
Intended Use / Indications for Use
The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.
Product codes
DWF
Device Description
The Stöckert Coronary Perfusion Cannulae are comprised of either a flexible plastic (PVC) or a malleable stainless steel body, with a soft silicone tip and either a ¼" barbed tubing connector or a luer lock. They are offered in various tip outer diameters ranging from 3.0 to 5.0 mm (9 to 15 Fr). The P605, P607, P615, and P617 Series Stöckert Coronary Perfusion Cannulae are 26 cm long. The P606, P616, and P618 Series Stöckert Coronary Perfusion Cannulae are 14 cm long.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary ostium
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 performance and biocompatibility tests demonstrate substantial equivalency of the Stöckert Coronary Perfusion Cannulae to the Medtronic DLP Coronary Ostial Perfusion Cannulae. The devices share the same intended use, design features, and performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic DLP Coronary Ostial Perfusion Cannulae
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
510(k) Pre-Market Notification: Stöckert Coronary Perfusion Cannulae
OCT 1 1 2002
510(k) Summarv
| SUBMITTER: | Stöckert Instrumente GmbH
Lindberghstrasse 25
D-80939 Munich, Germany |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mr. Helmut Höfl
Director, Quality and Regulatory Affairs
Phone: 49-89-323-010
Fax: 49-89-323-01100 |
| DATE PREPARED: | May 10, 2002 |
| DEVICE TRADE NAME: | Stöckert Coronary Perfusion Cannulae |
| COMMON/USUAL NAME: | Antegrade Cardioplegia Cannulae |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing |
| PREDICATE DEVICE: | Medtronic DLP Coronary Ostial Perfusion Cannulae |
DEVICE DESCRIPTION:
The Stöckert Coronary Perfusion Cannulae are comprised of either a flexible plastic (PVC) or a malleable stainless steel body, with a soft silicone tip and either a ¼" barbed tubing connector or a luer lock. They are offered in various tip outer diameters ranging from 3.0 to 5.0 mm (9 to 15 Fr). The P605, P607, P615, and P617 Series Stöckert Coronary Perfusion Cannulae are 26 cm long. The P606, P616, and P618 Series Stöckert Coronary Perfusion Cannulae are 14 cm long.
INDICATIONS FOR USE
The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
In-vitro performance and biocompatibility tests demonstrate substantial equivalency of the Stöckert Coronary Perfusion Cannulae to the Medtronic DLP Coronary Ostial Perfusion Cannulae. The devices share the same intended use, design features, and performance characteristics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three parallel lines that curve to form the shape of the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2002
Stöckert Instrumente GmbH c/o Ms. Lynne Leonard Leonard Regulatory Consulting 20193 Goins Drive Morrison, CO 80465
Re: K022280
Stöckert Coronary Perfusion Cannulae Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: July 11, 2002 Received: July 15, 2002
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 mav publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Lynne Leonard
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 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,
R. Zaleski M.D.
Bram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Pre-Market Notification: Stöckert Coronary Perfusion Cannulae
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Indications For Use
510(k) Number (If known): K022280
Device Name:
:
Stöckert Coronary Perfusion Cannulae
Indications For Use:
The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022880
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________