(23 days)
Not Found
Research Medical Inc. Pediatric Aortic Cannula
No
The 510(k) summary describes a physical medical device (aortic cannulae) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a cannula used to return arterial blood during cardiopulmonary bypass, which is a supportive function rather than directly treating a disease or condition.
No
The device is described as a perfusion cannula used to return arterial blood during cardiopulmonary bypass, which is a therapeutic function, not a diagnostic one.
No
The device description clearly indicates it is a physical medical device (cannulae) made of materials like stainless steel wire and designed for surgical use.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to return arterial blood to the patient during cardiopulmonary bypass. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a cannula designed for insertion into the aorta. This is a physical device used for blood flow management within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic or other information. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Stöckert Pediatric Aortic Cannulae, A272-15 through A272-35 are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are wire reinforced aortic cannulae with a curved distal tip.
The cannulae are comprised of two components, the cannula tube and the curved tip. Encapsulated within the cannula outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The devices range in diameter from 4.5 to 10.5 Fr and have an overall length of 22 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aortic
Indicated Patient Age Range
Pediatric
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 equivalence of the Stöckert Pediatric Aortic Cannulae to the Research Medical Inc. Pediatric Aortic Cannula.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Jostra Arterial Perfusion Cannulae
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Research Medical Inc. Pediatric Aortic Cannula
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 Pediatric Aortic Cannulae (11/19/02)
1623622
NOV 2 1 2002
| 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: | September 5, 2002 |
| DEVICE TRADE NAME: | Stöckert Pediatric Aortic Cannulae, A272-15 through A272-35 |
| COMMON/USUAL NAME: | Cardiovascular Aortic Cannulae |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing |
| PREDICATE DEVICE: | Jostra Arterial Perfusion Cannulae |
| DEVICE DESCRIPTION: | |
The Stöckert Pediatric Aortic Cannulae, A272-15 through A272-35 are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are wire reinforced aortic cannulae with a curved distal tip.
The cannulae are comprised of two components, the cannula tube and the curved tip. Encapsulated within the cannula outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The devices range in diameter from 4.5 to 10.5 Fr and have an overall length of 22 cm.
INDICATIONS FOR USE
The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
In-vitro performance and biocompatibility tests demonstrate substantial equivalence of the Stöckert Pediatric Aortic Cannulae to the Research Medical Inc. Pediatric Aortic Cannula. The devices share the same intended use and overall design features (flexible tapered aortic cannula with a distal tip including suture ring, and without an attached connector).
510(k) Summary
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2002
Stöckert Instrumente GMBH c/o Ms. Lynne Leonard Leonard Regulatory Consulting 20193 Goins Drive Morrison, CO 80465
Re: K023622
Stöckert Pediatric Aortic Cannulae (Models A272-15 through A272-35) Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: October 28, 2002 Received: October 29, 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. Iisting 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.
2
Page 2 - Ms. Lynne Leonard
Enclosure
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), please contact the Office of Compliance at (301) 594-4548. 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
Dna Alunhurfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications For Use
510(k) Number (If known):
Device Name:
Stöckert Pediatric Aortic Cannulae (Models A272-15 through A272-35)
K 023622
Indications For Use:
The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.
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