(23 days)
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.
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.
This document is a 510(k) pre-market notification for a medical device, specifically Stöckert Pediatric Aortic Cannulae. It is not a study describing the acceptance criteria or performance of an AI/ML powered device.
Therefore, most of the requested information regarding AI/ML device performance and study design cannot be extracted from this document. This document pertains to traditional medical device approval based on substantial equivalence to a predicate device.
However, I can extract the following relevant information:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a traditional medical device (cannulae) and not an AI/ML powered device, there are no "acceptance criteria" in the sense of performance metrics like accuracy, sensitivity, or specificity commonly associated with AI/ML. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same intended 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." This matches the implied intended use of the Jostra Arterial Perfusion Cannulae (predicate). |
| Overall design features (flexible tapered aortic cannula with a distal tip including suture ring, and without an attached connector) | "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)." |
| In-vitro performance | "In-vitro performance...tests demonstrate substantial equivalence of the Stöckert Pediatric Aortic Cannulae to the Research Medical Inc. Pediatric Aortic Cannula." Specific metrics are not provided in this summary. |
| Biocompatibility | "Biocompatibility tests demonstrate substantial equivalence of the Stöckert Pediatric Aortic Cannulae to the Research Medical Inc. Pediatric Aortic Cannula." Specific test results are not provided in this summary. |
| Sterility, non-pyrogenic, single-use | "The Stöckert Pediatric Aortic Cannulae...are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user." This is a characteristic of the device itself and likely aligns with the predicate. |
| Materials (e.g., wire reinforcement) | "Encapsulated within the cannula outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking." While not explicitly stated as an "acceptance criterion" from the predicate, it's a design feature described. |
| Dimensions (diameter range, overall length) | "The devices range in diameter from 4.5 to 10.5 Fr and have an overall length of 22 cm." These characteristics would be compared to the predicate device to establish equivalence. |
The study that proves the device meets the acceptance criteria:
The "study" in this context is a comparison to a predicate device using in-vitro performance and biocompatibility tests.
- Predicate Device: Jostra Arterial Perfusion Cannulae (mentioned in the first section) and Research Medical Inc. Pediatric Aortic Cannula (mentioned in the "STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON"). It seems two different predicate devices are referenced for different aspects of the comparison.
The following information cannot be provided as it is not relevant to this type of medical device submission for a cannulae:
- Sample sized used for the test set and the data provenance (Not applicable for a physical device where "test set" implies algorithmic evaluation)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable)
- Adjudication method (Not applicable)
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance (Not applicable, as this is not an AI/ML device)
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done (Not applicable)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc) (Not applicable)
- The sample size for the training set (Not applicable, as there is no "training set" for a physical device)
- How the ground truth for the training set was established (Not applicable)
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510(k) Pre-Market Notification: Stöckert Pediatric Aortic Cannulae (11/19/02)
1623622
NOV 2 1 2002
| SUBMITTER: | Stöckert Instrumente GmbHLindberghstrasse 25D-80939 Munich Germany |
|---|---|
| CONTACT PERSON: | Mr. Helmut HöflDirector, Quality and Regulatory AffairsPhone: 49-89-323-010Fax: 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
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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.
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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
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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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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) : : ・ . : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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§ 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).