(25 days)
The Jostra Pediatric Arterial Perfusion 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 6 hours or less.
The Jostra Pediatric Arterial Perfusion 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 6 hours or less.
This document is a 510(k) summary for a medical device modification, specifically the Jostra Pediatric Arterial Cannulae. It discusses the device, its intended use, and a comparison to a predicate device. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study data.
Here's an analysis of what can be extracted and what is missing, based on the provided text:
Key Takeaway: This 510(k) is for a modification to an already cleared device. The primary change is a material change for the white depth markings. The risk analysis and testing focuses on the impact of this specific modification, not a comprehensive de novo validation of the entire device.
Information Extracted from the Document:
Given the nature of this 510(k) for a modification, the acceptance criteria and supporting studies are limited to addressing the impact of the material change.
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria / Hazard Addressed Reported Device Performance / Assessment General Hazards related to biocompatibility Evaluated (implicitly by showing no risk potential, likely through existing biocompatibility data for the new material or component) Hazards related to manufacturing: adhesiveness of the position marker Tested (implicitly by showing no risk potential, confirming the new material / manufacturing process maintains sufficient adhesiveness) Overall Safety and Effectiveness "The evaluation and test results do not show any kind of risk potential for the user and/or the patient. Based on the test results and evaluation the Pediatric Arterial Perfusion Cannulae are safe and effective for its intended use..." Substantial Equivalence "are substantially equivalent to the named predicate device. The modification does not alter the fundamental scientific technologies..." -
Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's implied the testing was conducted by Maquet Cardiopulmonary AG in Germany.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of device modification study. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices or those requiring subjective assessment. The evaluation here is for material and manufacturing properties.
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Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of diagnostic outcomes.
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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. This is not an AI-enabled diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-enabled device.
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The type of ground truth used:
- For biocompatibility: Likely laboratory testing results against established standards (e.g., ISO 10993).
- For adhesiveness of the position marker: Likely mechanical integrity testing results (e.g., tensile strength, peel strength) against internal specifications or performance of the predicate device's markings.
- The "ground truth" here is the pass/fail result of these engineering and safety tests.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device.
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How the ground truth for the training set was established:
- Not applicable.
Summary of Missing Information and Why:
The provided document is a 510(k) summary for a minor modification to an existing device (material change for markings). Such submissions are typically brief and focus on demonstrating that the change does not adversely affect safety or effectiveness, thus maintaining "substantial equivalence" to the predicate device.
Therefore, the document does not contain:
- Specific quantitative acceptance criteria with numerical targets.
- Detailed test protocols or raw data.
- Explicit sample sizes for specific tests.
- Information related to human readers, AI, or "ground truth" in the medical image analysis sense, as the device is a physical medical instrument (pediatric arterial cannulae).
- Information on training sets, as it's not an AI/ML device.
The "study" referenced is a "risk analysis method used... acc. to the logic of a Failure Modes and Effects Analysis (FMEA)" and subsequent "design verification tests." The results of these unspecified tests are summarily reported as showing "no kind of risk potential" and confirming safety and effectiveness.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be 'K072172'. The characters are written in a bold, somewhat rough style, with varying stroke thicknesses. The 'K' is distinct with its angled lines, followed by the rounded '0' and the numbers '7', '2', '1', '7', and '2'.
MAQUET
Special 510(k): Device Modification: Jostra Pediatric Arterial Cannulae
Fax:
July 31, 2007
Arterial Cannulae
cannula or tubing
510(k) SUMMARY
AUG 3 1 2007
SUBMITTER:
Maquet Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen, Germany
Phone: (011) 49 7478 921- 151
Jostra Pediatric Arterial Cannulae
(011) 49 7478 921- 400
Cardiopulmonary bypass vascular catheter,
Katrin Schwenkglenks
CONTACT PERSON:
DATE PREPARED:
DEVICE TRADE NAME:
COMMON/USUAL NAME
CLASSIFICATION NAME
PREDICATE DEVICES OR LEGALLY MARKETED DEVICES
Jostra Pediatric Arterial Cannulae
DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT
The Jostra Pediatric Arterial Perfusion 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 6 hours or less.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
Jostra Pediatric Arterial Cannulae are identical to the originally cleared Jostra Pediatric Arterial Cannulae, with the only exception that the Jostra Pediatric Arterial Cannulae uses a different material for the white depth markings. Besides this difference the devices are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.
RISK ANALYSIS
The risk analysis method used to assess the impact of the modification was done acc. to the logic of a Failure Modes and Effects Analysis (FMEA). The design verification tests were performed as a result of this risk analysis assessment.
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MAQUET
All possible risks for the user and the patient related to the design change (material change) have been assessed by evaluation or testing acc. to the risk analysis for the Pediatric Arterial Perfusion Cannulae. The following hazards have been addressed:
General hazards related to
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· biocompatibility
Hazards related to manufacturing -
· adhesiveness of the position marker
The evaluation and test results do not show any kind of risk potential for the user and/or the patient. Based on the test results and evaluation the Pediatric Arterial Perfusion Cannulae are safe and effective for its intended use and are substantially equivalent to the named predicate device. The modification does not alter the fundamental scientific technologies of the Pediatric Arterial Perfusion Cannulae.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2007
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K072172
Jostra Pediatric Arterial Perfusion Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: Class II Product Code: DWF Dated: July 31, 2007 Received: August 6, 2007
Dear Ms. Schwenkglenks:
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 may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Katrin Schwenkglenks
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Dwna R. Lachner
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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Indications for Use
510(k) Number (if known): Ko72172 Device Name: Jostra Pediatric Arterial Perfusion Cannulae
Indications for Use:
The Jostra Pediatric Arterial Perfusion 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 6 hours or less. .
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (Please do not write BELOW THIS LINE-Continue on another page OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
una R. Vahner
Division Sign Off
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Koral 72
Page l of i
(Posted November 13, 2003)
§ 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).