The Pediatric Arterial Cannula is used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure.

Device Description

The Polystan pediatric arterial cannula is single-use, disposable, sterile and non-pyrogenic device. The cannula has a tapered wire reinforced PVC body with an open beveled distal tip. Three depth indicator marks are positioned at approximately 2 cm intervals from the distal tip. A stylet is incorporated to assist cannulation. The proximal cannula end terminates with either a " /16" or ¼" capped connector incorporating a female luer fitting. The cannulae range in size from 6 Fr. to12 Fr.

AI/ML Overview

This K023251 submission is for a medical device (Pediatric Arterial Cannula), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria like sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies are not applicable.

However, I can provide information based on the device's summary of safety and effectiveness as a medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	In accordance with USP 23, USP 24, and ISO 10993	Biocompatibility testing performed and demonstrated substantial equivalence to predicate device.
Performance	Equivalent to predicate device (Jostra Pediatric Arterial Cannula)	Performance testing (blood pressure drop vs. flow rate, blood cell damage, integrity) performed and demonstrated substantial equivalence to predicate device.
- Blood Pressure Drop vs. Flow Rate	Implicitly, comparable to predicate device performance	Testing performed; result supported substantial equivalence.
- Blood Cell Damage	Implicitly, comparable to predicate device performance	Testing performed; result supported substantial equivalence.
- Integrity Test	Implicitly, comparable to predicate device performance	Testing performed; result supported substantial equivalence.
Intended Use	To introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure.	Device is designed and tested for this intended use, demonstrating equivalence to predicate device.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in the provided summary. The summary mentions "testing," but details on the number of units tested for each performance criterion are not provided.
Data Provenance: Not explicitly stated. Given that it's a submission from a Danish company (POLYSTAN A/S), the testing would likely have been conducted in their facilities or contracted labs, adhering to international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to a medical device like a cannula. "Ground truth" in this context typically refers to an expert-validated diagnosis or finding, which is relevant for diagnostic AI algorithms. For a physical device, performance is measured against established scientific and engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for subjective interpretations of data, often in the context of diagnostic assessments. Device performance testing relies on objective measurements and comparison to predefined acceptance criteria.

5. 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. MRMC studies are for evaluating diagnostic accuracy, particularly for image-based diagnostics with human readers, and the impact of AI assistance on those readers. This device is a physical cannula, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This question pertains to AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the AI/ML sense. For this device, the "ground truth" (or basis for evaluation) is established by:

Adherence to recognized biocompatibility standards (USP 23, USP 24, ISO 10993).
Comparative performance data against a legally marketed predicate device (Jostra Pediatric Arterial Cannula - K012617), implying that the predicate's established safety and performance serve as the benchmark.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

Summary

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K023251

1. Summary of Safety and Effectiveness
  DEC 0 4 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for PEDIATRIC ARTERIAL CANNULA as required by section 807.92(c).

Submitter's Information

Name:	POLYSTAN A/S
Address:	Walgerholm 8, 3500 Værløse, Denmark
Phone:	+ 45 44 65 15 66
Fax	+ 45 44 68 15 66
Contact person:	Dana Olsen, Regulatory Affairs
Date of preparation:	November 11, 2002

Device name:

Trade Name: Common/Usual name: Classification name:

Pediatric Arterial Cannula Pediatric Arterial Cannula Cardiopulmonary bypass vascular cannula (21 CFR - 870.4210) Catheter Stylet (21 CFR - 870.1380) Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting (21 CFR -870.4290)

Predicate Device Name(s):

Jostra Pediatric Arterial Cannula - 510(k) no. K012617

Device Description

Intended Use

Pediatric Arterial Cannula is used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure.

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Technological Characteristics Summary

The Polystan pediatric arterial cannulae have the same intended use as the predicate cannulae.

Biocompatibility testing of the Polystan Pediatric Arterial Cannulae was performed in accordance with the USP 23, USP 24 and the international standard ISO 10993 "Biological Evaluation of Medical Devices".

Performance and in-vitro testing included the blood pressure drop vs. flow rate test, blood cell damage test and the integrity test.

Conclusion:

The biocompatibility and performance test data demonstrated that the Polystan Pediatric Arterial Cannulae are substantially equivalent to the predicate device, the Jostra Pediatric Arterial Cannulae.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administrat 200 Corporate Boulevard Rockville MD 20850

DEC 0 4 2002

Polystan A/S c/o Ms. Dana Olsen Walgerholm 8, 3500 Værløse Denmark

Re: K023251

Pediatric Arterial Cannula Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter. Cannula, and Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: September 27, 2002 Received: September 30, 2002

Dear Ms. Olsen:

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 (sec 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. Dana Olsen

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) 594-4646. 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,

Kaitlin

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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Indication for Use

Statement of Indication for Use

The Pediatric Arterial Cannula is used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure.

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)


	(Division Sign-Off)
	Division of Cardiovascular
	and Respiratory Devices
510(k) Number	K03325/

Prescription Use		OR	Over-The-Counter Use	_
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Regulation Number and Section

§ 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).