A patient with isolated pulmonary stenosis.
A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Device Description

The NuMED, Inc. Tyshak Mini Pediatric PTV catheter is a coaxial catheter for use in PTV applications where a small introduction site is necessary. The catheters inner and outer shafts are constructed of polymeric tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polymeric material. This balloon is of the non-compliant variety. This balloon is designed to insert through the smallest possible introduction sleeve. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter is blue in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y connector and the inflation extension is labeled with balloon diameter x balloon length x introducer size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches. The Tyshak Mini catheter is available in standard diameters from 3mm to 10mm. The lengths available will be 0.8cm - 4cm. The Guidewire size will be 0.014'', and the shaft size will be 2.5Fr and 3.5Fr.

AI/ML Overview

The provided text describes the NuMED Tyshak Mini Pediatric PTV Catheter as a device for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in pediatric applications. However, it does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on:

Device Description: What the catheter is made of and its specifications.
Biocompatibility Testing: States that the materials are the same as an already approved device and meet biocompatibility guidance.
Laboratory (Bench) Testing: Mentions that bench testing was performed in accordance with GMPs and results are on file, but does not provide any specific results or acceptance criteria for these tests.
Intended Use/Indications For Use: Specifies the medical conditions for which the catheter is intended.
Comparison Information: Compares the new device (with additional sizes) to the previously approved Tyshak Mini catheter, highlighting expanded size ranges.
Substantial Equivalence Determination: The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. This is a regulatory pathway, not a performance study proving specific clinical acceptance criteria.

Therefore, many of the requested details about acceptance criteria and a study proving performance cannot be extracted from the provided text because such information is not present. The document primarily serves as a 510(k) submission for substantial equivalence based on prior device approval and bench testing.

Here's an attempt to answer based on the available information, noting where information is explicitly not present:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as implied or stated)	Reported Device Performance	Source/Comment
Biocompatibility	Compliance with Tripartite Biocompatibility Guidance for Medical Devices.	Materials from the new device are the same as the already approved Tyshak Mini Catheter (510/k #K003276) which were tested for biocompatibility. All materials demonstrate biocompatibility.	Biocompatibility Testing section. Specific test results (e.g., cytotoxicity, sensitization) are not detailed but stated to be on file.
Manufacturing Quality	Adherence to Good Manufacturing Practices (GMPs).	All bench testing was performed in accordance with GMP's.	Laboratory (Bench) Testing section. This is an adherence criterion, not a performance metric for the device itself.
Material/Design Equivalence	Materials, construction, and principle of operation are substantially equivalent to predicate device.	Materials (Shaft: Pebax, Balloon: PES2, Image Band: Platinum) and construction (Coaxial with distally mounted non-compliant balloons) are identical to the predicate device.	Comparison Information table and Device Description.
Dimensional Specifications	Specific ranges for introducer, shaft, guidewire, usable length, balloon diameter, and balloon length.	Introducer: 2.5Fr - 3.5Fr; Shaft Size: 3Fr - 4Fr; Guidewire Size: 0.014"; Usable Length: 20cm - 65cm; Balloon Diameter: 3mm - 10mm; Balloon Length: 0.8cm - 4cm.	Comparison Information table. These are design specifications, not performance acceptance criteria from a study.
Clinical Performance	(No specific clinical acceptance criteria, e.g., success rate, complication rate, are provided.)	(No clinical performance data is reported in this document.)	Not provided.

2. Sample Size for Test Set and Data Provenance

Test Set Sample Size: Not applicable. This document does not describe a clinical performance study with a test set of patient data. The "bench testing" mentioned refers to laboratory tests, not a clinical study involving patient samples.
Data Provenance: Not applicable. No clinical data is presented. The document refers to "bench testing" and "biocompatibility testing," which are laboratory tests, not human data.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. There is no mention of a study involving experts establishing ground truth for a test set. The FDA's substantial equivalence determination is based on comparison to an existing device, not an evaluation of diagnostic or interventional performance against expert ground truth.

4. Adjudication Method

Not applicable. No study involving human experts and ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe an MRMC study or any study comparing human reader performance with or without AI assistance. This device is a catheter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical catheter, not an algorithm, so a standalone algorithm performance study is not relevant or described.

7. Type of Ground Truth Used

Not applicable. No ground truth for a diagnostic or interventional performance study is mentioned. The "ground truth" implicitly referred to for establishing substantial equivalence is the technical specifications and safety profile of the predicate device (NuMED Tyshak Mini Catheter 510/k #K003276) and compliance with relevant standards (biocompatibility, GMP).

8. Sample Size for Training Set

Not applicable. This document is for a physical medical device (catheter), not an AI/ML algorithm that employs a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable. As above, this is not an AI/ML device, so there is no training set or associated ground truth.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA

August 21, 2003

Submitted By: NuMED, Inc., 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491

Contact Person: Nichelle LaFlesh

NuMED Tyshak Mini Pediatric PTV Catheter; 21 CFR 870.1250 -Device Name: Percutaneous Catheter

Predicate Devices: NuMED Tyshak Mini Pediatric PTV Catheter

Device Description :

Biocompatibility Testing:

The materials used in the NuMED Tyshak Mini Pediatric PTV Catheter are the same as those used in the already approved Tyshak Mini Catheter (510/k) #K003276) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices.

Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc. Copies are included in this section.

Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc.

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Intended Use:

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.

A patient with isolated pulmonary stenosis.
A patient with valvular pulmonary stenosis with other minor congenital heart disease ■ that does not require surgical intervention.

Comparison Information:

MODEL:	NUMED TYSHAK MINI	NUMED TYSHAK MINI WITHADDITIONAL SIZES
Indications:	This catheter is recommendedfor Percutaneous TransluminalValvuloplasty (PTV) of thepulmonary valve in Pediatricapplications.A patient with isolatedpulmonary stenosis. A patient with valvularpulmonary stenosis withother minor congenitalheart disease that doesnot require surgicalintervention.	This catheter is recommendedfor Percutaneous TransluminalValvuloplasty (PTV) of thepulmonary valve in Pediatricapplications.A patient with isolatedpulmonary stenosis. A patient with valvularpulmonary stenosis withother minor congenitalheart disease that doesnot require surgicalintervention.
Introducer:	2.5Fr - 3.5Fr	2.5Fr - 3.5Fr
Shaft Size:	3Fr - 4Fr	3Fr - 4Fr
Guidewire Size:	0.014"	0.014"
Usable Length:	65cm	20cm - 65cm
Balloon Diameter:	4mm - 10mm	3mm - 10mm
Balloon Length:	2cm - 4cm	0.8cm - 4cm
Materials:	Shaft: PebaxBalloon: PES2Image Band: Platinum	Shaft: PebaxBalloon: PES2Image Band: Platinum
Construction:	Coaxial construction withdistally mounted non-compliantballoons.	Coaxial construction withdistally mounted non-compliantballoon.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuMED. Inc. c/o Ms. Nichelle R. LaFlesh Regulatory Affairs Manager 2880 Main Street Hopkinton, NY 12965

Re: K032591

Trade Name: NuMED, Inc. Tyshak Mini Pediatric PTV Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 21, 2003 Received: August 22, 2003

Dear Ms. LaFlesh:

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.

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

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Page 2 - Ms. Nichelle R. LaFlesh

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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Bran 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):

Device Name: NuMED Tyshak Mini Pediatric PTV Catheter

Indications For Use:

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.

A patient with isolated pulmonary stenosis. 트
A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).