Courier ST Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the Iliac, Femoral and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Courier ST Catheters are not indicated for use in coronary arteries or the neurovasculature.

Device Description

The proposed Courier™ ST Balloon Dilatation catheter is an over-the-wire catheter with three lumens. The Courer™ ST Balloon Dilatation catheters are recommended for percutaneous transluminal angioplasty of the Iliac, Femoral and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

AI/ML Overview

The provided document, a 510(k) premarket notification for the Medi-tech Courier™ ST Balloon Dilatation Catheter, describes the acceptance criteria and performance testing conducted. However, it does not contain information typically associated with studies proving device performance against acceptance criteria in the context of diagnostic or AI-assisted devices as outlined in your request.

This document is for a medical device (a balloon dilatation catheter) and focuses on "functional tests" and "biocompatibility tests" rather than diagnostic performance metrics like sensitivity, specificity, or AUC, or studies involving human readers and AI assistance.

Here's an analysis of the provided text in relation to your specific questions:

1. A table of acceptance criteria and the reported device performance

The document lists the types of tests performed, but it does not specify quantitative acceptance criteria (e.g., "Burst pressure > X psi") or the exact numerical results for each test. Instead, it broadly states that "The following in vitro functional tests were performed" and "The following biocompatibility tests were performed."

Acceptance Criteria Category	Reported Device Performance (as described in the document)
In vitro Functional Tests
Balloon Burst Testing	Performed
Multiple Inflation Testing	Performed
Inflation/Deflation Time Testing	Performed
Balloon Compliance Testing	Performed
Balloon Proximal Bond Testing	Performed
Sheath Withdrawal Testing	Performed
Biocompatibility Tests
Intracutaneous Reactivity	Performed
Sensitization	Performed
Cytotoxicity	Performed
Acute Systemic Toxicity	Performed
Haemocompatibility	Performed (completed as Hemolysis)
Pyrogenicity	Performed
Genotoxicity	Performed (completed as Mutagenicity)

The conclusion states: "Based on the Indications for Use, technological characteristics and safety and performance testing, the Courier® ST Balloon Dilatation Catheter has been shown to be safe and effective for its intended use." This implies the device met the unstated acceptance criteria for these tests.

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes (e.g., number of catheters tested) for any of the functional or biocompatibility tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, as these are typically not relevant for in vitro functional and biocompatibility testing of a physical medical device.

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

This question is not applicable to the type of device and testing described. Functional and biocompatibility tests for a balloon catheter do not involve expert interpretation or ground truth establishment in the way diagnostic imaging or AI devices do. The "ground truth" for these tests would be objective measurements (e.g., pressure readings, material analysis).

4. Adjudication method for the test set

Not applicable. There's no human interpretation or subjective assessment that would require an adjudication method.

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. This device is a physical medical instrument (a catheter), not a diagnostic AI or imaging device that would involve human readers or AI assistance in a diagnostic capacity.

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

Not applicable. This device is a physical medical instrument and does not involve an algorithm.

7. The type of ground truth used

For the functional tests, the ground truth would be based on objective physical measurements (e.g., burst pressure, inflation/deflation times, bond strength). For biocompatibility tests, the ground truth would be based on standardized laboratory assays and toxicology principles to assess the material's interaction with biological systems.

8. The sample size for the training set

Not applicable. This device does not use an "algorithm" or a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI or diagnostic application. Therefore, many of the questions regarding AI performance criteria, expert adjudication, MRMC studies, and training/test sets are not relevant to the information presented. The document confirms that standard functional and biocompatibility tests were performed and concluded that the device is safe and effective, implying it met the necessary (though unspecified) acceptance criteria for those tests.

Summary

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444444

Medi-tech Courier™ ST Balloon Dilatation Catheter

July 21, 1997

ATTACHMENT H

DEC | | | |997

SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects... "

The summary regarding the adverse health effects of the proposed Courier™ ST Balloon Dilatation Catheter is as follows:

Trade Name:	Courier™ ST Balloon Dilatation Catheter
Manufacturer:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760
Device Generic Name:	Balloon Dilatation Catheter
Classification:	According to Section 13 of the Federal Food, Drug and Cosmetic Act, thedevice classification is Class II, Performance Standards.

Predicate Devices:

The following devices are referenced in this premarket notification as predicate device for the Courier™ ST Balloon Dilatation Catheter:

BSC - Courier Balloon Dilatation Catheter

All of the devices mentioned above have been determined substantially equivalent by FDA.

Device Description:

Safety and Performance:

The following in vitro frunctional tests were performed on the Courier™ ST Balloon Dilatation Catheter:

Balloon Burst Testing
. Multiple Inflation Testing
. Inflation/Deflation Time Testing
Balloon Compliance Testing .
Balloon Proximal Bond Testing ●
. Sheath Withdrawal Testing

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Medi-tech Courier™ ST Balloon Dilatation Catheter

The following biocompatibility tests were performed:

Intracutaneous Reactivity .
Sensitization .
Cytotoxicity .
Acute Systemic Toxicity .
Haemocompatibility (completed as Hemolysis) .
Pyrogenicity .
Genotoxicity (completed as Mutagenicity) .

Conclusion:

Based on the Indications for Use, technological characteristics and safety and performance testing, the Courier® ST Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Rockville MD 20857

DEC I I 1997

Ms. Mary P. LeGraw Regulatory Affairs Project Manager Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

Re : K972744 Courier STTM Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: LIT Dated: November 6, 1997 November 8, 1997 Received:

Dear Ms. LeGraw:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prìor 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information'on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

K972744 510(k) Number (if known):

Courier ST Balloon Dilatation Catheter Device Name:

Indications For Use:

Courier ST Catheters are not indicated for use in coronary arteries or the neurovasculature.

(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, Respiratory, and Neurological Devices
510(k) Number	K972744
Prescription Use(Per 21 CFR 801.109)	✓
OR	Over-The-Counter Use

(Optional Format 1-2-96)

は、

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).