Blue Max 20 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.

Device Description

The proposed Blue Max™ -20 Balloon Dilatation catheter is an over-the-wire catheter with two lumens indicated for percutaneous transluminal angioplasty of narrowed or obstructed vessels in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Blue Max™ -20 Balloon Dilatation Catheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the information provided primarily revolves around in vitro functional testing and biocompatibility testing, not human clinical trials or AI-based performance metrics.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Criteria (if specified)	Reported Device Performance
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	Cytotoxicity	Performed
	Irritation	Performed
	Hemolysis	Performed
	Acute Systemic Toxicity	Performed
	Mutagenicity	Performed
	Sensitization	Performed
	Implantation	Performed
	Pyrogenicity	Performed
	Subchronic Toxicity	Performed

Note: The document states these tests were "performed" but does not provide specific numerical acceptance criteria (e.g., "burst pressure must exceed X psi") or the exact results obtained from these tests. The conclusion simply states that based on the testing, the device is "safe and effective for its intended use."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for any of the in vitro or biocompatibility tests.
Data Provenance: The tests would have been performed by Boston Scientific Corporation or their designated testing facilities. The country of origin of the data is not explicitly stated beyond the manufacturer being in Natick, MA. These are laboratory tests, not human data, so "retrospective or prospective" does not apply in the typical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to the studies described. The "ground truth" for in vitro functional and biocompatibility tests is typically established through standardized protocols and validated measurement techniques, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This is not applicable to the studies described, as "adjudication method" usually refers to resolving discrepancies in expert interpretations of data in clinical or image-based studies.

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

No. An MRMC study was not described. This device is a physical medical device (balloon catheter), not an AI algorithm or an imaging device requiring human reader interpretation, so AI assistance is not relevant here.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

For the in vitro functional tests, the ground truth would be based on engineering specifications and established test methodologies to assess physical performance characteristics (e.g., burst pressure, inflation time, bond strength).
For biocompatibility tests, the ground truth would be based on validated biological endpoints as defined by ISO standards and regulatory guidelines (e.g., cell viability, irritation response, systemic toxicity).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study. The device itself is manufactured. There isn't a "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set was Established

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

In Summary:

The K972357 submission for the Medi-tech Blue Max™ -20 Balloon Dilatation Catheter demonstrates safety and effectiveness primarily through in vitro functional testing and biocompatibility testing to establish substantial equivalence to predicate devices. It does not involve AI, human clinical trials with patient outcomes, or expert-adjudicated ground truth as would be seen in diagnostic device or AI software submissions. The provided document lists the types of tests performed but lacks specific numerical acceptance criteria or detailed results. The FDA's letter confirms substantial equivalence based on the submitted information.

Summary

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K972357

Medi-tech Blue Max™ -20 Balloon Dilatation Catheter

June 24, 1997

ATTACHMENT H

NOV 1 9 1997 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 Blue Max™ -20 Balloon Dilatation Catheter is as follows:

Trade Name:	Blue Max™ -20 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 devices for the Blue Max™ -20 Balloon Dilatation Catheter:

BSC -- Blue Max Balloon Dilatation Catheter BSC -- Ultra-thin Diamond 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 Blue Max™ -20 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 Blue Max™ -20 Balloon Dilatation Catheter

The following biocompatibility tests were performed:

Cytotoxicity .
Irritation .
Hemolysis .
Acute Systemic Toxicity .
Mutagenicity .
Sensitization .
Implantation .
Pyrogenicity .
Subchronic Toxicity .

Conclusion:

Based on the Indications for Use, technological characteristics and safety and performance testing, the Blue Max™ -20 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Career States

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HU. AN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 19 1997

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

Re: K972357 Blue Max-20™ Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: 74 LIT Dated: November 5, 1997 Received: November 6, 1997

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 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). 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 Regulations, 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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Page 2 - Ms. Mary P. LeGraw

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 requlation (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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New Application

510(k) Number (if known):

Blue Max 20 Balloon Dilatation Catheter Device Name:

Indications For Use:

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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).