indicated 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. A secondary function is the controlled selective regional infusion of contrast or therapeutic agents nto the peripheral vasculature.

Device Description

The proposed Channel™ Balloon catheter is an over-the-wire balloon catheter with four lumens indicated 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. A secondary function is the controlled selective regional infusion of contrast or therapeutic agents nto the peripheral vasculature.

AI/ML Overview

Here's an analysis of the provided text regarding the Medi-tech Channel 7M Balloon Catheter, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a Summary of Safety and Effectiveness for a 510(k) Premarket Notification. This type of submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials with specific statistical performance metrics. Therefore, many of the requested data points (like sample size for a test set, expert consensus for ground truth, or MRMC studies) are not typically present or required in this type of document for a medical device cleared in 1997. The information provided heavily emphasizes bench testing (in vitro functional tests) and biocompatibility testing.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for its functional tests. Instead, it lists the types of tests performed. Without the specific criteria, it's impossible to create a table directly comparing them to reported performance with numerical values. The conclusion broadly states the device "has been shown to be safe and effective," implying these tests met internal standards or common industry practices for that time.

Here's a breakdown of what can be inferred:

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary)
Balloon Functional Performance	All listed in vitro functional tests (Balloon Burst Testing, Multiple Inflation, Compliance, Inflation/Deflation Time, Sheath Withdrawal, Proximal Bond Tensile, Shaft Tensile, Flow Rate, Outer Sleeve Bonds, Flow Uniformity) were successfully performed.
Biocompatibility	All listed biocompatibility tests (Intracutaneous Reactivity, Sensitization, Cytotoxicity, Acute Systemic Toxicity, Haemocompatibility, Pyrogenicity, Mutagenicity) were performed, implying successful completion.
Vessel Depth of Penetration	Animal testing was conducted to establish this parameter, implying acceptable performance was observed.
Overall Safety and Effectiveness	Based on all testing, the device is concluded to be "safe and effective for its intended use."

Analysis of Supporting Studies

Given the context of a 510(k) submission from 1997, the "study" referred to is a collection of various tests rather than a single, comprehensive clinical trial with a defined test set.

1. A table of acceptance criteria and the reported device performance: As explained above, specific numerical criteria are not detailed in the provided summary. The table above provides the inferred categories.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for any of the individual functional or biocompatibility tests. For animal testing, the number of animals is not provided.
- Data Provenance: The manufacturer is Boston Scientific Corporation, located in Natick, MA, which suggests that the testing was conducted in the US or under their oversight. The data would be considered prospective in the sense that these tests were specifically designed and executed for this premarket submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For the types of functional and biocompatibility tests conducted, "ground truth" is typically established by standardized test methods (e.g., ASTM, ISO, or internal validated protocols) rather than expert consensus on diagnostic interpretations. These tests measure physical or biological properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data where there might be disagreement (e.g., reading medical images). Functional and biocompatibility tests have objective pass/fail criteria based on measured values.
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. MRMC studies are used for evaluating diagnostic devices, typically those involving human interpretation of images or data, often comparing AI assistance. This device is a balloon catheter for angioplasty and infusion; it's a therapeutic device, not a diagnostic one. No AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device (a catheter), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For functional tests: Ground truth is defined by established engineering specifications and validated test methods. For example, a burst pressure test would have a minimum pressure requirement.
- For biocompatibility tests: Ground truth is established by standardized biological response criteria (e.g., cytotoxicity levels, sensitization scores) as defined by ISO or FDA guidelines for medical device materials.
- For animal testing: Ground truth (Vessel Depth of Penetration) would be based on direct observation and measurement in the animal model according to predefined experimental protocols.
8. The sample size for the training set:
- Not Applicable. This device uses a traditional engineering design and testing approach, not a machine learning approach that requires training sets.
9. How the ground truth for the training set was established:
- Not Applicable. No training set was used.

Summary of what the document does provide:

The document serves as a summary for a 510(k) submission, demonstrating substantial equivalence to predicate devices primarily through:

A detailed list of in vitro functional tests performed on the catheter to ensure its mechanical and operational integrity.
A comprehensive list of biocompatibility tests to ensure the materials are safe for use in the human body.
Mention of animal testing to evaluate one specific performance aspect (Vessel Depth of Penetration).

The absence of detailed performance metrics, clinical trial data, or expert-driven evaluations reflects the regulatory requirements for this type of device and submission in the specified time period.

Summary

{0}------------------------------------------------

K970379

Medi-tech Channel 7M Balloon Catheter

January 31, 1997

ATTACHMENT I

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 cither 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 concearning adverse health effects ... "

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

Trade Name:	Channel™ Balloon 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 ChannelTM Balloon Dilatation Catheter:

BSC -- Courier Balloon Dilatation Catheter BSC -- Ultra-thin Diamond Balloon Catheter BSC -- Katzen Thrombolysis Guidewire LocalMed Inc. - Kaplan Simpson InfusSleeve Catheter

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

Device Description:

{1}------------------------------------------------

January 31, 1997

Medi-tech Channel TM Balloon Catheter

Safety and Performance:

The following in vitro frunctional tests were performed on the Channel™ Balloon Catheter:

Balloon Burst Testing 1.
Multiple Inflation Testing 2.
· 3. Balloon Compliance Testing
Inflation / Deflation Time Testing বা
Sheath Withdrawal Testing 5.
Proximal Bond Tensile Testig Q.
Shaft Tensile Testing 7.
Flow Rate Testing 8.
Outer Sleeve Distal and Proximal Bond Testing 9.
1. Flow Uniformity Testing

In addition, the following Biocompatibility Testing was performed:

1. Intracutaneousl Reactivity
Sensitization 2.
1. Cytotoxicity
1. Acute Systemic Toxicity
Haemocompatibility (completed as Hemolysis) న్.
1. Pyrogenicity
Mutagenicity 7.

Animal testing was also conducted to establish the Vessel Depth of Penetration for the proposed device.

Conclusion:

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

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).