The Renegade Fiber Braided Microcatheter is intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable quidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

Device Description

The device is a 3.0F/2.5F, single lumen catheter constructed with progressively softer shaft characteristics from its proximal to its distal ends. The device is tracked coaxially over a selectively placed guide wire. To facilitate catheter introduction, the device incorporates a hydrophilic coating applied to the outer sufface of the shaft. Once the subselective region has been accessed, the lumen of the catheter can be used for infusion of diagnostic agents, such as contrast medium, and therapeutic materials. The device is available in useable lengths of 130 cm and 150 cm and in distal segment lengths of 10cm, 20cm, and 30cm.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (intravascular infusion catheter) submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies that establish specific acceptance criteria and prove performance against those criteria in the way a modern clinical trial or AI/ML study would.

Therefore, the specific information requested in your prompt regarding acceptance criteria, study design for proving performance, and details related to AI/ML device testing (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in this document.

Historically, 510(k) submissions, especially from 1997, relied heavily on comparing device characteristics (materials, dimensions, mechanical properties, biocompatibility) and intended use to existing, legally marketed predicate devices. The "study" in this context refers to the comparison to predicate devices and bench/animal testing to show that any differences do not adversely affect safety and effectiveness.

Here's an attempt to answer based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific tensile strength, burst pressure, or flow rate thresholds that would confirm it "meets" a standard). Instead, the acceptance criteria are implicitly that the device is "substantially equivalent" to the predicate devices and that any dimensional/material differences "do not adversely affect safety and effectiveness."
Reported Device Performance: The document states that "mechanical, biocompatibility and animal testing demonstrated that these differences [between the proposed device and predicate] do not adversely affect safety and effectiveness." However, it does not provide specific performance values (e.g., actual tensile strength measurements, flow rates, or animal study outcomes) to put into a table.

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

Test Set Sample Size: Not specified. The document mentions "mechanical, biocompatibility and animal testing," but doesn't detail the number of units tested, animals used, or the origin of any data (e.g., country).
Data Provenance: Not specified.

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

This concept is not applicable to this type of device submission. There is no "ground truth" established by experts in the context of an AI/ML device for this intravascular catheter. Testing would have involved engineering assessments and biological responses.

4. Adjudication method for the test set

Not applicable. There's no mention of a process requiring expert adjudication for assessing the performance of this type of catheter.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are specific to diagnostic devices (often imaging-based) involving multiple human readers interpreting cases, usually with and without AI assistance. This is an intravascular catheter.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used

The "ground truth" (or basis for evaluation) for this device would be established by:
- Predicate Device Performance: The accepted safety and effectiveness profile of the Evolution Microcatheter, Eddy Infusion, TurboTracker Infusion Catheter, and Venture II™ Intravascular Infusion catheters.
- Biocompatibility Standards: Compliance with established biocompatibility testing standards to ensure the materials are safe for in-vivo contact.
- Mechanical Performance Specifications: The device's mechanical properties (e.g., flexibility, pushability, trackability, burst pressure) meeting internal design specifications and being comparable to predicate devices in a way that doesn't raise new safety/effectiveness concerns.
- Animal Study Endpoints: For animal testing, outcomes related to tissue reaction, thrombus formation, or successful navigation/infusion without adverse events.

8. The sample size for the training set

Not applicable. There is no AI/ML component or "training set" in this context.

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

Not applicable.

In summary: The provided document is a 510(k) summary for a conventionally regulated medical device from 1997. It demonstrates substantial equivalence primarily through comparison to predicate devices and confirmation that any differences do not negatively impact safety and effectiveness, based on "mechanical, biocompatibility and animal testing." It does not contain the specific details about acceptance criteria, study sizes, expert involvement, or AI/ML-specific testing methodologies that your prompt requests, as those concepts are either not relevant to this type of device or were not part of regulatory submissions in that era.

Summary

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NOV 19 1997

SUMMARY OF SAFETY AND EFFECTIVENESS K973645

Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

A. GENERAL INFORMATION

Owner Operator Submitting	Boston Scientific Corporation
this Premarket Notification:	One Boston Scientific Place
	Natick, MA 01757
	(508) 650.8174
Contact Person:	Wanda M. Carpinella
	Regulatory Affairs Department
Device Generic Name:	Intravascular Infusion Catheter
Device Classification:	74 DQO Catheter, Intravascular, Diagnostic

B. INDICATIONS FOR USE

C. DESCRIPTIVE CHARACTERISTICS

D. SUBSTANTIAL EQUIVALENCE

The proposed microcatheter is substantially equivalent to the Evolution Microcatheter, and the Eddy Infusion, TurboTracker Infusion Catheter and Venture II™ Intravascular Infusion catheters. Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical, biocompatibility and animal testing demonstrated that these differences do not adversely affect safety and effectiveness.

E. PACKAGING, STERILIZATION, AND PYROGENICITY

The proposed catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas.

F. CONCLUSION

Based on the information presented, Boston Scientific Corporation believes that the proposed infusion catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed intravscular infusion catheters.

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Image /page/1/Picture/2 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 a double helix-like design intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1997

Ms. Wanda M. Carpinella Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

K973645 Re: Fiber-braided Microcatheter Requlatory Class: II (two) Product Code: 74 KRA Dated: September 22, 1997 Received: September 24, 1997

Dear Ms. Carpinella:

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 requlations 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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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. Wanda M. Carpinella

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

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K973645

Renegade™ Fiber Braided Microcatheter with Device Name: Hydropass™ Ccating

The Renegade Fiber Braided Microcatheter is Indications for Use: intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

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

Concurrence of CDRH, Office of Device Evaluaiton (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, nd Neurological Device : Number

Prescription Use (Per 21 CRF 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).