SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 by SPECTRANETICS CORP.

The Spectranetics Support Catheters are designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

The Spectranetics Support Catheters are intravascular catheters, available in 3 models. Model 518-016 is a 0.014 inch guidewire compatible, 3.0 French (Fr.) outside diameter catheter. Model 518-017 is a 0.018 inch guidewire compatible. 3.4 Fr. outer diameter catheter. The new device, Model 518-028 is a 0.035 inch guidewire compatible, 4.8 Fr. outer diameter catheter. All models have a working length of 135 centimeters. All models have a radiopaque marker 2-3 mm from its tapered distal tip. A standard female luer is placed on the proximal end of each model. The distal 40 cm of each model is coated with a lubricious, hydrophilic coating.

AI/ML Overview

The provided text describes a premarket notification (510(k)) for the Spectranetics 0.035" Support Catheter. This is a medical device submission, not an AI/ML device, and therefore the criteria typically associated with AI/ML device performance (like accuracy metrics, ground truth, expert adjudication, MRMC studies) are not applicable.

The "acceptance criteria" for a medical device in a 510(k) submission generally refer to demonstrating substantial equivalence to a legally marketed predicate device, proving it is safe and effective for its indicated use through non-clinical testing.

Here's a breakdown of the information relevant to this specific device, framed as best as possible to your request, but highlighting where AI/ML specific information is irrelevant:

1. Table of "Acceptance Criteria" and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Design, Construction, Indications, Target Population, Risk Analysis, Performance, Materials (similar to predicate devices K991059 and K935425)	The Spectranetics Support Catheters (0.014", 0.018", and new 0.035") are similar in these aspects to predicate devices K991059 (Spectranetics 0.014" and 0.018" Support Catheters) and K935425 (Medtronic Buchbinder Transfer Catheter).
Safety and Effectiveness (for indicated use)	"Testing performed for the Spectranetics Support Catheter provides reasonable assurance that the device will perform in a safe and effective manner when used as indicated."
Mechanical/Physical Performance: Tensile Strength, Functionality, Visibility, Flow Rate	"The design validation protocols and risk analysis addressed all known aspects of the device including tensile strength, functionality, visibility, flow rate..." (Specific numerical results are not provided in this summary.)
Biocompatibility	"...sterility, and biocompatibility." (Specific test results are not provided.)
Sterility	"...sterility, and biocompatibility." (Specific test results are not provided.)

Study Proving Device Meets "Acceptance Criteria":

The study proving the device meets the "acceptance criteria" is a series of non-clinical tests conducted as part of the Spectranetics New Product Introduction procedure, in concert with Quality System Regulations. The submission states: "The design validation protocols and risk analysis addressed all known aspects of the device including tensile strength, functionality, visibility, flow rate, sterility, and biocompatibility."

The conclusion is: "The results of the testing demonstrate that the Spectranetics 0.035" Support Catheter is substantially equivalent to the predicate devices and it will perform in a safe and effective manner when used as indicated."

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

Test Set Sample Size: Not specified in the provided text. The testing methods mentioned (tensile strength, functionality, visibility, flow rate, sterility, biocompatibility) suggest laboratory-based, non-clinical tests rather than human subject testing with a specific "test set" as understood in AI/ML.
Data Provenance: The tests were conducted by Spectranetics Corporation as part of their internal design validation and quality system procedures. No information on country of origin for "data" (beyond being internal Spectranetics data) or retrospective/prospective status is relevant or available for this type of submission.

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 medical device submission. Ground truth for AI/ML models involves human expert annotations or independent verification of outcomes. For a physical device like a catheter, "ground truth" is established through engineering specifications, material science, and performance standards. The "experts" would be the engineers, quality control personnel, and potentially external laboratories conducting the specified tests. Their qualifications are inherent in their roles in medical device development and testing.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve discrepancies in expert labeling or diagnoses. For physical device testing, outcomes are typically quantitative measurements or pass/fail criteria based on predefined specifications.

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 comparative effectiveness study was not done. This type of study is specific to diagnostic imaging devices or AI/ML systems where human readers interpret medical images or data. The Spectranetics Support Catheter is a physical intravascular catheter.

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

Not applicable. This device is not an algorithm. Its performance is evaluated intrinsically through physical and material tests, and its function involves human intervention for placement and use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this physical medical device, "ground truth" is effectively defined by engineering specifications, material standards, and performance benchmarks verified through physical, chemical, and biological testing (e.g., tensile strength testing against a standard, biocompatibility testing per ISO standards). No expert consensus, pathology, or outcomes data in the AI/ML sense were used to establish the "ground truth" for these tests.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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

SEP 2 3 2002

Spectranetics

we get vour hlood flowing

Premarket Notification 510(k) Summary

Submitted By: Michael J. Ryan RA Manager Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907 Signature and Date:

Michael J. Jr. 1 July 2002

Device Trade Name: Common Name: Classification Name:

Device Description:

Indications for Use:

Substantial Equivalence:

Spectranetics 0.035" Support Catheter. Intravascular Catheter Percutaneous Catheter, CFR 870.1250

This product is substantially equivalent in design, composition, function, and intended use to the Spectranetics Support Catheter, 510(k) K991059, November 6, 1999, and the Medtronic Buchbinder Transfer Catheter, 510(k) K935425.

Coronary Arten Disease Therans

Cardian Lead Removal Systems

Peripheral Vascular
Disease Therapy

CVX-300 Excimer Technology TRANETICS CORPORATION 96 Talamine Court CO 80907-5186 Tel. 719-633-8333 Fax: 719-633-879

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

1622138

Technological Characteristics & Nonclinical Testing Summary:

The Spectranetics Support Catheters are similar in design, construction, indications, target population, risk analysis, performance and materials to the predicate devices, the Spectranetics 0.014" and 0.018" Support Catheters, K991059. Spectranetics New Production Introduction procedure has been used in concert with the Quality System Regulations for the introduction of the 0.035" Support Catheter. The design validation protocols and risk analysis addressed all known aspects of the device including tensile strength, functionality, visibility, flow rate, sterility, and biocompatibility. Testing performed for the Spectranetics Support Catheter provides reasonable assurance that the device will perform in a safe and effective manner when used as indicated

The Spectranetics 0.014", 0.018", and the new 0.035" Support Catheters are similar in the indications for use as the Medtronic Buchbinder Catheter (K935425), the previous predicate device for the Spectranetics 0.014" and 0.018" Support Catheter, K991059.

The results of the testing demonstrate that the Spectranetics 0,035" Conclusions: Support Catheter is substantially equivalent to the predicate devices and it will perform in a safe and effective manner when used as indicated.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with wavy lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2002

Mr. Michael J. Ryan RA Manager Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907

Re: K022138

Spectranetics 0.035" Support Catheter, Model 518-028 Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II (two) Product Code: 74 DQY Dated: July 1, 2002 Received: July 2, 2002

Dear Mr. Ryan:

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 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.

{3}------------------------------------------------

Page 2 - Mr. Michael J. Ryan

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

D. Z. , M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Applicant:	Spectranetics Corporation96 Talamine CourtColorado Springs, CO 80907
510(k):
Device Name:	Spectranetics 0.014", 0.018", and 0.035" Support Catheters

Statement of Indications for Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K022138

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).