The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the illiac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

Device Description

The AngioSculpt PTA Scoring Balloon Catheter with HydroCross™ Coating is a standard twolumen catheter with a scoring balloon near the distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure. As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).

AI/ML Overview

This section describes the acceptance criteria and study proving the device meets said criteria for the "AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating" based on the provided text.

Based on the provided document, the device described is a medical device, and the information presented is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device. This document does not describe the acceptance criteria and a study in the context of an AI/algorithm-driven device's performance metrics (e.g., sensitivity, specificity) against a ground truth established by experts.

Instead, the "acceptance criteria" discussed are related to the safety and effectiveness of a physical medical device, primarily through mechanical testing and biocompatibility testing, to demonstrate its substantial equivalence to a previously cleared predicate device.

Therefore, many of the requested categories for AI/algorithm performance studies are not applicable to this document. I will fill in the applicable information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance values for each criterion in the manner typical for AI/algorithm validation. Instead, it describes categories of tests performed to verify design outputs met design requirements and to confirm proper function and durability. The general outcome is that the device "demonstrated adequate device performance," and is "non-sensitizing, non-irritating, not systemically toxic, non-hemolytic, and non-mutagenic."

Acceptance Criteria Category (Evaluated Aspect)	Reported Device Performance (Summary)
Mechanical Performance
Catheter Diameter and Balloon Profile	Design outputs met design requirements; proper function and durability confirmed.
Device Preparation, Deployment, and Retraction	Design outputs met design requirements; proper function and durability confirmed.
Balloon Inflation and Deflation Time	Design outputs met design requirements; proper function and durability confirmed.
Catheter Bond (Tensile) Strength	Design outputs met design requirements; proper function and durability confirmed.
Tip Pull Strength	Design outputs met design requirements; proper function and durability confirmed.
Torque Strength	Design outputs met design requirements; proper function and durability confirmed.
Pushability, Trackability, Secure Edges	Design outputs met design requirements; proper function and durability confirmed.
Guidewire Compatibility	Design outputs met design requirements; proper function and durability confirmed.
Catheter Effective Length	Design outputs met design requirements; proper function and durability confirmed.
Catheter Surface Appearance	Design outputs met design requirements; proper function and durability confirmed.
Luer Compatibility	Design outputs met design requirements; proper function and durability confirmed.
Coating Length	Design outputs met design requirements; proper function and durability confirmed.
Coating Thickness	Design outputs met design requirements; proper function and durability confirmed.
Coating Lubricity	Design outputs met design requirements; proper function and durability confirmed.
Coating Integrity	Design outputs met design requirements; proper function and durability confirmed.
Particulate Evaluation	Design outputs met design requirements; proper function and durability confirmed.
Rated Burst Pressure	Design outputs met design requirements; proper function and durability confirmed.
Compliance	Design outputs met design requirements; proper function and durability confirmed.
Device Fatigue	Design outputs met design requirements; proper function and durability confirmed.
Flexibility and Kink	Design outputs met design requirements; proper function and durability confirmed.
Biocompatibility
Cytotoxicity	Non-cytotoxic (MEM Elution Test using L-929 Mouse Fibroblast cells).
Sensitization	Non-sensitizing (Guinea Pig Maximization Sensitization Test).
Irritation	Non-irritating (Intracutaneous Reactivity/Irritation Test).
Systemic Toxicity (Acute & Material-Mediated)	Not systemically toxic (Acute Systemic Injection Test, Material Mediated Pyrogens).
Hemocompatibility	Non-hemolytic (Partial Thromboplastin Time (PTT), Hemolysis Direct Contact/Extract Method, Direct Contact Complement Activation).
Thrombogenicity (in vivo)	No thrombo-embolism observed in GLP animal study under simulated use conditions.
Genotoxicity	Non-mutagenic (Reverse Bacterial Mutation, In vitro Mouse Lymphoma Assay-Extended Treatment, Rodent bone Marrow Micronucleus Assays).

Note: The document states that "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised."

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

Sample Size for Test Set: The document refers to "Test articles consisted of finished sterilized catheters" for bench testing. It does not specify the exact number of devices tested for each mechanical or biocompatibility test. For biocompatibility, it indicates studies were conducted, including a GLP animal study for thrombogenicity.
Data Provenance: The studies were conducted by Spectranetics, Inc. (the submitter). The context implies these were internal tests conducted to support the 510(k) submission. No information on country of origin of data (beyond the applicant being US-based) or retrospective/prospective nature is explicitly stated, though a GLP animal study would be prospective.

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

This is not applicable to this type of device submission. The "ground truth" for a physical medical device's performance is established by standardized testing methods and regulatory requirements, not expert consensus on diagnostic interpretations.

4. Adjudication method for the test set:

Not applicable for this type of device validation. Adjudication methods are typically for evaluating human or AI performance against a "truth" in diagnostic settings.

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 balloon catheter), not an AI diagnostic tool that assists human readers.

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, not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for the performance of this physical medical device is based on engineering specifications, established standards, and regulatory requirements for mechanical integrity, functional performance, and biocompatibility. For example, for biocompatibility, the ground truth is "non-toxic," "non-irritating," etc., as defined by ISO 10993-1:2009 and FDA GLP regulations. For mechanical tests, the ground truth is that the device must meet predefined design requirements and exhibit proper function and durability.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2016

Spectranetics, Inc. Kimberley Kline Senior Manager, Regulatory Affairs 5055 Brandin Court Fremont, CA 94538

Re: K142983

Trade/Device Name: AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: February 5, 2015 Received: February 6, 2015

Dear Ms. Kline:

This letter corrects our substantially equivalent letter of March 4, 2015.

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Misti L. Malone -S

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

Enclosure

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2016

Spectranetics, Inc. Kimberley Kline Senior Manager, Regulatory Affairs 5055 Brandin Court Fremont, CA 94538

Re: K142983

Dear Ms. Kline:

This letter corrects our substantially equivalent letter of March 4, 2015.

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

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http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Misti L. Malone -S

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

Enclosure

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510(k) Summary for the AngioSculpt Scoring Balloon Catheter with HydroCross™ Coating

1. Submitter's Name / Contact Person

Submitter:	Spectranetics, Inc.5055 Brandin CourtFremont, CA 94538
Contact Person:	Kimberley KlineSenior Manager, Regulatory AffairsPhone: 510-933-7989Fax: 510-933-7994

February 23, 2015 Summary Preparation Date:

2. General Information

Trade Name:	AngioSculpt® PTA Scoring Balloon Catheter withHydroCross™ Coating
Common / Usual Name:	Angioplasty catheter
Classification Name:	Percutaneous catheter
Product Codes:	LIT
Predicate Devices:	AngioSculpt® Scoring Balloon Catheter(K112182/K122685/K133998)

3. Indications for Use

4. Device Description

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As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).

Image /page/5/Figure/1 description: The image shows a medical device with a long, thin tube and a handle. The tube has a transition tube with a HydroCross coating. The handle is purple and has the word "AngioScore" printed on it. The device appears to be designed for use in medical procedures.

5. Technological Characteristics

The 2.0-6.0mm x 100mm AngioSculpt catheters with HydroCross™ Coating incorporate substantially equivalent design, dimensional, and performance specifications when compared to the 510(k) cleared AngioSculpt catheters (K112182; 4.0-6.0x100/K122685; 2.0-3.5x100/K133998; 4.0-6.0x200). The following minor differences are noted:

o The scoring element incorporates the same type of inner rings that may aid in scoring element deployment as the catheters cleared under K133998.
The hydrophilic coating cleared under K133998 was added to the transition tube of the catheters to improve lubricity and deliverability.
. The transition tube material was changed from Pebax 55 for manufacturability. This is the same material as cleared under K133998.
. The inner member of the subject catheters is of the same design as the currently marketed 2.0 – 6.0mm x 100mm product; however, the middle layer of the subject catheters will consist of two material options: plexar or orevac. The inner member outer layer of the 4.0 -6.0mm x 100mm product will also consist of two material options: Pebax 6333 with black colorant or Vestamid Care ML21 2%-3% Clariant Blue (AF53676007). These materials are currently used in cleared AngioSculpt Scoring Balloon Catheters.

6. Summary of Bench Testing

Mechanical testing of the AngioSculpt catheter with HydroCross™ Coating was conducted in accordance with AngioScore's Risk Analysis and all applicable FDA guidance documents and relevant standards.

The following subset of bench tests were conducted to verify that design outputs met design requirements and to confirm proper function and durability. Test articles consisted of finished sterilized catheters.

Catheter Diameter and Balloon Profile,
Device Preparation, Deployment and Retraction ●
Balloon Inflation and Deflation Time
Catheter Bond (Tensile) Strength
Tip Pull Strength

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Catheter Diameter and Balloon Profile (with Scoring Element) ●
o Torque Strength
Pushability, Trackability and Secure Edges
Guidewire Compatibility ●
Catheter Effective Length
Catheter Surface Appearance
Luer Compatibility
Coating Length
Coating Thickness
Coating Lubricity
Coating Integrity ●
Particulate Evaluation
Rated Burst Pressure
Compliance ●
Device Fatigue
Flexibility and Kink

7. Summary of Biocompatibility Testing

The materials of construction for the2.0-6.0mm x 100mm AngioSculpt catheters with HydroCross™ Coating are the same materials as those of the predicate AngioSculpt catheters. Biocompatibility testing of predicate devices cleared under K122685 and K133998 is applicable to the 2.0-6.0mm x 100mm AngioSculpt catheters with HydroCross™ Coating; the following is a summary.

The AngioSculpt catheter with HydroCross™ Coating is categorized as an "External communicating device in contact with circulating blood with limited exposure time". The biocompatibility of the device was assessed in accordance with ISO 10993-1:2009 – Biological evaluation of medical devices, Part 1 – Evaluation and tests within a risk management process.

The biocompatibility tests listed below, except Thrombosis (in-vivo), were conducted in accordance with the provisions of the FDA GLP regulations 21 CFR Part 58. Thrombogenicity was evaluated as part of a GLP animal study.

. Cytotoxicity - MEM Elution Test using L-929 Mouse Fibroblast cells (ISO)
Sensitization - Guinea Pig Maximization Sensitization Test
Irritation - Intracutaneous Reactivity (Irritation) Test
Systemic Toxicity Acute Systemic Injection Test (ISO) ●
Systemic Toxicity Material Mediated Pyrogens ●
Hemocompatibility - Partial Thromboplastin Time (PTT)
Hemocompatibility - Hemolysis Direct Contact/Extract Method (ASTM)
Hemocompatibility Direct Contact Complement Activation Testing With C3a and SC5b ●
Hemocompatibility Thrombosis (in vivo) ●
Genotoxicity Reverse Bacterial Mutation ●
Genotoxicity - In vitro Mouse Lymphoma Assay-Extended Treatment
Genotoxicity Rodent bone Marrow Micronucleus Assays ●

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The biocompatibility test results confirm that the AngioSculpt catheter with HydroCross™ Coating, including the minor material changes, is non-sensitizing, non-irritating, not systemically toxic, non-hemolytic, and non-mutagenic , when evaluated under the respective test conditions. As shown in the GLP animal study, no thrombo-embolism was observed when the subject catheters were evaluated under simulated use conditions.

8. Substantial Equivalence Comparison

The subject catheters share the same intended use, principles of operation, overall technical and functional capabilities, packaging and sterilization process, and similar design and materials as the predicate AngioSculpt catheters and are therefore substantially equivalent.

Although there are minor differences between the subject catheters and its predicate devices those differences do not raise new questions of safety or efficacy. Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised. The changes to the subject catheters do not affect the intended use of the device, alter the fundamental scientific technology of the device, or raise new issues of safety and effectiveness. The subject AngioSculpt PTA Scoring Balloon Catheters with HydroCross™ Coating are therefore, substantially equivalent to the predicate catheters.

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).