For dilatation of lesions in the iliac, 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 7.0/8.0mm x 40mm AngioSculpt PTA Scoring Balloon Catheters are comprised of a conventional balloon catheter that incorporates a nitinol scoring element over the balloon. The balloon is designed to expand to a specified diameter at a specified pressure. The catheter has radiopaque markers to aid in positioning of the balloon in the stenosis. The catheter has two lumens; one lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The product is provided in the over-the-wire (OTW) delivery platform. The catheters have a sheath compatibility of 6F and guidewire compatibility of 0.018". The catheter is single-use only and provided sterile to the user.

AI/ML Overview

Here's the information regarding the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

This device is an AngioSculpt PTA Scoring Balloon Catheter, and its 510(k) submission is for an expansion of existing product lines (new sizes 7.0/8.0mm x 40mm) of an already cleared device model (AngioSculpt PTA Scoring Balloon Catheters, K133998 and K091966). Therefore, the demonstration of substantial equivalence relies heavily on design verification and validation testing rather than new clinical trials or complex performance studies typically associated with novel devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by successful completion of the design verification and validation testing, demonstrating that the new device models perform comparably to the predicate devices and meet established engineering standards. The summary states that the subject device (7.0/8.0mm x 40mm AngioSculpt PTA Scoring Balloon Catheter) is "substantially equivalent" to the predicate devices because they share substantially the same indications for use, device operation, material type, basic design configuration, and overall technical and functional capabilities.

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance/Conclusion
Physical Dimensions	- Catheter Diameter and Balloon Profile- Catheter Diameter and Balloon Profile (post deflation)- Catheter Effective Length	Implied to meet specifications and be comparable to predicate devices. The new models are larger (7.0/8.0mm) but perform consistently with the established design principles.
Mechanical Performance	- Balloon Preparation, Deployment and Retraction- Rated Burst Pressure (RBP)- Device Fatigue- Balloon Compliance (Diameter vs. Pressure)- Balloon Inflation/ Deflation Time- Bond (Tensile) Strength- Tip Pull Strength- Catheter Flexibility and Kink- Torque Strength- Pushability, Trackability and Secure Edges- Freedom from Stent Interference- Focal Force	Implied to meet established engineering and safety standards, demonstrating functional equivalence to the predicate devices. The new sizes are expected to exhibit similar force application, durability, and handling characteristics.
Device Compatibility	- Radiopacity- Guide Wire Compatibility- Luer Compatibility- Catheter Surface Appearance	Implied to be compatible with standard interventional tools and imaging techniques. Radiopacity would ensure visibility during procedures, and guidewire compatibility is specified (0.018").
Sterilization	- Product adoption equivalency per AAMI TIR:28 2009	Sterilization process is validated as equivalent to established standards, ensuring the device is sterile for use.
Biocompatibility	- Cytotoxicity- Sensitization- Irritation- Systemic Toxicity- Hemocompatibility- Genotoxicity (all based on predicate device testing)	"The materials used in the subject device pose no greater significant biocompatibility challenge than the current AngioSculpt products." Biocompatibility test results of the currently marketed product, conducted according to current standards (e.g. ISO 10993-5), were used to confirm the biocompatibility due to similarities in design, materials, manufacturing, sterilization, and intended use. The device is considered biocompatible.

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for each individual test conducted (e.g., how many balloons were tested for RBP or fatigue). These are typically standard engineering tests with defined sample sizes per test method.
- Data Provenance: Not explicitly stated, but these are preclinical design verification and validation tests conducted by the manufacturer (Spectranetics). The tests are performed on the device itself (new and predicate models) in a controlled laboratory setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. This submission primarily relies on engineering and preclinical performance data, not on clinical evaluations requiring expert interpretation of ground truth (e.g., image-based diagnosis). The "ground truth" here is the adherence to specifications and performance standards established by internal testing and regulatory guidelines.
Adjudication method for the test set:
- Not applicable. No adjudication method is described because the tests are objective measurements against predefined specifications, not subjective interpretations requiring expert consensus.
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 device is a physical medical device (balloon catheter) for angioplasty, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to AI/software performance, which is not relevant to this physical device submission.
The type of ground truth used:
- The "ground truth" for this submission is based on:
  - Engineering specifications and standards: The device performance parameters (e.g., burst pressure, tensile strength, inflation/deflation time, dimensions) are measured against predefined engineering specifications and relevant ISO/ASTM standards.
  - Biocompatibility standards: ISO 10993-5 series for biocompatibility.
  - Comparison to predicate device performance: The performance of the new sizes is demonstrated to be equivalent to that of the previously cleared predicate devices under similar test conditions.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device's evaluation. This is not a machine learning or AI product.
How the ground truth for the training set was established:
- Not applicable. As above, no training set or associated ground truth establishment method is relevant for this conventional medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple and recognizable, conveying the department's mission and purpose.

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

May 31, 2016

The Spectranetics Corporation Ms. Kimberley Kline Senior Manager, Regulatory Affairs 9965 Federal Drive Colorado Springs, CO 80921

Re: K150634

Trade/Device Name: AngioSculpt PTA Scoring Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: March 10, 2015 Received: March 11, 2015

Dear Ms. Kline,

This letter corrects our substantially equivalent letter of April 8, 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 or any Federal statutes and regulations administered by other Federal agencies. You must

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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 vours.

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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Indications for Use

510(k) Number (if known) K150634

Device Name

AngioSculpt PTA Scoring Balloon Catheter, 7.0/8.0mm x 40mm

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K150634 Page 1 of 3

Image /page/3/Picture/1 description: The image shows the Spectranetics logo. The logo consists of a blue geometric shape to the left of the word "Spectranetics" in blue, with the registered trademark symbol to the right. Below the word "Spectranetics" is the tagline "Always Reaching Farther" in a smaller font.

510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92

Prepared on March 10, 2015

510(k) Submitter / Holder:	Spectranetics5055 Brandin CourtFremont, CA 94538Establishment Registration No: 3005462046
Contact:	Kimberley KlineSenior Manager, Regulatory AffairsDirect: 510.933.7989Fax: 510.933.7994Email: Kimberley.Kline@Spectranetics.com

Subject Device

Device Trade Name:	AngioSculpt® PTA Scoring Balloon Catheter
Device Common Name:	Angioplasty catheter
Device Class:	II
Classification Regulation:	21 CFR 870.1250
Regulation Description:	Percutaneous catheter
Product Code:	LIT
510(k) Type:	Special
Model Numbers:	2332, 2333, 2334

Predicate Device

The AngioSculpt PTA Scoring Balloon Catheter was compared to the following legally marketed predicate device:

Trade Name/510(k) Number:	AngioSculpt® PTA Scoring Balloon CathetersK133998 4.0-6.0x200mm (137cm length)
Manufacturer:	Spectranetics
Device Common Name:	Angioplasty catheter

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Image /page/4/Picture/1 description: The image shows the logo for Spectranetics. The logo consists of a blue diamond shape with a white center, followed by the word "Spectranetics" in blue, sans-serif font. Below the word "Spectranetics" is the tagline "Always Reaching Farther" in a smaller, sans-serif font.

Device Description

Intended and Indications for Use

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, 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.

Technological Characteristics

The 7.0/8.0mm x 40mm AngioSculpt PTA Scoring Balloon catheters are equivalent to the currently cleared and marketed 4.0-6.0mm x 40mm and 200mm AngioSculpt family of devices because they share substantially the same; indications for use, device operation, material type, basic design confiquration and overall technical and functional capabilities.

Performance Data

The following testing was conducted to validate and verify that the subject device was substantially equivalent to the predicate devices

Design Verification and Validation Testing

Catheter Diameter and Balloon Profile ●
Balloon Preparation, Deployment and Retraction
Rated Burst Pressure (RBP)
Device Fatigue
Balloon Compliance (Diameter vs. Pressure)
Balloon Inflation/ Deflation Time ●
Bond (Tensile) Strength
Tip Pull Strength
Catheter Diameter and Balloon Profile (post deflation) ●

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Image /page/5/Picture/1 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white circle in the center, followed by the word "Spectranetics" in blue, bold font. Below the word "Spectranetics" is the tagline "Always Reaching Farther" in a smaller, regular font.

Catheter Flexibility and Kink ●
Torque Strength
Radiopacity ●
Pushability, Trackability and Secure Edges ●
Freedom from Stent Interference
Guide Wire Compatibility
Catheter Effective Length
Catheter Surface Appearance ●
Luer Compatibility
o Focal Force

Sterilization

Product adoption equivalency per AAMI TIR:28 2009

Biocompatibility

The materials used in the subject device pose no greater significant biocompatibility challenge than the current AngioSculpt products. Biocompatibility test results of the currently marketed product have previously been performed and are biocompatible. Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, and Genotoxicity tests were conducted according to current standards (e.g. ISO 10993-5). Due to similarities in design, manufacturing processes, sterilization, intended use, and device categorization, the combined biocompatibility test results of predicate product can be used to confirm the biocompatibility of the subject device.

Preclinical and Clinical Data

Preclinical and clinical data were not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device.

Substantial Equivalence

Based on the similarities in design between the subject and predicate devices, and the performance testing performed, the subject AngioSculpt PTA Scoring Balloon Catheter, 7.0/8.0mm x 40mm, 50,90,137cm is substantially equivalent to the predicates, AngioSculpt 4.0-6.0x200mm (50, 90, 137cm length) devices cleared under K133998 and the 4.0-6.0 x 40mm AngioSculpt devices cleared under K091966.

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).