(74 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of the balloon catheter and its scoring elements. There is no mention of AI or ML in the provided text.
Yes
The device is intended for "dilatation of lesions" and "treatment of obstructive or synthetic arteriovenous dialysis fistulae," which are therapeutic interventions.
No
The device is described as a dilatation catheter used for percutaneous transluminal angioplasty (PTA) to treat lesions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical catheter with a balloon and embedded metal strips, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Serranator™ Alto PTA Serration Balloon Catheter is a physical device used inside the body (in vivo) to dilate blood vessels. It is a therapeutic device, not a diagnostic test performed on samples outside the body.
The description clearly indicates it's a catheter used for a medical procedure within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Serranator™ Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Product codes (comma separated list FDA assigned to the subject device)
PNO
Device Description
The Serranator™ Alto PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral vasculature as described in the Indications for Use statement. The Serranator™ has a nylon semi-compliant balloon with four embedded external metal strips, or scoring elements. The scoring elements are designed to create linear, interrupted scoring along the endoluminal surface that occurs during balloon angioplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, iliofemoral, and popliteal arteries; obstructive or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing in accordance with FDA guidance, ASTM and ISO standards was performed on sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples of Serranator™ Alto PTA Serration Balloon Catheter. The testing/assessments included: Shipping, environmental stresses; Flex/Kink; Peel Strength; Visual Inspection; Particulates; Delivery, Deployment, Retraction; Fatigue; Rated Burst/Compliance; Torsion; Corrosion; Tensile Test of Joints; Lubricious Coating Integrity. The non-clinical testing results demonstrated that the Serranator™ met all acceptance criteria and functions as intended.
Biocompatibility testing was conducted on sterile, finished devices manufactured using the manufacturing processes which will be used for the cleared devices. All testing passed the required acceptance criteria and the product is biocompatible for human use.
Animal studies: Peripheral vessels in a porcine model were treated with a Serranator™ Alto PTA Serration Balloon Catheter or control, AngioSculpt® PTA Scoring Balloon Catheter. Morphometric measurements were similar between Serranator™ and AngioSculpt. Neointimal areas, thickness and percent stenosis were minimal and similar in both groups.
Cadaver studies: Cadaver testing was performed comparing the Serranator™ to the predicate device and was found to have similar performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2017
Cagent Vascular, LLC Ms. Carol A. Burns President and CEO 150 Strafford Avenue #315 Wayne, PA 19087
Re: K163380
Trade/Device Name: Serranator Alto PTA Serration Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: December 1, 2016 Received: December 2, 2016
Dear Ms. Burns:
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. 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 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 devicerelated 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.
1
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" (21 CFR 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,
Fernando Aguel-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) K163380
Device Name
Serranator Alto PTA Serration Balloon Catheter
Indications for Use (Describe)
The Serranator™ Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Cagent Vascular. The logo features the word "CAGENT" in a bold, blue sans-serif font, with an exclamation point replacing the "I". Below "CAGENT" is the word "VASCULAR" in a smaller, red sans-serif font. The words are surrounded by a broken circle made of small, light-green dashes. To the right of the word "CAGENT" is the registered trademark symbol.
Cagent Vascular, LLC 150 Strafford Avenue #315 Wayne, PA 19087
510(k) Summary [as required by 21 CFR 807.92(c)]
Serranator™ Alto PTA Serration Balloon Catheter Cagent Vascular, LLC
510(k) M3855: 2__
| DATE PREPARED | November 28, 2016 |
|---|---|
| APPLICANT INFORMATION | Carol Burns/President & CEO |
| 150 Strafford Avenue #315 | |
| Wayne, PA 19087 | |
| CONTACT INFORMATION | Carol A. Burns, President and CEO |
| Phone: 610-688-2006 | |
| Email: cburns@cagentvascular.com | |
| TRADE NAME | Serranator™ Alto PTA Serration Balloon Catheter |
| DEVICE CLASSIFICATION | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION NAME | Percutaneous Catheter |
| PRODUCT CODE | PNO |
| PREDICATE DEVICE | AngioSculpt® Scoring Balloon Catheter (K122685) |
INTENDED USE/INDICATIONS FOR USE
The Serranator™ Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
4
DEVICE DESCRIPTION
The Serranator™ Alto PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral vasculature as described in the Indications for Use statement. The Serranator™ has a nylon semi-compliant balloon with four embedded external metal strips, or scoring elements. The scoring elements are designed to create linear, interrupted scoring along the endoluminal surface that occurs during balloon angioplasty.
COMPARISON WITH PREDICATE DEVICE
A comparison of the Serranator™ Alto PTA Serration Balloon Catheter and predicate device shows that the technological characteristics such as the components, design, materials, sterilization method, shelf life and operating principle of the Serranator™ are identical or similar to the currently marketed AngioSculpt® Scoring Balloon Catheter , the predicate device.
The intended use of the Subject Device and its primary predicate is identical. The indications for use of the Serranator™ Alto PTA Serration Balloon Catheter are similar (a subset) to that of the predicate device.
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| Item | Subject Device | Predicate Device | |
|---|---|---|---|
| Name | Serranator™ Alto | ||
| PTA Serration | |||
| Balloon Catheter | AngioSculpt® Scoring | ||
| Balloon Catheter | |||
| Manufacturer | Cagent Vascular | Spectranetics | |
| 510(k) Number | Current Application | K122685 | |
| Intended Use | Dilatation of lesions | ||
| in the iliac, femoral, | |||
| ilio-femoral, and | |||
| popliteal arteries, and | |||
| for the treatment of | |||
| obstructive lesions of | |||
| native or synthetic | |||
| arteriovenous dialysis | |||
| fistulae. Not for use | |||
| in the coronary or | |||
| neuro-vasculature. | Dilatation of lesions in the | ||
| iliac, femoral, ilio-femoral, | |||
| 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. | |||
| Target Body Location | Peripheral | Peripheral | |
| Principle of Operation | Balloon dilatation | ||
| with interrupted, | |||
| axial scoring | Balloon dilatation with | ||
| continuous helical scoring | |||
| Platform | Over-The-Wire | ||
| (OTW) | Over-The-Wire (OTW) | ||
| Design | Maximum OD | 6 Fr | 6 Fr |
| Effective Length | |||
| [cm] | 150 | 137 | |
| Balloon | |||
| Characteristic | Balloon Diameters | ||
| [mm] | 4.0, 5.0, and 6.0 | 3.5 through 6.0 | |
| Balloon lengths | |||
| [mm] | 40, 80, and 120 | 40 through 200 |
NON CLINICAL TESTING / PERFORMANCE DATA
Bench testing in accordance with FDA guidance[]', ASTM and ISO standards was performed
on sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples of Serranator™ Alto PTA Serration Balloon Catheter.
[1] Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, April 2010. Only the sections associated with Delivery Systems were applied to Serranator.
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The following testing/assessments were performed:
- Shipping, environmental stresses ●
- Flex/Kink ●
- Peel Strength ●
- Visual Inspection ●
- Particulates ●
- Delivery, Deployment. Retraction ●
- Fatigue
- Rated Burst/Compliance
- Torsion
- Corrosion
- Tensile Test of Joints ●
- Lubricious Coating Integrity ●
The non-clinical testing results demonstrated that the Serranator™ met all acceptance criteria. Performance data demonstrate that the device functions as intended.
BIOCOMPATIBILITY
FDA guidance document Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" Draft Guidance for Industry and Food and Drug Administration Staff, April 23, 2013, ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and ISO-10993 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials were followed in selecting and conducting the biocompatibility testing of the Serranator™ Alto PTA Serration Balloon Catheter.
Biocompatibility testing was conducted on sterile, finished devices manufactured using the manufacturing processes which will be used for the cleared devices. All testing passed the required acceptance criteria and the product is biocompatible for human use.
ANIMAL STUDIES
Peripheral vessels in a porcine model were treated with a Serranator™ Alto PTA Serration Balloon Catheter or control, AngioSculpt® PTA Scoring Balloon Catheter.
Morphometric measurements were similar between Serranator™ and AngioSculpt. Neointimal areas, thickness and percent stenosis were minimal and similar in both groups.
CADAVER STUDIES
Cadaver testing was performed comparing the Serranator™ to the predicate device and was found to have similar performance.
7
CONCLUSION
The Serranator™ Alto PTA Serration Balloon Catheter has identical intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference devices. Performance data demonstrates that the device functions as intended.
Data presented in this 510(k) Submission support that the Serranator™ Alto PTA Serration Balloon Catheter is substantially equivalent to the predicate device AngioSculpt® PTA Scoring Balloon Catheter.