(19 days)
No
The description focuses on the mechanical design of the balloon catheter and its physical interaction with the plaque, with no mention of AI or ML for image analysis, diagnosis, or treatment planning.
Yes
The device is used for dilatation of lesions in arteries and dialysis fistulae for treatment, which is a therapeutic intervention.
No
The device is described as a "balloon dilatation catheter" intended for "dilatation of lesions" and "Percutaneous Transluminal Angioplasty (PTA)" to modify plaque and aid arterial expansion. These are therapeutic, not diagnostic, actions.
No
The device description clearly describes a physical catheter with a balloon and embedded metal strips, indicating it is a hardware device, not software-only.
Based on the provided information, the Serranator® PTA Serration Balloon Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Serranator® is a physical device used within the body (in vivo) to mechanically dilate blood vessels. Its function is to physically interact with and modify the plaque in arteries and fistulae.
The description clearly indicates it's a catheter designed for a medical procedure (Percutaneous Transluminal Angioplasty) performed directly on the patient's vascular system.
N/A
Intended Use / Indications for Use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the illiac, femoral, and poplited arteries for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Product codes
PNO
Device Description
The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
illiac, femoral, popliteal arteries, 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)
Non-clinical bench testing was performed on the subject device to determine substantial equivalence. The following tests were performed:
- Catheter Delivery. Deployment and Retraction
- Balloon Rated Burst Test
- Balloon Fatigue
- Catheter Torsion
- Catheter Flex/Kink
- Catheter Tensile Test
In vitro bench testing demonstrated that the subject device performed as intended and similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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December 15, 2021
Cagent Vascular, LLC Carol Burns CEO 150 Strafford Avenue #315 Wayne, Pennsylvania 19087
Re: K213728
Trade/Device Name: Serranator® PTA Serration Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: November 24, 2021 Received: November 26, 2021
Dear Carol 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213728
Device Name Serranator® PTA Serration Balloon Catheter
Indications for Use (Describe)
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the illac, femoral, and poplited arteries for the treatment of obstructive lesions of native 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/1 description: The image is a logo for Cagent Vascular. The word "CAGENT" is written in large, dark blue letters. Below it, the word "VASCULAR" is written in smaller, teal letters. A semi-circle made of teal dashes surrounds the logo. The registered trademark symbol is located to the right of the word "CAGENT".
510(k) Summary [as required by 21 CFR 807.92(c)]
Serranator® PTA Serration Balloon Catheter 510(k) K213728
| DATE PREPARED: | November 24, 2021 |
|---|---|
| APPLICANT: | Carol Burns/ President & CEO |
| 150 Strafford Avenue, #315 | |
| Wayne, PA 19087 | |
| CONTACT: | Carol A. Burns, President and CEO |
| Phone: (610) 688-2006 | |
| Fax: (610) 688-2667 | |
| Email: cburns@cagentvascular.com | |
| TRADE NAME: | Serranator® PTA Serration Balloon Catheter |
| COMMON NAME: | Percutaneous Catheter |
| CLASSIFICATION | 21CFR 870.1250 |
| DEVICE CLASS: | Class II |
| PANEL CODE: | PNO |
| PREDICATE DEVICE: | K163380 |
| REFERENCE DEVICE: | K203437 |
INTENDED USE/INDICATIONS FOR USE:
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the illiac, femoral, iliofemoral, 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.
DEVICE DESCRIPTION:
The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along
4
the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
COMPARISON WITH PREDICATE AND REFERENCE DEVICES:
A detailed comparison of the subject device (Serranator) and the predicate device (K163380) along with the reference device K203437 is shown in the table below demonstrates that the technological characteristics of the subject device such as components, design, sterilization method, shelf life and operating principle are identical or similar to the predicate device (K163380).
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| Table 1. Comparison with Predicate Device: |
|---|
| -------------------------------------------- |
| | Subject Device | Predicate Device
Serranator Alto1 PTA Serration Balloon Catheter
(Not Commercialized) | Reference Device
Serranator PTA Serration
Balloon Catheter
(Commercialized) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Serranator® PTA Serration
Balloon Catheter | Same | Same |
| Manufacturer | Cagent Vascular, Inc. | Cagent Vascular, Inc. | Cagent Vascular, Inc. |
| 510(k) | - | K163380 | K203437 |
| Intended
Use/Indication for
Use | The Serranator® PTA
Serration Balloon Catheter
is intended for dilatation of
lesions in the iliac, femoral,
iliofemoral, and popliteal,
arteries for the treatment of
obstructive lesions of native
or synthetic arteriovenous
dialysis fistulae. Not for use
in the coronary or neuro-
vasculature. | 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 lesions of native or synthetic arteriovenous
dialysis fistulae. Not for use in the coronary or neuro-
vasculature. | The Serranator® PTA
Serration Balloon
Catheter is intended for
dilatation of lesions in
infrapopliteal arteries. Not
for use in the coronary or
neuro-vasculature. |
| Regulation | 21CFR870.1250 | 21CFR870.1250 | 21CFR870.1250 |
| Regulation Name | Percutaneous catheter | Percutaneous catheter | Percutaneous catheter |
| Regulation Class | Class II | Class II | Class II |
| Product Code | PNO | PNO | PNO |
| Prescription/OTC | Prescription | Prescription | Prescription |
| Catheter Design | OTW | OTW | OTW |
| Balloon diameter
(mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 | 2.5, 3.0, 3.5 |
| Balloon length (mm) | 40, 120 | 40, 80, 120 | 40, 80, 120 |
| Number of Strips | 4 | 4 | 3 |
| Strip material | Stainless Steel | Stainless Steel | Stainless Steel |
| Strip coating | Plasma with Silane | n.a. | Plasma with Silane |
| Effective Length (cm) | 150 | 150 | 150 |
| Balloon Compliance | Semi Compliant | Semi Compliant | Semi Compliant |
| | Subject Device | Predicate Device
Serranator Alto1 PTA Serration Balloon Catheter
(Not Commercialized) | Reference Device
Serranator PTA Serration
Balloon Catheter
(Commercialized) |
| Balloon top layer | Pre-Fabricated Cover
(PFC) | Urethane (dip coat) | Pre-Fabricated Cover
(PFC) |
| Balloon base layer | Urethane | Urethane | Urethane |
| Balloon base | Nylon | Nylon | Nylon |
| Sterilization Method | Ethylene Oxide Gas | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Nominal Pressure
(atm) | 6 | 6 | 6 |
| Hydrophilic Coating | No | Yes | No |
| Rated Burst Pressure
(atm) | 10 | 12 | 12 |
| Packaging | Tyvek® Pouch and Carton
Packaging Hoop/Hoop
Attachment | Tyvek® Pouch and Carton
Packaging Hoop/Hoop Attachment | Tyvek® Pouch and Carton
Packaging Hoop/Hoop
Attachment |
6
7
NON-CLINICAL TESTING/PERFORMANCE DATA:
The following bench tests were performed based on a risk assessment of the subject device and its alignment with the cleared predicate (K163380) and the reference device (K203437) catheter design, materials, and processes,
Non-clinical bench testing was performed on the subject device to determine substantial equivalence. The following tests were performed:
- . Catheter Delivery. Deployment and Retraction
- . Balloon Rated Burst Test
- Balloon Fatigue
- . Catheter Torsion
- . Catheter Flex/Kink
- . Catheter Tensile Test
In vitro bench testing demonstrated that the subject device performed as intended and similar to the predicate device.
BIOCOMPATIBILITY:
Biocompatibility testing was not repeated for the subject device as there were no new materials or manufacturing process changes as compared to the identical fabrication methods of the previously cleared reference device K203437.
SHELF LIFE:
Shelf life testing was not repeated for the subject device as there were no new materials or manufacturing process changes as compared to the identical fabrication methods of the previously cleared reference device K203437. The testing for the subject device of K203437 indicated that there were no differences in performance of unaged and aged devices.
CONCLUSION:
The Serranator® PTA Serration Balloon Catheter included in this notification is substantially equivalent to the previously cleared predicate device in terms of intended use and technological characteristics as demonstrated by bench testing.