(29 days)
Not Found
No
The device description and performance studies focus on mechanical properties and physical design, with no mention of AI/ML or data-driven analysis.
Yes
The device is a balloon catheter intended for dilatation of lesions in infrapopliteal arteries, which is a therapeutic intervention.
No
The device description indicates it is a balloon dilatation catheter designed to modify plaque by creating linear, interrupted scoring along the endoluminal surface, which is a therapeutic intervention, not a diagnostic one.
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).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Serranator® is a physical device (a balloon catheter) used within the body (in infrapopliteal arteries) to perform a therapeutic procedure (dilatation of lesions). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic intervention within the body, not a diagnostic test on a sample.
Therefore, the Serranator® PTA Serration Balloon Catheter falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. 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 three 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
infrapopliteal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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 Fatigue
- . Catheter Torsion
- . Catheter Flex/Kink
- Catheter Tensile Test
In vitro bench testing demonstrated that the subject device performed as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 22, 2020
Cagent Vascular, LLC Carol Burns CEO 150 Strafford Avenue #315 Wayne, Pennsylvania 19087
Re: K203437
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 20, 2020 Received: November 23, 2020
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203437
Device Name Serranator® PTA Serration Balloon Catheter
Indications for Use (Describe)
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapoplited arteries. Not for use in the coronary or neuro-vasculature.
| 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)
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510(k) Summary
[as required by 21 CFR 807.92(c)]
Serranator® PTA Serration Balloon Catheter 510(k) K203437
| DATE PREPARED: | November 20, 2020 |
|---|---|
| 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 |
| REGULATION: | |
| DEVICE CLASS: | Class II |
| PANEL CODE: | PNO |
| PREDICATE DEVICE: | K193181 |
INTENDED USE/INDICATIONS FOR USE:
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. 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 three 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.
4
COMPARISON WITH PREDICATE DEVICE:
Comparison of the subject device (Serranator) and the predicate device (Serranator, K193181) show 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 currently marketed predicate device.
The intended use/indications for use between the subject device and the predicate device are identical.
5
COMPARISON WITH PREDICATE DEVICE:
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Serranator® PTA Serration | |
| Balloon Catheter | Same | |
| Manufacturer | Cagent Vascular, LLC | |
| 510(k) | K193181 | |
| Intended Use/Indication for | ||
| Use | 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 | |
| Regulation Name | Percutaneous catheter | |
| Regulation Class | Class 2 | Same |
| Product Code | PNO | |
| Prescription/OTC | Prescription | |
| Catheter Design | OTW | |
| Balloon diameter (mm) | 2.5, 3.0, 3.5 | |
| Balloon length (mm) | 40, 80, 120 | |
| Effective Length (cm) | 150 | |
| Balloon Compliance | Semi Compliant | |
| Sterilization Method | Ethylene Oxide Gas | |
| Nominal Pressure (atm) | 6 | |
| Rated Burst Pressure (atm) | 12 | |
| Dispenser | Yes (unchanged) | |
| Pouch | Yes (unchanged) |
6
NON-CLINICAL TESTING/PERFORMANCE DATA:
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 Fatigue
- . Catheter Torsion
- . Catheter Flex/Kink
- Catheter Tensile Test
In vitro bench testing demonstrated that the subject device performed as intended.
BIOCOMPATIBILITY:
Biocompatibility testing was not repeated for the subject device as there were no new materials and no manufacturing process changes as compared to the predicate device.
The subject device meets all acceptance criteria and is biocompatible.
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.