(55 days)
No
The description focuses on the mechanical design of the balloon catheter and its physical interaction with plaque, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the "dilatation of lesions" and "treatment of native or synthetic arteriovenous dialysis fistulae," which are therapeutic interventions. Its function is to modify plaque to aid arterial expansion, directly addressing a medical condition.
No
The device description and intended use clearly state that it is a balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for treatment purposes (modifying plaque and aiding arterial expansion), not for diagnosis.
No
The device description clearly states it is a physical catheter with a balloon and embedded metal strips, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Serranator® PTA Serration Balloon Catheter is a physical device used within the body (in vivo) to dilate blood vessels. It is a therapeutic device, not a diagnostic one. It does not analyze samples taken from the body.
The description clearly states its purpose is to "dilatation of lesions in the iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae." This is a direct intervention on the patient's anatomy, not a laboratory test.
N/A
Intended Use / Indications for Use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment of native 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® 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 multiple 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
iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
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)
No new data are included in this bundled 510(K) application. The Serranator® PTA Serration Balloon Catheters represented in this bundled submission do not differ in purpose, design, materials, energy source, function, or any other feature. Performance data previously provided in K213728 and K203437 demonstrate that the devices function as intended.
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.
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).
0
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May 4, 2022
Cagent Vascular, LLC Ms. Carol Burns President and CEO 150 Strafford Avenue #315 Wayne, Pennsylvania 19087
Re: K220704
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: March 8, 2022 Received: March 10, 2022
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. 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,
For
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) K220704
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 iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment 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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1 K220704
Image /page/3/Picture/1 description: The image shows the logo for Cagent Vascular. The logo features the word "CAGENT" in a bold, blue font, with the exclamation point in "CAGENT" being red. Below "CAGENT" is the word "VASCULAR" in a smaller, blue font. To the right of "CAGENT" is the registered trademark symbol. The logo is surrounded by a broken circle made of small, light green dashes.
Cagent Vascular, Inc.
150 Strafford Avenue #315 Wayne, PA 19087
510(k) Summary
Serranator® PTA Serration Balloon Catheter Cagent Vascular, Inc.
K220704
| DATE PREPARED | May 4, 2022 |
|---|---|
| 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 | |
| Fax: (610) 688-2667 | |
| Email: cburns@cagentvascular.com | |
| TRADE NAME | Serranator® PTA Serration Balloon Catheter |
| DEVICE CLASSIFICATION | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION NAME | Percutaneous Catheter |
| PRODUCT CODE | PNO |
| PREDICATE DEVICE | Predicate Device: Serranator® PTA Serration Balloon Catheter (K213728) |
| Reference Device: Serranator® PTA Serration Balloon Catheter (K203437) |
5.1 Intended Use/Indications for Use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal arteries and for the treatment of obstructive
4
lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
5.2 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 multiple 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.
This 510(k) Summary represents a consolidation (i.e., bundling) of previously cleared 510(k) indication statements and labeling. Bundled devices are identical to previously cleared devices, the predicate device Serranator® PTA Serration Balloon Catheter (K213728) and reference device Serranator® PTA Serration Balloon Catheter (K203437). The bundled device sizes are shown in Table 5.1.
| | Balloon
Nominal OD
[mm] | Balloon Length
[mm] | | | |
|--------------------------------------------------------------|-------------------------------|------------------------|-------|-----|--------------------------------------------------------------------------------|
| | | 40 | 80 | 120 | |
| Subject Device Serranator® PTA
Serration Balloon Catheter | 2.5 | ✓ | ✓ | ✓ | Reference Device
Serranator® PTA
Serration Balloon
Catheter (K203437) |
| | 3.0 | ✓ | ✓ | ✓ | |
| | 3.5 | ✓ | ✓ | ✓ | |
| | 4.0 | ✓ | | ✓ | Predicate Device |
| | 5.0 | ✓ | N.A.* | ✓ | Serranator® PTA
Serration Balloon
Catheter (K213728) |
| | 6.0 | ✓ | | ✓ | |
| .1
| Table
U | |
|---------|------------|--|
|---------|------------|--|
*The 80mm length size is commercially available for the below the knee sizes only.
5.3 Comparison to Predicate and Reference Devices
A comparison of the Serranator® PTA Serration Balloon Catheter (Serranator) to the predicate device shows that the technological characteristics such as the components, design, materials,
5
sterilization method, and operating principle of the Serranator are identical to the currently marketed Serranator® PTA Serration Balloon Catheter (Serranator) (K213728) and the Serranator® PTA Serration Balloon Catheter (Serranator) (K203437).
The intended use of the subject device is identical to the combination of the predicate device, Serranator® PTA Serration Balloon Catheter (K213728) and the Serranator® PTA Serration Balloon Catheter (Serranator) (K203437), as shown in Table 5.2.
| Table 5.2 |
|---|
| Indications for Use statements of the Subject and Predicate Device |
| Device Name | Indications For Use | |
|---|---|---|
| Subject Device | Serranator® | |
| PTA Serration | ||
| Balloon Catheter | The Serranator® PTA Serration Balloon Catheter is | |
| intended for dilatation of lesions in the iliac, femoral, | ||
| iliofemoral, popliteal, infrapopliteal arteries and for the | ||
| treatment of obstructive lesions of native or synthetic | ||
| arteriovenous dialysis fistulae. Not for use in the | ||
| coronary or neuro-vasculature. | ||
| Predicate | ||
| Device | Serranator® | |
| PTA Serration | ||
| Balloon Catheter | ||
| (K213728) | The Serranator® 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. | ||
| Reference | ||
| Device | Serranator® | |
| PTA Serration | ||
| Balloon Catheter | ||
| (K203437) | The Serranator® PTA Serration Balloon Catheter is | |
| intended for dilatation of lesions in infrapopliteal arteries. | ||
| Not for use in the coronary or neuro-vasculature. |
5.4 Previous Non-Clinical and Pre-Clinical Testing
The devices represented herein are identical to the predicate and reference devices (Serranator® PTA Serration Balloon Catheter (Serranator) (K213728) and the Serranator® PTA Serration Balloon Catheter (Serranator) (K203437). All non-clinical and pre-clinical testing has been leveraged from those submissions.
5.5 Conclusion
No new data are included in this bundled 510(K) application. The Serranator® PTA Serration Balloon Catheters represented in this bundled submission do not differ in purpose, design, materials, energy source, function, or any other feature. Performance data previously provided in K213728 and K203437 demonstrate that the devices function as intended.