(92 days)
No
The device description and performance studies focus on the mechanical and physical properties of a balloon catheter, with no mention of AI or ML.
Yes.
The device is used for Percutaneous Transluminal Angioplasty (PTA) to dilate obstructive lesions in blood vessels, which is a medical procedure aimed at treating a disease or condition.
No
This device is used for Percutaneous Transluminal Angioplasty (PTA) to dilate obstructive lesions, which is a therapeutic procedure, not a diagnostic one. While it uses fluoroscopy for placement, the device itself is not designed to diagnose conditions.
No
The device description clearly details a physical catheter with a balloon, guidewire passage, manifold, and luer connector, all of which are hardware components.
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 Function: The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is a medical device used within the body (in vivo) to physically dilate blood vessels. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic procedure (PTA) performed directly on the patient's vasculature.
- Device Description: The description details a physical catheter with a balloon for mechanical dilation, not a system for analyzing biological samples.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT
Device Description
The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native 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)
Results of design verification testing demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The device has been evaluated through the following tests:
- Rated burst pressure (RBP)
- Inflation & deflation time
- -Balloon diameters at nominal pressure to RBP
- -Simulated use - Pushability & Trackability & Sheath Compatibility
- -Coating integrity (b)
- Multiple inflation/fatique & leak test
- Tensile strength Balloon to Shaft (proximal bond)
- -Particulate
Performance Bench Tests have been leveraged from predicate device for the following:
- Balloon Length & Marker Band Position
- -Radiopacity
- -Ancillary Tool Compatibility (Guidewire)
- Catheter Effective Length
- Tensile Strength Manifold to Shaft (Manifold Bond)
- -Tensile Strength (Distal / Tip Bond)
- Tip Profile (Geometry of the catheter most distal tip)
- -Simulated Use, Push & Track
- -Flexibility & Kink
- Coating Lubricity
- -Coating Integrity (a)
- -Torque Strength
No clinical studies were required for the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K180007)
Reference Device(s)
Sterling™ Over-the-Wire (OTW) PTA Balloon Dilatation Catheter (K132430)
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2024
Creagh Medical Ltd. dba Surmodics, Inc. Anne-Marie Keenan Senior Regulatory Affairs Specialist IDA Business Park, Ballinasloe Co. Galway Ballinasloe, H53 K8P4 Ireland
Re: K242419
Trade/Device Name: Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: September 19, 2024 Received: September 19, 2024
Dear Anne-Marie Keenan:
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 (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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
| Ariel G.
Ash-
shakoor -S | Digitally signed by
Ariel G. Ash-shakoor
-S
Date: 2024.11.15
19:09:54 -05'00' |
| -------------------------------- | ------------------------------------------------------------------------------------------- |
|---|
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
3
Indications for Use
510(k) Number (if known) K242419
Device Name
Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
| 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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4
Image /page/4/Picture/0 description: The image contains the word "SURMODICS" in all capital letters. To the left of the word is a blue and green graphic. The graphic is a stylized shape that looks like a ribbon or folded piece of paper. The word "SURMODICS" is in a sans-serif font and is black.
510k Summary
Date Prepared: November 14, 2024
Submitters Name/Contact Person
510K Submitter and Contact for Routine Correspondence
Anne-Marie Keenan Senior Regulatory Affairs Specialist Creagh Medical Ltd. (Surmodics Inc.) Ballinasloe Co. Galwav H53 K8P4 IRELAND
Email: akeenan@surmodics.com
510k Submitter Establishment Registration Number
3005994106
| General Information | |
|---|---|
| Trade Name: | Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter |
| Common / Usual Name: | PTA Balloon Dilatation Catheter |
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal |
| Regulation/Product Code | 21 CFR 870.1250 |
| Device Panel | Cardiovascular |
| Regulatory Classification: | Class II |
| Product Code: | LIT |
| Predicate Device: | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K180007) |
| Reference Device | Sterling™ Over-the-Wire (OTW) PTA Balloon Dilatation Catheter (K132430) |
1.1 Device Description
The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Anqioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only.
Surmodics, Inc. 9924 West 74th Street Eden Prairie, MN 55344 USA Phone 952-500-7001 www.surmodics.com Creagh Medical Ltd. & Vetex Medical Ltd are now part of Surmodics, Inc. IDA Business Park Ballinasloe, Co. Galway Ireland Phone +353 90 9646300
5
1.2 Indications for Use
The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
1.3 Comparison of Technological Characteristics
The subject Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is substantially equivalent to the predicate 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K180007) in design, intended use, principles of use, biocompatibility, sterility, and labeling. Changes to the predicate device that have led to the submission of this new 510(k), are the expansion of the matrix of dilatation balloons available for peripheral balloon angioplasty. All characteristics that were not identical to the predicate device were verified through performance bench testing and determined to be substantially equivalent.
| Characteristic | Subject Device: K242419
Advance Serenity 18
Hydrophilic PTA Balloon
Dilatation Catheter | Predicate Device: K180007
018 Hydrophilic Coated OTW
PTA Balloon Dilatation
Catheter | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Indications for Use | The Advance Serenity 18
Hydrophilic PTA Balloon
Dilatation Catheter is indicated
for Percutaneous Transluminal
Angioplasty (PTA) of the
peripheral vasculature in the
iliac, femoral, popliteal, infra-
popliteal, and renal arteries,
and for the treatment of
obstructive lesions of native or
synthetic arteriovenous dialysis
fistulae. | The 018 Hydrophilic Coated
OTW PTA Balloon Dilatation
Catheter is indicated for
Percutaneous Transluminal
Angioplasty (PTA) of the
peripheral vasculature in the
iliac, femoral, popliteal, infra-
popliteal, and renal arteries,
and for the treatment of
obstructive lesions of native or
synthetic arteriovenous dialysis
fistulae. | Identical |
| Principles of
Operation | Inflation of semi-compliant balloon for dilatation | | Identical |
| Guidewire
Compatibility | 018" | | Identical |
| Catheter Shaft
Length (cm) | 40, 90, 120, 135 | 40, 90, 120, 135, 150 | Identical
(40, 90, 120, 135cm) |
| Sheath
Compatibility | 5Fr | 4Fr, 5Fr | Identical
(5Fr) |
| Catheter Shaft
Outer Diameter
(mm) | 5Fr: ≤1.667 | 4Fr: ≤1.333
5Fr: ≤1.667 | Identical
(5Fr) |
| Balloon Length
(mm) | 220 | 15, 20, 40, 60, 80, 100, 120,
150, 220 | Identical
(220mm) |
| Balloon Diameters
(mm) | 5.0, 6.0 & 7.0 | 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0,
5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 | Identical
(5.0, 6.0 & 7.0mm) |
| Nominal Pressure | 8 ATM | 8 ATM | Identical |
| Rated Burst
Pressure | 14 & 16 ATM | 10, 12, 14, 16 ATM | Identical
(14 & 16 ATM) |
| Balloon Material | Semi-Compliant | | Identical |
| Catheter Shaft
Materials | Polymers, all materials are biocompatible | | Substantially
Equivalent |
6
| Characteristic | Subject Device: K242419
Advance Serenity 18
Hydrophilic PTA Balloon
Dilatation Catheter | Predicate Device: K180007
018 Hydrophilic Coated OTW
PTA Balloon Dilatation
Catheter | Comparison |
|----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------|
| Radiopaque Marker
Bands | Two radiopaque marker bands | | Identical |
| Coating Material | Hydrophilic Coating | | Identical |
| Packaging
Configuration | Same function and design | | Identical |
| Sterilization Method | Ethylene Oxide | | Identical |
| Biocompatibility | Externally communicating device in contact with circulating blood
for limited exposure duration. | | Substantially
Equivalent |
| Single Use/
Reprocess | Single use only | | Identical |
1.4 Performance Bench Testing
Results of design verification testing demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The device has been evaluated through the following tests:
- Rated burst pressure (RBP) -
- Inflation & deflation time -
- -Balloon diameters at nominal pressure to RBP
- -Simulated use - Pushability & Trackability & Sheath Compatibility
- -Coating integrity (b)
- Multiple inflation/fatique & leak test -
- Tensile strength Balloon to Shaft (proximal bond) -
- -Particulate
Performance Bench Tests have been leveraged from predicate device for the following:
- Balloon Length & Marker Band Position -
- -Radiopacity
- -Ancillary Tool Compatibility (Guidewire)
- Catheter Effective Length -
- Tensile Strength Manifold to Shaft (Manifold Bond) -
- -Tensile Strength (Distal / Tip Bond)
- Tip Profile (Geometry of the catheter most distal tip) -
- -Simulated Use, Push & Track
- -Flexibility & Kink
- Coating Lubricity -
- -Coating Integrity (a)
- -Torque Strength
1.5 Clinical Studies and Testing
No clinical studies were required for the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter.
1.6 Conclusion
Based on the device description, materials, technological characteristics, and accompanying performance data, it can be concluded that the device modifications made to the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter are substantially equivalent to the predicate device.