(78 days)
The Vela RX PTA Balloon Dilatation Catheter is intended for use in percutaneous transluminal angioplasty (PTA) of the femoral, popliteal, infra popliteal and renal arteries.
The Vela RX PTA Balloon Dilatation Catheter has a 0.014" (0.36mm) rapid exchange co-axial design, which consists of proximal tube with hub and strain relief, transition tube, and distal tube with a balloon at the distal tip. The balloon is made of a Pebax low-compliant material and will expand to a known diameter and length at 6 atmospheres pressure. Two radiopaque markers under the balloon aid in positioning the balloon working length under the fluoroscopy. The nominal inflated balloon diameters range from 1.5mm to 4.0mm with balloon working lengths of 10mm to 40mm. The effective catheter length is 140cm, and is provided with a hydrophilic coating on the distal catheter shaft. The maximum compatible guide wire to be used with the Vela RX PTA Balloon Dilatation Catheter is 0.014" (0.36mm), and the compatible introducer sheath size is 4F.
The provided text is a 510(k) Summary for the Vela RX PTA Balloon Dilatation Catheter. It outlines the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence for FDA clearance.
Crucially, this document does NOT describe the acceptance criteria or a study that proves a device (like an AI algorithm) meets acceptance criteria in the context of human-AI collaboration or standalone AI diagnostic performance. Instead, it discusses the acceptance criteria and testing for a physical medical device (a balloon dilatation catheter) qua physical medical device, not an AI or software as a medical device.
Therefore, I cannot extract the information required by your prompt, as the provided text does not contain details about:
- AI algorithm performance
- Test set sample size for AI
- Data provenance for AI
- Experts establishing ground truth for AI
- Adjudication methods for AI ground truth
- MRMC comparative effectiveness study for AI
- Standalone AI performance
- Type of ground truth (e.g., pathology, outcomes data) in an AI context
- Training set sample size for AI
- How ground truth for the training set was established for AI
The document focuses on engineering performance tests for a physical catheter (e.g., burst pressure, flexibility, biocompatibility) and comparisons to existing predicate catheters.
If you have a document describing an AI medical device or software, please provide that, and I would be happy to analyze it against your criteria.
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Image /page/0/Picture/2 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. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
Curatia Medical Co. % Mr. Bill Jacqmein Regulatory Affairs Consultant JCO Consulting 11218 Zest Court Blaine, MN 55449
Re: K171290
Trade/Device Name: Vela RX PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 28, 2017 Received: May 2, 2017
Dear Mr. Jacqmein:
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
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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.
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.
Kenneth J. Cavanaugh -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) K171290
Device Name
Vela RX PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The Vela RX PTA Balloon Dilatation Catheter is intended for use in percutaneous transluminal angioplasty (PTA) of the femoral, popliteal, infra popliteal and renal arteries.
| 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
A 510(k) summary in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Curatia Medical Co.3227 Kifer RoadSanta Clara, CA 95051Establishment Number: 3008361782 | |
|---|---|---|
| Company ContactPerson: | Jessica Chiu, CEO | |
| Phone:Fax:Email: | (408) 414-2188(408) 413-3000jchiu@curatiamed.com | |
| SubmissionCorrespondent: | Bill Jacqmein, Regulatory Affairs Consultant | |
| Address:Phone:Email: | 11218 Zest Court, Blaine, MN 55449(404) 216-6190bjacqmein@gmail.com | |
| Date Prepared: | March 2017 | |
| Proprietary Name: | Vela RX PTA Balloon Dilatation Catheter | |
| Common Name: | Percutaneous catheter | |
| Product Code: | LIT – Catheter, Angioplasty, Peripheral, Transluminal | |
| Device Classification: | Class II, 21 CFR 870.1250 - Percutaneous Catheter | |
| Predicate Devices: | Ultraverse RX PTA Balloon Dilatation Catheter (K131199 | |
| Reference Device: | Navajo PTA Catheter (K141354) |
Device Description:
The Vela RX PTA Balloon Dilatation Catheter has a 0.014" (0.36mm) rapid exchange co-axial design, which consists of proximal tube with hub and strain relief, transition tube, and distal tube with a balloon at the distal tip. The balloon is made of a Pebax low-compliant material and will expand to a known diameter and length at 6 atmospheres pressure. Two radiopaque markers under the balloon aid in positioning the balloon working length under the fluoroscopy. The nominal inflated balloon diameters range from 1.5mm to 4.0mm with balloon working lengths of 10mm to 40mm. The effective catheter length is 140cm, and is provided with a hydrophilic coating on the distal catheter shaft. The maximum compatible guide wire to be used with the Vela RX PTA Balloon Dilatation Catheter is 0.014" (0.36mm), and the compatible introducer sheath size is 4F.
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Figure 1: Detailed Device Description
Image /page/4/Figure/2 description: This image is a technical drawing of a medical device, possibly a catheter or similar instrument, with several dimensions labeled. The total length of the device is 140cm, with the inflatable balloon section measuring 26cm. The diameter of the shaft varies, with one section measuring 0.037"/0.035" (2.8F/2.7F) and another measuring 0.027" (2.1F), and a 10cm section is also labeled.
Indications for Use:
The Vela RX PTA Balloon Dilatation Catheter is intended for use in percutaneous transluminal angioplasty (PTA) of the femoral, popliteal, infra popliteal and renal arteries.
Comparison to Predicate Devices:
Vela RX PTA Balloon Dilatation Catheter is functionally equivalent to the following predicate device: Ultraverse RX PTA Balloon Dilatation Catheter (Bard Peripheral Vascular, K131199 cleared May 30, 2013).
The following table demonstrates the functional specifications of Vela RX PTA Balloon Dilatation Catheter are substantially equivalent to the predicate devices.
| FunctionalSpecification | Vela RX PTABalloon DilatationCatheter | Ultraverse RX PTADilation Catheter | Comparison Result |
|---|---|---|---|
| Balloon andCatheter Materials | Nylon/Pebax | Nylon/Pebax | Same |
| Catheter Design | Distal OTW w. RXwire exchange,Proximal hypotube | Distal OTW w. RXwire exchange,Proximal hypotube | Same |
| Min. Sheath Size | 4F | 4-5F | Same |
| Max. Guide WireSize | 0.014" | 0.014" | Same |
| Catheter Length | 140cm | 80, 150, 200 cm | Within range |
| Balloon OD | 1.5-4.0mm | 1.25, 1.5-4.0mm | Within range |
| Balloon Length | 10,20,30,40mm | 15,20,40,60,120,200,250mm | 5mm shorter than thepredicate device. But withinother similar products' spec.(See table below)Additionally, shorter balloonssizes are less risk becausethey do not cover/dilate asmuch healthy tissue as alarger balloon size would. |
| Balloon Marker | Dual Pt/Ir Markers | Dual Pt/Ir Markers | Same |
| Nominal Pressure | 6atm | 6atm | Same |
| Balloon RBP | 16atm for 3.5-4.0mm balloons;18atm for 2.5-3.0mm balloons20atm for 1.5-2.0mm | 15-16atm | RBP of 2 atm higher than itspredicate devices in someballoon sizes, but within othersimilar products' spec. (Seetable below) |
Table 1: Functional Specification Comparison
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| Indication for Use | For use inpercutaneoustransluminalangiogplasty (PTA)of the femoral,popliteal, infrapopliteal and renalarteries. | For use inPercutaneousTransluminalAngioplasty of therenal, femoral,popliteal, infra-popliteal, tibial, andperoneal arteries.This catheter is notfor use in coronaryarteries. | Similar |
|---|---|---|---|
| -------------------- | --------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------- |
In addition to the Ultraverse, the Curatia Navajo PTA catheter is also provided as a reference.
Please see the comparison table below.
| Functional Specification | Vela RX (CML) | Navajo PTA(CML) |
|---|---|---|
| FDA registration No. | K171290 | K141354 |
| Min. Sheath Size | 4F | 5F |
| Max. Guide Wire Size | 0.014" | 0.035" |
| Catheter Length | 140 cm | 80 to 130 cm |
| Balloon OD | 1.5-4.0 mm | 5 to 10 mm |
| Balloon Length | 10,20,30,40 mm | 40 to 80 mm |
| Nominal Pressure | 6 atm | 6 to 8 atm |
| Balloon RBP | 20atm: 1.5-2.0mm18 atm: 2.5-3.0 mm16 atm: 3.5-4.0 mm | 14 to 16 atm |
| Indication for Use | For use in percutaneoustransluminal angiogplasty(PTA) of the femoral,popliteal, infra poplitealand renal arteries. | The catheter is intended to dilatestenoses in the peripheral arteries (iliac,femoral, ilio-femoral, popliteal, infrapopliteal, renal arteries); and forthe treatment of obstructive lesions ofnative or synthetic arteriovenous dialysisfistulae. |
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Comparison of Indications for Use to Predicate Devices:
Based on the above comparison, the indications for use of the Vela RX PTA Balloon Dilatation Catheter is similar to that of the Ultraverse. Therefore, the Vela RX PTA Balloon Dilatation Catheter can be considered substantially equivalent to its predicate device.
Comparison of Technological Characteristics to Predicate Devices:
Based on the above comparison, the design, construction, and performance characteristics of the Vela RX PTA Balloon Dilatation Catheter is similar to that of Ultraverse. Therefore, the Vela RX PTA Balloon Dilatation Catheter can be considered substantially equivalent to its predicate devices.
Summary of Performance Data and Substantial Equivalence:
The Vela RX PTA Balloon Dilatation Catheters were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre-defined acceptance criteria. The Vela RX PTA Balloon Dilatation Catheters have been tested and shown to be compliant with the following standards documents:
- . ISO 10555-1:2013- Intravascular catheters - Sterile, single-use intravascular catheters -Part 1: General requirements
- . ISO 10555-4:2013- Intravascular catheters - Sterile, single-use intravascular catheters -Part 4: Balloon dilatation catheter
- . ISO 10993-1:2009- Biological evaluation of medical devices - Part 1: Evaluation and testina
- ISO 10993-3:2014- Biological evaluation of medical devices Part 3: Tests for . genotoxicity, carcinogenicity and reproductive toxicity
- . ISO 10993-4:2002+AMD1:2006-Biological testing of medical and dental materials and devices - Part 4: Selection of tests for interactions with blood
- ISO 10993-5: 2009- Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation ● and skin sensitization
- ISO 10993-11:2006- Biological testing of medical and dental materials and devices Part . 11: Tests for systemic toxicity
- . ISO 10993-12:2012- Biological testing of medical and dental materials and devices – Part 12: Sample Preparation And Reference Materials
- . ISO 11135: 2014 Sterilization of health-care products-Etylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
- . EN ISO 11607-1: 2009(R2014)- Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
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Performance Testing:
To demonstrate substantial equivalence of Vela RX PTA Balloon Dilatation Catheter to the predicate devices, the technological characteristics and performance criteria were evaluated using the bench testing recommendations outlined in the FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" dated September 8, 2010. The following performance tests were completed:
- Dimension Catheter Preparation, In/deflation Time Catheter Flexibility and Kink Torque Strength Balloon Fatigue (w/ & w/o stent) Balloon Compliance Balloon Rated Rupture Pressure (w/ & w/o stent ) Catheter Shaft Pressure Integrity GW Lumen Collapse Pressure Catheter Bond Tensile Strength Catheter Shaft Coating Integrity Radiopacity
The results of these tests demonstrate the technological characteristics and performance criteria of the Vela RX PTA Balloon Dilatation Catheter are adequate for its intended use, and is substantially equivalent to the predicate devices.
Biocompatibility:
To demonstrate the biological safety of the body-contacting materials and substantial equivalence of the Vela RX PTA Balloon Dilatation Catheter to its predicate devices, the following biocompatibility testing was performed in accordance with ISO 10993 and the FDA Guidance Document "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"" dated June, 2016:
Cytotoxicity Sensitization Irritation (Intracutaneous Reactivity) Systemic Toxicity (acute) Pvrogenicitv Hemocompatibility (Hemolysis, Thrombogenicity, and Immunology) Genotoxicity (Bacterial Reverse Mutation Assay, Mouse Lymphoma Mutagenesis Assay)
The results from these tests demonstrate that Vela RX PTA Balloon Dilatation Catheter is biocompatible for its intended use.
Conclusion:
Based on comparison of indications for use, technological characteristics, safety and performance testing, biocompatibility testing, the Vela RX PTA Balloon Dilatation Catheter has been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate devices.
§ 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).