(154 days)
Not Found
No
The summary describes a physical medical device (a balloon catheter) and its mechanical properties and performance. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended for the dilatation of lesions in arteries, which is a therapeutic intervention to treat a medical condition.
No
The device is a dilatation catheter used for treatment (dilatation of lesions), not for identifying or diagnosing a condition.
No
The device description clearly outlines a physical catheter with a balloon, radiopaque markers, and a hydrophilic coating, indicating it is a hardware medical device. The performance studies also focus on bench testing of physical properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is a device used inside the body (in vivo) to physically dilate blood vessels. It's a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries." This is a treatment procedure, not a diagnostic test.
- Device Description: The description details a catheter with a balloon for physical expansion, not a system for analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of an in vivo therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not intended for use in coronary or neuro-vasculature.
Product codes
LIT
Device Description
The EBONY® PTA 0.014" RX Dilatation Catheter is a standard rapid exchange (RX) PTA catheter with a semi-compliant inflatable balloon and tapered tip on the distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature.
The modified EBONY® PTA 0.014" RX Dilatation Catheter line extension adds a 1.5 mm diameter balloon and additional balloon lengths to the currently available sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra popliteal, and renal arteries
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
Bench testing was performed on the modified Ebony PTA .014" RX Catheter, including:
- Balloon compliance
- Balloon burst pressure
- Balloon fatigue
- Shaft resistance (Torque Test)
- Bond strength
- Catheter dimensions
- Deflation time
- Guide wire and introducer compatibility.
The new balloon sizes met all of the verification/validation acceptance criteria.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2015
Natec Medical Ltd. c/o Ms. Judith Danielson Senior Regulatory Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, MD 21228
Re: K142459
Trade/Device Name: Ebony PTA 0.014" Rx Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: December 2, 2014 Received: December 3, 2014
Dear Ms. Danielson.
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
1
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 yours.
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Ebony® PTA 0.014" RX Peripheral Dilatation Catheter
Indications for Use (Describe)
The Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not intended for use in 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Ebony® PTA 0.014'' RX Peripheral Dilatation Catheter 510(k) SUMMARY 21 CFR 807.92
Applicant:
| Company Name: | Natec Medical Ltd. |
|---|---|
| Company Address: | Maeva Centre Building - Ebene Business Park |
| Reduit, Mauritius | |
| Telephone: | +230 466 30 54 |
| Fax: | +230 466 67 70 |
| Contact Person: | Xavier De Buchere |
| Regulatory Affairs & Quality Manager | |
| xdbuchere@natec-medical.com |
Summary Preparation Date: August 17, 2014
Device Name:
| Trade Name: | Ebony® PTA 0.014" RX Peripheral Dilatation Catheter |
|---|---|
| Common/Usual Name: | PTA Catheter |
| Classification Name: | Percutaneous Transluminal Angioplasty Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | LIT |
| Device Class: | Class II |
Predicate Devices:
- Ebony® PTA 0.014" RX Peripheral Dilatation Catheter (K112513) ●
- ev3 Inc., RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter (K123544) ●
- ev3 Inc., NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter . (K141118)
Device Description:
The EBONY® PTA 0.014" RX Dilatation Catheter is a standard rapid exchange (RX) PTA catheter with a semi-compliant inflatable balloon and tapered tip on the distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature.
The modified EBONY® PTA 0.014" RX Dilatation Catheter line extension adds a 1.5 mm diameter balloon and additional balloon lengths to the currently available sizes.
4
Indication for Use:
The Ebony® PTA 0.014" RX Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not for use in coronary or neuro-vasculature.
Technological Characteristics:
The modified Ebony® PTA 0.014" RX Peripheral Dilatation Catheter has the same indication for use and is manufactured using the same rapid exchange design and materials as the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter cleared under K112513.
The balloon size matrix of the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter was modified to include 1.5 mm diameter balloons, and longer balloon lengths (up to 200 mm) to the previously cleared balloon sizes. The new balloon sizes are similar to ev3's NanoCross™ Elite 0.014" PTA catheter with 1.5 mm diameter balloon, and RapidCross™ PTA Catheter with balloon lengths ranging up to 210mm long.
Performance Data:
Based on a risk analysis, the following bench testing was performed on the modified Ebony PTA .014" RX Catheter:
- I Balloon compliance
- 트 Balloon burst pressure
- I Balloon fatigue
- 트 Shaft resistance (Torque Test)
- I Bond strength
- I Catheter dimensions
- I Deflation time
- I Guide wire and introducer compatibility.
Conclusion
The modified Ebony® 0.014" RX Peripheral Dilatation Catheters and the predicate Ebony 0.014" RX Peripheral Dilatation Catheter (K112513) have the same intended use, same materials and the same RX design. The new balloon sizes met all of the verification/validation acceptance criteria and demonstrated that the modified Ebony® 0.014" RX Peripheral Dilatation Catheters are as safe and effective as the predicate device.