(101 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the dilatation of lesions in various arteries, which is a therapeutic intervention.
No
The device is a Peripheral Dilatation Catheter intended for dilatation of lesions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical catheter with a balloon, lumens, radio opaque markers, and a hydrophilic coating. It is a hardware medical device.
No, 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 (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Ebony 0.014'' PTA Catheter is a device used inside the body to physically dilate (widen) narrowed arteries. 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, renal and carotid arteries." This is a treatment procedure, not a diagnostic test.
- Device Description: The description details the physical components and function of a catheter used for angioplasty, which is an interventional procedure performed within the body.
Therefore, based on its intended use and description, the Ebony 0.014'' PTA Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ebony 0.014'' PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries.
This catheter is not for use in coronary or neuro-vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The Ebony® PTA 0.014'' Peripheral Dilatation Catheter is a standard Rapid Exchange (RX) PTA catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenoses.
The catheter is double lumen in the distal part, one lumen is used for inflation and deflation of the balloon, and the second lumen allows access to the distal part of the catheter for guide wire insertion (max. 0.014"). The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows the connection with an inflation device. The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel.
An hydrophilic coating solution is applied on the catheter body to improve the pushability of the catheter by reduction of the friction coefficient of the outer body. The balloon material expands to a known diameter at specific pressure defined in a compliance table supplied with the catheter. The device is available in balloon diameter of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 mm, and balloon lengths of 10, 15, 20, 25, 30, 35, 40, and 60 mm.
It will be supplied sterile and is intended for one time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra popliteal, renal and carotid 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Ebony PTA .014" Catheter has been demonstrated via data collected from non-clinical tests and analyses, which addressed, among other considerations, the following:
- Biocompatibility
- Balloon compliance
- Balloon burst pressure
- Balloon fatigue (repeated balloon inflation) endurance
- Balloon inflation/deflation performance
- Bond strengths
- Catheter dimensions and balloon profile
- Catheter body minimum burst strength
- Device preparation (guide wire and introducer compatibility)
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.
Not Found
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
K112513 page 1 of 3
DEC - 9 2011
510(k) SUMMARY 807.92(c)
SPONSOR
Company Name: Company Address:
Natec Medical Ltd. Maeva Centre Building - Ebene Business Park Reduit, Mauritius
Telephone: Fax:
+230 466 30 54 +230 466 67 70
Contact Person:
Alain Valorge Quality Manager info@natec-medical.com
Summary Preparation Date: July 14, 2011
DEVICE NAME
Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:
807.92(a)(2)
807.92(a)(1)
Ebony® PTA .014" RX Peripheral Dilatation Catheter PTA .014" Catheter Percutaneous Catheter 21 CFR 870.1250 LIT and DQY Class II
PREDICATE DEVICE
Legally Marketed Equivalent Devices:
- " Invatec Amphirion Deep PTA 0.014" Balloon Catheter K083919
- Cordis AVIATOR Plus PTA Balloon dilatation catheter K071189
- Boston Ultra Soft SV PTA Dilatation Catheter K050389
DEVICE DESCRIPTION
807.92(a)(4)
807.92(a)(3)
The Ebony® PTA 0.014'' Peripheral Dilatation Catheter is a standard Rapid Exchange (RX) PTA catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenoses.
The catheter is double lumen in the distal part, one lumen is used for inflation and deflation of the balloon, and the second lumen allows access to the distal part of the catheter for guide wire insertion (max. 0.014"). The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows the connection with an inflation device. The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel.
1
An hydrophilic coating solution is applied on the catheter body to improve the pushability of the catheter by reduction of the friction coefficient of the outer body. The balloon material expands to a known diameter at specific pressure defined in a compliance table supplied with the catheter. The device is available in balloon diameter of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 mm, and balloon lengths of 10, 15, 20, 25, 30, 35, 40, and 60 mm.
It will be supplied sterile and is intended for one time use.
DEVICE INTENDED USE
807.92(a)(5)
The Ebony 0.014'' PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries.
This catheter is not for use in coronary or neuro-vasculature.
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a){6}
The Ebony PTA .014" Dilatation Catheter incorporates substantially equivalent indications for use, design, and dimensional and performance specifications as those found with the aforementioned predicate devices.
NONCLINICAL TESTS
807.92(b)
SAFETY and EFFECTIVENESS
BIOCOMPATIBILITY
All materials used in the Ebony "PTA .014" Catheter are biocompatible based on biocompatibility testing results. The device has been tested according to ISO 10993 Part 1, 2, 4, 5, 10, 11, 12, ASTM F756-00 and 21 CFR 58 (GLP regulations)
PERFORMANCE DATA
The safety and effectiveness of the Ebony PTA .014" Catheter has been demonstrated via data collected from non-clinical tests and analyses, which addressed, among other considerations, the following:
- · Biocompatibility
- · Balloon compliance
- · Balloon burst pressure
- Balloon fatigue (repeated balloon inflation) endurance
- Balloon inflation/deflation performance
- · Bond strengths
- Catheter dimensions and balloon profile
- · Catheter body minimum burst strength
- Device preparation (guide wire and introducer compatibility)
2
CONCLUSION
807.92(b)(3)
Kbl2 513 page
The subject device, the Ebony PTA 0.014" Catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols.
Since the Ebony PTA 0.014'' Catheter have the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, same mode of operation, and no new safety or effectiveness issues, the Ebony PTA 0.014'' Catheter may be considered substantially equivalent to the aforementioned predicate devices.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 9 2011
NATEC Medical Ltd. c/o E.J. Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114
Re: K112513
Trade/Device Name: Ebony PTA 0.014" Peripheral Dilatation Catheter Regulation Number: 21 CFR 870. 1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: November 23, 2011 Received: November 23, 2011
Dear Mr. Smith:
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.
4
Page 2 - Mr. E.J. Smith
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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRI-'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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M. A. Hellelenne
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Traditional
Pre-Market Notification
Indications for Use Statement
510(k) Number:
Device Name:
Ebony 0.014 PTA Catheter
Indication for Use:
The Ebony 0.014'' PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries.
This catheter is not for use in coronary or neuro-vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The —Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEWS OF OF SEE SECTION NEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Killebenne
(Division Sign-Off) Division of Cardiovascular De
510(k) Number K112513
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