(27 days)
Not Found
No
The summary describes a standard balloon catheter with no mention of AI or ML capabilities. The performance studies are bench tests related to the physical properties of the device.
Yes
The device is intended for "dilatation of lesions" in arteries, which is a therapeutic intervention aimed at treating a medical condition (stenosis).
No
This device is a dilatation catheter intended for treatment (dilatation of lesions), not for diagnosis.
No
The device description clearly describes a physical catheter with a balloon, tip, markers, and coating, indicating it is a hardware medical device, not software-only.
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 the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is a device used for dilatation of lesions in arteries. This is a procedure performed inside the body (in vivo) to physically open up narrowed blood vessels.
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological markers, or any other activity typically associated with IVD devices.
Therefore, based on the provided information, the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
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 has a new hydrophilic coating, applicable to all 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
Based on a risk analysis, the following bench testing was performed on the modified Ebony PTA .014" RX Catheter or leveraged from similar catheters:
- I Coating Integrity test
- 트 Particulate evaluation
- I Biocompatibility
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
Natec Medical, Ltd Xavier de Buchere Regulatory Affairs and Quality Manager Maeva Centre Building Silicon Avenue Ebene Business Park Reduit 72201 - Mauritius
Re: K152230
Trade/Device Name: Ebony PTA .014" RX Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 25, 2015 Received: August 7, 2015
Dear Mr. de Buchere:
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
1
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 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/Resourcesfor You/Industry/default.htm. 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/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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152230
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)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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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 |
| Silicon Avenue, | |
| Ebene Business Park | |
| Reduit 72201, | |
| 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 25th, 2015
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)
- Ebony® PTA 0.014" RX Peripheral Dilatation Catheter (K142459)
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 has a new hydrophilic coating, applicable to all 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 and K142459.
The hydrophilic coating on the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter was modified from Slipskin to Proglide.
Performance Data:
Based on a risk analysis, the following bench testing was performed on the modified Ebony PTA .014" RX Catheter or leveraged from similar catheters:
- I Coating Integrity test
- 트 Particulate evaluation
- I Biocompatibility
Conclusion
The modified Ebony® 0.014" RX Peripheral Dilatation Catheters and the predicate Ebony 0.014" RX Peripheral Dilatation Catheter (K112513) & (K142459) have the same intended use, same materials and the same RX design. The modified catheters met all of the verification/validation acceptance criteria and demonstrated that the modified Ebony® 0.014" RX Peripheral Dilatation Catheters are substantially equivalent to the predicate device.