(159 days)
The Ebony® PTA .035 Peripheral Dilatation Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal & renal arteries. The Ebony® PTA . 035'' OTW Peripheral Dilatation Catheter is not for use in the coronary arteries and neuro-vasculature.
The Ebony® PTA 0.035 Peripheral Dilatation Catheter is a standard Over The Wire (OTW) PTA catheter with a semi-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its 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 0.035 Peripheral Dilatation Catheter line extension adds 3.0 mm and 4.0 mm diameter balloon and additional balloon lengths to the currently available sizes.
Here's a breakdown of the acceptance criteria and the study information based on the provided document.
It's important to note that this document is a 510(k) premarket notification summary for a medical device. For such devices, the "study" demonstrating that the device meets acceptance criteria often refers to non-clinical bench testing to show substantial equivalence to a predicate device, rather than a clinical trial with human participants if the changes are minor. This is the case here.
Acceptance Criteria and Device Performance for Ebony® PTA 0.035 Peripheral Dilatation Catheter (K143036)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Balloon Compliance | Met verification/validation acceptance criteria |
| Balloon Burst Pressure | Met verification/validation acceptance criteria |
| Balloon Fatigue | Met verification/validation acceptance criteria |
| Biocompatibility Testing | Results demonstrated substantial equivalence; summary provided in file 002 |
| Shaft Resistance (Torque Test) | Met verification/validation acceptance criteria |
| Bond Strength | Met verification/validation acceptance criteria |
| Catheter Dimensions | Met verification/validation acceptance criteria |
| Coating Integrity (Visual Inspection) | Met verification/validation acceptance criteria |
| Deflation Time | Met verification/validation acceptance criteria |
| Guide Wire and Introducer Compatibility | Met verification/validation acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes for each non-clinical bench test. It generally states that the "new balloon sizes met all of the verification/validation acceptance criteria."
- Data Provenance: The data provenance is from non-clinical bench testing. It's not human data and therefore does not have a country of origin in the typical sense; these tests are performed in a laboratory setting. These were retrospective in relation to the original K103354 device, as the tests were performed on the modified device to show equivalence to the previously cleared predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- N/A. For non-clinical bench testing (like mechanical and material properties of a catheter), "expert ground truth" in the way it's described for image analysis or clinical outcomes is not applicable. The "ground truth" for these tests is based on established engineering principles, material science, and regulatory standards for device performance, which are evaluated by qualified engineers and scientists.
4. Adjudication Method for the Test Set:
- N/A. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in clinical or image-based studies. For bench testing, the results are typically quantitative measurements against predefined specifications; there's no "adjudication" of expert opinions involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. This device is a physical medical device (a catheter) and not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This question is typically relevant for AI algorithms. Since this is a physical medical device (catheter), the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission is based on regulatory standards and established engineering specifications for the physical and functional performance of a PTA catheter. This includes parameters like balloon burst pressure, fatigue, material biocompatibility, and physical dimensions, all of which are defined and verified through objective measurements and tests. The predicate device (K103354) served as the benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set:
- N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are likely refined through engineering development and quality control, but this isn't analogous to an AI training set.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As there is no "training set" in the AI sense, this question is not applicable. The performance characteristics and specifications for the device are derived from engineering design, material properties, and regulatory requirements for safe and effective medical devices.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2015
Natec Medical, Ltd. % Judith Danielson Senior Regulatory Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K143036
Trade/Device Name: Ebony PTA 0.035 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: March 23, 2015 Received: March 25, 2015
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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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/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,
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) K143036
Device Name
Ebony® PTA .035 Peripheral Dilatation Catheter
Indications for Use (Describe)
The Ebony@ PTA. 035 Peripheral Dilatation Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal & renal arteries.
The Ebony® PTA . 035'' OTW Peripheral Dilatation Catheter is not for use in the coronary arteries and 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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
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Ebony® PTA 0.035'' Peripheral Dilatation Catheter 510(k) SUMMARY 21 CFR 807.92
Applicant:
| Company Name: | Natec Medical Ltd. |
|---|---|
| Company Address: | Maeva Centre Building - Ebene Business ParkReduit, Mauritius |
| Telephone: | +230 466 30 54 |
| Fax: | +230 466 67 70 |
| Contact Person: | Xavier De BuchereRegulatory Affairs & Quality Managerxdbuchere@natec-medical.com |
| Summary Preparation Date: | October 14th. 2014 |
Device Name:
| Trade Name: | Ebony® PTA 0.035 Peripheral Dilatation Catheter |
|---|---|
| Common/Usual Name: | PTA Catheter |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | LIT |
| Device Class: | Class II |
Predicate Devices:
- Ebony® PTA 0.035 Peripheral Dilatation Catheter (K103354) ●
Device Description:
The Ebony® PTA 0.035 Peripheral Dilatation Catheter is a standard Over The Wire (OTW) PTA catheter with a semi-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its 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 0.035 Peripheral Dilatation Catheter line extension adds 3.0 mm and 4.0 mm diameter balloon and additional balloon lengths to the currently available sizes.
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Indication for Use:
Ebony® PTA 0.035 Peripheral Dilatation Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infra popliteal and renal arteries.
The Ebony® PTA .035'' OTW Catheter is not for use in the coronary arteries and neurovasculature.
Technological Characteristics:
The modified Ebony® PTA 0.035 Peripheral Dilatation Catheter has the same indication for use, and is manufactured with the same over the wire design and materials as the Ebony® PTA 0.035 Peripheral Dilatation Catheter cleared under K103354. The modification involved adding balloon diameter 3.0mm and 4.0mm and longer balloon lengths (100, 120, 150 and 200 mm) to the previously cleared balloon size matrix and a change in the hydrophilic coating material.
Non-Clinical Testing Summary:
The following bench testing was performed according to the same testing method used with the original Traditional 510(k) cleared under K103354.
- I Balloon compliance
- 트 Balloon burst pressure
- 트 Balloon fatigue
- 트 Biocompatibility testing (A summary of biocompatibility results is provided in file 002).
- I Shaft resistance (Torque Test)
- I Bond strength
- 트 Catheter dimensions
- I Coating integrity (Visual inspection)
- 트 Deflation time
- I Guide wire and introducer compatibility.
Clinical Testing Summary:
No clinical study was performed.
Conclusion
The proposed device and the predicate Ebony® PTA 0.035 Peripheral Dilatation Catheter (K103354) have the same indication, similar materials and a similar design. The new balloon sizes met all of the verification/validation acceptance criteria and the biocompatibility results demonstrated that the modified Ebony® PTA 0.035 Peripheral Dilatation Catheter is substantially equivalent to the predicate device.
§ 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).