(347 days)
Not Found
No
The summary describes a standard mechanical medical device (a balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for "Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion," which is a therapeutic intervention.
No
The device is a dilatation catheter used for balloon angioplasty, a therapeutic procedure to open stenotic coronary arteries or bypass grafts. It does not perform any diagnostic function.
No
The device description clearly outlines a physical catheter with a balloon, radiopaque markers, and a hydrophilic coating. The performance studies also focus on physical characteristics and mechanical testing of the catheter and balloon. There is no mention of software as the primary or sole component of this medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Filao NC RX PTCA Dilatation Catheter Function: This device is a catheter designed to be inserted into the body (specifically, coronary arteries or bypass grafts) to physically dilate a stenosis (narrowing). It is a therapeutic device used in vivo (within the living body).
The description clearly outlines a device used for a surgical procedure within the body, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The Filao NC RX PTCA Dilatation Catheters are indicated for:
- Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
- Balloon dilatation of a stent after implantation (balloon models 2.00mm - 4.50mm)
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The Filao NC RX PTCA Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a non-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenosis. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating improves pushability of the catheter.
The Filao NC PTCA RX Catheter is available in balloon diameters ranging from 2.00 mm to 4.50 mm, and balloon lengths ranging from 8mm to 30 mm in step of 1 mm. The maximum recommended guide wire diameter is 0.014"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery or bypass graft
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)
Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:
- Catheter dimensions and balloon profile
- Balloon preparation, deployment and retraction
- Balloon rated burst pressure (within a stent)
- Balloon compliance
- Balloon fatigue (within a stent)
- Balloon inflation and deflation time
- Bond strengths
- Tip pull test
- Flexibility and kink test
- Torque strength test
- Coating integrity test
- Particulate Evaluation test
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
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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June 26, 2015
NATEC Medical Ltd. Xavier De Buchere Regulatory Affairs & Ouality Manager Maeva Centre Building - Ebene Business Park Silicon Avenue Reduit 72201, Mauritius
Re: K141933
Trade/Device Name: Filao NC RX PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 28, 2015 Received: May 29, 2015
Dear Xavier 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. Iisting 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
1
Page 2 - Xavier De Buchere
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 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 vours.
M. A. Lillehemen
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) K141933
Device Name Filao NC RX PTCA Dilatation catheter
Indications for Use (Describe) The Filao NC RX PTCA Dilatation Catheters are indicated for:
Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
Balloon dilatation of a stent after implantation (balloon models 2.00mm - 4.50mm)
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
L 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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3
K141933 510(K) SUMMARY
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Applicant: | Natec Medical Ltd.
Maeva Centre Building - Ebene Business Park
Reduit, Mauritius |
|-------------------------|----------------------------------------------------------------------------------------|
| Official Correspondent: | Xavier De Buchere |
| | Regulatory Affairs & Quality Manager |
| | Tel: +230 466 30 54 |
| | FAX: +230 466 67 70 |
| | xdbuchere@natec-medical.com |
| | Alain Valorge |
| | Quality Consultant |
| | Tel: +230 466 30 54 |
| | FAX: +230 466 67 70 |
| | avalorge@natec-medical.com |
Summary Preparation Date: June 25, 2015
Device Name:
:
| Trade Name: | Filao NC RX PTCA Dilatation Catheter |
|---|---|
| Common/Usual Name: | PTCA Catheter |
| Classification Name: | Percutaneous transluminal coronary angioplasty catheter |
| Generic name: | PTCA Catheter |
| Regulation Number: | 870.5100 |
| Product Code: | LOX |
| Device Class: | Class II |
| Predicate Devices: | ■ Tamarin Blue PTCA Dilation catheter - K112735 |
- NC Trek Abbott Vascular Inc. − K110134
4
Device Description:
The Filao NC RX PTCA Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a non-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenosis. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating improves pushability of the catheter.
The Filao NC PTCA RX Catheter is available in balloon diameters ranging from 2.00 mm to 4.50 mm, and balloon lengths ranging from 8mm to 30 mm in step of 1 mm. The maximum recommended guide wire diameter is 0.014"
Device Intended Use:
The Filao NC RX PTCA Dilatation Catheters are indicated for:
- Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, . for the purpose of improving myocardial perfusion.
- Balloon dilatation of a stent after implantation (balloon models 2.00mm 4.50mm). ●
Comparison of Technical Characteristics:
The design, materials and manufacturing of the Filao NC RX PTCA Dilatation Catheter are the same or similar to those of used for the predicate devices. The indication for use for the Filao NC RX PTCA Dilatation Catheter is also comparable to the predicate devices.
Performance Data:
Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:
- 이 Catheter dimensions and balloon profile
- Balloon preparation, deployment and retraction 비
- Balloon rated burst pressure (within a stent) 미
- Balloon compliance 트
- 트 Balloon fatigue (within a stent)
- . Balloon inflation and deflation time
- 트 Bond strengths
- 피 Tip pull test
- Flexibility and kink test
- 트 Torque strength test
- 트 Coating integrity test
- I Particulate Evaluation test
5
Conclusion:
Based on the similarities in the indication for use, device design and materials, and the results of the non-clinical testing and analysis, the Filao NC RX PTCA Dilatation Catheter is considered substantially equivalent to the aforementioned predicate devices.
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