(116 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes
The device is indicated 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 Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter, indicated for balloon dilatation of a coronary artery or bypass graft stenosis and for post-delivery expansion of balloon expandable stents. These are therapeutic interventions, not diagnostic procedures.
No
The device description clearly outlines a physical catheter with a balloon, tip, shaft, and radiopaque markers. The performance studies also detail testing on physical properties like bond strength, flexibility, and balloon fatigue, which are characteristic of a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis" and "post-delivery expansion of balloon expandable stents." This is a therapeutic procedure performed directly on a patient's body to improve blood flow.
- Device Description: The description details a physical catheter with a balloon designed for mechanical intervention within the body.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the placement and use of the device within the body.
- Anatomical Site: The device is used in the "Coronary artery or bypass graft," which are internal anatomical structures.
In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens. It is a therapeutic device used for a medical procedure.
N/A
Intended Use / Indications for Use
The Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.
Product codes
LOX
Device Description
Mozec™ NC - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon, a soft tip, a coaxial dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium markers contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec™ NC balloon's working length. The Mozec™ NC balloons are offered in diameters ranging from 2.00mm to 4.50mm and lengths varying from 8mm to 38mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery or bypass graft stenosis
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
The safety and effectiveness of the Mozec™ NC – Rx PTCA Balloon Dilatation Catheter has been evaluated in the following non Clinical tests;
- . Dimensional verification Test
- Balloon preparation, deployment and retraction Test
- Balloon rated burst pressure and Balloon compliance Test
- . Balloon fatigue Test
- . Balloon inflation and deflation time Test
- . Bond strength Test
- Flexibility and kink test
- Balloon rated burst pressure (In stent) Test
- Balloon fatigue (In Stent) Test
- Radiopacity
- Torque test
- Performance testing on the Looper Clip accessory
- Biocompatibility testing in compliance with the ISO 10993-1
- In Vitro Cytotoxicity study
- Skin Sensitization Study
- Intracutaneous reactivity test
- Acute Systemic Toxicity Study
- In vitro Hemolysis test Study
- In vitro C3a and SC5b-9 complement activation Assay
- Material Mediated Pyrogen Test
- In vivo thromboresistance
The Mozec™ NC – Rx PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols. No safety and efficacy issues were raised during the testing program.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three profiles, symbolizing the department's focus on health, human services, and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
July 30, 2016
Meril Life Sciences Private Limited % Semih Oktay, Ph.D. CardioMed Device Consultants 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K160961
Trade/Device Name: Mozec NC-Rx PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: June 30, 2016 Received: July 1, 2016
Dear Dr. Oktay:
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
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Page 2 - Semih Oktay, Ph.D.
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 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" (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,
Brian D. Pullin -S
for Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160961
Device Name
Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter
Indications for Use (Describe)
The Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | checked |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "Meril" in a sans-serif font. The letters are white, and they are set against a blue background. There is a small yellow circle above the "i" in "Meril", which is slightly offset to the right. The logo is simple and modern.
5. 510(k) SUMMARY
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 92.
5.1 Applicant:
Meril Life Sciences Private Limited Bilakhia house, Survey No. 135/139 Muktanand Marg, Chala, Vapi Gujarat 396191 INDIA
5.2 Contact Person:
Utpal Thakor Director Meril Life Sciences Private Limited Bilakhia house, Survey No. 135/139 Muktanand Marg, Chala, Vapi Gujarat 396 191 INDIA Phone: +91 - 2603052100 Mobile: +91 - 9601260306 E mail: utpal.thakor@merillife.com
5.3 Date prepared: Mar 15, 2016
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5.4 Device information:
| Proprietary Name: | MozecTM NC – Rx PTCA Balloon Dilatation Catheter |
|---|---|
| Common / Usual Name: | Rapid Exchange PTCA Balloon Dilatation Catheter |
| Regulation name: | Percutaneous Transluminal Coronary Angioplasty |
| (PTCA) Catheter | |
| Regulation Number | 21CFR 870.5100 |
| Product Code: | LOX |
| Device Class: | Class II |
5.5 Predicate device:
- NC TREK RX Coronary Dilatation Catheter (K103153) (Primary Predicate device) .
- EMPIRA NC Rx PTCA Dilatation Catheter (K110133) (Secondary Predicate device) .
- Mozec™ Rx PTCA Balloon Dilatation Catheter (K131169) (Secondary Predicate . device)
5.6 Device description:
Mozec™ NC - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon, a soft tip, a coaxial dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium markers contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec™ NC balloon's working length. The Mozec™ NC balloons are offered in diameters ranging from 2.00mm to 4.50mm and lengths varying from 8mm to 38mm.
5.7 Indication for use:
The Mozec™ NC – Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec™ NC - Rx PTCA Balloon
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Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.
5.8 Comparison of Technological characteristics:
The Mozec™ NC – Rx PTCA Balloon Dilatation Catheter is the same or similar to the primary and secondary predicate devices with respect to intended use, device design, and method of sterilization. The Mozec™ NC has the same RBP as the secondary predicate EMPIRA NC and material composition of the subject device is the same as the secondary predicate Mozec™
5.9 Non clinical Performance data:
To ensure that the device design and construction are suitable for the intended use, the Mozec N NC - Rx PTCA Balloon Dilatation Catheter was subjected to the performance testing recommended in the Guidance for Industry and FDA Staff- Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010).
The safety and effectiveness of the Mozec™ NC – Rx PTCA Balloon Dilatation Catheter has been evaluated in the following non Clinical tests;
- . Dimensional verification Test
- Balloon preparation, deployment and retraction Test ●
- Balloon rated burst pressure and Balloon compliance Test ●
- . Balloon fatigue Test
- . Balloon inflation and deflation time Test
- . Bond strength Test
- Flexibility and kink test
- Balloon rated burst pressure (In stent) Test
- Balloon fatigue (In Stent) Test
- Radiopacity
- Torque test ●
- Performance testing on the Looper Clip accessory
- Biocompatibility testing in compliance with the ISO 10993-1
- In Vitro Cytotoxicity study o
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Image /page/6/Picture/0 description: The image shows the word "Meril" in a sans-serif font. The letters are white, and the background is light blue. There is a small yellow circle above the "i" in "Meril", which serves as the dot for the "i".
- Skin Sensitization Study O
- o Intracutaneous reactivity test
- Acute Systemic Toxicity Study O
- In vitro Hemolysis test Study O
- In vitro C3a and SC5b-9 complement activation Assay O
- Material Mediated Pyrogen Test O
- In vivo thromboresistance O
5.10 Conclusion
The Mozec™ NC – Rx PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols. No safety and efficacy issues were raised during the testing program.
The Mozec™ NC – Rx PTCA Balloon Dilatation Catheter is substantially equivalent to the primary predicate, NC TREK RX Coronary Dilatation Catheter. Substantial equivalence is further supported with comparison to the secondary predicate devices.