(244 days)
P790017, P860019, K112735
Not Found
No
The summary describes a standard balloon catheter and its performance testing, with no mention of AI, ML, or any computational analysis of data for decision-making or image processing.
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 direct therapeutic intervention to improve a patient's health condition.
No
The device is a Mozec™ - Rx PTCA Balloon Dilatation Catheter. Its intended use is for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," and "for post-delivery expansion of balloon expandable stents." These are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines a physical catheter with a balloon, shaft, tip, and radiopaque markers. The performance studies also focus on physical characteristics and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for balloon dilatation of coronary arteries and bypass grafts to improve blood flow. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical catheter with a balloon designed for mechanical intervention within the body.
- Lack of In Vitro Testing: The description and performance studies focus on the physical properties and performance of the catheter and balloon within a simulated or in-vivo environment, not on analyzing samples taken from the body.
- No Mention of Samples: There is no mention of the device being used to test or analyze biological samples (blood, tissue, etc.) outside of the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is a therapeutic tool used directly within the body.
N/A
Intended Use / Indications for Use
The Mozec™ - 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™ - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for post-delivery expansion of balloon expandable stents.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
Mozec™ - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a semi-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec ™ balloon's working length (2.00 mm to 4.50 mm sizes) or the center of the balloon's working length (1.50 mm size). The Mozec"™ balloons are offered in diameters ranging from 1.50mm to 4.50mm and lengths varying from 9mm to 41mm.
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)
To ensure that the device design and construction are suitable for the intended use, the Mozec " - 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™ - Rx PTCA Balloon Dilatation Catheter has been evaluated in the following non Clinical tests;
- Dimensional verification.
- Balloon preparation, deployment and retraction.
- Balloon rated burst pressure
- Balloon compliance.
- Balloon fatigue.
- Balloon inflation and deflation time.
- Catheter bond strength(s).
- Tip pull test.
- Flexibility and kink test.
- Radiopacity.
- Coating integrity.
- Particulate evaluation.
- Balloon rated burst pressure (In stent).
- Balloon fatigue (In Stent)
- Biocompatibility testing in compliance with the ISO 10993-1
- Cytotoxicity
- Sensitization
- Irritation / Intracutaneous reactivity
- Systemic Toxicity
- Hemolysis
- C3a complement activation
- SC5b-9 complement activation
- In vivo thromboresistance
- Material mediated pyrogenicity
The Mozec™ - 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 (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.
P790017, P860019, K112735
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
Image /page/0/Picture/0 description: The image shows a combination of handwritten and printed text. The handwritten text at the top appears to be a code or identifier, "R131169". Below this, there is a printed date, "DEC 24 2013", indicating December 24, 2013. The text is clear and legible, set against a plain white background.
Image /page/0/Picture/1 description: The image shows a logo with the word "Merii" in a stylized font. The letters are bold and outlined, giving them a three-dimensional appearance. The logo is contained within a rectangular border, and the overall design is simple and clean.
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
396 191
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
Fax: +91 260-3052125
E mail: utpal.thakor@merillife.com
5.3 Date prepared: April 11, 2013
1
Image /page/1/Picture/1 description: The image shows the word "Meril" in white text against a black background. The text is simple and sans-serif. There are some small white specks scattered around the text, which could be dust or imperfections in the image.
5.4 Device information:
| Proprietary Name: | MozecTM – Rx PTCA Balloon Dilatation Catheter |
|---|---|
| Common / Usual Name: | Rapid Exchange PTCA Balloon Dilatation Catheter |
| Regulation name: | Percutaneous Transluminal Coronary Angioplasty |
| (PTCA) Catheter - 21CFR 870.5100 (a) | |
| Product Code: | LOX |
| Device Class: | Class II |
5.5 Predicate device:
-
- Sprinter Legend Rx PTCA Balloon Dilatation Catheter (P790017)
-
- Apex Monorail Balloon Catheter (P860019)
-
- Tamarin blue® PTCA Rx Dilatation Catheter (K112735)
5.6 Device description:
Mozec™ - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a semi-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec ™ balloon's working length (2.00 mm to 4.50 mm sizes) or the center of the balloon's working length (1.50 mm size). The Mozec"™ balloons are offered in diameters ranging from 1.50mm to 4.50mm and lengths varying from 9mm to 41mm.
5.7 Indication for use:
The Mozec™ - 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™ - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for postdelivery expansion of balloon expandable stents.
2
5.8 Comparison of Technological characteristics:
The Mozec™ - Rx PTCA Balloon Dilatation Catheter is similar to the predicate devices with respect to intended use, device design, materials, rated burst pressure, and method of sterilization.
5.9 Non clinical Performance data:
To ensure that the device design and construction are suitable for the intended use, the Mozec " - 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™ - Rx PTCA Balloon Dilatation Catheter has been evaluated in the following non Clinical tests;
- Dimensional verification .
- Balloon preparation, deployment and retraction .
- . Balloon rated burst pressure
- Balloon compliance .
- Balloon fatigue .
- Balloon inflation and deflation time .
- Catheter bond strength(s) .
- Tip pull test .
- Flexibility and kink test .
- Radiopacity .
- Coating integrity .
- Particulate evaluation .
- Balloon rated burst pressure (In stent) .
- Balloon fatigue (In Stent) t
- Biocompatibility testing in compliance with the ISO 10993-1 .
- o Cytotoxicity
- Sensitization o
- Irritation / Intracutaneous reactivity O
- Systemic Toxicity O
3
Image /page/3/Picture/0 description: The image shows the word "Meril" in a white sans-serif font against a black background. The text is centered and appears to be a logo or brand name. There are some artifacts around the letters, possibly due to image compression or scanning.
- Hemolysis 0
- C3a complement activation o
- SC5b-9 complement activation 0
- In vivo thromboresistance o
- Material mediated pyrogenicity o
5.10 Conclusion
The Mozec™ - 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™ - Rx PTCA Balloon Dilatation Catheter is similar to the predicate devices with respect to intended use, device design, materials, rated burst pressure, and method of sterilization. Therefore, Meril Life Sciences Pvt. Ltd. believes the Mozec™ - Rx PTCA Balloon Dilatation Catheter is considered substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human figures connected in a flowing design. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2013
Meril Life Sciences Private Limited C/O Judith Danielson Senior Regulatory Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 360 Baltimore, MD 21228
Re: KI31169
Trade/Device Name: Mozec 100 - 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: December 6, 2013 Received: December 9, 2013
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
5
Page 2 - Judy Danielson
- device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 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 yours.
Adal Stei
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Image /page/6/Picture/0 description: The image shows the word "Meril" in a bold, sans-serif font. The letters are outlined in black, and the interior of the letters appears to be white. The word is set against a textured background, which is also outlined in black. The background texture appears to be a pattern of small, irregular shapes or dots.
4. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): _K131169
Device Name: Mozec 131 - Rx PTCA Balloon Dilatation Catheter
Indications for Use: The Mozec™ - 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™ - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for post-delivery expansion of balloon expandable stents.
Prescription Use X
AND/OR
Over-The-Counter Use
2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (OD)
CONFIDENTIAL -1-1
MERIL LIFE SCIENCES 510(x) - Rx PTEA Bolloan Dilatation Catherer MAI::::::
April 11, 2017
05'00"