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.

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.

AI/ML Overview

The provided document describes the Meril Life Sciences Mozec™ - Rx PTCA Balloon Dilatation Catheter and its conformity to acceptance criteria through non-clinical performance data.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was subjected to performance testing as 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)."

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Physical/Mechanical	Dimensional verification	Met predetermined criteria
	Balloon preparation, deployment and retraction	Met predetermined criteria
	Balloon rated burst pressure	Met predetermined criteria
	Balloon compliance	Met predetermined criteria
	Balloon fatigue	Met predetermined criteria
	Balloon inflation and deflation time	Met predetermined criteria
	Catheter bond strength(s)	Met predetermined criteria
	Tip pull test	Met predetermined criteria
	Flexibility and kink test	Met predetermined criteria
	Radiopacity	Met predetermined criteria
	Coating integrity	Met predetermined criteria
	Particulate evaluation	Met predetermined criteria
	Balloon rated burst pressure (In stent)	Met predetermined criteria
	Balloon fatigue (In Stent)	Met predetermined criteria
Biocompatibility (ISO 10993-1)	Cytotoxicity	Met predetermined criteria
	Sensitization	Met predetermined criteria
	Irritation / Intracutaneous reactivity	Met predetermined criteria
	Systemic Toxicity	Met predetermined criteria
	Hemolysis	Met predetermined criteria
	C3a complement activation	Met predetermined criteria
	SC5b-9 complement activation	Met predetermined criteria
	In vivo thromboresistance	Met predetermined criteria
	Material mediated pyrogenicity	Met predetermined criteria

Conclusion: The document explicitly states: "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical performance data, which typically refers to laboratory testing and does not involve human subjects or clinical data. Therefore, terms like "test set sample size," "country of origin," "retrospective or prospective" are not applicable in this context. The tests were performed on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. For non-clinical performance testing of a medical device like a balloon catheter, "ground truth" is typically established by engineering specifications, validated test methods, and regulatory standards rather than expert medical consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where multiple human experts assess the same cases and a method is needed to resolve discrepancies. The provided document describes non-clinical, laboratory-based testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to the Mozec™ - Rx PTCA Balloon Dilatation Catheter. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would be evaluated for its impact on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical balloon catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance tests conducted, the "ground truth" would be established by engineering specifications, regulatory standards, and validated test methods. For example, the rated burst pressure has a defined specification, and the test method measures if the device meets that specification. Biocompatibility tests rely on established ISO standards.

8. The sample size for the training set

This information is not applicable. The document describes the testing of a physical medical device, not a machine learning model, and therefore there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for a physical medical device.

Summary

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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

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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:

1. Sprinter Legend Rx PTCA Balloon Dilatation Catheter (P790017)
1. Apex Monorail Balloon Catheter (P860019)
1. Tamarin blue® PTCA Rx Dilatation Catheter (K112735)

5.6 Device description:

5.7 Indication for use:

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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

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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.

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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

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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

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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"

Regulation Number and Section

§ 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.