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.

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.

AI/ML Overview

This document describes the Mozec™ NC – Rx PTCA Balloon Dilatation Catheter. The information needed to address the user's request, specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria, is limited to the non-clinical performance data provided. There is no mention of an AI-based device or a comparative effectiveness study involving human readers. The document pertains to a medical device approval through a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing, rather than extensive clinical efficacy trials.

Here's a summary of the available information based on the provided text, with many fields indicated as "Not Applicable" or "Not Provided" due to the nature of the device and the submission document:

1. A table of acceptance criteria and the reported device performance

The document states: "The Mozec™ NC – Rx PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols." However, the specific quantitative acceptance criteria and the detailed reported device performance values are not explicitly provided in this summary. The summary lists the types of tests performed, which implies these tests had corresponding acceptance criteria.

Acceptance Criteria Category (Implied)	Reported Device Performance
Dimensional verification	Met criteria
Balloon preparation, deployment and retraction	Met criteria
Balloon rated burst pressure and Balloon compliance	Met criteria
Balloon fatigue	Met criteria
Balloon inflation and deflation time	Met criteria
Bond strength	Met criteria
Flexibility and kink test	Met criteria
Balloon rated burst pressure (In stent)	Met criteria
Balloon fatigue (In Stent)	Met criteria
Radiopacity	Met criteria
Torque test	Met criteria
Performance testing on the Looper Clip accessory	Met criteria
Biocompatibility (ISO 10993-1)	Met criteria (no safety/efficacy issues)
- In Vitro Cytotoxicity study	Met criteria
- Skin Sensitization Study	Met criteria
- Intracutaneous reactivity test	Met criteria
- Acute Systemic Toxicity Study	Met criteria
- In vitro Hemolysis test Study	Met criteria
- In vitro C3a and SC5b-9 complement activation Assay	Met criteria
- Material Mediated Pyrogen Test	Met criteria
- In vivo thromboresistance	Met criteria

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

Sample size used for the test set: Not provided. The document mentions "performance testing," but does not specify the number of devices or components tested for each category.
Data provenance: Not explicitly stated, but assumed to be internal testing conducted by Meril Life Sciences Private Limited, which is based in India. The testing is non-clinical/bench testing.

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)

Not Applicable. This request is relevant for AI/diagnostic devices where expert ground truth is established. This document describes a PTCA Balloon Dilatation Catheter, for which ground truth is typically established through engineering and biological testing against established standards, not expert consensus on interpretations.

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

Not Applicable. See point 3.

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

No. This is not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant to this device.

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

Not Applicable. This is not an algorithm or AI device. Performance is assessed through engineering and biocompatibility testing of the physical catheter.

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

Type of ground truth: For the non-clinical performance testing, the "ground truth" refers to established engineering standards, FDA guidance documents (e.g., "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and ISO standards (e.g., ISO 10993-1 for biocompatibility). The device's performance is compared against these predetermined specifications and accepted norms for safety and function.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. See point 8.

Summary

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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

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Indications for Use

510(k) Number (if known) K160961

Device Name

Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter

Indications for Use (Describe)

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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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:

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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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.

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.