Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter

K181023 · Meril Life Sciences Private Limited · LOX · May 17, 2018 · Cardiovascular

Device Facts

• Record ID: K181023
• Device Name: Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter
• Applicant: Meril Life Sciences Private Limited
• Product Code: LOX · Cardiovascular
• Decision Date: May 17, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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) is also indicated for post delivery expansion of balloon expandable stents. 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 Dilatation Catheter is also indicated for post delivery expansion of balloon expandable stents.

Device Story

Sterile, single-use rapid exchange PTCA balloon dilatation catheters; semi-compliant (Mozec) or non-compliant (Mozec NC) balloon; soft tip; dual-lumen distal shaft; single-lumen proximal shaft. Radiopaque platinum/iridium markers facilitate fluoroscopic visualization during procedures. Used by physicians in clinical settings to dilate stenotic coronary arteries/bypass grafts or expand stents. Device provides mechanical dilatation via inflation; performance monitored via fluoroscopy. Benefits include improved myocardial perfusion and optimized stent apposition.

Clinical Evidence

Bench testing only. Performance evaluated per FDA Class II Special Controls Guidance for PTCA Catheters. Tests included dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, balloon compliance, inflation/deflation time, catheter bond strength, and flexibility/kink testing.

Technological Characteristics

Rapid exchange PTCA catheter; semi-compliant or non-compliant balloon; platinum/iridium radiopaque markers; dual-lumen distal/single-lumen proximal shaft. Sterilized device. Materials and design consistent with predicate devices.

Indications for Use

Indicated for patients requiring balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion; also indicated for post-delivery expansion of balloon-expandable stents.

Regulatory Classification

Identification

Standard PTCA Catheter: 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. Cutting/scoring PTCA Catheter: 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.

Special Controls

*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.

Predicate Devices

• Mozec™ Rx PTCA Balloon Dilatation Catheter (K131169)
• Mozec™ NC Rx PTCA Balloon Dilatation Catheter (K160961)

Submission Summary (Full Text)

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May 17, 2018

Meril Life Sciences Private Limited % H. Semih Oktay President CardioMed Device Consultants, LLC 1783 Forest Drive, # 254 Annapolis, Maryland 21401

Re: K181023

Trade/Device Name: Mozec - Rx PTCA Balloon Dilatation Catheter, 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: April 13, 2018 Received: April 17, 2018

Dear H. Semih 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

M.A. Wilhelm

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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# Indications for Use

510(k) Number (if known) K181023

### Device Name

Mozec - Rx PTCA Balloon Dilatation Catheter, Mozec NC - Rx PTCA Balloon Dilatation Catheter

### Indications for Use (Describe)

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) is also indicated for post delivery expansion of balloon expandable stents.

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 Dilatation Catheter is also indicated for post delivery expansion of balloon expandable stents.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### 510(k) SUMMARY 6

## 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 92.

#### 6.1 Applicant:

Meril Life Sciences Private Limited Bilakhia house, Survey No. 135/139 Muktanand Marg, Chala, Vapi Gujarat 396 191 INDIA

# 6.2 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: [e-mail]

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- Date prepared: April 05, 2018 6.3
#### 6.4 Device information:

| Proprietary Name: | MozecTM – Rx PTCA Balloon Dilatation Catheter<br>MozecTM NC – Rx PTCA Balloon Dilatation Catheter |
|----------------------|---------------------------------------------------------------------------------------------------|
| Common / Usual Name: | Rapid Exchange PTCA Balloon Dilatation Catheter |
| Regulation name: | Percutaneous Transluminal Coronary Angioplasty<br>(PTCA) Catheter – 21CFR 870.5100 (a) |
| Product Code: | LOX |
| Device Class: | Class II |

### 6.5 Predicate device:

- 1. Mozec™ Rx PTCA Balloon Dilatation Catheter (K131169)
- 2. Mozec™ NC Rx PTCA Balloon Dilatation Catheter (K160961)

### 6.6 Device description:

#### Mozec – Rx PTCA Balloon Dilatation Catheter a.

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 centre of the balloon's working length (1.50 mm size). The Mozec balloons are offered in diameters ranging from 1.50 mm to 4.50 mm and lengths varying from 9 mm to 41 mm.

#### Mozec NC – Rx PTCA Balloon Dilatation Catheter b.

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 dual lumen distal shaft and a single lumen proximal shaft. Radiopaque

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# Meril

platinum/iridium marker(s) 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 2.00 mm to 4.50 mm and lengths varying from 8 mm to 38 mm.

#### 6.7 Indication for use:

#### Mozec™ – Rx PTCA Balloon Dilatation Catheter a.

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 2.25 mm to 4.50 mm) is also indicated for post delivery expansion of balloon expandable stents.

#### Mozec™ NC – Rx PTCA Balloon Dilatation Catheter b.

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 Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

## 6.8 Comparison of Technological characteristics:

The Mozec - Rx PTCA Balloon Dilatation Catheter and Mozec NC - Rx PTCA Balloon Dilatation Catheter are similar to the predicate devices with respect to intended use, device design, materials, rated burst pressure, and method of sterilization.

## 6.9 Non clinical Performance data:

To ensure that the modifications made to the devices are suitable for the intended use, the modified devices were subjected to the performance testing recommended in the

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# Meril

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 modified Mozec and Mozec NC has been evaluated in the following non clinical tests;

- . Dimensional verification
- Balloon preparation, deployment and retraction .
- Balloon rated burst pressure ●
- . Balloon compliance
- Balloon inflation and deflation time
- Catheter bond strength(s)
- Flexibility and kink test .

## 6.10 Conclusion

The Mozec – Rx PTCA Balloon Dilatation Catheter and 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.

Both the devices i.e. Mozec and Mozec NC are 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 modified Mozec -Rx PTCA Balloon Dilatation Catheter and Mozec NC – Rx PTCA Balloon Dilatation Catheters are considered substantially equivalent to the predicate devices.