Sapphire NC 24

K211807 · OrbusNeich Medical (Shenzhen) Co., Ltd. · LOX · Oct 14, 2021 · Cardiovascular

Device Facts

• Record ID: K211807
• Device Name: Sapphire NC 24
• Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
• Product Code: LOX · Cardiovascular
• Decision Date: Oct 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sapphire NC 24 Coronary Dilatation Catheter is indicated for: - balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion - balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction - in-stent restenosis - post-delivery expansion of balloon expandable coronary stents

Device Story

Sapphire NC 24 is a rapid-exchange coronary dilatation catheter; used by physicians in clinical settings for percutaneous transluminal coronary angioplasty (PTCA). Device features a minimally compliant balloon (1.5mm-5.0mm diameter) mounted on a catheter shaft; proximal shaft includes PTFE-coated stainless steel tube and female luer connector. Radiopaque platinum/iridium marker bands facilitate positioning. Physician advances catheter over a 0.014-inch guidewire to the target lesion; balloon is inflated to high pressures (up to 24 atm) to dilate stenotic vessels or expand stents. High-pressure capability allows precise control of balloon diameter/length during dilatation. Benefits include improved myocardial perfusion and treatment of coronary occlusions.

Clinical Evidence

Bench testing only. Performance data included visual inspection, dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, fatigue, compliance, inflation/deflation time, bond strength, tip pull strength, flexibility, kink, torque, radiopacity, coating integrity, and particulate evaluation. Biocompatibility testing followed ISO 10993-1, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, pyrogenicity, and genotoxicity. All results met acceptance criteria.

Technological Characteristics

Minimally compliant balloon; diameters 1.5mm-5.0mm. Rated burst pressure: 24 atm (1.5-3.5mm), 22 atm (3.75-4.0mm), 20 atm (4.5-5.0mm). Proximal shaft: PTFE-coated stainless steel tube with female luer. Marker bands: platinum/iridium. Rapid-exchange design for 0.014-inch guidewire. Hydrophilic and silicone coatings. Sterilization: Ethylene Oxide (EtO).

Indications for Use

Indicated for patients with coronary ischemia, acute myocardial infarction, or in-stent restenosis requiring balloon dilatation of coronary artery/bypass graft stenoses or post-delivery expansion of coronary 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

• Sapphire NC Plus Coronary Dilatation Catheter (K162209)
• Sapphire NC Plus Coronary Dilatation Catheter (K192344)

Reference Devices

• Sapphire II Pro Coronary Dilatation Catheter (K163114)
• Sapphire II Pro Coronary Dilatation Catheter (K173680)

Submission Summary (Full Text)

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October 14, 2021

OrbusNeich Medical (Shenzhen) Co., Ltd. Daniel Zhang Director of Regulatory Affairs and Quality No.1 Jinkui Road, Futian Free Trade Zone Shenzhen, Guangdong 518038 China

Re: K211807

Trade/Device Name: Sapphire NC 24 Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX

Dear Daniel Zhang:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 14, 2021. Specifically, FDA is updating this SE Letter due to a missing digital signature as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, 301-796-6075, [e-mail].

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.10.14
09:09:58 -04'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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October 14, 2021

OrbusNeich Medical (Shenzhen) Co., Ltd. Daniel Zhang Director of Regulatory Affairs and Quality No.1 Jinkui Road, Futian Free Trade Zone Shenzhen, Guangdong 518038 China

Re: K211807

Trade/Device Name: Sapphire NC 24 Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: September 9, 2021 Received: September 15, 2021

Dear Daniel Zhang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K211807

Device Name

Sapphire NC 24 Coronary Dilatation Catheter

Indications for Use (Describe)

The Sapphire NC 24 Coronary Dilatation Catheter is indicated for:

- · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
- · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
- · in-stent restenosis
- · post-delivery expansion of balloon expandable coronary stents

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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FORM FDA 3881 (6/20)

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#### K211807

### 510(k) Summary

This 510(k) summary is submitted in accordance with 21 CFR 807.92.

#### Submitter Information:

| 510(k) Submitter: | OrbusNeich Medical (Shenzhen) Co., Ltd<br>No.1 Jinkui Road, Futian Free Trade Zone<br>Shenzhen, Guangdong, 518038, China<br>Phone: [phone]<br>Fax: [phone] |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Daniel Zhang<br>Phone: [phone]-8302<br>Fax: [phone] |
| Submission date: | May 30, 2021 |

### Subject Device Information:

| Device name: | Sapphire NC 24 Coronary Dilatation Catheter |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Regulation name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Trade or propriety name | Sapphire NC 24 |
| Regulation Number: | 21 CFR 870.5100(a) |
| Panel Code: | Cardiovascular |
| Classification: | Class II |
| Product Code: | LOX |
| Predicate Device: | Sapphire NC Plus Coronary Dilatation Catheter<br>(K162209; cleared October 6, 2016)<br>(K192344; cleared September 19, 2019) |
| Reference Device: | Sapphire II Pro Coronary Dilatation Catheter<br>(K163114; cleared January 05, 2017)<br>(K173680; cleared March 1, 2018) |

#### Device Description:

The Sapphire NC 24 Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.5mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.5mm to 3.5mm balloons have a rated burst pressure of 24 atmospheres, 3.75mm to 4.0mm balloons have a rated burst pressure of 22 atmospheres and 4.5mm to 5.0mm balloons have a rated burst pressure of 20 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows for superior pushability and trackability with a smooth transition to a distal shaft.

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Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of 1.5mm balloon diameter which incorporate a centrally positioned single marker band. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marker sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

# Indication for Use:

The indication for use for Sapphire NC 24 Coronary Dilatation Catheter remains the same as the predicate device (Sapphire NC plus):

The Sapphire NC 24 Coronary Dilatation Catheter is indicated for:

- balloon dilatation of the stenotic portion of a coronary artery or bypass graft . stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
- balloon dilatation of a coronary artery occlusion for the treatment of acute . myocardial infarction
- in-stent restenosis .
- post-delivery expansion of balloon expandable coronary stents .

# Technological Characteristics:

The subject device has the following similarities to the predicate device and reference device:

- Same indications for use ●
- Same catheter design ●
- Similar materials of construction ●
- Same hydrophilic coating ●
- Same silicone coating .
- Same method of sterilization (EtO) ●

# Performance Test Summary:

The following performance data were provided in support of the substantial equivalence determination.

- A In vitro performance tests were conducted on subject device in accordance with FDA guidance "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" issued on September 8, 2010, including:
- Visual Inspection .
- Dimensional Verification ●
- Balloon Preparation, Deployment, and Retraction ●
- Balloon Rated Burst Pressure
- Balloon Fatigue ●
- Balloon Compliance .
- Balloon Inflation and Deflation Time .

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- Catheter Bond Strength ●
- Tip Pull Strength ●
- Flexibility and Kink ●
- Torque Strength ●
- Marker Band Radiopacity ●
- Coating Integrity
- Particulate Evaluation .
- Balloon Rated Burst Pressure (in-stent) ●
- Balloon Fatigue (in-stent) ●
- Biocompatibility testing, conducted in accordance with the FDA guidance "Use of > International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a Risk Management Process" issued on June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA, included:
- Cytotoxicity
- Sensitization .
- Intracutaneous reactivity ●
- Acute systemic toxicity ●
- Hemocompatibility .
- Hemolysis
- . Partial thromboplastin time
- Platelet and leukocyte counts ●
- . Complement activation
- In vivo thromboresistance .
- Pyrogenicity ●
- Genotoxicity ●
- bacterial mutagenicity test ●
- . in vitro mouse lymphoma Assay
- Packaging and sterilization validation >
- Shelf Life >

The test results met all acceptance criteria, which are same or similar to the predicate device and reference device. It ensures that the design and construction of Sapphire NC 24 Coronary Dilatation Catheter are suitable for its intended use.

## Conclusions

This information supports a determination of substantial equivalence between the Sapphire NC 24 Coronary Dilatation Catheter and the predicate device/reference device listed above.