Selethru PTCA Balloon Dilatation Catheter

K182699 · Kossel Medtech (Suzhou) Co., Ltd. · LOX · Nov 26, 2018 · Cardiovascular

Device Facts

• Record ID: K182699
• Device Name: Selethru PTCA Balloon Dilatation Catheter
• Applicant: Kossel Medtech (Suzhou) Co., Ltd.
• Product Code: LOX · Cardiovascular
• Decision Date: Nov 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Selethru 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.

Device Story

Rapid exchange (RX) PTCA balloon dilatation catheter; used in coronary artery or bypass graft procedures. Device consists of proximal PTFE-coated stainless steel shaft; distal shaft with outer/inner tubes and semi-compliant balloon; hydrophilic coating on distal section. Two radiopaque Platinum/Iridium marker bands within balloon segment aid positioning; proximal shaft markers assist gauging position relative to guiding catheter. Physician operates device in clinical setting; guidewire facilitates advancement through stenosis. Balloon inflated with contrast medium via dedicated lumen; expansion dilates stenotic vessel to improve myocardial perfusion. Single-use, sterile device.

Clinical Evidence

Bench testing only. In vitro performance testing included dimensional verification, balloon rated burst pressure, fatigue, compliance, inflation/deflation time, bond strength, tip pull strength, flexibility, kinking, torque strength, radiopacity, coating integrity, and particulate evaluation. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, complement activation, in vivo thromboresistance), and pyrogenicity. All results met acceptance criteria.

Technological Characteristics

Rapid exchange PTCA catheter; 142cm working length. Materials: PTFE-coated stainless steel proximal shaft; Platinum/Iridium marker bands. Semi-compliant balloon (1.5-4.0mm diameter, 10-30mm length); rated burst pressure 16 atm. Hydrophilic coating on distal section. Dual lumen design for inflation and guidewire passage. Sterilized, single-use.

Indications for Use

Indicated for patients requiring balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion.

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 II PRO (K163114)

Submission Summary (Full Text)

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November 26, 2018

Kossel Medtech (Suzhou) Co., Ltd. % Ms. Jessica Schultz Senior Project Manager North American Science Associates (NAMSA) 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426

Re: K182699

Trade/Device Name: Selethru 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: September 26, 2018 Received: September 27, 2018

Dear Ms. Schultz:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Gregory O'Connell 2018.11.26 19:10:46 -05'00' 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) K182699

Device Name Selethru PTCA Balloon Dilatation Catheter

Indications for Use (Describe)

The Selethru PTCA Balloon Dilatation Catheted for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

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

| Prescription Use (Part 201 CFR 201 Subpart D) | <span style="text-decoration: overline;">☒</span> |
|-----------------------------------------------|---------------------------------------------------|
| Over-The-Counter Use (21 CFR 330) | □ |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(K) SUMMARY

| 510(K) SUMMARY | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Kossel Medtech (Suzhou) Co., Ltd<br>F3, BLDG 6, No. 8 Jinfeng Road<br>Suzhou New District, JiangSu Province, China |
| 510(k) Number: | K182699 |
| Contact Person: | Jessica Schultz<br>400 Highway 169 South, Suite 500,<br>Minneapolis, MN 55426<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | September 26, 2018 |
| Trade Name: | Selethru PTCA Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous (21 CFR<br>870.5100), Class II (special controls)<br>Product Code: LOX |
| Predicate Device: | Primary Predicate: Sapphire II PRO (K163114; cleared January 5, 2017) |
| Device Description: | The Selethru PTCA Balloon Dilatation Catheter is a rapid exchange (RX)<br>PTCA Balloon Catheter used for the purpose of dilatation of the stenotic<br>portion of a coronary artery or bypass graft stenosis for the purpose of<br>improving myocardial perfusion.<br>The Selethru is a sterile, single-use, intravascular medical device with a<br>working length of 142cm. The proximal shaft is PTFE coated stainless<br>steel tube, which allows for exceptional pushability and a smooth<br>transition to the distal shaft, which is composed of an outer tube, an inner<br>tube, and a balloon. A hydrophilic coating is applied to the distal section.<br>The semi-compliant balloons are available in diameters ranging from 1.5-<br>4.0mm and lengths from 10-30mm, and have a rated burst pressure of 16<br>atm.<br>The proximal shaft of the catheter has two marker sections of 5mm<br>length that aid in gauging dilatation catheter position relative to the<br>guiding catheter tip (marker located closest to the dilatation catheter<br>adaptor is for femoral guiding catheters and the other marker is for<br>brachial guiding catheters).<br>The distal shaft of the catheter has an integrated shaft system. The shaft<br>has a combination of single lumen and dual lumen tubing. One lumen is<br>used for inflation of the balloon with contrast medium. The other lumen,<br>in the distal shaft, permits the use of a guide wire to facilitate |
| | advancement of the dilatation catheter to and through the stenosis to be<br>dilated. The guidewire enters the catheter tip and advances coaxially out<br>the distal Rx port, thereby allowing both coaxial guidance and rapid<br>exchange of the catheter with a single standard length guidewire.<br>Two radiopaque Platinum/Iridium marker bands are located within the<br>balloon segment to aid in positioning the balloon in the stenosis, and are<br>designed to provide an expandable segment of known diameter and<br>length at a specific pressure. The design of this dilatation catheter does<br>not incorporate a lumen for distal dye injections and distal pressure<br>measurements. |
| Intended Use: | The Selethru PTCA Balloon Dilatation Catheter is indicated for balloon<br>dilatation of the stenotic portion of a coronary artery or bypass graft<br>stenosis for the purpose of improving myocardial perfusion. |
| Technological<br>Characteristics: | Comparisons of the new and predicate devices show that the<br>technological characteristics such as product performance, design, and<br>intended use are substantially equivalent to the currently marketed<br>predicate devices. |
| Performance Data: | Both <i>in vitro</i> performance tests, such as dimensional verification, balloon<br>rated burst pressure, balloon fatigue, balloon compliance, balloon<br>inflation and deflation time, catheter bond strength, tip pull strength,<br>flexibility and kinking, torque strength, radiopacity, coating integrity, and<br>particulate evaluation, and also biocompatibility tests, such as<br>cytotoxicity, sensitization, intracutaneous reactivity, acute systemic<br>toxicity, hemocompatibility (hemolysis, complement activation, and <i>in<br/>vivo</i> thromboresistance), and pyrogenicity were conducted. The test<br>results met all acceptance criteria and ensure that the Selethru Catheter<br>design and construction are suitable for its intended use as recommended<br>by the Class II Special Controls Guidance Document for Certain<br>Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters<br>(FDA; September 8, 2010). |
| Conclusion: | This information supports a determination of substantial equivalence<br>between the Selethru PTCA Balloon Dilatation Catheter and the predicate<br>device described above. |

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