DK-PTCA BALLOON CATHETER

K123264 · Intuit Medical, LLC · LOX · Jan 16, 2013 · Cardiovascular

Device Facts

• Record ID: K123264
• Device Name: DK-PTCA BALLOON CATHETER
• Applicant: Intuit Medical, LLC
• Product Code: LOX · Cardiovascular
• Decision Date: Jan 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intuit Medical, LLC, DK-PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Device Story

The DK-PTCA Balloon Catheter is a torqueable, rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter used by physicians in clinical settings. The device features a semi-compliant balloon at the distal end with two radiopaque markers for positioning, and a proximal hypo-tube hub for inflation via standard inflation devices. It is compatible with 0.014" guidewires and 6F guide catheters. During a procedure, the physician navigates the catheter to the stenotic site; the balloon is inflated to expand the vessel, improving myocardial perfusion. The device is single-use and supplied sterile. It functions as a mechanical tool for vessel dilation; it does not involve electronic processing, AI/ML, or software-based analysis.

Clinical Evidence

Bench testing only. Testing included dimensional verification, balloon preparation/deployment/retraction, flexibility/kink resistance, rated burst pressure, fatigue, compliance, inflation/deflation, bond strength, tip pull, torque strength, radiopacity, and comprehensive biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, genotoxicity, and material-mediated pyrogenicity).

Technological Characteristics

Torqueable, rapid-exchange PTCA catheter; 142cm working length; semi-compliant balloon; hypo-tube proximal shaft; plastic hub; radiopaque markers. Compatible with 0.014" guidewires and 6F guide catheters. Biocompatibility per ISO 10993-1 and FDA Bluebook Memorandum G-95. Sterilized for 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

• Glider™ PTCA Balloon Catheter (K111544)
• EMPIRA™ & EMPIRA™ NC Balloon Catheters (K110133)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 7, 2016

Intuit Medical, LLC Jack Griffis Vice President, Research & Development 6018 Eagle's Rest Trail Sugar Hill, GA 30518

Re: K123264

Trade/Device Name: DK-PTCA Balloon Catheter

Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: October 17, 2012 Received: October 18, 2012

Dear Mr. Griffis:

This letter corrects our substantially equivalent letter of January 16, 2013.

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

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Page 2 - Mr. Griffis

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 [phone] or [phone] 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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kenneth J. Cavanaugh -S

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:** K123264

Device Name: DK-PTCA Balloon Catheter

Indications for Use:

The Intuit Medical, LLC, DK-PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

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

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

1

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eus Willer

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K123264

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Traditional 510(k) Page 22 of 135

### 510(k) Summary

510(k) Number: K#123264

## JAN 1 6 2013

January 7th, 2013 Date Prepared:

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

- A. Submitter: Intuit Medical, LLC 6018 Eagle's Rest Trail Sugar Hill, Georgia 30518
- B. Company Contact: Jack Griffis Vice President, Research & Development [phone] (direct) [e-mail]
- C. Device Information: DK-PTCA Balloon Catheter Trade Name: Rapid Exchange Balloon Angioplasty Catheter Common Name:
- D. Classification: Percutaneous Transluminal Coronary Angioplasty Catheter LOX, 21 CFR 870.5100(a)
- E. Predicate Device(s): Glider™ PTCA Balloon Catheter, K111544 EMPIRA™ & EMPIRA™ NC Balloon Catheters, K110133

### F. Physical Description:

The DK-PTCA Balloon Catheter is a torqueable, rapid-exchange, percutaneous transluminal coronary angioplasty catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters (MIN inner diameter of 0.074"). Catheter working length is approximately 142cm.

The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has two radiopaque markers to assist with positioning. The proximal end of the device is a common PTCA catheter design consisting of a hypo-tube connected to a plastic hub and strain relief and which assists with torque transmission. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The DK-PTCA Balloon Catheter is supplied sterile and intended for single use.

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#### Indications for Use: ઉ.

The DK-PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving mvocardial perfusion.

#### Comparison of Characteristics / Performance Testing / Substantial Equivalence: H.

The DK-PTCA Balloon Catheter is substantially equivalent to the predicate devices in intended use, indications for use, fundamental scientific technology, and important performance specifications. The device was subjected to the following performance tests according to FDA Guidance Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010):

- Dimensional Verification .
- Balloon Preparation, Deployment & Retraction
- Flexibility & Kink �
- Balloon Rated Burst Pressure (RBP)
- . Balloon Fatigue
- Balloon Compliance
- . Balloon Inflation and Deflation
- Catheter Bond Strength .
- . Tip Pull Test
- Torque Strength .
- Radiopacity
- Biocompatibility Testing in Compliance with the ISO 10993-1 and the FDA ● Bluebook Memorandum (G-95)
- 0 Cytotoxicity
- Sensitization (Guinea Pig Maximization) O
- Irritation and (Acute) Systemic Toxicity O
- Hemocompatibility (both complement activation and in-vivo thrombo-O resistance)
- o Genotoxicity
- Material-mediated Pyrogenicity o

No new questions of safety or effectiveness were identified during device testing; therefore, the DK-PTCA Balloon Catheter is considered substantially equivalent to the predicate devices.

Jack Griffis Vice President, Research & Development

Image /page/4/Picture/25 description: The image shows a logo for Intuit Medical, LLC. The logo features the word "Intuit" in bold, black letters, with the words "Medical, LLC" in a smaller font size underneath. To the right of the text is a circular graphic with a textured, layered design, resembling an eye or a lens. The overall design is simple and professional, conveying a sense of medical expertise.

6018 Eagle's Rest Trail Sugar Hill, GA 30518 404-583-6889 phone [e-mail]