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 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.

AI/ML Overview

This document describes the DK-PTCA Balloon Catheter, a device intended for balloon dilatation of coronary artery or bypass graft stenosis. It's a 510(k) submission, meaning the manufacturer is demonstrating that its device is "substantially equivalent" to an already legally marketed predicate device.

Hence, the acceptance criteria and study information provided here are not for an AI/ML algorithm or a new novel device proving its standalone accuracy against a ground truth. Instead, these are performance criteria for a physical medical device (a balloon catheter) to demonstrate its safety and effectiveness through engineering and biological testing, showing it performs comparably to existing, approved devices.

Given this context, I will adapt the requested information structure to fit the provided document's content.

Device: DK-PTCA Balloon Catheter
510(k) Number: K123264

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

The document lists performance tests conducted, implying these tests are designed to meet established acceptance criteria for PTCA catheters. However, the specific numerical acceptance criteria for each test (e.g., maximum allowable balloon burst pressure, minimum bond strength) and the exact quantitative reported performance for each test are not explicitly detailed in this summary. The summary states that "No new questions of safety or effectiveness were identified during device testing," which indicates the device met its internal acceptance criteria.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Dimensional Verification (e.g., balloon diameters, lengths)	Met specifications; details not provided.
Balloon Preparation, Deployment & Retraction (e.g., smooth operation)	Met specifications; details not provided.
Flexibility & Kink Resistance (e.g., catheter maneuverability)	Met specifications; details not provided.
Balloon Rated Burst Pressure (RBP)	Met specifications; details not provided.
Balloon Fatigue (e.g., durability under pulsatile flow)	Met specifications; details not provided.
Balloon Compliance (e.g., expansion characteristics)	Met specifications; details not provided.
Balloon Inflation and Deflation Times	Met specifications; details not provided.
Catheter Bond Strength (e.g., integrity of joints)	Met specifications; details not provided.
Tip Pull Test (e.g., secureness of distal tip)	Met specifications; details not provided.
Torque Strength (e.g., ability to transmit rotational force)	Met specifications; details not provided.
Radiopacity (e.g., visibility under fluoroscopy)	Met specifications; details not provided.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity)	Passed all tests according to ISO 10993-1 and FDA Bluebook Memorandum (G-95).

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each performance test. The data provenance is internal testing conducted by Intuit Medical, LLC, likely on manufactured samples of the DK-PTCA Balloon Catheter. The data would be prospective in the sense that the tests were designed and executed specifically for this 510(k) submission. There is no information on country of origin of the data beyond the manufacturer being in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the typical AI/ML context. For a physical medical device like a balloon catheter, "ground truth" is established by adherence to engineering standards, validated test methods, and regulatory guidelines (e.g., ISO, FDA guidance). The "experts" involved would be engineers, material scientists, and biomedical experts responsible for designing, conducting, and interpreting these physical performance and biocompatibility tests. Their qualifications are not specified but are implied by their roles in a medical device company and adherence to regulatory standards.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods are typically used for expert consensus in clinical data or image interpretation. For physical device testing, results are typically objective measurements against pre-defined specifications. Any discrepancies would involve re-testing, calibration, or review of test methodology, not "adjudication" in the clinical sense.

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

This question is not applicable. An MRMC study is relevant for diagnostic AI/ML devices involving human readers. The DK-PTCA Balloon Catheter is a therapeutic physical device.

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

This question is not applicable. This is a physical medical device, not an algorithm. The "standalone performance" refers to the device's physical and biological performance as measured by the tests listed.

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

For this physical device, the "ground truth" is based on:

Engineering Specifications and Standards: (e.g., material properties, dimensional tolerances, force requirements).
Biocompatibility Standards: (e.g., ISO 10993-1, FDA Bluebook Memorandum G-95) which dictate acceptable levels of biological response.
Performance Requirements: Established by predicate device characteristics and regulatory guidance for PTCA catheters.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a physical medical device. The device's design and manufacturing processes are refined through engineering development and iterative testing, but not in the "training set" sense of machine learning.

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

This question is not applicable for the same reasons as #8.

Summary

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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 (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/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 (800) 638-2041 or (301) 796-7100 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:

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)

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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Image /page/3/Picture/1 description: The image shows the 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 smaller circle inside of it.

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 (404) 583-6889 (direct) jgriffis@intuitmedical.com
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:

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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 jgriffis@intuitmedicol.com

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.