(90 days)
No
The device description and performance studies focus on the physical and mechanical properties of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for "balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which is a therapeutic intervention.
No
This device is a therapeutic device (balloon catheter) used for dilatation of stenotic coronary arteries, not for diagnosing conditions.
No
The device description clearly details a physical catheter with a balloon, lumens, and other hardware components, and the performance studies focus on physical properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The Intuit Medical, LLC, DK-PTCA Balloon Catheter is used inside the body to physically dilate a narrowed coronary artery or bypass graft. It's a therapeutic device used for a medical procedure, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion." This is a treatment, not a diagnostic process.
- Device Description: The description details a catheter with a balloon for inflation within the body, a guidewire lumen, and connections for inflation devices. This aligns with an interventional medical device, not an IVD.
The device is a therapeutic medical device used for a procedure (angioplasty) performed in vivo (within the living body).
N/A
Intended Use / 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.
Product codes
LOX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery or bypass graft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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)
- Cytotoxicity
- Sensitization (Guinea Pig Maximization)
- Irritation and (Acute) Systemic Toxicity
- Hemocompatibility (both complement activation and in-vivo thrombo-resistance)
- Genotoxicity
- Material-mediated Pyrogenicity
No new questions of safety or effectiveness were identified during device testing.
Key Metrics
Not Found
Predicate Device(s)
Glider™ PTCA Balloon Catheter, K111544, EMPIRA™ & EMPIRA™ NC Balloon Catheters, K110133
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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
3
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:
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.
4
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