(103 days)
No
The description focuses on the mechanical design and materials of a balloon catheter, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion," which describes a direct medical intervention to treat a physiological condition, thus making it a therapeutic device.
No
This device is a therapeutic device used for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft." It is not described as providing diagnostic information.
No
The device description clearly describes a physical catheter with balloons, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion." This is a therapeutic procedure performed in vivo (within the living body) to treat a medical condition.
- Device Description: The description details a physical catheter with balloons designed for mechanical intervention within the circulatory system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The information provided describes a medical device used for interventional cardiology, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.
Product codes
LOX
Device Description
The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon that enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.
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 Flash-C PTCA Balloon Dilatation Catheter is identical in design, materials, and manufacturing to the Ostial Corporation's Flash PTA Balloon Dilatation Catheter, cleared by the FDA in 510(k) #K102482 on February 25, 2011. As such, in vivo and in vitro testing submitted in the Flash PTA 510(k) is applicable to the Flash-C PTCA device.
Biocompatibility testing was completed and submitted as part of the Flash PTA 510(k) #K 102482. Requirements for biological evaluation of the device were based on ISO-10993, "Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the device are non-toxic and nonsensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:
- . ISO MEM Elution Assay
- . ASTM Hemolysis Assay
- . Complement Activation C3a and SC5b-9 Assay
- . Thromboresistance Evaluation
- . Pyrogen (LAL) Chromogenic
- Materials Mediated Pyrogen ●
- ISO Guinea Pig Maximization Sensitization .
- ISO Acute Systemic Toxicity ◆
- . ISO Intracutaneous Reactivity
The Flash device was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics:
- . Balloon Crossing Profile
- . Catheter Shaft Diameter
- . Balloon Rated Burst Pressure (Angioplasty)
- . Balloon Burst Volume (Anchoring)
- . Angioplasty Balloon Compliance
- . Balloon Inflation Time
- Balloon Deflation Time .
- . Angioplasty Balloon Fatigue
- . Anchoring Balloon Fatigue
- . Catheter Bond Strength
- . Catheter Tip Pull Strength
- . Catheter Torque Strength
- Simulated Use/Flexibility/Kink .
Additional simulated use testing was performed on the Flash-C PTCA device to compare the performance to the current predicate device, the Maverick XL Monorail PTCA Dilatation Catheter. The testing demonstrated that the performance of the two devices is substantially equivalent.
In-vivo testing was completed on the Flash device using a swine model. A simulated angioplasty procedure was performed on test and control groups (the control group used the Sterling PTA Balloon Dilatation Catheter). Post procedure animals were survived and observed for a predetermined period to assess for downstream and cognitive effects.
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Flash-C PTCA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
KII1284
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 5:
AUG 1 7 2011
| A. Submitter Information | |
|---|---|
| Submitter's Name: | Ostial Corporation |
| Address: | 510 Clyde Avenue |
| Mountain View, CA 94043 | |
| Telephone: | 650-903-9100 |
| Fax: | 650-903-9119 |
| Email: | msmutka@comcast.net |
| Contact Person: | Mark Smutka |
| Regulatory, Clinical, and Quality Consultant | |
| Date of Preparation: | May 5, 2011 |
| B. Subject Device | |
| Trade Name: | Flash-C PTCA Balloon Dilatation Catheter |
| Common/Usual Name: | PTCA Catheter |
| Classification Name: | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| (21 CFR 870.5100, Product Code LOX) | |
| C. Predicate Device Name(s) | |
| Trade Name(s): | Maverick XL Monorail PTCA Dilatation Catheter |
| Classification Name: | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| (21 CFR 870.5100, Product Code LOX) |
D. Device Description:
The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon that enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.
E. Intended Use:
The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The Flash-C PTCA Balloon Dilatation Catheter and the predicate Maverick XL Monorail PTCA Dilatation Catheter have the equivalent intended use. Both are indicated for treatment of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The indication statement for the Flash-C PTCA Balloon Dilatation Catheter is a subset of the broader indication statement of the Maverick XL device, since the Maverick XL device is also indicated for the post delivery expansion of balloon expandable stents.
The Flash-C PTCA Balloon Dilatation Catheter and the predicate device both contain an inflatable semicompliant balloon for dilation of obstructive lesions. The Flash-C PTCA Balloon Dilatation Catheter includes a second compliant balloon for locating and anchoring the device at ostial vessel locations.
The usable length of the Flash-C PTCA Balloon Dilatation Catheter is 135 cm which is a similar usable length as the predicate device (153cm). Both the proposed and predicate devices are offered in 5mm and
1
6mm balloon diameter sizes and approximately 20mm balloon lengths. The Maverick XL device is also available in additional diameters and lengths.
The Flash-C device and predicate device are substantially equivalent in terms of intended use, fundamental scientific technology, target population, and operating principles.
G. Performance Data:
The Flash-C PTCA Balloon Dilatation Catheter is identical in design, materials, and manufacturing to the Ostial Corporation's Flash PTA Balloon Dilatation Catheter, cleared by the FDA in 510(k) #K102482 on February 25, 2011. As such, in vivo and in vitro testing submitted in the Flash PTA 510(k) is applicable to the Flash-C PTCA device.
Biocompatibility testing was completed and submitted as part of the Flash PTA 510(k) #K 102482. Requirements for biological evaluation of the device were based on ISO-10993, "Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the device are non-toxic and nonsensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:
- . ISO MEM Elution Assay
- . ASTM Hemolysis Assay
- . Complement Activation C3a and SC5b-9 Assay
- . Thromboresistance Evaluation
- . Pyrogen (LAL) Chromogenic
- Materials Mediated Pyrogen ●
- ISO Guinea Pig Maximization Sensitization .
- ISO Acute Systemic Toxicity ◆
- . ISO Intracutaneous Reactivity
The Flash device was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics:
- . Balloon Crossing Profile
- . Catheter Shaft Diameter
- . Balloon Rated Burst Pressure (Angioplasty)
- . Balloon Burst Volume (Anchoring)
- . Angioplasty Balloon Compliance
- . Balloon Inflation Time
- Balloon Deflation Time .
- . Angioplasty Balloon Fatigue
- . Anchoring Balloon Fatigue
- . Catheter Bond Strength
- . Catheter Tip Pull Strength
- . Catheter Torque Strength
- Simulated Use/Flexibility/Kink .
Additional simulated use testing was performed on the Flash-C PTCA device to compare the performance to the current predicate device, the Maverick XL Monorail PTCA Dilatation Catheter. The testing demonstrated that the performance of the two devices is substantially equivalent.
In-vivo testing was completed on the Flash device using a swine model. A simulated angioplasty procedure was performed on test and control groups (the control group used the Sterling PTA Balloon Dilatation Catheter). Post procedure animals were survived and observed for a predetermined period to assess for downstream and cognitive effects.
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Flash-C PTCA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use.
H. Conclusions:
The Flash-C PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs. The Flash-C PTCA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Ostial Corporation c/o Mr. Mark Smutka Clinical, Regulatory, and Quality Consultant 510 Clyde Avenue Mountain View, CA 94043
AUG 1 7 2011
Re: K111284
Trade/Device Name: Flash-C PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty Catheter Regulatory Class: Class II (two) Product Code: LOX Dated: July 27, 2011 Received: July 29, 2011
Dear Mr. Smutka:
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.
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.
3
Page 2 – Mr. Mark Smutka
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT SECTION 4:
| 510(k) Number: | K111284 |
|---|---|
| Device Name: | Flash-C PTCA Balloon Dilatation Catheter |
| Indication For Use: | The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation |
| of the stenotic portion of a coronary artery or bypass graft for the purpose of | |
| improving myocardial perfusion. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
LL
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_