(190 days)
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML.
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 is a therapeutic intervention.
No
The device is indicated for balloon dilatation of stenotic portions of coronary arteries or bypass grafts to improve myocardial perfusion, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly describes a physical catheter with balloons, guidewire compatibility, and materials, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Flash-C PTCA Balloon Dilatation Catheter is a device used inside the body to physically dilate a narrowed coronary artery or bypass graft. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion." This describes a treatment procedure, not a diagnostic test.
The information provided describes a medical device used for interventional cardiology procedures, which are performed in vivo (within the living body).
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 a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which 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
Biocompatibility testing was completed and submitted as part of the Flash PTA 510(k) #K102482. The Flash-C PTCA Balloon Dilatation Catheter (#K111284) 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. Since no changes have been implemented which would affect the biocompatibility of the device, these results are applicable to the subject device. 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 non-sensitizing 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-9Assay
• Thromboresistance Evaluation
• Materials Mediated Pyrogen
• ISO Guinea Pig Maximization Sensitization
• ISO Acute Systemic Toxicity
• ISO Intracutaneous Reactivity
• Pyrogen (LAL) Chromogenic
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
In-vivo testing was completed on the previously cleared 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, manufacturing process, and design of the Flash-C PTCA Balloon Dilatation Catheter meet the established specifications necessary for consistent performance according to its intended use.
Key Metrics
Not Found
Predicate Device(s)
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
SECTION 5: 510(k) SUMMARY
- A. Submitter Information
Submitter's Name: Address:
Telephone: Fax: Email: Contact Person: Date of Preparation:
B. Subject Device Trade Name: Common/Usual Name: Classification Name:
Ostial Corporation 510 Clyde Avenue Mountain View, CA 94043 650-903-9100 650-903-9119 kvonhoffmann(@ostialcorp.com Kaitlin von Hoffmann December 19, 2011
Flash-C PTCA Balloon Dilatation Catheter PTCA Catheter Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX per 21 C.F.R. 870.5100
Product Code:
C. 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 device uses a dual balloon design featuring a compliant anchoring balloon, which 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.
D. 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.
Summary of Similarities and Differences in Technological Characteristics, Performance E. and Intended Use:
The Flash-C PTCA Balloon Dilatation Catheter that is the subject of this 510(k) is an extension of a product line of the same name, which was cleared via 510(k) #K 11284 on August 19, 2011. Minor design and process changes to decrease the crossing profile of the device have been implemented. This submission includes devices with balloon diameters ranging from 4.0 to 6.0mm and balloon lengths of 14 to 19mm. The new sizes are 135cm in length and compatible with 6 French guide catheters.
F. Performance Data:
Biocompatibility testing was completed and submitted as part of the Flash PTA 510(k) #K102482. The Flash-C PTCA Balloon Dilatation Catheter (#K111284) 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. Since no changes have been
JUN 2 9 2012
1
510(k) Notification: Flash-C PTCA Balloon Dilatation Catheter
K113775
p. 20fa
implemented which would affect the biocompatibility of the device, these results are applicable to the subject device.
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 non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:
| • ISO MEM Elution Assay | • Materials Mediated Pyrogen |
|---|---|
| • ASTM Hemolysis Assay | • ISO Guinea Pig Maximization |
| • Complement Activation C3a and SC5b-9 | |
| Assay | Sensitization |
| • Thromboresistance Evaluation | • ISO Acute Systemic Toxicity |
| • ISO Intracutaneous Reactivity |
- .
- Pyrogen (LAL) Chromogenic
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
- g Catheter Torque Strength
- . Simulated Use/Flexibility/Kink
In-vivo testing was completed on the previously cleared 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, manufacturing process, and design of the Flash-C PTCA Balloon Dilatation Catheter meet the established specifications necessary for consistent performance according to its intended use.
G. Conclusions:
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 purpose of this 510(k) is to request clearance for an extension of the Flash-C PTCA Balloon · Dilatation Catheter product line, which was initially cleared via 510(k) K111284 on August 19, 2011. All test results demonstrate that the Flash-C PTCA Balloon Dilatation Catheter meets all predetermined design verification and validation acceptance criteria.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 9 2012
Ostial Corp. c/o Ms. Kaitlin von Hoffmann Clinical and Regulatory Associate 510 Clyde Avenue Mountain View, CA 94043
Re: K113775
Trade/Device Name: Flash-C PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous Regulatory Class: Class II Product Code: LOX Dated: June 1, 2012 Received: June 4, 2012
Dear Ms. von Hoffmann:
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
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
3
Page 2 - Ms. Kaitlin von Hoffman
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" (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/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,
M. G. Hillen
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ostial Corporation
510(k) Notification: Flash-C PTCA Balloon Dilatation Catheter
SECTION 4:
| 510(k) Number: | K113775 |
|---|---|
| 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 ਮ (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)
M.A. Hillebran
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________