(17 days)
No
The summary describes a mechanical device (balloon catheter) and its physical properties and performance, with no mention of AI/ML or related concepts.
Yes
The device is a balloon dilatation catheter used for angioplasty, which is a medical procedure to widen narrowed or obstructed blood vessels, thus providing a therapeutic effect on the patient's anatomy.
No
The device is described as a "Percutaneous Transluminal Angioplasty" catheter used for "balloon dilatation" and "luminal dilatation," which are therapeutic procedures, not diagnostic ones.
No
The device description clearly describes a physical catheter with balloons, guidewire compatibility, and mechanical properties, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Flash PTA Balloon Dilatation Catheter is a device used within the body (in the peripheral vasculature) for a physical procedure (angioplasty). It is a mechanical device used to dilate blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Flash PTA Balloon Dilatation Catheter is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.
Product codes
LIT, DQY
Device Description
The Flash PTA 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
peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries
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
Bench testing performed on the Flash PTA device included the following:
- Balloon crossing profile
- Catheter shaft diameter
- Angioplasty balloon rated burst pressure and maximum burst pressure
- Anchoring balloon rated burst volume
- Balloon compliance and diameter
- Balloon inflation and deflation time
- Angioplasty balloon fatigue
- Anchoring balloon fatigue
- Catheter bond and tip pull strength
- Catheter torque strength, flexibility and kink
- Simulated use
- Radiopacity
All test results demonstrate that the materials, manufacturing process, and design of the Flash PTA 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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
K120738 page 1 of 2
MAR 2 9 2012
510(k) SUMMARY
A. Submitter Information
- Submitter's Name: Address:
SECTION 5:
Telephone: Fax: Email: Contact Person: Date of Preparation:
B. Subject Device
Trade Name: Common/Usual Name: Classification Name: Product Code:
Ostial Corporation 510 Clyde Avenue Mountain View. CA 94043 650-903-9100 650-903-9119 kvonhoffmann@ostialcorp.com Kaitlin von Hoffmann March 9, 2012
Flash PTA Balloon Dilatation Catheter Balloon Catheter Catheters, Angioplasty, Peripheral, Transluminal LIT per 21 C.F.R. 870.1250
C. Device Description:
The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries. The Flash PTA 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 PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.
E. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The Flash PTA 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) #K102482 on February 25, 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:
Bench testing performed on the Flash PTA device included the following:
- Balloon crossing profile .
- . Catheter shaft diameter
- . Angioplasty balloon rated burst pressure and maximum burst pressure
- . Anchoring balloon rated burst volume
- . Balloon compliance and diameter
- . Balloon inflation and deflation time
- . Angioplasty balloon fatigue
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K120738 page 2 of 2
Ostial Corporation 510(k) Notification: Flash PTA Balloon Dilatation Catheter
- Anchoring balloon fatigue .
- . Catheter bond and tip pull strength
- Catheter torque strength, flexibility and kink .
- . Simulated use
- . Radiopacity
All test results demonstrate that the materials, manufacturing process, and design of the Flash PTA Balloon Dilatation Catheter meet the established specifications necessary for consistent performance according to its intended use.
G. Conclusions:
The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries. The purpose of this 510(k) is to request clearance for an extension of the Flash PTA Balloon Dilatation Catheter product line, which was initially cleared via 510(k) #K102482 on February 25, 2011. All test results demonstrate that the Flash PTA Balloon Dilatation Catheter meets all predetermined design verification acceptance criteria.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 9 2012
Ostial Corporation c/o Ms. Kaitlin von Hoffman 510 Clyde Ave. Mountain View, CA 94043
Re: K120738
Trade/Device Name: Flash PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: March 9, 2012 Received: March 12, 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.
3
Page 2 - Ms. Kaitlin von Hoffmann
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 (OS) 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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M. G. Allehen
Ja Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K120738 page 1 of 1
INDICATIONS FOR USE STATEMENT SECTION 4:
510(k) Number:
Device Name:
Flash PTA Balloon Dilatation Catheter
Indication For Use:
The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.
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)
CM of Hillehem
Division Sign-C (Division of Cardiovascular Devices
201388 510(k) Number