(30 days)
No
The summary describes a physical medical device (a balloon catheter) and its mechanical and material properties. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to dilate stenotic lesions and post-dilate stents in the peripheral vasculature. This involves a direct medical intervention to treat a physiological condition, which aligns with the definition of a therapeutic device.
No
The device, a PTA Balloon Catheter, is indicated for percutaneous transluminal angioplasty, which is a therapeutic procedure to dilate stenotic lesions, not to diagnose a condition.
No
The device description clearly describes a physical balloon catheter, which is a hardware medical device, not software. The performance studies also focus on physical properties and biocompatibility of the hardware.
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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that the Flash PTA Balloon Catheter is used for "Percutaneous Transluminal Angioplasty in the peripheral vasculature". This is a procedure performed inside the body to dilate blood vessels.
- Lack of Specimen Testing: There is no mention of the device being used to test or analyze any biological specimens.
- Performance Studies: The performance studies described focus on the physical and mechanical properties of the catheter and its balloons, as well as biocompatibility, which are relevant to a device used internally. They do not involve the analysis of biological samples for diagnostic purposes.
Therefore, based on the provided information, the Flash PTA Balloon Catheter is a therapeutic medical device used for a procedure within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flash PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DOY
Device Description
The Flash PTA Balloon Dilatation Catheter is designed for the dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design, which prevents distal migration of the balloon during angioplasty. The distal semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing has previously been completed on the Flash PTA Balloon Dilatation Catheter. Requirements for biological evaluation of the proposed device were based on the Blue Book Memorandum issued on May 1, 1995, Use of International Standard 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 proposed 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
- Materials Mediated Rabbit Pyrogen
- ISO Guinea Pig Maximization Sensitization
- Complement Activation C3a and SC5b-9 Assay
- Thromboresistance Evaluation
- Pyrogen (LAL) Chromogenic
- ISO Acute Systemic Injection Test
- ISO Intracutaneous Reactivity Test
The Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics as compared to the predicate device:
- Balloon Crossing Profile
- Catheter Shaft Diameter
- Angioplasty Balloon Rated Burst Pressure
- Anchoring Balloon Burst Volume
- Angioplasty Balloon Compliance
- Balloon Inflation Time
- Balloon Deflation Time
- Angioplasty Balloon Rated Burst Pressure (in Stent)
- Anchoring Balloon Fatigue (in Stent)
- Anchoring Balloon Burst Volume (in Stent)
- Angioplasty Balloon Fatigue
- Anchoring Balloon Fatigue
- Catheter Bond Strength
- Catheter Tip Pull Strength
- Catheter Torque Strength
- Simulated Use
- Flexibility and Kink Resistance
- Radiopacity
- Angioplasty Balloon Fatigue (in Stent)
All test results demonstrate that the device materials, the manufacturing process, and the design for the Flash PTA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
A. Submitter Information
SECTION 5:
Submitter's Name: Address:
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 August 3, 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 designed for the dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design, which prevents distal migration of the balloon during angioplasty. The distal semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
D. Intended Use:
The Flash PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
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) #K121175 on June 29, 2012. This submission includes devices with balloon diameters ranging from 4.0 to 7.0mm and balloon lengths of 14 and 19mm. The new sizes feature a working catheter length of 135cm, and are compatible with either 6 or 7 French guide catheters. With the exception of the 7mm model, all of these models have previously been cleared by the FDA for a subset of the proposed indication via 510(k) #K120738 on March 29, 2012.
F. Performance Data:
Biocompatibility testing has previously been completed on the Flash PTA Balloon Dilatation Catheter. Requirements for biological evaluation of the proposed device were based on the Blue Book Memorandum issued on May 1, 1995, Use of International Standard 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 proposed 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 .
- Materials Mediated Rabbit Pyrogen ●
- ISO Guinea Pig Maximization Sensitization
5 2012
SEP
08/03/12
1
510(k) Notification: Flash PTA Balloon Dilatation Catheter
- Complement Activation C3a and SC5b-9 Assay t
- . Thromboresistance Evaluation
- Pyrogen (LAL) Chromogenic .
- . ISO Acute Systemic Injection Test
- . ISO Intracutaneous Reactivity Test
The Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics as compared to the predicate device:
- Balloon Crossing Profile .
- . Catheter Shaft Diameter
- . Angioplasty Balloon Rated Burst Pressure
- Anchoring Balloon Burst Volume .
- Angioplasty Balloon Compliance .
- . Balloon Inflation Time
- . Balloon Deflation Time
- Angioplasty Balloon Rated Burst Pressure (in . Stent)
- · Anchoring Balloon Fatigue (in Stent)
- Anchoring Balloon Burst Volume (in Stent)
- Angioplasty Balloon Fatigue .
- Anchoring Balloon Fatigue ◆
- Catheter Bond Strength
- . Catheter Tip Pull Strength
- . Catheter Torque Strength
- . Simulated Use
- . Flexibility and Kink Resistance
- Radiopacity ●
- Angioplasty Balloon Fatigue (in Stent)
All test results demonstrate that the device materials, the manufacturing process, and the design for the Flash PTA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use.
G. Conclusions:
The Flash PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
The purpose of this 510(k) is to request clearance for an extension of the Flash PTA Balloon Dilatation Catheter product line cleared via 510(k) #K121175 on June 29, 2012. The Fiash PTA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 5 2012
Ostial Corporation c/o Kaitlin von Hoffmann 510 Clyde Avenue Mountain View, CA 94043
Re: K122379
Trade/Device Name: Flash PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870:1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: August 03, 2012 Received: August 06, 2012
Dear Ms. 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 iddictions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmants, 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, lists 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 devine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA may publish further announcements concerning your device in the Federal Reguster.
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 (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.
Guig Hillen
Gram 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 PTA Balloon Dilatation Catheter
INDICATIONS FOR USE STATEMENT SECTION 4:
510(k) Number:
K122379
Device Name:
Flash PTA Balloon Dilatation Catheter
Indication for Use:
The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
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)
R. Hilleben
Division Sign-Off (Division Sign-Oil)
Division of Cardiovascular Devices
510(k) Number K122379