(179 days)
No
The document describes a mechanical device (balloon catheter) and its performance testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "Balloon Dilatation Catheter" indicated for "Percutaneous Transluminal Angioplasty" to treat lesions in peripheral vasculature, which directly addresses a medical condition (vascular narrowing) and restores function through physical intervention.
No
Explanation: The device is a balloon dilatation catheter used for therapeutic purposes (angioplasty) to dilate vessels, not to diagnose a condition.
No
The device description clearly details a physical catheter with balloons and guidewire compatibility, indicating it is a hardware device, not software only. The performance studies also focus on biocompatibility and bench testing of physical characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "Percutaneous Transluminal Angioplasty in the peripheral vasculature". This is a therapeutic procedure performed on the patient's body to treat a condition.
- Device Description: The description details a physical catheter with balloons designed for mechanical dilation of blood vessels. This is a medical device used for intervention, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic intervention tool.
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 proposed Flash PTA Balloon Dilatation Catheter is designed for dilation of aorto-ostial lesions of peripheral vessels in the arterial system. The Flash PTA Balloon Dilatation Catheter is a .014" guidewirecompatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA 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
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
Biocompatibility testing:
- ISO MEM Elution Assay
- ASTM Hemolysis Assay
- Complement Activation C3a and SC5b-9 Assay
- Thromboresistance Evaluation
- Materials Mediated Rabbit Pyrogen
- ISO Guinea Pig Maximization Sensitization
- ISO Acute Systemic Injection Test
- ISO Intracutaneous Reactivity Test
- Pyrogen (LAL) Chromogenic
In-vitro performance bench testing:
- 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
- Radiopacity
In-vivo testing:
- Swine model
- Simulated angioplasty procedure performed on test and control comparator groups.
- Post procedure animals were survived and observed for a predetermined period to assess for downstream and cognitive effects.
Key results: All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Flash PTA Balloon Dilatation Catheter met 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
SECTION 5.0: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
CONFIDENTIAL
| A. Submitter Information | |
|---|---|
| Submitter's Name: | Ostial Corporation |
| Address: | 510 Clyde Avenue |
| Mountain View, CA 94043 | |
| Telephone: | 650-903-9100 |
| Fax: | 650-903-9119 |
| Contact Person: | Eric Ankerud |
| Executive Vice President Clinical, Regulatory, Quality | |
| Date of Preparation: | August 25, 2010 |
| B. Subject Device | |
| Trade Name: | Flash PTA Balloon Dilatation Catheter |
| Common/Usual Name: | Balloon Catheter |
Classification Name:
B
Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250, Product Code LIT)
C. Predicate Device Name(s)
Trade Name(s): Classification Name:
Sterling PTA Balloon Dilation Catheter, K053118 Catheter, Percutaneous (21 CFR 870.1250, Product Code DQY)
D. Device Description:
The proposed Flash PTA Balloon Dilatation Catheter is designed for dilation of aorto-ostial lesions of peripheral vessels in the arterial system. The Flash PTA Balloon Dilatation Catheter is a .014" guidewirecompatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA 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 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.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The proposed Flash PTA Balloon Dilatation Catheter and the predicate Sterling PTA Balloon Dilation Catheter have the same intended use. Both are indicated for treatment of obstructive lesions by high pressure dilation in the arterial system. The indication statement for the Flash PTA Balloon Dilatation Catheter is a subset of the broader indication statement of the Sterling PTA Balloon Dilation Catheter.
The proposed Flash PTA Balloon Dilatation Catheter and the Sterling PTA Balloon Dilation Catheter contain an inflatable semi-compliant balloon for dilation of obstructive lesions. The proposed Flash PTA Balloon Dilatation Catheter includes a second compliant balloon for locating and anchoring the device at ostial vessel locations.
The usable length of the proposed Flash PTA Balloon Dilatation Catheter is 135 cm which is the same usable length as the predicate Sterling Balloon Dilation Catheter. Both the proposed and predicate devices are offered in 5mm and 6mm balloon diameter sizes and approximately 20mm balloon lengths.
1
The proposed device and predicate device are substantially equivalent in terms of intended use, fundamental scientific technology, target population, and operating principles.
G. Performance Data:
Biocompatibility testing on the proposed Flash PTA Balloon Dilatation Catheter has been completed. 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
- Complement Activation C3a and SC5b-9 Assay .
- . Thromboresistance Evaluation
- Materials Mediated Rabbit Pyrogen .
- . ISO Guinea Pig Maximization Sensitization
- ISO Acute Systemic Injection Test .
- . ISO Intracutaneous Reactivity Test
- Pyrogen (LAL) Chromogenic �
The proposed 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 �
- 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 .
- Radiopacity .
In-vivo testing was completed using a swine model. A simulated angioplasty procedure was performed on test and control comparator groups. 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 PTA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use.
H. Conclusions:
The Flash 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. The Flash PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 5 2511
Ostial Corporation c/o Mr. Mark Smutka Clinical, Regulatory, and Quality Consultant 510 Clyde Avenue Mountain View, CA 94043
Re: K102482
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, DQY Dated: February 15, 2011 Received: February 16, 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 idence) on 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 Amendmonts, 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 lightlity warranties. However, we remind you 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 - 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 devicerelated 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,
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4.0: INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Indication For Use:
Flash PTA Balloon Dilatation Catheter
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)
Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K102482