(78 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and its function, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is used for therapeutic purposes, specifically for balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion and for post-delivery expansion of balloon expandable stents.
No
The device is indicated for balloon dilatation and post-delivery expansion of stents, which are therapeutic interventions rather than diagnostic procedures.
No
The device description clearly describes a physical medical device (a balloon catheter) with hardware components (guidewire, balloons).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (in vivo) to improve blood flow in coronary arteries and bypass grafts. This involves physical intervention (balloon dilatation) on anatomical structures.
- Device Description: The device is a catheter with balloons designed for insertion into the coronary vasculature. This is a medical device used for treatment, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
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 device used for a medical procedure.
N/A
Intended Use / Indications for Use
The FLASH Mini Ostial System 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 Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.
Product codes
LOX
Device Description
The FLASH Mini Ostial System is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant 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
coronary artery or bypass graft, coronary vasculature
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
- Catheter Working Length
- Catheter Inner 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 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)
- Anchoring Balloon Fatigue (in Stent)
Key Results: All test results demonstrated that the FLASH Mini Ostial System meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the device for its Indications for Use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for "Ostial corporation". The logo consists of a circular design on the left, made up of repeating shapes that resemble stylized bows or knots. To the right of the circular design is the word "Ostial" in a bold, sans-serif font, with a horizontal line underneath. Below "Ostial" and the line is the word "corporation" in a smaller, sans-serif font.
Ostial Corporation 510 Clyde Avenue Mountain View, CA 94043 t. 650-903-9100 f. 650-903-9119
510(k) Summary FLASH Mini Ostial System
A. Submitter Information
Submitter's Name: Address:
- Telephone: Fax: Email: Contact Person: Date of Preparation:
Ostial Corporation 510 Clyde Avenue Mountain View, CA 94043 650-903-9100 650-903-9119 jwolenberg@ostialcorp.com Jake Wolenberg May 17, 2013
AUG 0 6 2013
B. Subject Device Proprietary Name:
Common/Usual Name: Classification Name:
Product Code:
C. Predicate Device Name
Proprietary Name:
510(k) #'s: Common/Usual Name: Classification Name:
Product Code:
FLASH Mini Ostial System PTCA Catheter Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX per 21 C.F.R. 870.5100
FLASH Ostial System (a.k.a. Flash-C PTCA Balloon Dilatation Catheter; Flash Ostial Balloon PTCA) K111284. K113775 and K122178 PTCA Catheter Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX per 21 C.F.R. 870.5100
D. Device Description:
The FLASH Mini Ostial System is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
E. Intended Use:
The FLASH Mini Ostial System 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 Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.
1
Image /page/1/Picture/1 description: The image shows the logo for Ostial corporation. To the left of the text is a geometric design that looks like a flower or star. The word "Ostial" is written in a bold, sans-serif font, and the word "corporation" is written in a smaller, sans-serif font below a line.
Ostial Corporation 510 Clyde Avenue Mountain View, CA 94043 t. 650-903-9100 f. 650-903-9119
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The FLASH Mini Ostial System that is the subject of this 510(k) is an extension of the FLASH Ostial System product line. The previously cleared device sizes included balloons ranging in diameter from 4.0-6.0mm with working lengths of either 12mm or 17mm. These sizes have a catheter working length of 135cm and are either 6F or 7F compatible. Minor design and process changes have been made to allow for smaller diameter balloons with shorter working length. This submission introduces devices with balloon diameters ranging from 3.0 to 4.5mm and working lengths of 8mm. These new sizes have a catheter length of 135cm and are compatible with 6 French guide catheters.
The only difference between the cleared 6F compatible device sizes and the new device sizes subject to this Special 510(k) are the balloon lengths and diameters. All other aspects of the catheter design and the Indications for Use are the same.
Note: The proprietary name for the previous 510(k)'s filed for this product line was "Flash-C Balloon Dilatation Catheter". Following clearance of the 510(k)'s, the proprietary name was modified for better market positioning. The device is currently marketed under the proprietary name "FLASH Ostial System". The line extension device sizes are intended to be marketed under the proprietary name "FLASH Mini Ostial System".
2
Ostial Corporation 510 Clyde Avenue Mountain View, CA 94043 t. 650-903-9100 f. 650-903-9119
G. Performance Data:
Biocompatibility testing has previously been completed on product equivalent to the FLASH Mini Ostial System. 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 FLASH Mini Ostial System or product equivalent was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics as compared to the product performance requirements:
- Balloon Crossing Profile .
- Catheter Shaft Diameter .
- . Catheter Working Length
- Catheter Inner 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 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)
- Anchoring Balloon Fatigue (in Stent)
All test results demonstrate that the FLASH Mini Ostial System meets the established product specifications.
H. Conclusions:
All test results demonstrated that the FLASH Mini Ostial System meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the device for its Indications for Use in "balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion" and "post delivery expansion of balloon expandable stents within the coronary vasculature." As such, Ostial Corporation is requesting clearance for the FLASH Mini Ostial System product line extension to the FLASH Ostial System product family, which was most recently cleared via Premarket Notification 510(k) # K122178 on October 11, 2012.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white and appears to be of low resolution.
August 6, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ostial Corporation Jake Wolenberg 510 Clyde Avenue Mountain View, CA 94043 US
Re: K131450
Trade/Device Name: FLASH Mini Ostial System Regulation Number: 21 CFR 870.5100 Regulation Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous Regulatory Class: Class II Product Code: LOX Dated: July 5, 2013 Received: July 8, 2013
Dear Mr. Jake Wolenberg:
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 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
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Page 2 - Jake Wolenberg
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.goy/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ostial Corporation 510(k) Notification: FLASH Mini Ostial System
SECTION 4: INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K131450 |
|---|---|
| Device Name: | FLASH Mini Ostial System |
The FLASH Mini Ostial System is indicated for balloon dilatation of the Indication For Use: stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary 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)
M.A. Hillerman
Confidential
Page 7 of 77
05/17/2013