(119 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of a balloon catheter with an embolic capture feature. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used for "peripheral transluminal angioplasty" and "capture and removal of embolic material," which are medical procedures aimed at treating or alleviating a disease or condition.
No.
The device is described as a Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter used for therapeutic purposes (angioplasty) and for capture and removal of embolic material. Its function is to treat blockages and remove emboli, not to diagnose a condition. The mention of "two radiopaque markers (8) for positioning the balloon relative to stenosis" is for guiding the therapeutic procedure, not for diagnostic imaging or assessment.
No
The device description clearly details a physical catheter with a balloon, lumens, shafts, and a handle, indicating it is a hardware device.
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 device used for a medical procedure (peripheral transluminal angioplasty) and for capturing embolic material during that procedure. This is an interventional device used directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon and features for manipulating it within the body. This is consistent with a medical device used for treatment or intervention, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical and procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9).
One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.
The shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock (11) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock (11) and pulling the pulling knob away from the handle (1). The inward-folding of the balloon forms a cavity and allows for collection and removal of embolic material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda 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)
Study Type: In vitro bench testing, Design Verification and Validation, Comparative Capture Efficiency Testing, Biocompatibility Testing, Sterilization, Packaging, Shelf Life.
Sample Size: Sample sizes used for the testing were based on required confidence/reliability levels as per FDA Guidance "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems " and the results of the risk analysis (DFMEA) performed for the PROTEUSTM PTA catheter. The number of units utilized for each test depends on whether the data to be collected was variable data or attribute data, therefore the number of units tested varies from test to test. However, in all cases, the number utilized for testing met the required number of units based on the risk analysis, and the required confidence/reliability levels. Specific numbers not disclosed for each test.
Key Results: The results of verification and validation testing demonstrated that the modified PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature design met all specifications, and is adequate for its intended use. Additionally, the test results demonstrated substantial equivalence of the modified PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature to its predicate devices. All tests listed in the table (Visual inspection, Distal Bond Outer Diameter, Distal Balloon Cone to Distal Tip, Wrapped Balloon Outer Diameter, Guide Wire Lumen Inner Diameter, Proximal Bond Outer Diameter, Marker Band Spacing, Balloon Working Length, Catheter Overall Effective Length, Catheter Overall Length, Distal Tip Inner Diameter, Minimum Balloon Burst Pressure (RBP), Balloon Fatigue, Tensile Strength for various components, Liquid Leakage, Balloon Inflation/Deflation Testing, Balloon Compliance, Balloon OD at Nominal Pressure, Flow Characteristics, Stroke Length, Simulated Use in Tortuous Anatomy (guide wire compatibility, Introducer Sheath Compatibility, Kink Resistance)) passed their respective criteria. No additional capture efficiency testing was required. No additional biocompatibility testing was required. Sterilization and packaging methods are unchanged. Shelf life for most sizes is 3 years, with 6x60, 6x80, and 6x100mm balloons validated for 1 year.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
December 15, 2017
Angioslide, Ltd. % Ilya Burovoy Principal Consultant Ilya Burovoy- Regulatory and Quality Consulting 21 Montefiore St. #17 Kiryat Ono, 5522635 Israel
Re: K172494
Trade/Device Name: PROTEUS PTA Balloon Catheter with Embolic Capture Feature Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 19, 2017 Received: November 22, 2017
Dear Ilya Burovoy:
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);
1
Page 2 - Ilya Burovoy
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172494
Device Name
PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature
Indications for Use (Describe)
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
PROTEUS™ PTA Catheter with Embolic Capture Feature
Introduction:
This document contains the 510(k) summary for the modified PROTEUS™ PTA Catheter with Embolic Capture Feature. The content of this summary is based on the requirements of 21 CFR Section 807.92(c).
Applicant Name and Address:
| Name: | Angioslide, Ltd. |
|---|---|
| Address: | 4 Ha'Omanut St, |
| Poleg Industrial Area | |
| Netanya 4250438 | |
| Israel | |
| Tel: +972-4-790-4600 | |
| Fax: +972-4-790-4620 | |
| Official Contact: | Ilya Burovoy |
| Principal Consultant | |
| Ilya Burovoy – Regulatory and Quality Consulting | |
| Address: | 21 Montefiore St. #17 |
| Kiryat Ono 5522635 | |
| Israel | |
| Phone: +972-54-479-7217 | |
| Fax: +972-4-790-4620 | |
| E-mail: ilyab700@gmail.com |
Summary Preparation Date: August 2, 2017
Device Name and Classification:
| Trade Name: | PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature |
|---|---|
| Common Name: | Percutaneous Transluminal Angioplasty Balloon Catheter |
| Classification Name: | Catheter, Percutaneous |
| Classification: | Class II, 21 CFR 870.1250 |
| Product Code | LIT |
Predicate Devices:
The modified PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is claimed to be substantially equivalent to the following legally marketed predicate devices:
4
- 2 Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature (K133043)
Performance Standards: There are no mandatory performance standards for this device.
Device Description: (see Figure 1)
Image /page/4/Figure/5 description: This image is a technical drawing of a medical device with several labeled parts. The main body of the device is labeled as '3', with a handle labeled as '1'. A tube is connected to the device, labeled as '2', and a thin, elongated section is labeled as '4'. Details A and B show magnified views of the device's tip, labeled with numbers 6, 7, 8, and 9.
Figure 1
The Angioslide PROTEUSTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9).
One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.
The shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock (11) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock (11) and pulling the pulling knob away from the handle (1). The inward-folding of the balloon forms a cavity and allows for collection and removal of embolic material.
5
The balloon size and diameter are printed on the strain relief (12). Refer also to the package label for information about catheter length, balloon nominal and rated burst pressure, balloon size, balloon compliance, guidewire compatibility and sheath compatibility.
Indications for Use:
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Comparison of Indications for Use:
The Indications for Use for the predicate PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature (K133043) are identical to the modified PROTEUSTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature.
Comparison of Technological Characteristics:
The PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over the wire co-axial dual lumen catheter with a foldable balloon located near the distal atraumatic soft tip. The catheter is compatible with a 0.014" guidewire in the 3x100mm size only, and a 0.035" guidewire for all other sizes, which are currently cleared.
The balloon technological characteristics of the modified PROTEUSTM PTA Balloon Catheter are substantially equivalent to those of the predicate PROTEUS™ PTA Balloon. In both devices lesion dilation is achieved by means of an inflatable balloon.
The modified PROTEUS™ PTA Balloon Catheter overall length, balloon diameter, balloon length, balloon nominal pressure, balloon rated burst pressure and end hole diameter are the same or similar to the PROTEUS™ PTA Balloon Catheter.
The modified PROTEUS™ PTA Balloon Catheter differs from the predicate device in that the introducer sheath sizing for 6x60mm, 6x80mm and 6x100mm balloons is 6Fr as compared to 7Fr for the predicate PROTEUS™ PTA Balloon Catheter. The change of the PROTEUS™ device 6x60, 6x80 and 6x100mm balloons compatibility from 7Fr to 6Fr introducer sheath includes minor changes to the balloons' distal end geometry to facilitate passage of the folded balloon through the introducer sheath of a smaller diameter.
The modified PROTEUS™ PTA Balloon Catheter differs from the predicate device in cancelling the handle pulling knob end position lock feature for the 5x60, 5x80, 5x100, 6x60, 6x80 and 6x100mm balloon sizes. This modification is aimed to improve user comfort by improving usability of the pulling knob feature.
6
The modified PROTEUS™ PTA Balloon Catheter differs from the predicate device in the handle internal sealing design for the 5x60, 5x80, 5x100, 6x60, 6x80 and 6x100mm balloon sizes.
The embolic capture technological characteristics of the modified PROTEUS™ PTA Balloon Catheter are identical to those of the PROTEUS™ PTA Balloon Catheter. In both devices the capture and removal of embolic material is achieved by proximal vessel occlusion, by means of an inflatable balloon, and subsequent aspiration of embolic material.
Summary of Non-Clinical Testing:
In vitro bench testing of the Angioslide PROTEUS™ PTA Balloon Catheter was conducted in accordance with Angioslide's Risk Analysis and all applicable FDA Guidance documents and ISO standards, including:
ISO 10555-1 - Sterile, Single Use Intravascular Catheters- Part 1: General Requirements
ISO 10555-4 - Sterile, Single Use Intravascular Catheters- Part 4: Balloon Dilatation Catheters
FDA Guidance - Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, April 18, 2010
FDA Guidance - Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions, February 15, 2008
FDA Guidance - Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010
All bench testing, unless otherwise specified, was conducted using finished devices which were sterilized by the final validated sterilization process.
Design Verification and Validation:
Sample sizes used for the testing were based on required confidence/reliability levels as per FDA Guidance "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems " and the results of the risk analysis (DFMEA) performed for the PROTEUSTM PTA catheter. The number of units utilized for each test depends on whether the data to be collected was variable data or attribute data, therefore the number of units tested varies from test to test. However, in all cases, the number utilized for testing met the required number of units based on the risk analysis, and the required confidence/reliability levels.
The results of verification and validation testing demonstrated that the modified PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature design met all specifications, and is adequate for its intended use. Additionally, the test results demonstrated substantial equivalence of the modified PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature to its predicate devices.
Verification and validation testing of the modified PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature included catheter and balloon dimensional evaluation, minimum balloon burst strength (RBP), balloon compliance, balloon inflation and deflation time, balloon fatigue, tensile strength and simulated use. No additional capture efficiency testing was required for the modified PROTEUS™ PTA Balloon Catheter as previous testing continues to support the capture efficiency performance.
7
| Test | Accept/Reject Criteria | Results |
|---|---|---|
| Visual inspection - external surface | External surface of catheter effective length, | |
| including the distal end, is free from extraneous | ||
| matter and surface defects ( |