(29 days)
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material 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.
The PROTEUS™ PTA Balloon Catheter with Embolic Capture is an over the wire coaxial dual lumen catheter with a foldable balloon located near the distal atraumatic soft tip.
The PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature consists of a foldable balloon with radiopaque markers which aid in positioning the balloon in the artery during the angioplasty procedure, the co-axial shaft comprising the inner shaft and the outer shaft, and the handle comprising the handle enclosure, the T-connector, the inflation port, the pulling rod with the guidewire port, and the pulling rod locks.
Following embolic capture, the user can opt to use the PROTEUS™ Particle Visualization Kit (PVK) to facilitate the visualization of the embolic material captured by the PROTEUS™ PTA Balloon Catheter.
The provided text describes a Special 510(k) submission for the PROTEUS™ PTA Catheter with Embolic Capture Feature. This submission is for modifications to an already cleared device, specifically the addition of a Particle Visualization Kit (PVK) accessory.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantitative acceptance criteria or provide a table of reported device performance in terms of metrics like sensitivity, specificity, accuracy, etc. This is common for Special 510(k) submissions focusing on modifications, especially when the modification is an accessory and the core function (embolic capture) of the device remains identical to a predicate.
The primary "acceptance criterion" implied throughout is substantial equivalence to the predicate device (Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature K090364) in terms of indications for use, technological characteristics, and performance characteristics.
The document states:
- "The balloon technological characteristics of the modified version of PROTEUS™ PTA Balloon Catheter are substantially equivalent to those of the unmodified version of the device."
- "The modified PROTEUSTM PTA Balloon Catheter overall length, catheter sheath sizing, balloon diameter, balloon length, balloon nominal pressure, balloon rated burst pressure and end hole diameter are identical to the unmodified version of the device."
- "The embolic capture technological characteristics of the modified PROTEUSTM PTA Balloon Catheter are identical to those of the unmodified version of the device."
The only specific testing mentioned relates to the new accessory:
- "Verification and validation testing of the PROTEUS™ Particle Visualization Kit included simulated use testing."
Without specific metrics or quantitative data from this simulated use testing, a formal table cannot be constructed.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "simulated use testing" for the Particle Visualization Kit but does not specify the sample size (e.g., number of simulated procedures, number of particles visualized).
- Data Provenance: The testing was "simulated," implying in-house lab testing, not patient data from a specific country, nor retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- The document does not mention the use of experts to establish ground truth for any test set. The nature of the device (a catheter and a visualization kit) and the type of testing described (simulated use for an accessory) likely did not necessitate independent expert ground truth establishment in the way a diagnostic AI algorithm would.
4. Adjudication Method for the Test Set:
- Since there's no mention of experts establishing a ground truth for a test set, no adjudication method was needed or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically done for diagnostic imaging devices or AI algorithms where human interpretation is involved. This submission is for a medical device (catheter) and an accessory, not a diagnostic imaging AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:
- Not applicable. The device is a physical catheter and a visualization kit, not an algorithm. Therefore, no standalone algorithm performance study was mentioned.
7. Type of Ground Truth Used:
- For the simulated use testing of the Particle Visualization Kit, the "ground truth" would likely be engineer-defined criteria and observations of whether the kit successfully facilitated the visualization of deliberately introduced embolic material. This is based on the functional description of the PVK. No mention of expert consensus, pathology, or outcomes data for this specific testing.
8. Sample Size for the Training Set:
- Not applicable. This device is hardware (catheter and accessory), not a machine learning or AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.
In summary, the provided document focuses on establishing substantial equivalence for a non-AI physical medical device and an accessory. It describes the device's characteristics and notes that non-clinical simulated use testing was performed for the new accessory, but it does not delve into detailed quantitative acceptance criteria or elaborate on study designs typical of AI/diagnostic device submissions. The core argument is that the modified device is identical or substantially equivalent in its critical features to an already cleared predicate.
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Angioslide Ltd. - Special 510(k) PROTEUS™ PTA Catheter with Embolic Capture Feature Section 7: 510(k) Summary
510(k) Summary
JUL 2 1 2011
PROTEUSTM PTA Catheter with Embolic Capture Feature
Introduction
This document contains the 510(k) summary for the modified PROTEUSTM 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: | 32 Maskit St.P.O. Box 12489Herzilya 46733Israel |
| Tel: +(972) 9-970-0300Fax: +(972) 9-970-0307ilyab@angioslide.com | |
| Official Contact: | Ilya BurovoyVice President, Regulatory Affairs and Quality Assurance |
Summary Preparation Date: June 16th, 2011
Device Name and Classification:
| Trade Name: | PROTEUS™ PTA Balloon Catheter withEmbolic Capture Feature |
|---|---|
| Common Name: | Percutaneous Transluminal AngioplastyBalloon Catheter |
| Classification Name: | Catheter, Percutaneous |
| Classification: | Class II, 21 CFR 870.1250 |
| Product Code | DQY/LIT |
Predicate Device:
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 device:
- Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature (K090364) .
Device Description:
The PROTEUS™ PTA Balloon Catheter with Embolic Capture is an over the wire coaxial dual lumen catheter with a foldable balloon located near the distal atraumatic soft tip.
The PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature consists of a foldable balloon with radiopaque markers which aid in positioning the balloon in the artery during the
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Angioslide Ltd. - Special 510(k) PROTEUS™ PTA Catheter with Embolic Capture Feature Section 7: 510(k) Summary
angioplasty procedure, the co-axial shaft comprising the inner shaft and the outer shaft, and the handle comprising the handle enclosure, the T-connector, the inflation port, the pulling rod with the guidewire port, and the pulling rod locks.
Following embolic capture, the user can opt to use the PROTEUS™ Particle Visualization Kit (PVK) to facilitate the visualization of the embolic material captured by the PROTEUS™ PTA Balloon Catheter.
Indications for Use:
The PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Summary 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 0.035" guidewire.
The balloon technological characteristics of the modified version of PROTEUS™ PTA Balloon Catheter are substantially equivalent to those of the unmodified version of the device. The modification that is the subject of this Special 510(k) is the addition of a Particle Visualization Kit (PVK) accessory that is used outside of the sterile field to allow users to visualize embolic particles captured by the embolic capture feature of the catheter.
The modified PROTEUSTM PTA Balloon Catheter overall length, catheter sheath sizing, balloon diameter, balloon length, balloon nominal pressure, balloon rated burst pressure and end hole diameter are identical to the unmodified version of the device.
The embolic capture technological characteristics of the modified PROTEUSTM PTA Balloon Catheter are identical to those of the unmodified version of the device. In both devices the containment 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
Verification and validation testing of the PROTEUS™ Particle Visualization Kit included simulated use testing.
Conclusion
The Angioslide PROTEUS™ PTA Balloon Catheter is substantially equivalent with respect to the indications for use, technological characteristics, and performance characteristics to the following legally marketed predicate device:
- eXtraTM PTA Balloon Catheter, Angioslide K090364 .
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Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HC." is arranged vertically along the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Angioslide, LTD. c/o Clay Anselmo President and CEO Reglera, LLC 11925 West I-70 Frontage Road North, Suite 900 Wheatridge, CO 80033
JUL 2 1 2011
Re: K111750
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: DQY, LIT Dated: June 20, 2011 Received: June 22, 2011
Dear Mr. Anselmo:
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, Or us 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. 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.
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Page 2 - Mr. Clay Anselmo
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 vours.
Arlile B. Bow
Bram Zuckerman. M.D. M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K111750
Device Name: PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature
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 containment of embolic material during angioplasty, for the femoral, ilia-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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Cardiovascular Devices
510(k) Number K111750
§ 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).