(101 days)
The Emboshield® Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV6 Embolic Protection System is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: Bare Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
The provided text describes a 510(k) premarket notification for the Emboshield NAV6 Embolic Protection System. It outlines the device's intended use and design, and summarizes the substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria or provide a detailed study report proving the device meets specific performance criteria beyond general statements of safety and performance.
Thus, a direct answer to the request to populate the table with "acceptance criteria" and "reported device performance" is not possible from the provided text, as these specific metrics are not present. Similarly, details for most of the other questions are either not provided or only vaguely mentioned.
Here's an analysis of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Information Not Provided in the Text. The document states:
- "Results of testing have demonstrated that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
- "In vitro and in vivo testing was conducted."
- "The PROTECT Study was conducted enrolling a total of two hundred and twenty (220) patients at 34 sites."
- "In summary, the results of the testing and clinical study support the safety and performance of the Emboshield NAV6 device and its components for the intended indication when used in accordance with the Instructions for Use."
These are general conclusions, not specific quantitative acceptance criteria or reported performance metrics.
2. Sample size used for the test set and the data provenance
- Sample size for the test set: 220 patients (from the PROTECT Study).
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective outside of "clinical study"), but given it's a 510(k) submission to the US FDA, it likely includes US data, potentially multi-national given "34 sites". The study was "conducted," implying prospective collection for the clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Information Not Provided in the Text.
4. Adjudication method for the test set
Information Not Provided in the Text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The device is an Embolic Protection System (a physical medical device, not an AI or imaging diagnostic tool). Therefore, an MRMC comparative effectiveness study involving human readers (typically associated with AI/imaging for diagnosis/detection) is not applicable to this type of device. The "PROTECT Study" seems to be a clinical trial for the device's safety and performance in patients, not an AI efficacy study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the PROTECT Study (clinical trial): It can be inferred that outcomes data (related to safety and efficacy in removing embolic material during carotid procedures) would be the primary ground truth. Specific details on how "embolic material" removal or "protection" was quantified and verified are not provided.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set for a physical device.
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SEP 1 1 2008
2.0 510(k) Summary
1
| Sponsor/Submitter: | Abbott Vascular3200 Lakeside DriveSanta Clara, CA 95054 |
|---|---|
| Contact Person: | Danielle TaylorRegulatory Affairs ManagerPhone: (408) 845-0883Fax:(408) 845-0921 |
| Date of Submission: | May 30, 2008 |
| Device Trade Name: | Emboshield NAV6 Embolic Protection System |
| Device Common Name: | Embolic Protection System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1250 |
| Classification Name: | catheter, carotid, temporary, for embolization capture |
| Product Code: | NTE |
| Predicate Device: | Emboshield® Embolic Protection System (K052454) |
| Intended Use: | The Emboshield® Embolic Protection System is indicated foruse as a guidewire and embolic protection system to containand remove embolic material (thrombus/debris) whileperforming angioplasty and stenting procedures in carotidarteries. The diameter of the artery at the site of the FiltrationElement placement should be between 2.5 and 7.0 mm. |
| Device Description: | The Emboshield NAV6 Embolic Protection System is atemporary percutaneous transluminal filtration systemdesigned to capture embolic material released duringangioplasty and stent procedures within carotid arteries. Thesystem consists of the following components: |
| Bare WireThe BareWire is a 0.014" PTFE coated stainless steelguidewire with a 3.0cm (0.014") platinum radiopaque distaltip section. Three BareWire designs are available asseparately packaged items offering different support levels. |
:
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The BareWire Workhorse is supplied with the Emboshield NAV® Embolic Protection System and is available packaged separately in two lengths, 315cm and 190cm.
RX Delivery Catheter
The RX Delivery Catheter usable length is 135 cm. The crossing profile is between 0.0365" and 0.0415", depending on Filtration Element size. A pull handle is used to deploy the loaded Filtration Element from the pod. Two pairs of indicator bands are provided along the catheter shaft. A proximal pair (90 cm and 100 cm from the catheter tip) to indicate the catheter tip position during advancement through the guide catheter, and a distal pair to indicate the proximity of the RX exit port during catheter retraction. A radiopaque marker band is positioned proximal to the pod.
Filtration Element
The Filtration Element consists of a nylon membrane with an internal nitinol support structure with radiopaque coils. There are two proximal triangular entry ports and multiple 120 micron distal perfusion pores. There is a proximal and a distal marker band. The Filtration Element is available in two sizes; small (φ5.0mm) to treat vessel diameters of 2.5 - 4.8mm and large ($7.2mm) to treat vessel diameters of 4.0 to 7.0mm.
RX Retrieval Catheter
The RX Retrieval Catheter has a usable length of 139cm and a moulded, expansile distal tip with a maximum outer diameter of 0.067''. A handle is situated at the proximal end. Two pairs of marker bands indicate the position of the Retrieval Catheter RX guidewire exit port and catheter tip.
Summary of Substantial Equivalence:
Abbott Vascular has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the Emboshield NAV® Embolic Protection System is substantially equivalent to the currently marketed predicate device.
The Emboshield NAV® Embolic Protection System has the same intended use as the predicate device. Results of testing have demonstrated that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. In vitro and in vivo testing was conducted. The PROTECT Study was conducted enrolling a total of two hundred and twenty (220) patients at 34 sites.
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In summary, the results of the testing and clinical study support the safety and performance of the Emboshield NAV6 device and its components for the intended indication when used in accordance with the Instructions for Use.
:
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
SEP 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abbott Vascular Inc. c/o Ms. Danielle Taylor Regulatory Affairs Manager 3200 Lakeside Drive Santa Clara, CA 95054
Re: K081523
RX Accunet® LP Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: August 15, 2008 Received: August 18, 2008
Dear Ms. Taylor:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Ms. Danielle Taylor
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerelv vours.
Donna R. Vahmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K081523 510(k) Number (if known):
Device Name:
Emboshield NAV® Embolic Protection System
Indications For Use:
The Emboshield NAV® Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in the carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 mm and 7.0 mm.
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)
Duna R. Vumer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KU8)523
Page 1 of 1
§ 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).