(8 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 2.8 mm and 6.2 mm.
The Emboshield® 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: RX BareWire™, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
The provided text describes a 510(k) premarket notification for the "Emboshield® Embolic Protection System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving device performance against specific acceptance criteria. While a clinical study (SECuRITY Registry Trial) is mentioned, details about acceptance criteria, specific performance metrics, and study methodologies for those criteria are largely absent from this document.
However, based on the information provided, here's an attempt to answer the questions, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "device must achieve X accuracy with Y confidence"). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The general "acceptance criteria" are implied to be that the device is as safe and effective as the predicate device.
The reported device performance is broadly summarized as:
- "results of the testing and clinical study support the safety and performance of the Emboshield device and its components for the intended indication."
Missing Information: Specific quantitative acceptance criteria (e.g., % reduction in embolic events, % successful deployment, filtration efficiency) and the corresponding achieved performance values are not detailed in this document.
2. Sample size used for the test set and the data provenance
- Sample Size: The "SECuRITY Registry Trial" enrolled 399 patients.
- Data Provenance: The document does not explicitly state the country of origin. It mentions 30 sites, suggesting a multi-center study, but location is not specified. The trial name "Registry Trial" implies it's a prospective observational study, gathering data on standard clinical practice rather than a randomized controlled trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: The document does not provide any information about the use of experts to establish a "ground truth" for the test set outcomes. Clinical trials typically rely on clinical endpoints (e.g., stroke rates, neurological deficits), which are evaluated by treating physicians and potentially adjudicated by independent clinical events committees, but the specifics are not mentioned here.
4. Adjudication method for the test set
Missing Information: The document does not describe any specific adjudication method for the test set outcomes.
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
Not Applicable: This device is an embolic protection system (a physical medical device), not an imaging or diagnostic AI device that would involve human readers interpreting cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable: This is a physical device, not an algorithm or AI system. Its performance is evaluated through its mechanical function and clinical outcomes, not through "standalone algorithm performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for evaluating the device's safety and performance would be clinical outcomes data from the SECuRITY Registry Trial, likely pertaining to embolic events, device-related complications, and successful protection during procedures.
Missing Information: Specific details on how these clinical outcomes were defined and assessed (e.g., what constituted an embolic event, how it was diagnosed, etc.) are not provided.
8. The sample size for the training set
Not Applicable/Missing Information: This is a physical medical device. The concept of a "training set" is generally applicable to machine learning algorithms. While the device undergoes extensive R&D and engineering testing (which could conceptually be seen as "training" its design), there isn't a "training set" in the machine learning sense for its clinical application. If the question implies prior data used to inform the device design or predicate device data synthesis, that detail isn't provided.
9. How the ground truth for the training set was established
Not Applicable/Missing Information: As mentioned above, the concept of a "training set" in the context of an algorithm's ground truth is not directly applicable to a physical device like this.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with three heads, which are represented by curved lines. The figure is positioned to the right of the logo. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abbott Vascular Devices c/o Mr. Ric Ruedy Director, Regulatory Affairs 400 Saginaw Drive Redwood City, CA 94063
Re: K052454
Emboshield® Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: March 23, 2005 Received: September 6, 2005
Dear Mr. Ruedy:
This letter corrects our substantially equivalent letter of September 14, 2005.
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 (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 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.
NOV 2 8 2005
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Page 2 - Mr. Ric Ruedy
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); 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.
This letter will allow you to continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Dinh R. Vahner
Image /page/1/Picture/7 description: The image contains a signature on the left side and the words "Branch Director" on the right side. The signature is illegible, but it appears to be written in cursive. The words "Branch Director" are written in a simple, sans-serif font. The image is likely a document that has been signed by a branch director.
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
| 510(k) Number (if known): | K052454 |
|---|---|
| Device Name: | The Emboshield ® Embolic Protection System |
| Indications For Use: | 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 2.8 mm and 6.2 mm. |
Prescription Use × (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)
Khemmer
(Diston Sign-Off) Division of Cardlovascular Devices 510(k) Number Kos 2454
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SEP 1 4 2005
APPENDIX A. 510(k) SUMMARY
Abbott Vascular Devices Emboshield® Embolic Protection System
KOS2454 510(k) Premarket Notification CONFIDENTIAL
| Sponsor/Submitter: | Abbott Vascular Devices (on behalf of MedNova, Ltd) |
|---|---|
| 400 Saginaw Drive | |
| Redwood City, CA 94063 | |
| Contact Person: | Debbie Cogan |
| Regulatory Affairs Manager | |
| Phone:(650) 474-3263 | |
| Fax:(650) 474-3041 | |
| Date of Submission: | March 22, 2005 |
| Device Trade Name: | Emboshield® Embolic Protection System |
| Device Common Name: | Embolic Protection System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1250 |
| Classification Name: | Device, coronary saphenous vein bypass graft, temporary, forembolization protection |
| Product Code: | NFA |
| Predicate Device: | Guidant RX Accunet Embolic Protection System (K042908) |
| 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 2.8 and 6.2 mm. |
| Device Description: | The Emboshield® Embolic Protection System is a temporarypercutaneous transluminal filtration system designed to captureembolic material released during angioplasty and stentprocedures within carotid arteries. The system consists of thefollowing components:RX BareWire™™ |
The RX BareWire™ is a 0.014" PTFE coated stainless steel guidewire with a 3.0cm (0.014") platinum radiopaque distal tip The RX BareWire™ is available in two lengths, section. 315cm and 190cm and a variety of stiffness.
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RX Delivery Catheter
The RX Delivery Catheter usable length is 135 cm. The crossing profile is between 0.048" and 0.051", 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 polyurethane membrane with internal Nitinol arms. There are two proximal triangular entry ports and multiple distal perfusion pores of 140microns. There is a proximal and a distal marker band. The Filtration Element is available in 3.0 mm, 4.0 mm, 5.0 mm and 6.0 mm diameters.
RX Retrieval Catheter
The RX Retrieval Catheter has a 139 cm usable length, a retractable Centering Catheter, and a distal expansile tip. The maximum outer diameter is 0.072''. A handle with a flushing port is situated at the proximal end. Two pairs of indicator bands are provided along the catheter shaft. Another proximal pair of indicator bands (90 cm and 100 cm from the catheter tip) allows indication of the catheter tip position during advancement through the guide catheter and a distal pair to indicate the proximity of the RX Retrieval Catheter exit port during catheter retraction. A radiopaque marker band is positioned approximately 3.5cm from the distal tip on the outer sheath.
Abbott Vascular Devices has submitted information on Summary of Substantial Equivalence: indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that Emboshield Embolic Protection System is substantially equivalent to the currently marketed predicate device.
The Emboshield Embolic Protection System has the same intended use as the predicate device. Results of scientific testing have ensured 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 SECuRITY Registry Trial was conducted
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enrolling a total of three hundred ninety nine (399) patients at 30 sites.
In summary, the results of the testing and clinical study support the safety and performance of the Emboshield device and its components for the intended indication when used in accordance with the Instructions for Use.
§ 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).