(28 days)
Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
The modified EchoTip® Ultra Fiducial Needle is generally identical to the cleared predicate device. The modified device is also composed of a delivery system (i.e., needle, sheath, handle, and stylet) with four pure gold fiducials preloaded and secured within a laser-cut track in the needle. The needle is dimpled to enhance its echogenicity, allowing the user to target tissues using endoscopic ultrasound guidance. The needle stylet is advanced to deploy the fiducials. Once deployed, the fiducials are permanent implants that serve as radiopaque reference points for future therapeutic procedures. The Intended Use and Indications for Use are identical in the modified device as is the fundamental operating principle. Modifications to this iteration of the device include minor dimensional, geometric and tolerance adjustments.
The provided text is a 510(k) summary for a medical device (EchoTip Ultra Fiducial Needle) and a clearance letter from the FDA. This type of submission is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a clinical study proving performance against explicit acceptance criteria for a novel device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/human-in-the-loop system. The device described is a physical medical instrument, not an AI or software device that would typically have acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.
Here's why the requested information is not present:
- Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a predicate device, not on meeting specific performance acceptance criteria for a novel technology. The "Discussion of Tests and Test Results" section states that "Cook conducted verification and validation testing specific to the risks identified to ensure that risks were mitigated and the device continued to perform as intended," but it does not list specific numerical performance criteria or results.
- Sample Size and Data Provenance (for a test set): Not applicable, as there's no diagnostic AI algorithm being tested on a "test set" of data. The "tests" mentioned are likely engineering and bench tests for the physical device.
- Number and Qualifications of Experts for Ground Truth: Not applicable for a physical device. Ground truth is usually relevant for diagnostic software where human experts label images or data.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study investigates the impact of AI assistance on human reader performance, which isn't relevant for a physical fiducial needle.
- Standalone (Algorithm-Only) Performance: Not applicable. This device is a physical instrument, not an algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for the Training Set: Not applicable. This device is not an AI model that requires a training set.
- How Ground Truth for the Training Set was Established: Not applicable.
In summary, the provided submission describes a physical medical device and its regulatory clearance process through substantial equivalence, not the performance evaluation of a software or AI device against acceptance criteria in a clinical study.
{0}------------------------------------------------
510(k) SUMMARY
Submitted By:
Marge Walls-Walker, Senior Regulatory Specialist Wilson-Cook Medical, Inc. /Cook Endoscopy 4900 Bethania Station Road Winston-Salem, NC 27105 (336) 744-0157 x-6290 May 12, 2014
Name of Device
| Trade Name: | Ecl |
|---|---|
| Common/Usual Name: | lmı |
| Proposed Classification Name(s): Ma |
hoTip® Ultra Fiducial Needle plantable clip rker, Radiographic, Implantable 21CFR 878.4300, NEU, Class II, and Kit, Needle, Biopsy 21 CFR 876.1075, FCG, Class II
Predicate Devices
EchoTip® Ultra Fiducial Needle, k 111895, cleared 4.27.2012
Intended Use
This device is intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Device Description
The modified EchoTip® Ultra Fiducial Needle is generally identical to the cleared predicate device. The modified device is also composed of a delivery system (i.e., needle, sheath, handle, and stylet) with four pure gold fiducials preloaded and secured within a laser-cut track in the needle. The needle is dimpled to enhance its echogenicity, allowing the user to target tissues using endoscopic ultrasound guidance. The needle stylet is advanced to deploy the fiducials. Once deployed, the fiducials are permanent implants that serve as radiopaque reference points for future therapeutic procedures. The Intended Use and Indications for Use are identical in the modified device as is the fundamental operating principle. Modifications to this iteration of the device include minor dimensional, geometric and tolerance adjustments.
{1}------------------------------------------------
Substantial Equivalence
The EchoTip® Ultra Fiducial Needle, subject of this Special 510(k) is substantially equivalent to the EchoTip® Ultra Fiducial Needle (K111895). Both devices are composed of pure gold fiducials (e.g., tissue markers) preloaded within a delivery system intended to be introduced through an ultrasound endoscope. Once deployed, the radiopaque fiducials permanently mark soft tissue for therapeutic procedures.
The delivery system (i.e., needle, sheath, handle, and stylet) of the subject EchoTip® Ultra Fiducial Needle is substantially equivalent to the EchoTip® Ultra Fiducial Needle (K111895). Both are dimpled, endoscopic ultrasound needles that may be used to inject materials into tissues. No changes have been made to the implantable fiducials. Minor modifications have been made to the delivery system of the EchoTip® Ultra Fiducial Needle. Specifically, geometric, dimensional and tolerance changes have been made to the laser cut track with notch the needle sheath and the needle tip to enhance fiducial delivery. The modified ECHO Tip Ultra Fiducial needle is substantially equivalent to the referenced Wilson-Cook Fiducial needle with respect to technological characteristics and Intended Use, Indications for Use, method of operation, fundamental scientific technology and labeling.
Discussion of Tests and Test Results
Potential new risks due to the modifications to the cleared device were identified and evaluated. Cook conducted verification and validation testing specific to the risks identified to ensure that risks were mitigated and the device continued to perform as intended.
Conclusions Drawn from the Tests
Outcomes from the evaluation of the EchoTip® Ultra Fiducial Needle provide evidence of its ability to delivery fiducials to mark soft tissues for future therapeutic procedures via endoscopic ultrasound placement and establish that it is substantially equivalent to the predicate device in terms of intended use, indications for use, technological characteristics and fundamental scientific technology.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【購入】【送料無料】【
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines representing its wings or feathers. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G608
Silver Spring, MD 20993-0002
Public Health Service
June 20, 2014
Wilson-Cook Medical % Ms. Marge Walls-Walker Senior Regulatory Specialist - Engineering 4900 Bethania Station Road WINSTON- SALEM NC 27105
Re: K141356
Trade/Device Name: ECHO Tip Ultra Fiducial Needle Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU, FCG Dated: May 22, 2014 Received: May 23, 2014
Dear Ms. Walls-Walker:
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 Mav 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 (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.
{3}------------------------------------------------
Page 2-Ms. Walls-Walker
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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 yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141356
Device Name ECHO Tip Ultra Fiducial Needle
Indications for Use (Describe)
Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm.h.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
•DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.