(297 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the fiducial needle and gold markers, with no mention of AI or ML for image analysis, guidance, or any other function.
No
The device is used to mark soft tissue for future therapeutic procedures, indicating it is a diagnostic or marking device, not one performing therapy itself.
No
The device is intended to implant fiducials that serve as radiopaque reference points for future therapeutic procedures, not for diagnosing medical conditions. While it uses imaging (endoscopic ultrasound) for guidance during implantation, the implanted fiducials themselves are markers for therapy, not diagnostic tools.
No
The device description clearly outlines physical components (needle, sheath, handle, stylet, gold fiducials) and describes a mechanical deployment mechanism, 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 is to implant fiducials to radiographically mark soft tissue for future therapeutic procedures. This is a therapeutic/interventional use, not a diagnostic one.
- Device Description: The device is a delivery system for implantable fiducials. It is used to physically place markers within the body.
- Lack of Diagnostic Function: The device itself does not perform any in vitro analysis of biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The fiducials are markers for imaging, not diagnostic tools themselves.
- Imaging Modality: While it uses imaging (endoscopic ultrasound and radiographic imaging) for guidance and visualization of the implanted markers, the device's primary function is the physical implantation, not the interpretation or analysis of the images for diagnostic purposes.
IVD devices are specifically designed 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
This device is intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
NEU, FCG
Device Description
The EchoTip® Ultra Fiducial Needle is 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic ultrasound
Anatomical Site
soft tissue
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)
Cook conducted verification and validation testing establishing that design outputs met the design inputs. No toxicological concerns for pure gold implanted fiducials were identified by a Risk Assessment inclusive of exhaustive extraction under polar and non-polar conditions with accompanying chemical characterizations as well as the following biocompatibility tests: cytotoxicity, irritation sensitization and implantation. Additionally, simulated use demonstrated that the device could be used effectively without detachment or breakage, the fiducials were visible under ultrasound and common radiographic imaging techniques, and the fiducials are MR Conditional, as defined by ASTM F2503-08, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment and the FDA guidance, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.
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
§ 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.
0
KIII895
Submitted By:
Marge Walls-Walker, Senior Regulatory Specialist: Engineering Wilson-Cook Medical, Inc./Cook Endoscopy 4900 Bethania Station Road (336) 744-0157 June 30, 2011
510(k) SUMMARY
Name of Device
| Trade Name: | EchoTip ® Ultra Fiducial Needle |
|---|---|
| Common/Usual Name: | Implantable clip |
| Proposed Classification Name(s): | Marker, Radiographic, Implantable |
| 21CFR 878.4300, NEU, Class II, and | |
| Kit, Needle, Biopsy | |
| 21 CFR 876.1075, FCG, Class II. |
Predicate Devices
BiomarC® Preloaded Tissue Marker Device, 510(k) No. K042296, cleared September 20, 2004
EchoTip® Ultra Ultrasound Needle, 510(k) No. K083330, cleared February 6, 2009
Intended Use
This device is intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Device Description
The EchoTip® Ultra Fiducial Needle is 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.
Substantial Equivalence
The EchoTip® Ultra Fiducial Needle is substantially equivalent to the Biomarce Preloaded Tissue Marker Device (510(k) No. K042296). Both devices are composed of fiducials (i.e., tissue markers) preloaded within a delivery system. Once deployed, the radiopaque fiducials permanently mark soft tissue for therapeutic procedures.
APR 2 7 2012
1
The delivery system (i.e., needle, sheath, handle, and stylet) of EchoTip® Ultra Fiducial Needle is substantially equivalent to the EchoTip® Ultra Ultrasound Needle (510(k) No. K083330). Both are dimpled, endoscopic ultrasound needles that may be used to inject materials into tissues. The delivery system of the EchoTip® Ultra Fiducial Needle is a modified version of the EchoTip® Ultra Ultrasound Needle. Specifically, a laser cut track with notch has been added to the needle to secure the fiducials and a thumb ring has been added to the stylet hub to improve the ergonomics of fiducial deployment.
Discussion of Tests and Test Results
Cook conducted verification and validation testing establishing that design outputs met the design inputs. No toxicological concerns for pure gold implanted fiducials were identified by a Risk Assessment inclusive of exhaustive extraction under polar and non-polar conditions with accompanying chemical characterizations as well as the following biocompatibility tests: cytotoxicity, irritation sensitization and implantation. Additionally, simulated use demonstrated that the device could be used effectively without detachment or breakage, the fiducials were visible under ultrasound and common radiographic imaging techniques, and the fiducials are MR Conditional, as defined by ASTM F2503-08, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment and the FDA guidance, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.
Conclusions Drawn from the Tests
Outcomes from the evaluation of the EchoTip® Ultra Fiducial Needle provide evidence of its ability to mark soft tissues for future therapeutic procedures via endoscopic ultrasound placement and establish that it is substantially equivalent to the predicate devices in terms of intended use, biological safety and technological characteristics.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
APR 2 7 2012
Ms. Marge Walls-Walker Senior Regulatory Specialist: Engineering Wilson-Cook Medical, Inc. /Cook Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K111895
Trade/Device Name: EchoTip® Ultra Fiducial Needle Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU and FCG Dated: April 19, 2012 Received: April 23, 2012
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 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
EchoTip® Ultra Fiducial Needle
Indications for Use:
Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Prescription Use XX
AND/OR
Over-the-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CRF 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off)
Division of Radiologic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
810K. K111895
Page 1 of