(77 days)
Not Found
No
The document describes a physical needle guide system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a needle guide used for positioning interventional tools and does not directly provide therapy. It assists in diagnostic or interventional procedures, but is not a therapeutic device itself.
No
The device provides guidance for interventional tools during procedures like biopsies or precise needle placement, which are typically interventional or treatment-oriented rather than solely diagnostic. While a diagnostic ultrasound procedure might precede or accompany its use, the device itself is for guiding instruments, not for diagnosing conditions.
No
The device description explicitly lists four primary components, three of which are single-use disposable hardware components (transducer cover, guide clip, and retainer clip) and one reusable hardware component (adapter). This indicates the device is a system with both hardware and potentially software elements, not a software-only 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 guide interventional devices (needles, catheters, biopsy apparatus) during diagnostic ultrasound procedures for biopsy or precise needle placement. This is a procedural guidance device, not a device used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The components are described as providing a physical guide for tools in relation to the ultrasound image. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), performing tests on samples, or providing diagnostic information based on the analysis of these samples.
The device is a medical device used to facilitate a medical procedure (biopsy or needle placement) performed in conjunction with a diagnostic imaging modality (ultrasound). It does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Sheathes Needle Guide provides guidance for a needle, catheter, biopsy apparatus, or other interventional device by positioning it relative to the ultrasound image during a diagnostic ultrasound procedure in order to perform a visually guided biopsy or precise needle placement.
Product codes
90 ITX
Device Description
The Sheathes Needle Guide system consists of 4 primary components which are used to provide alignment with an ultrasound transducer, in order to precisely position an interventional tool in relation to the ultrasound image. Three components (a transducer cover, a guide clip, and retainer clip) are single use disposable, while the fourth component, the adapter, is a reusable component, providing a system interface to various transducers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for SHEATHES Technologies. The logo is in black and white and features the word "SHEATHES" in large, bold letters. Above the word "SHEATHES" is the word "SHEATHING" and below it is the word "TECHNOLOGIES". The date "FEB 28 2005" is also visible in the upper left corner of the image.
510 (k) Summary
Application date: 12/09/04
ﺎ ﺑﺎ
Document Mail Center (HFZ401) Document for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 USA
Re: 510(k) Notification
Dear Sir or Madam:
This letter along with the attached materials is to notify your office of the intention (00) This letter along with the attachou materials to to houly your can be any and days from this date.
Trade Name - Sheathes Needle Guide System
Common Name - Needle Guide for Ultrasound
Classifications Name - Diagnostic Ultrasound Transducer
Craduct Equivalence: The Needle Guide system covered in this application is Product Equivalence: "The Neodio Guide marketed by Bard Access. Substantially Equivalient to the Okershop Needle Guide system marketed by Civco Medical Systems Co., Inc of Kalona, Iowa.
| | Site Rite Needle Guide | Civco Maggi II
Plus |
|--------------------|-----------------------------------|------------------------|
| 510(k) Number | K931403 (Dymax –
modification) | K882383 |
| 510K Approval Date | 07/27/1993 | 11/28/1988 |
Labeling for Predicate Devices is contained in Appendix C
SHEATHING TECHNOLOGIES, INC. 18431 TECHNOLOGY DRIVE MORGAN HILL, CA 95037 PHONE: 1-800-873-3776 FAX: 1-877-244-5048 WEBSITE: http://www.sheathingtechnologies.com E-MAIL: sheathes@msn.com
Page 12 of 39
1
-
- Design, Application Method Clip on plastic components providing various Design, Application frees, and supporting various size needles.
-
- Materials: Thermoplastic disposable components Nylon and ABS
- Sterility: Single use components provided presterilized. 4.
Summary description: The Sheathes Needle Guide system consists of 4 primary Summaly description. The Bheatios is alignment with an ultrasound transducer, in order components willen are used to pro rise interventional tool in relation to the ultrasound image. Three components (a transducer cover, a guide clip, and retainer clip) are single use disposable, while the fourth component, the adapter, is a reusable component, providing a system interface to various transducers.
Intended use of device. The Sheathes Needle Guide provides guidance for a needle, micided use of devices. The entear interventional device by positioning it relative to the catherer, blopsy apparates, or other image during a diagnostic ultrasound procedure in order to perform a visually guided biopsy or needle placement.
In compliance with regulations according the Safe Medical Devices Act, in compliante with Pogalations according upon request.
We believe this document provides the necessary information for your office to determine whether our device is equivalent to a legally marketed predicate device. All this information is deemed to be confidential and may not be released without consent of Sheathing Technologies.
Thank you for your assistance and should you have any questions, please contact us at (408) 782-2720.
Sincerely,
Láwrence S. Polayes CEO Sheathing Technologies, Inc. 18431 Technology Drive Morgan Hill, CA 95037 (408) 782-2720 Phone (408) 778-8523 FAX
SHEATHING TECHNOLOGIES, INC. 18431 TECHNOLOGY DRIVE MORGAN HILL CA 95037 PHONE: 1-800-873-3776 FAX: 1-877-244-5048 WEBSITE: http://www.sheathingtechnologies.com E-MAIL: sheathes@msn.com
PAGE 13 OF 39
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is represented by three parallel lines that curve and merge at the bottom.
FEB 2 8 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lawrence S. Polayes CEO Sheathing Technologies, Inc. 18431 Technology Drive MORGAN HILL CA 95037
Re: K043425
R045423
Trade/Device Name: Sheathes Needle Guild System Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: February 7, 2005 Received: February 14, 2005
Dear Mr. Polayes:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premained is substantially equivalent to legally marketed at a t predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of predicale devices markets or to devices that have been reclassified in accordance with the the Medical Device Amendins of to ac receive Act (Act). You may, therefore, market the provisions of the rederal controls provisions of the Act. However, you are responsible to device, subject to the general controls provise in the kit have either been determined determine that the medical do recess you are the premarket notification 510(k) of the act), as substantially cquivalent under the promized of the enactment date of the Medical Device or well legally on the market pro. worthase your device components in bulk (i.e., unfinished) Allendinents. I rease note: '11 you paul submit a new 510(k) before including these and furner process (c.g., neimer) 3) controls provisions of the Act include requirements for components in your kit. The generas, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), If your device is classified (300 above) into interest and on affecting your device can be it may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I casiants concerning your device in the Federal Register.
Please be advised that FIDA's issuance of a substantial equivalence determination does not mean Prease or advised that 1 12/15 155dailed 07 a device complies with other requirements of the Act mat I DA has made a determination administered by other Federal agencies. You must
3
comply with all the Act's requirements, including, but not limited to: registration and listing (21)
and interest and any and expective and comments as set comply with all the Act s requirements, including to recommon ...
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Parl of ); good manatating platf arophicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if arolicable, forth in the quality systems (QS) regulation (21 CFR Parcelo) (21 CFR 1000-1050.
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)
The same of the support of a line of a list as tisk aspivalence of your device t This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The PDA Intuing of Subscance of Subdevice to proceed to the market.
If you desire specific advice for your device on the labeling regulation, please contact the Office If you desire specific advice for your devices on an other regulation entitled, "Misbranding by
of Compliance at (240) 276-0120. Also, please note the option other general of Compliance at (240) 270-0120. "Also, prease no 07.97). You may obtain other general
reference to premarket notification" (21 CFR Part 807.97). Dunnier of Small Manufact reterence to premarket noutication (21 Cr R an 60 m ) - Division of Small Manufacturers, information on your responsibilities under the river (800) 638-2041 or (301) 443-6597,
International and Consumer Assistance at its toll free number (800) free humber international and Collsumer Assistance as we cdrh/industry/support/index.html.
Sincerely yours,
David Ch. Lyonn
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Sheathes Needle Guide System
Indications for Use:
The Sheathes Needle Guide provides guidance for a needle, catheter, biopsy apparatus, or other interventional device by positioning it relative to the ultrasound apparatus, of other moreman as aring a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement.
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 OF NEEDED)
David R. Bergson