(108 days)
Couplant: HybriSonic Sheaths will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics, intended for use in sterile and non-sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures when used alone or in combination with an ultrasound coupling gel or fluid alone or in combination with a latex, polypropylene protective transducer cover. The Combination are intended to be used without additional lubrication for typically ultrasound such as ultrasound guided biopsy and aspiration.
Microbial barrier: HybriSonic Sheaths are also intended for use as ultrasound transducer Microbial barriers that are in vivo biocompatible with tissue and body fluids and leave no residue with the transducer, are single use and disposable.
Device lubricant: In addition to coupling ultrasound, the HybriSonic Sheath is intended for use as a device lubricant and microbial barrier during transcutaneous ultrasound exams and with ultrasound imaging and transcutaneous ultrasound guided biopsy or aspiration.
HybriSonic Sheath
The provided text describes a 510(k) premarket notification for the "HybriSonic Sheath" but does not contain information regarding acceptance criteria, study details, or performance results.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a clearance letter from the FDA, confirming the device's substantial equivalence to a predicate device for its stated indications for use, without detailing the specific studies or performance metrics used to reach that conclusion.
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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1999
Margaret J. Larson President Sonotech, Inc. P.O. Box 2189 Bellingham, WA 98227-2189 Re:
K983985 HybriSonic Sheath Dated: January 7, 1999 Received: January 20, 1999 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Larson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have have have be We have reviewed your Section billion to makes the use states in the enclosure) to legally
delemined the device is substantially equivalent for the indications for use of the delemined the devices markets in interstate commerce proc to May 28, 1976, the enactinent date of the marketed predicate devices marked in interseasified in accroclance with the provisions of the provisions of the provisions of the provisions of the provisions of the general Medical Device Amendments, or to devices that nave neurosanies nibed to the general control.
Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to rapul Federal Food, Drug, and Cosmelle Act (Act). Tourney, the Act include requirements for annual registration, listing of
provisions of the Act. The general continient of the A provisions of the Act. The general controls provisions of the Accuration in the Actually and adulteration.
lf your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may
(Sode of the Collines and a Figitire majar regu If your device is classified (see above) into einer class in (special on the more on the count in the Code of be subject to such additional control. Existing major regulations assumes compliance with
Federal Regulations, Title 21, Parts 800 to 805. A substantiality equivalion (QS) Federal Regulations, Title 21, Parts 800 to 895. A substantially equility System Regulation (QS) for the Current Good Manufacturing Packor requirements, as series of Concerner on the Frod and Medical Devices: General regulation Drug Administration (FDA) will verty such assumply vier in ovin device in the Federal regulatory action. In addition, FDA may publish numentis ronicen in affect any obligation your a
Register. Please note: this response to your premarket notification contro Register. Please note: this response to your premail.com adon's and the encontribution only and might inns, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification for This letter will allow you to begin marketing your device in your of the promote the management in a classification for finding of substantial equivalence of your device to proceed to the market.
If you desire specific advice for your labeling regulation (21 CFR Pat 801 and additionally for guestions on lf you desire specific advice for your device on our labelly (en 1 at on a manus and services on questions on questions on questions on questions on vitte diagnostic devices), please contact the Office of Corriviance at (301) 594-4639. Also,
the promotion and advertising of your device, please continue at (301) 594-4639. the promotion and advertising of your devel, please online the Onlines of (21 cm .
please note the regulation entitled, "Misbranding by reference to premation of Small Manufa please note the regulation entitled, "Mishang of reletics including in in on in on in of Small Manufacturers
general information on your responsibilities under the Act its in general information on your responsibilities under the Act 1,63 may 2017 - 1,11 its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
signature
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/1/Picture/0 description: The image shows the logo for SONOTECH. The logo consists of a stylized image of a dolphin jumping out of the water, with a black semicircle above it, followed by the word "SONOTECH" in bold, black letters. The dolphin and semicircle are also black, creating a strong visual contrast.
Sonotech, Inc. 774 Marine Drive, Bellingham, WA 98225 fax: 360/671-9024 360/671-9121
Registration # 2523891
510(k) Application: HybriSonic Sheath
510(k) Number (if known):
HYBRISONIC SHEATH Device Namc:
Indications For Use:
Couplant: HybriSonic Sheaths will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics, imaging to couple sound waves betwoon the pation of the strenged for use intended for use in provide lubilcation and act as a miorobiar sames and cavity or transcutaneous ultrasound
sterile and non-sterile fields, including intraoperative, endocavity or transcuration stenie and non-stenic nolog, including in an altrasound coupling gel or fluid alone or in imaging procedures whilen ourlority as a polypropylene protective transducer cover. The Combination with a latox, poly are harrer of program to be used without additional lubrication for ryphoonly onound such as ultrasound guided biopsy and aspiration.
Microbial barrier: HybriSonic Sheaths are also intended for use as ultrasound transducer Microbial barriers that are in vivo biocompatible with tissue and body fluids and leave no residue milerobial barners than with the transducer, are single use and disposable.
Device lubricant: In addition to coupling ultrasound, the HybriSonic Sheath is intended for use Device lubricant and microbial barrier during transcutaneous ultrasound exams and with as a device lubhoant and microbial but ultrasound imaging and transcutaneous ultrasound quided biopsy or aspiration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Virgil b. Hageman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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.