(92 days)
Not Found
Not Found
No
The summary describes a sterile probe cover, a passive device, and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a sterile non-latex probe cover for diagnostic ultrasound procedures, which serves as a barrier and does not directly provide therapeutic benefit to the patient.
No
The device is described as "Sterile Non-Latex Probe Covers" and its intended use is "during diagnostic ultrasound procedures". This indicates the device is an accessory used during a diagnostic procedure, not a diagnostic device itself.
No
The device description clearly states "Sheathes (Non-Latex), Sterile," indicating a physical, non-software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device is a "STERILE NON-LATEX PROBE COVER" used "DURING DIAGNOSTIC ULTRASOUND PROCEDURES". This indicates it's a physical barrier used with an imaging device (ultrasound) and does not involve testing samples taken from the body.
- Intended Use: The intended use is to cover an ultrasound probe, primarily for hygiene and to address potential latex sensitivity. This is a procedural aid, not a diagnostic test performed on a biological sample.
Therefore, this device falls under the category of a medical device used in a diagnostic procedure, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
STERILE NON-LATEX PROBE COVERS ARE INDICATET) DURING DIAGNOSTIC ULTRASOUND PROCEDURES in CASES WHERE.. PATIENT SENSITIVITY TO LATEX is SPECULATIVE.
Product codes
90 ITX
Device Description
Sheathes (Non-Latex), Sterile
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ULTRASOUND
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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): 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.
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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
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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.
Lawrence S. Polayes CEO Sheathing Technologies, Inc. Medical Resources Division 334 Commercial St. San Jose, CA 95112
Re:
K990175 Sheathes (Non-Latex), Sterile Dated: March 4, 1999 Received: March 8, 1999 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Polayes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
ART P. Galido, M.D.
APT 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
1
K990175 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ (NON - LATEX) STERILE SHEATHES Device Name:__ Indications For Use:
STERILE NON-LATEX PROBE COVERS
ARE INDICATET) DURING DIAGNOSTIC
ULTRASOUND PROCEDURES in CASES
WHERE.. PATIENT SENSITIVITY TO
LATEX is SPECULATIVE.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David L. Szyrmer
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number .
OR
Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter Use_
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