(92 days)
STERILE NON-LATEX PROBE COVERS ARE INDICATET) DURING DIAGNOSTIC ULTRASOUND PROCEDURES in CASES WHERE.. PATIENT SENSITIVITY TO LATEX is SPECULATIVE.
Sheathes (Non-Latex), Sterile
The provided text is a 510(k) clearance letter from the FDA for a non-latex sterile sheath, not a study report or clinical trial. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, or performance data for a device.
The clearance letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It does not provide any specific quantitative acceptance criteria or the results of any performance studies.
To answer your questions, I would need a different document, such as a summary of safety and effectiveness data (SSE) or a clinical study report that was part of the 510(k) submission.
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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
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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_
↑ ↑ ΛΔ
§ 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.