(59 days)
The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unasisted
Vail 1000 Enclosed Bed
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The document is a US FDA 510(k) clearance letter for a device called "Vail 1000 Enclosed Bed". It states that the device is substantially equivalent to a legally marketed predicate device and outlines the general controls provisions of the Act it falls under. It also includes the "Indications For Use" for the device, which describes its intended purpose.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 1098
Ms. Nancy Vail Vail Products, Incorporated 235 First Street Toledo, Ohio 43605
Re : K982783 Vail 1000 Enclosed Bed Trade Name: Regulatory Class: İI Product Code: FNL Dated: September 16, 1998 Received: September 17, 1998
Dear Ms. Vail:
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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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Page 2 - Ms. Vail
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) 594-4692. 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/dsmamain.html" .
Sincerely yours
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name:_Vail_1000_Enclosed_Red
Indications For Use:
The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unasisted
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pulchera Crescenti
Division Sign-Division of Dental, Infection Control. and General Hospital Devices
510(k) Number 1982783
Prescription Use (Per 21 CFR 801.109)
្រី
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 880.5100 AC-powered adjustable hospital bed.
(a)
Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.