(73 days)
The Soma™ Safe Transport Bed is to be used for the management of patients who are excessive in size and those who are the most difficult to care for. The use of this device will assure the prevention of personal injury to the patient and staff.
Soma 900 Transport Bed
I apologize, but the provided text from the FDA 510(k) K971546 approval letter for the "Soma 900 Transport Bed" (later referred to as "Soma Safe Transport Bed") does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
This document is a regulatory approval letter, specifically a "substantially equivalent" determination letter, which indicates the device can be marketed. It refers to the "indications for use" but does not detail the technical performance studies that would have been submitted as part of the 510(k) application.
Therefore, I cannot extract the information required to populate the table and answer the subsequent questions about acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory compliance and approval, not on the technical performance data.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Samuel N. Paul Executive Vice President Vivax Medical Corporation 545 Middle Street Bristol, Connecticut 06010
JUL 1 0 1997
Re: K971546 Soma 900 Transport Bed Trade Name: . Requlatory Class: II Product Code: FNL Dated: April 22, 1997 Received: April 28, 1997
Dear Mr. Paul:
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, Druq, and Cosmetic Act (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, qood 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
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Page 2 - Mr. Paul
through 542 of the Act for devices under the Electronic chrough 542 or the noorol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sia nequivalence of your device to a legally Finding of bubbeansfarice results in a classification for your marketed predicate acits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regaracian ostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on compreator as (od advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation chercica) Hibbidiang II Other general information on your responsibilities under the Act may be Information on Journal Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fqa.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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510(k) Number (if known): K971546
Device Name: Soma™ Safe Transport Bed
Indications For Use:
The Soma™ Safe Transport Bed is to be used for the management of patients who are excessive in size and those who are the most difficult to The use of this device will assure the prevention of personal care for. injury to the patient and staff.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) falava Cuconte
Division of Dental, Infection Control,
and General Heepita! Davicos
510(k) Number K971546
Prescription Use __ OR Over The Counter Use
(Per 21 CFR 801.109)
§ 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.