(73 days)
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Not Found
No
The summary describes a transport bed and does not mention any AI or ML related terms or functionalities.
No
The device is described as a transport bed for managing patients, primarily focused on preventing injury during transport, not on treating a medical condition or disease.
No
Explanation: The device is described as a transport bed for managing large or difficult-to-care-for patients, focusing on preventing injury, not on diagnosing medical conditions.
No
The device description clearly identifies it as a "Transport Bed," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the Soma™ Safe Transport Bed is used for the "management of patients" and "prevention of personal injury to the patient and staff." This indicates a physical device used for patient handling and transport, not for analyzing biological samples.
- Lack of IVD-related information: The provided text lacks any mention of biological samples, testing, analysis, or diagnostic purposes.
Therefore, based on the provided information, the Soma™ Safe Transport Bed is a medical device used for patient care and transport, not an in vitro diagnostic device.
N/A
Intended Use / 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 personal care for. The use of this device will assure the prevention of injury to the patient and staff.
Product codes
FNL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
1
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
2
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)