(174 days)
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No
The description mentions a "microprocessor based controller" for programmable functions (time, angle, speed, manual/automatic operation), but there is no mention of AI, ML, or any learning or adaptive capabilities based on data. The functionality appears to be based on pre-programmed parameters.
Yes
The device is described as being used to "aide in the prevention of decubitus ulcers in bed ridden patients" and is designed for "the prevention of decubitus ulcers," which indicates a therapeutic purpose.
No
The device is described as a repositioning bed designed for the prevention of decubitus ulcers, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components including platen sections, hinges, and a microprocessor-based controller, indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Freedom Bed PAR 3 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Freedom Bed PAR 3 Function: The Freedom Bed PAR 3 is a mechanical bed designed to reposition patients to prevent pressure ulcers. It interacts directly with the patient's body externally.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the Freedom Bed PAR 3 falls under the category of a therapeutic or assistive medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Freedom Bed PAR 3 is used to automatically reposition immobilized persons from side to side either manually or on a programmed schedule aide in the prevention of decubitus ulcers in bed ridden patients.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The device is a programmable, automatically or manually operated repositioning bed designed for the prevention of decubitus ulcers. The device consists of 3 separate platen sections joined together with flexible hinges. The center section rotates left and right to a maximum of 30 degrees on each side, while the appropriate outer section rotates up to support and contain the sleeper. This provides a surface to transfer weight onto, as well as prevents the user from sliding or falling out of bed. The microprocessor based controller provides adjustment of time, angle and speed, as well as a choice of manual operation, automatic operation, or patient control. This allows most users to achieve independence from night time attendants and higher quality and duration of sleep. The bed has received UL 544, CSA, and FCC approvals.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.5225 Powered patient rotation bed.
(a)
Identification. A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.(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 § 890.9.
0
510(k) Summary of Safety and Effectiveness
ProBed Medical Technologies Inc. Freedom Bed - Model PAR 3 APR - 1 1996
1. Submitter:
The 510(k) is submitted by ProBed Medical Technologies Inc., 44325 Yale Rd.W. Chilliwack, B.C., Canada V2R 4H2 Attn: Stephen B. Plummer. This 510(k) summary was prepared in September 1995.
2. Device name:
The 510(k) submission is for the ProBed Medical Technologies Inc., Freedom Bed™ Model PAR3.
3. Predicate device:
The device described in this submission is considered to be substantially equivalent to (list predicate). The predicate devices are legally marketed, having been found to be substantially equivalent through the 510(k) premarket notification process.
4. Device description:
The device is a programmable, automatically or manually operated repositioning bed designed for the prevention of decubitus ulcers. The device consists of 3 separate platen sections joined together with flexible hinges. The center section rotates left and right to a maximum of 30 degrees on each side, while the appropriate outer section rotates up to support and contain the sleeper. This provides a surface to transfer weight onto, as well as prevents the user from sliding or falling out of bed. The microprocessor based controller provides adjustment of time, angle and speed, as well as a choice of manual operation, automatic operation, or patient control. This allows most users to achieve independence from night time attendants and higher quality and duration of sleep. The bed has received UL 544, CSA, and FCC approvals.
5. Intended use:
The Freedom Bed PAR 3 is used to automatically reposition immobilized persons from side to side either manually or on a programmed schedule aide in the prevention of decubitus ulcers in bed ridden patients.
6. Comparison of technological characteristics:
We believe that the device has the same or similar technological features as compared to other devices currently manufactured or distributed in the United States. All 3 are electronically controlled and turn to a maximum of 30 degrees. The main difference is that while the predicate devices utilize air pressure to initiate the turning, the Freedom Bed uses 12 VDC powered actuators. Any variation in technology or difference of mechanism would not adversely affect the safety and effectiveness of the device.