(154 days)
Stryker Circ-O-lectric Bed Model 46() Preamendment Device, Stryker Wedge Turning Frame Model 965 Preamendment Device
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No
The device description and intended use focus on a mechanical, non-powered accessory for patient turning, with no mention of AI, ML, or related concepts.
No.
The device assists caregivers in changing patient positions, which can indirectly help treat complications, but it is not directly delivering a therapeutic treatment itself. It's a positioning accessory to other therapeutic devices (hospital beds).
No
The device is described as an accessory to assist caregivers in turning patients for therapeutic purposes (treating pulmonary complications), not for diagnosing medical conditions.
No
The device description explicitly states it is a "non-powered, portable accessory" and describes its physical function in assisting with patient turning, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist caregivers in physically turning patients. This is a mechanical action performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is described as a "portable accessory" to a hospital bed that helps with patient positioning. It's a physical aid for patient handling.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
To assist caregivers in turning patients to or from the supine or prone position. Turning immobile patients can assist in treating pulmonary complications or disorders commonly associated with immobility.
Product codes
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Device Description
The Vollman Pronc Positioner Device is an independent, non-powered, portable accessory to any med-surg or critical care hospital bed with a flat surface that allows an immobile patient with respiratory complications, such as Acute Respiratory Distress Syndrome (ARDS) to be moved from a supine position to a prone position and held there. This position change occurs while the patient remains on either a regulation hospital frame (critical care or med-surg frame) or a therapeutic air support surface. This device allows this position change to be accomplished in most cases with only three caregivers. Currently, the most common method of proning a patient is manually lifting the patient and placing them prone. Other methods of proning a patient are the Stryker Wedge Turning Frame and the Stryker Circ-O-lectric Bed.
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
Caregivers / hospital bed (med-surg or critical care)
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)
Stryker Circ-O-lectric Bed Model 46() Preamendment Device, Stryker Wedge Turning Frame Model 965 Preamendment Device
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.3490 Truncal orthosis.
(a)
Identification. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
Vollman Prone Positioner 510(k) 1/2/96
510(k) Summary 15
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| 1 | Submitted by: | Hill-Rom, Inc
4349 Corporate Road
Charleston, SC 29405 | JAN - 9 1997 |
|---|-----------------|--------------------------------------------------------------|--------------|
| | | | |
| | Contact Person: | Edwin Bills | |
| | Phone: | (803)740-8380 | |
| | Fax: | (803)740-8059 | |
| 2 | Name of Device: | | |
| Trade Name: | Vollman Prone Positioner |
|---|---|
| Common Name: | Patient Positioner |
| Classification Name: | Manual Patient Rotation Bed |
- 3 Predicate Device: Strvker Circ-O-lectric Bed Model 46() Preamendment Device Stryker Wedge Turning Frame Model 965 Preamendment Device
- 4 Description:
The Vollman Pronc Positioner Device is an independent, non-powered, portable accessory to any med-surg or critical care hospital bed with a flat surface that allows an immobile patient with respiratory complications, such as Acute Respiratory Distress Syndrome (ARDS) to be moved from a supine position to a prone position and held there. This position change occurs while the patient remains on either a regulation hospital frame (critical care or med-surg frame) or a therapeutic air support surface. This device allows this position change to be accomplished in most cases with only three caregivers. Currently, the most common method of proning a patient is manually lifting the patient and placing them prone. Other methods of proning a patient are the Stryker Wedge Turning Frame and the Stryker Circ-O-lectric Bed.
-
5 Intended Use:
To assist caregivers in turning patients to or from the supine or prone position. Turning immobile patients can assist in treating pulmonary complications or disorders commonly associated with immobility. -
6 Technological Charactcristics:
All of these devices have metal frames. In each device. the patient is held in place by a manual device such as a strap or padded surface. The Stryker Wedge Turning Frame and the Vollman Prone Positioner are manually-operated devices. The Stryker porducts have mattresses, where the subject device is an accessory to med-surg and critical care hospital beds with flat mattress surfaces.