(72 days)
510K951112
Not Found
No
The description focuses on the mechanical function of air flow and pressure reduction, with no mention of AI/ML terms or capabilities.
Yes
The device is intended for the "prevention and treatment of pressure ulcers," which directly addresses a health condition.
No
The device description and intended use indicate its function is for prevention and treatment of pressure ulcers through air flotation and pressure reduction, not for diagnosing conditions.
No
The device description clearly states it is a "powered air flotation mattress" which is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the prevention and treatment of pressure ulcers." This is a therapeutic and preventative use related to a physical condition, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "powered air flotation mattress." This is a physical device used externally on a patient, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
In summary, the PressureGuard Low Air Loss Mattress System is a medical device used for patient care and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
For the prevention and treatment of pressure ulcers.
Product codes (comma separated list FDA assigned to the subject device)
Unknown
Device Description
The PressureGuard Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air cylinders as a portion of the air is vented inside the mattress. The air flow is designed to provide and maintain an inflation level to achieve pressure reduction in the prevention and treatment of pressure ulcers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
510K951112
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.
Not Found
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).
Not Found
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(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.
0
SPAN-AMERICA MEDICAL SYSTEMS, INC.
APR 2 5 1996
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM 510K SUMMARY
- 1.0 SUBMITTER: ADDRESS: TELEPHONE: FACSIMILE:
Span-America Medical Systems, Inc. 70 Commerce Center; Greenville, SC 29615 864/288-8877 864/288-8692
CONTACT PERSON: Charles B. Mitchell, President & CEO Wanda J. Totton, Director of Quality
DATE PREPARED: February 8. 1996
- 2.0 TRADE NAME: PressureGuard: Low Air Loss Mattress System COMMON NAME: Powered Low Air Loss Mattress System CLASSIFICATION NAME: Unknown
- 3.0 PREDICATE DEVICE: PressureGuard® IV. 510K951112.
- 4.0 DESCRIPTION: The PressureGuard Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air cylinders as a portion of the air is vented inside the mattress. The air flow is designed to provide and maintain an inflation level to achieve pressure reduction in the prevention and treatment of pressure ulcers.
- 5.0 INDICATIONS FOR USE: For the prevention and treatment of pressure ulcers.
- 6.0 SUBSTANTIAL EQUIVALENCE: The product is similar in function and intended use to the PressureGuard® IV, 510K951112 for the Center Mode.