(84 days)
Not Found
No
The description focuses on the mechanical function of the mattress system and does not mention any AI or ML components.
Yes
The device is indicated for the prevention and treatment of pressure ulcers, which implies a therapeutic purpose.
No
The device description indicates its use for prevention and treatment of pressure ulcers by providing a continuous flow of air to achieve pressure reduction, not for diagnosing medical conditions.
No
The device description clearly states it is a "powered air flotation mattress system," which 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 for the prevention and treatment of pressure ulcers, which is a physical condition.
- Device Description: The device is a powered air flotation mattress that provides pressure reduction. This is a mechanical/physical intervention.
- 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 or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on analysis of biological samples.
The device is clearly designed to interact with the patient's body externally to manage pressure, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress with low air loss. The pressure-reducing surface is indicated for the prevention and treatment of pressure ulcers.
Product codes
Not Found
Device Description
The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air sacks 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
510K960620
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
THE I THE FOOD
SPAN-AMERICA HORIZONTAL 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
System
May 28, 1996
DATE PREPARED:
2.0. TRADE NAME:
COMMON NAME: CLASSIFICATION NAME:
3.0. PREDICATE DEVICE:
4.0. DESCRIPTION:
Unknown
Powered Low Air Loss Mattress System
Span-America Horizontal Low Air Loss Mattress
DYNAGUARD ® LOW AIR LOSS MATTRESS SYSTEM, 510K960620
The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air sacks 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.
- INDICATIONS FOR USE: The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress with low air loss. The pressurereducing surface is indicated for the prevention and treatment of pressure ulcers.
6.0. SUBSTANTIAL EQUIVALENCE:
5.0.
The product is similar in function and intended use to the DYNAGUARD LOW AIR LOSS MATTRESS SYSTEM, 510K960620.