(260 days)
510K951112
Not Found
No
The summary describes a powered air mattress with adjustable firmness and a CPR mode, with no mention of AI or ML terms or functionalities.
Yes
The device is intended for the "prevention and treatment of pressure ulcers," which is a therapeutic purpose.
No
The device description and intended use indicate it is a therapeutic device (for prevention and treatment of pressure ulcers) rather than a diagnostic one. It does not analyze patient data or provide medical insights to identify conditions.
No
The device description explicitly states it is a "powered air flotation mattress," which is a hardware component.
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 function related to patient care, not the diagnosis of a disease or condition using in vitro methods.
- Device Description: The description details a "powered air flotation mattress" that provides pressure-reducing support. This is a physical device used externally on a patient.
- Lack of IVD Indicators: The document 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
The device is clearly a medical device, but its function is related to patient support and pressure management, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
For the prevention and treatment of pressure ulcers.
Product codes
Not Found
Device Description
The PressureGuard SelectCare is a powered air flotation mattress which provides pressure-reducing support within a range of adjustable firmness to meet individual comfort needs. The system also includes a CPR mode, providing a firm surface for performing CPR.
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
A K960188
OCT - 2 1998
PRESSUREGUARD: SELECT CARE
510K SUMMARY
| 1.0. | Submitter: | Span-America Medical Systems, Inc. |
|---|---|---|
| Address: | 70 Commerce Drive; Greenville, SC 29615 | |
| Telephone: | (864) 288-8877 | |
| Contact Person: | Charles B. Mitchell, President & CEO | |
| Wanda J. Totton, Director of Quality | ||
| Date Prepared: | January 8, 1995 | |
| 2.0. | Trade Name: | PressureGuard: SelectCare Mattress System |
| Common Name: | Powered Air Flotation Mattress | |
| Classification Name: | Unknown | |
| 3.0. | Predicate Device: | PressureGuard IV, 510K951112 |
| 4.0. | Description: | The PressureGuard SelectCare is a powered air flotation |
| mattress which provides pressure-reducing support within | ||
| a range of adjustable firmness to meet individual comfort | ||
| needs. The system also includes a CPR mode, providing | ||
| a firm surface for performing CPR. | ||
| 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 and CPR | ||
| Modes. |
P.O. Box 5231, Greenville, S.C. 29606 ●803-288-8877 ● FAX 803-288-8692