(87 days)
Not found
Not Found
No
The summary describes a pressure relieving support system with an electromechanical pump and overlay, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to prevent or treat pressure ulcers, which falls under therapeutic use.
No
The device is described as a pressure-relieving support system intended to prevent or treat pressure ulcers. Its function is therapeutic, not diagnostic.
No
The device description explicitly states it consists of an electromechanical inflation pump control unit and an overlay, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce the potential for development of pressure ulcers on at risk patients or to be used in the treatment of existing pressure ulcers." This describes a therapeutic or preventative medical device that acts on the patient's body externally.
- Device Description: The description details an "electromechanical inflation pump control unit" connected to an "overlay." This is consistent with a physical support system, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Measuring biomarkers or other indicators of disease
Therefore, the SPR+II overlay system is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SPR+II overlay system is a pressure relieving support system intended to reduce the potential for development of pressure ulcers on at risk patients or to be used in the treatment of existing pressure ulcers.
Product codes
Not Found
Device Description
The SPR+II System consists of an electromechanical inflation pump control unit which is connected to an overlay through a hose assembly connected to the inflation pump.
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
Acute care and alternate care settings
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.
CLA 1500 System
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
AUG - 9 1996
Image /page/0/Picture/2 description: The image shows the logo for Gaymar Industries, Inc. The word "GAYMAR" is in large, bold, black letters, with a registered trademark symbol to the right of the word. Below the logo, the words "GAYMAR INDUSTRIES, INC." are printed in a smaller font.
Premarket Notification [510(K)] Summary
| Submitter: | Peter Scott |
|---|---|
| Phone: | 716/662-2551, ext. 676 |
| FAX: | 716/662-8763 |
| Date Summary | |
| Prepared: | June 17, 1996 |
| Device Name: | SPR+ II System |
| Common Name: | Low Air Loss System |
| Classification Name: | Alternating Pressure Air Flotation Mattress per |
| 21 CFR, Section 880.5550 | |
| Predicate Device: | CLA 1500 System |
Intended use of Device:
The SPR+II overlay system is a pressure relieving support system intended to reduce the potential for development of pressure ulcers on at risk patients or to be used in the treatment of existing pressure ulcers.
Description: The SPR+II System consists of an electromechanical inflation pump control unit which is connected to an overlay through a hose assembly connected to the inflation pump.
10 CENTRE DRIVE ORCHARD PARK, NY 14127 (716) 662-2551 / (800) 828-7341 FAX #: (716) 662-6120
1
Substantial Equivalence:
The following tables, SPR+II substantial equivalence matrix and the safety testing comparison table, summarize the technological characteristics and the nonclinical performance data upon which the substantial equivalence submission was made to the Food and Drug Administration.
2
SPR + II SUBSTANTIAL EQUIVALENCE MATRIX
5/7/96
CLA-1500
SPR + II
| PERFORMANCE | ||
|---|---|---|
| Overlay | Single cell with micro-vents for low air loss | Single cell with micro-vents for low air loss |
| Air Source | Blower | Electro-mechanical reciprocating pump |
| Pressure control mechanism | Microprocessor controlled pressure relief valve | Microprocessor controlled pressure relief valve |
| Voltage | 120v 60Hz Nominal | 120v 60Hz Nominal |
| Ambient | 60-90°F | 60-90°F |
| Tissue interface pressure measurements | Pressure relief | Pressure relief |
| Safety | ||
| Maximum allowable pressure controlled by | Mechanical relief valve (Below 60 mmHg) | Mechanical relief valve (Below 5 mmHg) |
| CPR Deflate mechanism | Quick-disconnect feature of hose from pump | Remove screw cap at mattress |
| Physical characteristics | ||
| Construction (Patient support surface) | Air filled cell used as an overlay | Air filled cell used as an overlay |
| Function & Intended uses | ||
| Type of therapy provided | Prevention and treatment of pressure ulcers | Prevention and treatment of pressure ulcers |
| (Primary) Target population | Acute care and alternate care settings | Acute care and alternate care settings |
| Life Expectancy (pump) | Reusable | Reusable |
| Life Expectancy (cell) | Support surface, single patient use, replaceable | Support surface, single patient use, replaceable |
| Approvals | UL 544 | UL 2601-1 pending |
file spreqiv.xls
3
COMPARISON OF MAJOR CHARACTERISTICS
| Characteristic | CLA-1500 | SPR + II |
|---|---|---|
| Alerts | ||
| Audible Alerts | yes | yes |
| Visual Alerts | yes | yes |
| Auto Reset | yes | yes |
| Alert Delay | yes | yes |
| Hi/Lo Pressure Alerts | yes | yes |
| Out of Range Alert | yes | yes |
| Hose Disconnect Alert | yes | yes |
Support Surface
| CPR Deflate | yes | yes |
|---|---|---|
| Low Air Loss | yes | yes |
| Pressure Relieving | yes | yes |
| Disposable Support Surface | yes | yes |
| Pressure Control | Digital (microprocessor | |
| controlled) | Setpoints (microprocessor | |
| controlled) | ||
| Pressure Range (mm Hg) | 8-32 | 18-30* |
| Remote Pressure Sensing** | yes | no |
Air Control Pump
| Digital Pressure Display | yes | setpoint indicator |
|---|---|---|
| 120 Volt AC | yes | yes |
| 60 Hz | yes | yes |
| Amperage | 1-5 | 1 |
| Control Panel Lock-out | yes | no |
| Microprocessor Control | yes | yes |
| U.L. Listed | yes | Prepared for Submittal |
| Air Source | DC Blower | Electro-mechanical reciprocating pump |
- Values of SPR+II range are within predicate device range.
** Improvement in design eliminates the need for remote pressure sensing.