SPR PLUS II OVERLAY SYSTEM (CL250/CL212

K961854 · Gaymar Industries, Inc. · FNM · Aug 9, 1996 · General Hospital

Device Facts

• Record ID: K961854
• Device Name: SPR PLUS II OVERLAY SYSTEM (CL250/CL212
• Applicant: Gaymar Industries, Inc.
• Product Code: FNM · General Hospital
• Decision Date: Aug 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5550
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

SPR+II is a low air loss pressure-relieving support system. It consists of an electromechanical reciprocating pump control unit connected via hose to an air-filled overlay. The system uses a microprocessor-controlled pressure relief valve to maintain air pressure within the overlay, facilitating pressure relief to prevent or treat pressure ulcers. The device is intended for use in acute and alternate care settings. Healthcare providers monitor the system via visual and audible alerts (Hi/Lo pressure, hose disconnect, out-of-range). The system includes a CPR deflate mechanism (manual screw cap removal). By maintaining specific pressure ranges, the device reduces tissue interface pressure, aiding in patient skin integrity and ulcer management.

Clinical Evidence

Bench testing only. Comparison of technological characteristics and safety performance data provided against the predicate device.

Technological Characteristics

Low air loss overlay system. Components: electromechanical reciprocating pump, air-filled cell overlay with micro-vents. Microprocessor-controlled pressure relief valve. Power: 120V 60Hz. Safety: mechanical relief valve (max pressure < 56 mmHg). Alerts: audible and visual (Hi/Lo pressure, hose disconnect). Reusable pump, single-patient-use replaceable overlay.

Indications for Use

Indicated for patients at risk of developing pressure ulcers or requiring treatment for existing pressure ulcers in acute and alternate care settings.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• CLA 1500 System

Submission Summary (Full Text)

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K96/854

GAYMAR®

GAYMAR INDUSTRIES, INC.

AUG - 9 1996

# Premarket Notification [510(K)] Summary

Submitter: Peter Scott

Phone: [phone], ext. 676

FAX: [phone]

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

[phone] / [phone]

FAX #: [phone]

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# 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.

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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 56 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

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# 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.