AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM

K962123 · Lumex, Inc. · FNM · Jul 18, 1996 · General Hospital

Device Facts

• Record ID: K962123
• Device Name: AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
• Applicant: Lumex, Inc.
• Product Code: FNM · General Hospital
• Decision Date: Jul 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5550
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System is a portable powered low air loss flotation therapy mattress intended to promote pressure reduction by redistributing patient weight over a surface area or by shifting patient weight from one area to another.

Device Story

The AkroTech 4000T is a powered low air loss (LAL) flotation therapy mattress system consisting of an electromechanical, computer-controlled Air Control Unit (ACU) and an air flotation mattress. The system redistributes patient weight to reduce pressure; it incorporates a kinetic turning feature to shift patient weight. The ACU uses a blower and valves to manage air flow across six zones within the mattress. Operators input patient weight, height, rotation angle, and time-in-angle via a keypad; the system provides feedback on patient time-in-use and cumulative operating time. The device is used in clinical settings to manage pressure ulcer risk. It benefits patients by providing automated pressure relief and rotational therapy, reducing the risk of skin breakdown.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and shared design features with the predicate device.

Technological Characteristics

System comprises an electromechanical ACU and air flotation mattress. ACU features computer-controlled blower and valve system for six air zones. Mattress utilizes 14 air cells. Safety standards include UL544 and CSA listing; mattress meets California #117 flammability standards. Connectivity is standalone via keypad input and LCD display. Software is a rotational-specific program.

Indications for Use

Indicated for patients requiring pressure reduction therapy to prevent or treat pressure ulcers via weight redistribution or shifting.

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

• AkroTech 4000 Dynamic Low Air Loss System (K923977)

Submission Summary (Full Text)

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JUL 18 1996

K962123

510(k) Summary

AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System

Lumex

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LUMEX

A Fuqua Enterprises Company

510(k) Summary

Submitter: Lumex Medical Products, Inc.
100 Spence St.
Bay Shore, NY 11706
Phone [phone]
Fax [phone]

Contact Person: Joseph Zanetti
Divisional Quality Assurance Manager

Date Summary Prepared: 5-22-96

Classification Name: Low air loss mattress flotation therapy - 89IOQ (890.5170)

Common / Usual Name: Portable powered low air loss flotation therapy mattress

Trade / Proprietary Name: AkroTech 4000T Kinetic Turning Low Air Loss System

Establishment Registration: 2427360 (Lumex Div. of Lumex, Inc.)
1318909 (Site of manufacture)

Classification: Class II

Performance Standards: None established under section 514

Labeling / Promotional Materials: See attachments

Substantial Equivalence: This product is similar to the AkroTech 4000 product submitted by Lumex Div. of Lumex, Inc. approved by the FDA reference number K923977.

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# 510(k) Summary (cont'd)

The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss System (K923977).

Both Low Air Loss support systems consist of two operating components:

1. The electromechanical, computer controlled Air Control unit (ACU)
2. The Air Floatation Mattress.

Both Systems promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient weight from one area to another. As with the AkroTech 4000, the AirBed Corporation (1240 S. Claudina St., Anaheim, CA 92805) is responsible for manufacturing the AkroTech 4000T ACU and Lumex (100 Spence St., Bay Shore, NY 11706-2290) is responsible for manufacturing the 4000T air flotation mattress and marketing the product. AirBed is registered with the FDA (#2029170) as is Lumex (#2427360). AirBed Corporation operates under operator #9010115.

## COMPARISON OF OVERALL FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM TO AKROTECH 4000T TURNING SYSTEM

| FEATURE | AKROTECH 4000 DYNAMIC | AKROTECH 4000T TURNING |
| --- | --- | --- |
| Switch | On / Off Toggle | On / Off Toggle |
| Modality | Firm, Float, CPR, Key Pad Lock, Alarm | Firm, Float, CPR, Key Pad Lock, Alarm |
| Data Input Control | Up / Down | Up / Down |
| Input Information | Patient Weight | Patient Weight, Height, Rotation Angle, Time In Angle |
| Data Feedback | Patient Time In Use, Cumulative Operating Time | Patient Time In Use, Cumulative Operating Time |
| Air Control Zones | Six | Six |
| Air Flow Lines | One | One |

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510(k) Summary (cont'd)

## COMPARISON OF ACU FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM ACU TO AKROTECH 4000T TURNING SYSTEM ACU

| ACU FEATURE | AKROTECH 4000 DYNAMIC | AKROTECH 4000T TURNING |
| --- | --- | --- |
| Computer | Same | Same |
| Hardware | Same | Same |
| Blower | Same | Same |
| Valves | Same | Same |
| Materials | Same | Same |
| Overall Dimensions | Same | Same |
| LCD Display | Same | Same |
| Key Pad | Same | Same |
| Labeling | See Attachment | See Attachment |
| Operator’s Manual | See Attachment | See Attachment |
| Safety | UL544 and CSA Listed | UL544 and CSA Listed |
| Hose Connections | Locking Collet | Quick Disconnect |
| Graphic Overlay | Dynamic | Rotational |
| Computer Program / Software | Dynamic | Rotational |

## COMPARISON OF MATTRESS FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM MATTRESS TO AKROTECH 4000T TURNING SYSTEM MATTRESS

| MATTRESS FEATURE | AKROTECH 4000 DYNAMIC | AKROTECH 4000T TURNING |
| --- | --- | --- |
| Air Control Zones | Same | Same |
| Air Flow Lines | Same | Same |
| Base | Same | Same |
| Bottom Cover | Same | Same |
| Top Cover | Same | Same |
| Tie Down Straps | Same | Same |
| Mattress Size | Same | Same |
| Safety | California # 117, UL544 and CSA Listed | California # 117, UL544 and CSA Listed |
| Intermediate Comfort Cover | Zipper Closure | Button Closure |
| CPR Deflate | Manual Release at Head End Only | Manual Release at Both Ends |
| Air Lines | Colored Extruded Air Hoses | Clear Air Hose with Colored Spirals |
| Air Cells | 18 | 14 |