CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM

K962788 · Gaymar Industries, Inc. · IKZ · Apr 30, 1997 · Physical Medicine

Device Facts

• Record ID: K962788
• Device Name: CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
• Applicant: Gaymar Industries, Inc.
• Product Code: IKZ · Physical Medicine
• Decision Date: Apr 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.

Device Story

CLINI-DYNE Rotational Therapy System is an electromechanical mattress replacement system. It consists of an inflation pump control unit connected to air-filled bladder cells via hose assemblies. The system provides programmed patient rotation (supine to left/right side) and low air loss therapy to manage pressure and aid circulation. Used in acute and alternate care settings, the device is operated by healthcare staff to assist patients with limited mobility. The system uses a microprocessor-controlled pressure relief valve to maintain safe interface pressures. Clinical staff configure rotation cycles and angles via the control panel. By automating position changes and providing pressure relief, the device aims to prevent decubitus ulcers and manage complications associated with prolonged immobility.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (primary skin irritation, delayed contact sensitization, cytotoxicity), tissue interface pressure testing, and flammability testing. All tests passed. Electrical safety verified via UL 2601-1 compliance.

Technological Characteristics

Electromechanical reciprocating pump; microprocessor-controlled pressure relief valve; air-filled bladder cells in foam crib; 120V 60Hz power; UL 2601-1 safety standard; reusable materials; variable rotation angles (0-40°) and cycle times (15-60 minutes).

Indications for Use

Indicated for patients in acute or alternate care settings requiring pressure relief and rotation to treat or prevent decubitus ulcers, urinary tract blockage, circulatory issues, or complications from immobility.

Regulatory Classification

Identification

A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.

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 § 890.9.

Predicate Devices

• CLA 1400 System

Submission Summary (Full Text)

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GAYMAR

GAYMAR INDUSTRIES, INC.

K 962788

APR 30 1997

Premarket Notification [510(K)] Summary

Submitter: Peter Scott

Phone: [phone], ext. 676

FAX: [phone]

Date Summary Prepared: January 30, 1997

Device Name: CLINI-DYNE Rotational Therapy System

Common Name: Rotation/Low Air Loss System

Classification Name: Alternating Pressure Air Flotation Mattress per 21 CFR, Section 880.5550

Predicate Device: CLA 1400 System

Intended use of Device:

The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.

Description: The CLINI-DYNE Rotational Therapy System consists of an electromechanical inflation pump control unit which is connected to a mattress with cells (air filled bladders) through hose assemblies connected to the inflation pump. The system affords programmed patient position changes by gently turning the patient from supine to left side or right side and back to supine position when staff is unable to do so or needs assistance.

10 CENTRE DRIVE

ORCHARD PARK, NY 14127

[phone] / [phone]

FAX #: [phone]

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# Substantial Equivalence:

The following tables, CLINI-DYNE 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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# CLINI-DYNE SUBSTANTIAL EQUIVALENCE MATRIX

7/11/96

| CLA-1400
(Predicate) | CLD-1000 |
| --- | --- |
| PERFORMANCE | | |
| --- | --- | --- |
| Patient Support Surface | Overlay | Mattress |
| 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 |
| Rotation angle | 0-45° | 0-40° ** |
| Safety | | |
| Maximum allowable pressure controlled by | Mechanical relief valve (55-60 mmHg) | Mechanical relief valve (56 mmHg) |
| CPR Deflate mechanism | Quick-disconnect feature of hose from pump | Remove panel at mattress |
| | | |
| Physical characteristics | | |
| Construction (Patient support surface) | Air filled cells used as an overlay | Air filled cells contained in a foam crib used as a mattress |
| | | |
| Function & Intended uses | | |
| Type of therapy provided | Treatment of the diseases of immobility and treatment of pressure ulcers | Treatment of the diseases of immobility 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) | Resusable* | Reusable* |
| Product Labeling | Refer to TAB C - LABELING | Refer to TAB B - LABELING |
| | | |
| Approvals | UL 544 | UL 2601-1 (submitted) |

* Cleanable using suggested disinfectants and cleaning agents.
** Dependent on physical characteristics of the patient. (40° minimum when set at maximum angle setting for each patient.)

file clneqmtx.xls

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# COMPARISON OF MAJOR CHARACTERISTICS

| Characteristic | CLA-1400 (PREDICATE) | CLD-1000 |
| --- | --- | --- |
| Alerts | | |
| Audible Alerts | yes | yes |
| Alert Silence (minutes) | 30 | no |
| Head of Bed Elevation Alert | yes | no* |
| Out of Rotation Alert | yes | no* |
| Siderail UP/Down Alert | yes | no* |
| Visual Alerts | yes | yes |
| Rotation | CLA-1400 (PREDICATE) | CLD-1000 |
| --- | --- | --- |
| Automatic Left Only | yes | yes |
| Automatic Left to Right | yes | yes |
| Automatic Right Only | yes | yes |
| Center Only (no rotation) | yes | yes |
| Manual Left Only | yes | yes |
| Manual Right Only | yes | yes |
| Var.Angle, Min.range (degrees) | 0-45 | 0-45 |
| Variable Rate | yes | yes |
| Rotation Cycle Times (minutes) | 90, 30, 10, 2 | 60, 45, 30, 15 |
| Cushion | CLA-1400 (PREDICATE) | CLD-1000 |
| --- | --- | --- |
| Placed onto Hospital Bed | yes | no (mattress replacement) |
| CPR Deflate | yes | yes |
| Low Air Loss | yes | yes |
| Pressure Relieving | yes | yes |
| Support Surface Inflation Control | yes | yes |
| Disposable Covers | yes | no** |
| Disposable Support Surface | yes | no** |
| Footboard/Foot Support Cushion | yes | yes |
| Air Control Pump | CLA-1400 (PREDICATE) | CLD-1000 |
| --- | --- | --- |
| 120 Volt AC | yes | yes |
| 60 Hz | yes | yes |
| Amperage | 1-5 | 1 |
| Control Panel Lock-out | yes | yes |
| Microprocessor Control | yes | yes |
| U.L. Listed | yes | yes |
| Weight (lbs.) | 25 | 19 |

* See Substantial Equivalence
**Reusable mattress
5/6/96

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# VI. SAFETY SUMMARY

Safety Testing Comparison Table

| | CLA 1400 | CLD 1000 |
| --- | --- | --- |
| Biocompatibility | | |
| a) primary skin irritation | pass | pass |
| b) delayed contact sensitization | pass | pass |
| c) cytotoxicity | pass | pass |
| Tissue Interface Testing | pass | pass |
| Flammability | pass | pass |
| UL Approvals | UL 544 | UL 2601-1
(pending) |
| Alerts | | |
| a) hi/low pressure | yes | yes |
| b) out of range | yes | yes |