SIMPULSE
Device Facts
| Record ID | K972549 |
|---|---|
| Device Name | SIMPULSE |
| Applicant | Kinetic Concepts, Inc. |
| Product Code | FNM · General Hospital |
| Decision Date | Nov 18, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5550 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Simpulse mattress is for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. It employs a series of transverse inflatable cushions that can be sequentially inflated and deflated to provide pulsation pressures beneath the patient.
Device Story
Simpulse is a powered, pulsating air suspension mattress system for home, acute, and extended care settings. It consists of an Air Supply Unit and a Mattress Assembly (cushions, base, underliner, cover). The system operates in Pulsation or Static modes. The microprocessor-controlled Air Supply Unit uses two pumps and valves to manage air pressure in two channels (A and B) within the mattress. Caregivers adjust firmness via a membrane panel; the system maintains pressure within +/- 1" H2O. In Pulsation mode, the system cycles inflation/deflation between channels A and B over 5, 10, or 20-minute intervals. An 'Auto Firm' mode provides maximum inflation for patient transfers. The device provides pressure relief and pulsation to assist in preventing and treating skin breakdown and decubitus ulcers in bedridden patients. The hose connection serves as an emergency CPR deflation mechanism.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Powered air flotation mattress system. Components: nylon/urethane cover, interlocking air cushions. Energy source: electric (microprocessor-controlled pumps). Connectivity: standalone. Operation: two-channel (A/B) pneumatic system with pressure feedback loop. Control: membrane panel with LED indicators. Safety features: CPR emergency deflation via hose disconnection, Auto Firm mode. Sterilization: not specified.
Indications for Use
Indicated for bedridden patients who would benefit from a pressure-relieving surface with pulsation to prevent/treat complications of immobility (skin breakdown, decubitus ulcers). Contraindicated for patients with unstable spinal cord injuries or those requiring cervical/skeletal traction.
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
- Premium (K930673)
Submission Summary (Full Text)
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II.
## 510 (k) Summary
NOV 1 8 1997
K972549
I. Name of Device: Simpulse™
Class II, Mattress, Air Flotation, Alternating Pressure; (per 21 CFR Section 880.5550)
#### Substantial Equivalence: III.
Classification Name:
Premium 510(k) No. K930673
#### IV. Device Description:
The Simpulse™ is a powered, Pulsating Therapy Mattress that can be used as an Overlay or Mattress Replacement System and is designed for use in all care settings (home, acute and extended). The Simpulse provides pulsating air suspension therapy that combines the benefits of pressure relief with the advantages of pulsation therapy.
The Simpulse" is comprised of two major components: the Air Supply Unit, and the Mattress Assembly.
The Mattress Assembly is comprised of: the pulsating air surface, the air base, the underliner and the cover sheet. The pulsating air surface is the component that pulses. It consists of ten separate interlocking air cushions that are plumbed to provide pulsation (five cushions are plumbed to Channel A and five are plumbed to Channel B). By only inflating the 5 inch pulsating air surface, the Simpulse " can be used as a mattress overlay.
When the Simpulse is used as a Mattress Replacement System, the 3 inch air base is inflated and serves as a static pressure air base that keeps the patient suspended when the bed is articulated. It also serves as an air support and remains inflated in case of a power outage. The underliner serves as an envelope to provide structure to the mattress. It has tie points that snap together and hold the pulsating air surface in place in relation to the air base. It also has straps that secure the entire Mattress Assembly to the bed frame.
The cover sheet is a fitted sheet made of nylon with a urethane backing that fits over the Mattress Assembly and provides a protective barrier between the patient and the air bladders.
The Air Supply Unit is mountable on the footboard of a standard hospital bed or can be placed upright on the floor and is microprocessor controlled to achieve the two modes of operation (Pulsation and/or Static). All user input to the microprocessor control
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is accomplished through the membrane panel switch are located on the Air Supply Unit.
The Air Supply Unit utilizes two separate pump and valve assemblies to channel compressed air to the Mattress Assembly, creating two sections referred to as Channel A and Channel B. This provides a single target pressure for the entire mattress as well as the means for the mattress to pulsate. The hose set has a connection on one end that mates to an air connection on the side of the Air Supply Unit. This connection also serves as a CPR emergency air deflation system by simply disconnecting the hose from the Air Supply Unit. The other end connects to the air cushions (Channel A, Channel B and the Air Base).
The target pressure is set by pressing the "Soft/Firm" buttons located on the membrane control panel. These buttons have five LED's evenly spaced between them and the user can adjust the firmness of the mattress within the range of these five LED's. If the user pushes and holds one of the buttons, the LED location will not increment until the user releases the button and pushes it again. Once the user selects the pressure setting, the pressure feedback system will automatically maintain the pressure setting within a target pressure range of plus or minus 1" H2O. If the actual pressure moves out of the target pressure range, the microprocessor controller will activate the corresponding pump to increase the pressure or open the corresponding valve to decrease the pressure until the pressure is within the target pressure range.
In the Static mode, all of the cushions in the air surface are inflated to an equal pressure and operate in a continuous pressure feedback mode as previously described. In the Pulsating On mode, the cushion closest to the footboard will decrease in pressure together with every other cushion along the mattresses length (Channel A), while the other set of cushions (Channel B) increase in pressure. Once the cushions of Channel A reach the lowest point and begin to increase in pressure, the cushions of Channel B start to decrease in pressure. When the Channel B cushions reach the minimum pressure and then begin to increase in pressure, the cushions of Channel A will once again begin to decrease in pressure. This completes a full cycle. By pressing the "Pulsation Cycle Time" button, the pulsation cycle time can be adjusted over a range of between 5, 10 or 20 minutes. An LED light will indicate which time period has been selected.
The "Auto Firm" control will fill Channels A & B and the Air Base to a maximum inflation level. During the time that Auto Firm is activated, The Pulsation On/Off buttors, Pulsation Cycle Time Button and the Soft/Firm buttons as well as their respective LED indicators will be disabled. The mattress will stay at the maximum inflation level until the Auto Firm Off button is pushed or twenty minutes elapse from the time the Auto Firm On button was first pushed. The Simpulse will then default to the same settings of operation as before the AutoFirm was activated.
Prepared by: J. Harbour Kinetic Concepts, Inc. P.O. Box 659508 San Antonio, TX 78265
Date Prepared: July 1, 1997
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# INTENDED USE OF THE SIMPULSE™
The Simpulse mattress is for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. It employs a series of transverse inflatable cushions that can be sequentially inflated and deflated to provide pulsation pressures beneath the patient.
#### INDICATIONS
The Simpulse is indicated for patients who would benefit from:
A pressure relieving surface with the additional benefit of pulsation to assist in the prevention and treatment of the complications of immobility such as skin breakdown and decubitus ulcers.
### CONTRAINDICATIONS
Patient conditions for which the application of Pressure Relieving Therapy in addition to Pulsation therapy are contraindicated include:
Unstable Spinal Cord Injuries. Cervical or Skeletal Traction.
#### DIFFERENCES BETWEEN CURRENT AND PREDICATE DEVICES
The Simpulse is a modification of the predicate device Premium. Both products provide Pulsation therapy but the mechanical means in which they render the therapy is different.
Simpulse 510(k) Summary
Prepared by: J. Harbour Kinetic Concepts, Inc. P.O. Box 659508 San Antonio, TX 78265
Date Prepared: July 1, 1997
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The major differences between the Simpulse and the Premium predicate device are:
- · The DynaPulse® Premium is blower driven and the Simpulse uses two pumps.
- · The DynaPulse® Premium has a heater and the Simpulse does not.
- · The DynaPulse · Premium has an Alpha Numeric LED display and the Simpulse only uses LED lights
- · The DynaPulse Premium has height and weight presets that the care giver can enter so the microprocessor can make pressure changes based on the height/weight data. With the Simpulse, the care giver must manually select the firmness of the mattress by pressing the "Soft/Firm" buttons.
- · The DynaPulse Premium allows the care giver to change the intensity of the pulsation. The Simpulse pulses at only one pulsation intensity level.
- · The DynaPulse Premium mattress has four sections (head, body, seat and feet) and each of the sections can have a different air pressure setting. The Simpulse has one mattress section and will maintain one pressure setting for the entire body.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV 1 8 1997
Mr. William H. Quirk Director of Regulatory Affairs Kinetic Concepts, Incorporated P.O. Box 659508 78265 San Antonio, Texas
Re : K972549 Simpulse Trade Name: Requlatory Class: II Product Code: FNM August 18, 1997 Dated: Received: August 20, 1997
Dear Mr. Quirk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Quirk
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D, MD Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| annone and the differences of | with and property and proportion and proportunities and managements of the control of the county of the county of the county of the county of the county of the county of the<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>---------------------------------------------------------------------------------<br>STATUTE OF CLAIM OF CHEARTH ANNUAL PROPERTY |
510(k) Number (if known):
Device Name: Simpulse_ _______________________________________________________________________________________________________________________________________________________
Indications for Use:
.
The Simpulse mattress is indicated for patients who would benefit from a pressure relieving surface with the additional benefit of pulsation to assist in the prevention and treatment of the complications of immobility such as skin breakdown and decubitus ulcers.
Note: The indications for use of the Simpulse are identical to the predicate device, Premium [510(k) No. K930673].
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| | (Division Sign-Off) Division of General Restorative Devices |
|---------------|---------------------------------------------------------------|
| 510(k) Number | 2972549 |
| Prescription Use (Per 21 CFR 801.109) | X |
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OR
| Over-The-Counter Use | ____ |
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(Optional Format 1-2-96)
