HYDROTEC LOW AIR LOSS THERAPY BED

K970363 · Apex Metal, Inc. · IOQ · Nov 17, 1997 · Physical Medicine

Device Facts

• Record ID: K970363
• Device Name: HYDROTEC LOW AIR LOSS THERAPY BED
• Applicant: Apex Metal, Inc.
• Product Code: IOQ · Physical Medicine
• Decision Date: Nov 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers (bed sores).

Device Story

HydroTec™ is a low air loss therapy bed designed for pressure ulcer prevention and treatment. Device provides support surface with air circulation to manage skin microclimate and pressure distribution. Used in clinical or home settings; operated by healthcare providers or patients/caregivers. Output is a therapeutic support surface that reduces interface pressure; aids in healing existing ulcers and preventing new ones. Device functions as a passive therapeutic support system.

Clinical Evidence

No clinical data provided; substantial equivalence based on regulatory review of device characteristics.

Technological Characteristics

Low air loss therapy bed; provides pressure redistribution and microclimate management via air circulation. Class II device (Product Code IOQ).

Indications for Use

Indicated for prevention and treatment of pressure ulcers (bed sores) in patients requiring low air loss therapy.

Regulatory Classification

Identification

A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Jean Rozint
Apex Metal, Inc.
c/o Clinically Effective Outcomes, Inc.
P.O. Box 1026
Mount Pleasant, South Carolina 29465-1026

NoV 17 1997

Re: K970363
Trade Name: HydroTec™ Low Air Loss Therapy Bed
K970364
Trade Name: AirTec2™ Low Air Loss Therapy Bed
Regulatory Class: II
Product Code: IOQ
Dated: August 18, 1997
Received: August 19, 1997

Dear Ms. Rozint:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 devices in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Jean Rozint

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 regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosures

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Page 1 of 1

510(k) Number (if known): __________

Device Names: **HydroTec™ Low Air Loss Therapy Bed**

Indications for Use:

The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers (bed sores).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Services
510(k) Number: **K970363**

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)