(179 days)
510K953503
Not Found
No
The device description focuses on mechanical features (air flotation, alternating pressure, customized firmness selection) and does not mention any computational or data-driven aspects indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for "prevention and treatment of pressure ulcers," which is a therapeutic purpose.
No
Explanation: The device description states its purpose is to provide support for the prevention and treatment of pressure ulcers, not to diagnose them. It's a therapeutic/supportive device.
No
The device description explicitly states it is an "air flotation, alternating pressure support system," which indicates it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the prevention and treatment of pressure ulcers." This describes a therapeutic and preventative function applied directly to the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details an "air flotation, alternating pressure support system." This is a physical support system, not a device designed to analyze biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on biological markers.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
For the prevention and treatment of pressure ulcers.
Product codes (comma separated list FDA assigned to the subject device)
80 FMN
Device Description
The PressureGuard Site Select is an air flotation, alternating pressure support system which provides for customized selection of surface firmness for a head, upper torso, lower torso, and heel zones.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, upper torso, lower torso, and heel zones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
510K953503
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5550 Alternating pressure air flotation mattress.
(a)
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).(b)
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.
0
SPAN-AMERICA | K973169 MEFICAL SYSTEMS; TNC.
博
FEB 20 1998
PressureGuard Site Select 510K Summary
| 1. | Submitter's Name: | Span-America Medical Systems, Inc. |
|---|---|---|
| Address: | 70 Commerce Center | |
| Greenville, SC 29615 | ||
| Telephone Number: | (864) 288-8877 | |
| Contact Person: | James D. Ferguson, President & CEO | |
| Wanda Totton, Director of Quality | ||
| Date Prepared: | October 21, 1997 | |
| 2. | Trade Name: | PressureGuard Site Select, Model A |
| Common Name: | Alternating Pressure Mattress | |
| Classification Name: | Alternating Pressure Air Flotation Mattress, | |
| CFR 880.5550, Classification No. 80 FMN. | ||
| 3. | Predicate Device: | PressureGuard IV, 510K953503 |
| 4. | Description: | The PressureGuard Site Select is an air flotation, |
| alternating pressure support system which provides for | ||
| customized selection of surface firmness for a head, upper | ||
| torso, lower torso, and heel zones. | ||
| 5. | Indications for Use: | For the prevention and treatment of pressure ulcers. |
| 6. | Substantial Equivalence: | The product is similar in function and intended use to the |
| PressureGuard IV, 510K953503. Both systems consists of | ||
| an air inflation system within a foam shell. The foam shell | ||
| includes a foam topper with bolsters that frame the | ||
| mattress. For the PressureGuard IV, four air cylinders | ||
| run lengthwise within the mattress and operate as two- | ||
| pairs. For the PressureGuard Site Select, the air cylinders | ||
| run side-to-side and operate as four zones, defined as | ||
| head, upper torso, lower torso, and heel zones |
1
Span-America Medical Systems, Inc. PressureGuard Site Select 510K Summary Page 2 of 2
For both systems, air in the air cylinders is adjusted to defined pressure set points for four defined modes of operation. For the PressureGuard IV, a Center Mode (supine surface), CPR Mode (firm surface for performing CPR with a crash board), Fixed Roll ( 30 degree left and right rolls with two-hour dwell times), and Custom Roll (provides for options for roll pattern, roll angles, and dwell times) are provided.
For the PressureGuard Site Select, Normal Mode, Alternating Off; Normal Mode, Alternating On; Heel Relief Mode, Alternating Off; Heel Relief Mode, Alternating On; Contour, and CPR modes are provided. The Normal Mode, Alternating Off Mode is comparable to the Center Mode for PressureGuard IV. The Heel Relief Mode, Alternating Off is comparable to the Center Mode for PressureGuard IV with lowered internal air pressures for the heel zone. The CPR Mode is comparable to the CPR Mode for PressureGuard IV. In addition, alternating pressure modes are options for both the Normal Mode and Heel Relief Modes. The Contour Mode provides for customized adjustment of firmness settings for each of the four zones to meet individual patient needs.
Both products are indicated for the prevention and treatment of pressure ulcers.
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with its wings spread, symbolizing protection and service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 20 1998
Ms. Wanda J. Totton Director of Quality Span-America Medical Systems, Inc. P.O. Box 5231 29606 Greenville, South Carolina
Re: K973169 PressureGuard Site Select Trade Name: Requlatory Class: II Product Code: _ ENM _ _ _ _ _ Dated: January 26, 1998 Received: January 27, 1998
Dear Ms. Totton:
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 regulations 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does 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.
3
Page 2 - Ms. Wanda J. Totton
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Other general premarket notification" (21 CFR 807.97). 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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page ol
510(k) Number (if known):
Device Name: Pressure Guard Site Alert
Indications For Use:
For the prevention and treatment of
Pressure ulcers.
L.C. Patterson
8-7-97
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tion. (GLE)
(Division Sign-Off)
Division of General Restorative Devices K973169:
510(k) Number.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)