(179 days)
For the prevention and treatment of pressure ulcers.
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.
The provided 510(k) summary for the PressureGuard Site Select primarily focuses on demonstrating substantial equivalence to a predicate device (PressureGuard IV) based on similar function and intended use. It describes the features and modes of operation of the device but does not include information about specific acceptance criteria or a study proving that the device meets such criteria.
Therefore, I cannot populate most of the requested fields based on the given document.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated as per specific performance metrics. The document focuses on describing the device's features and comparability to a predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided, as there's no mention of a clinical or performance study with a test set requiring ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-powered device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided.
8. The sample size for the training set
- Not applicable/Not provided, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
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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 CenterGreenville, SC 29615 | |
| Telephone Number: | (864) 288-8877 | |
| Contact Person: | James D. Ferguson, President & CEOWanda 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 forcustomized selection of surface firmness for a head, uppertorso, 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 thePressureGuard IV, 510K953503. Both systems consists ofan air inflation system within a foam shell. The foam shellincludes a foam topper with bolsters that frame themattress. For the PressureGuard IV, four air cylindersrun lengthwise within the mattress and operate as two-pairs. For the PressureGuard Site Select, the air cylindersrun side-to-side and operate as four zones, defined ashead, upper torso, lower torso, and heel zones |
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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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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.
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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
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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)
§ 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.