(233 days)
For the prevention and treatment of pressure ulcers. Patient lateral rotation of up to 30 degrees may also be used as a preventive tool against further complications associated with critically ill patients or immobility.
The PressureGuard Turn Select is an air flotation, alternating pressure support system. It consists of a foam shell manufactured with medical grade, polyurethane foam that meets the California Technical Bulletin 117. The perimeter bolsters are designed to safely prompt the patient toward the center of the surface, facilitating safe transfers and edge-of-bed sittings. The inflation system is cradled and securely positioned within the foam shell. Through computerized technology, the internal air pressures of the inflation system are controlled to achieve four operating modes. The CENTER Mode provides a level supine surface. The FIXED ROLL Mode provides automatic turning, turning the patient to the left followed by a 2 hour dwell time, then returning to center for a 2 hour dwell time, followed by a turn to the right followed by a 2 hour dwell time. The CUSTOM ROLL Mode provides for selection of roll patterns, roll angles and dwell times to meet individual patient needs. The CPR Mode provides a firm surface to aid in CPR Procedures (with a crash board). A Service Required Feature is provided to alert the health care provider in the event of system malfunction. CPR Alarm and Lock-Out features are also included.
The provided text describes a 510(k) submission for the "PressureGuard Turn Select" alternating pressure mattress, which is intended for the prevention and treatment of pressure ulcers and for patient lateral rotation. The submission focuses on demonstrating substantial equivalence to a predicate device (PressureGuard IV, 510K953503) rather than defining and proving specific acceptance criteria through a clinical study with performance metrics.
Therefore, many of the requested categories for a study that proves device meets acceptance criteria cannot be directly answered from the given document, as this submission is for a medical device cleared via substantial equivalence, not typically a clinical trial demonstrating performance against quantitative acceptance criteria for software or an AI algorithm.
However, I can extract information related to the closest aspects from the provided text.
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A table of acceptance criteria and the reported device performance
No quantifiable acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are provided in the document for the PressureGuard Turn Select. The demonstration is based on "substantial equivalence" to a predicate device. The performance is implied to be similar to the predicate device.
Acceptance Criterion Reported Device Performance Not specified Not specified (Implied) Substantial Equivalence to predicate device for intended use and safety The device is similar in function and intended use to the predicate. (Implied) Pressure-management Verified through interface pressure testing (no results or criteria provided). (Implied) Conformance to UL 544 and CSA 122.25 System is designed to conform to these standards. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of clinical data or AI validation. The "interface pressure testing" mentioned is likely an engineering or bench test, not a clinical study on a patient sample. No sample size for such testing is provided, nor is the provenance of any data.
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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. The submission does not describe a clinical study requiring expert-established ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is described.
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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 device is a mattress system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" for clinical outcomes or diagnostic accuracy is not relevant to this 510(k) submission, which focuses on similarity to a predicate device and engineering testing.
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The sample size for the training set
Not applicable. A "training set" is relevant for AI/ML algorithms. This is a physical medical device.
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How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
SPAN-AMERICA MEDICAL SYSTEMS, INC.
972486
PressureGuard Turn Select 510K Summary
FEB 20 1998
- Span-America Medical Systems, Inc. 1. Submitter's Name: 70 Commerce Center Address: Greenville, SC 29615 Telephone Number: (864) 288-8877 James D. Ferguson, President & CEO Contact Person: Wanda Totton, Director of Quality October 9, 1997 Date Prepared: PressureGuard Turn Select. Model L 2. Trade Name: Alternating Pressure Mattress Common Name: Alternating Pressure Air Flotation Mattress, Classification Name: CFR 880.5550, Classification No. 80 FMN. PressureGuard IV, 510K953503 3. Predicate Device: The PressureGuard IV is an air flotation, alternating Description : 4. pressure support system. It consists of a foam shell manufactured with medical grade, polyurethane foam that meets the California Technical Bulletin 117. The perimeter bolsters are designed to safely prompt the patient toward the center of the surface, facilitating safe transfers and edge-of-bed sittings. The inflation system is cradled and securely positioned within the foam shell. Through computerized technology, the internal air pressures of the inflation system are controlled to achieve four operating modes. The CENTER Mode provides a level supine surface. The FIXED ROLL Mode provides automatic turning, turning the patient to the left followed by a 2 hour dwell time, then returning to center for a 2 hour dwell time, followed by a turn to the right followed by a 2 hour dwell time. The CUSTOM ROLL Mode
P.O. Box 5231, Greenville, S.C. 29606 •864-288-8877 • FAX 864-288-8692
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Span-America Medical Systems, Inc. 510K Summary, October 9, 1997 PressureGuard Turn Select Page 2 of 2
by a 2 hour dwell time. The CUSTOM ROLL Mode provides for selection of roll patterns, roll angles and dwell times to meet individual patient needs. The CPR Mode provides a firm surface to aid in CPR Procedures (with a crash board).
A Service Required Feature is provided to alert the health care provider in the event of system malfunction. CPR Alarm and Lock-Out features are also included.
ડ. Indications for Use: For the prevention and treatment of pressure ulcers. Patient lateral rotation of up to 30 degrees may also be used as a preventive tool against further complications associated with critically ill patients or immobility.
് വാഹ് വിശ്വാസ് വിശ്വാസ് വാഹ്യമങ്ങളും വിശ്വാസം വിശ്വാസം വിശ്വാസം
ക
Substantial Equivalence: The product is similar in function and intended used to 6. the PressureGuard IV, 510K953503. The PressureGuard Turn Select utilizes the same foam material, but with a modified design. It uses the same air cylinder design, but with a new material. A new cover fabric has been selected to improve system performance for heavy incontinent situations. Pressure-management with the new design is verified through interface pressure testing performed.
The computerized technology is the same, but the controls have been incorporated into the foot-end of the supportsurface. A pendant control is provided for user interface, with same buttons and functions as the PressureGuard IV, Model K.
A wall mount transfer is incorporated to supply 12 VAC to the enclosure to reduce thermal load for the controls. As with PressureGuard IV, Model L, the system is designed to conform to UL 544 and CSA 122.25.
The indications for use for the PressureGuard Turn Select are identical to those for the PressureGuard IV Model K.
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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 a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health 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 Greenville, South Carolina 29606
Re: K972486 PressureGuard Turn Select Trade Name: Requlatory Class: II Product Code: IKZ. ..... Dated: January 14, 1998 Received: January 15, 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 reqistration, 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 Regulations, Title 21, Parts 800 to 895. તે substantially equivalent determination assumes compliance with i the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
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,
ia 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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08:13
Page / of /
SIOK 972486 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: essure Indications For Use:
For the prevention and treatment of pressure ulcers.
Patient latual gatation of up to 30° may also be
used as a preventive tool against further
Complications associated with critically ill patients
or immobility.
Wanda g. Dotton
2-20-98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (GDB
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K972
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 890.5225 Powered patient rotation bed.
(a)
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.(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 § 890.9.