(708 days)
The BariAir bed is indicated for patients weighing up to 850 pounds to aid in the prevention and treatment of complications of immobility. Particularly:
- · patients who would benefit from a pressure relieving surface with the additional benefits of pulsation, percussion and/or continuous or regular turning from side to side.
- · patients whose body weight and size pose a significant risk of injury to the patient or nursing staff during the performance of routine nursing care procedures.
BariAir is a bariatric patient care system that combines the flexible patient-positioning capabilities of the predicato device (BariKare Plus) with a pressure relieving, dynamic low-air-loss mattress. The BariAir mattess is a three-section air mattress consisting of a scries of transverse, inflatable cushions that can be alternately inflated and deflated to provide pulsation therapy, four turning bladders to rotate the patient side to side, and an air bladder beneath the patient chest region cushions to provide vibration/percussion therapy. The BariAir device includes support and caster frames substantially the same as the predicate device.
BariAir also provides continuous lateral rotation therapy, automatically turning the patient, as well as other adjunct therapies such as pulsation and vibration/percussion.
This 510(k) summary (K955243) describes a device called BariAir, a low air loss bed. However, the provided document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond establishing substantial equivalence to a predicate device.
The document is a 510(k) submission summary, which primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This regulatory pathway often relies on comparison to a predicate device and does not typically include detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it is not present.
The 510(k) summary highlights:
- Predicate Device: BariKare Plus.
- Device Description: BariAir combines features of the predicate device (flexible patient positioning, built-in scale) with a pressure-relieving, dynamic low-air-loss mattress. It offers pulsation, four turning bladders for rotation, and air bladders for vibration/percussion therapy.
- Intended Use: For patients up to 850 pounds to prevent and treat immobility complications, especially those needing pressure relief with pulsation, percussion, and/or turning, or where patient weight/size poses risk to patient/staff during routine care.
- Contraindication: Unstable spinal cord injuries.
- Substantial Equivalence: The FDA determined the BariAir device is substantially equivalent to devices marketed prior to May 28, 1976.
The FDA's finding of "substantial equivalence" is based on the comparison of the new device to a predicate device, focusing on similar technological characteristics and intended use. This typically does not involve new clinical performance studies with predefined acceptance criteria.
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510(K) SUMMARY Prepared October 21, 1997
| Submitter's Name: | Kinetic Concepts, Inc. |
|---|---|
| Address: | 8023 Vantage DriveSan Antonio, TX 78230 |
| Telephone Number: | 210/255-4545 |
| Contact Person: | William II. Quirk |
OCT 2 3 1997
| Device Name: | BariAir |
|---|---|
| Trade or Proprietary Name: | BariAir |
| Common or Usual Name: | Low Air Loss Bed |
| Classification Name: | Bcd, AC-Powered, Adjustable Hospital |
BariKare Plus
[4] [6] Device Description & Technological Comparison.
Predicate Device:
(3)
BariAir is a bariatric patient care system that combines the flexible patient-positioning capabilities of the predicato device (BariKare Plus) with a pressure relieving, dynamic low-air-loss mattress. The BariAir mattess is a three-section air mattress consisting of a scries of transverse, inflatable cushions that can be alternately inflated and deflated to provide pulsation therapy, four turning bladders to rotate the patient side to side, and an air bladder beneath the patient chest region cushions to provide vibration/percussion therapy. The BariAir device includes support and caster frames substantially the same as the predicate device.
BariAir also provides continuous lateral rotation therapy, automatically turning the patient, as well as other adjunct therapies such as pulsation and vibration/percussion.
[ર] Intended Use
The BariAir device is a hospital bed system designed to support patients whose weights exceed standard hospital bed weight limitations or whose weight and size cannot be managed by the nursing staff. BariAir combines the flexible patient-positioning capabilities and built-in scale feature of the predicate device with a pressure relieving. low-air-loss mattress system that is designed to help in the prevention of skin breakdown and decubitus ulcers caused by prolonged patient immobility.
The BariAir bed is indicated for patients weighing up to 850 pounds to aid in the prevention and treatment of complications of immobility. Particularly:
- · patients who would benefit from a prossure relieving surface with the additional benefits of pulsation, percussion and/or continuous or regular turning from side to side.
- · patients whose body weight and size pose a significant risk of injury to the patient or nursing staff during the performance of routinc nursing care procedures.
BairAir is contraindicated for patients with unstable spinal cord injuries.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 2 3 1997
Mr. William H. Quirk Director, Regulatory Affairs Kinetic Concepts, Incorporated P.O. Box 659508 San Antonio, Texas 78265-9508
K955243 Re : BARIAIR (w/o the remote hand controller) Trade Name: Requlatory Class: II Product Code: FNM Dated: Auqust 14, 1997 August 18, 1997 Received:
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. ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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
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Page 2 - Mr. Quirk
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 findinq 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 labelinq 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
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): Device Name: BAR i ARIAIR
Indications for Use:
The BariAir bed is indicated for patients weighing up to 850 pounds to aid in the prevention and treatment of complications of immobility. Particularly:
- · patients who would benefit from a pressure relieving surface with the additional benefits of pulsation, percussion and/or continuous or regular turning from side to side.
- · patients whose body weight and size pose a significant risk of injury to the patient or nursing staff during the performance of routine nursing care procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pastina Cassevet
Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(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.