(680 days)
No
The description focuses on mechanical and pneumatic functions for patient positioning and pressure management, with no mention of AI or ML technologies.
Yes
The device is described as preventing and treating complications of immobility such as skin breakdown and decubitus ulcers, and providing kinetic therapy for the care management and prevention of decubitus ulcers and treatment or mitigation of pulmonary complications. These are therapeutic uses.
No
Explanation: The device described is a critical care bed designed to prevent and treat complications of immobility, such as skin breakdown and decubitus ulcers, and to mitigate pulmonary complications. Its functions (pulsation therapy, vibration/percussion therapy, patient turning, low-pressure support, kinetic therapy) are all therapeutic and preventative in nature, not diagnostic. It does not identify or detect a disease or condition.
No
The device description clearly details a physical medical bed with an air mattress and various mechanical components for patient support, rotation, and therapy. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases or other conditions.
- Device Description: The description clearly states that the Modified PediKair is a critical care bed with an air mattress designed to support bedridden pediatric patients and prevent complications of immobility. It provides physical therapies like pulsation, vibration/percussion, and kinetic therapy (turning).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
The device is a medical bed providing physical support and therapy, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Not Found
Product codes
FNM
Device Description
Modified PediKair is a critical care bed with an air mattress for supporting bedridden pediatric patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. The air mattress consists of a series of transverse, inflatable cushions that can be alternately inflated and deflated to provide pulsation therapy (as on the predicate device), an air bladder beneath the patient's chest region to provide vibration/percussion therapy, and left and right turning bladders to rotate the patient side to side. Inflatable support cushions on each side of the patient's head and body keep the patient positioned properly during rotation. PediKair includes the collapsible side rails and removable head and foot rails of the predicate device for maximum and immediate access to the patient-CPR can be performed without the hindrance of rails and without removing the patient from the bed.
As with the predicate device, the re-designed PediKair mattress is also a lowpressure air mattress. Low-pressure support mattresses are effective in preventing or reducing the incidence of decubitus ulcers in immobile patients by lowering the pressure on any portion of the body to below capillary pressure (25-35 mmHg).
Modified PediKair also provides kinetic therapy, which is effective in the care management and prevention of decubitus ulcers and in the treatment or mitigation of pulmonary complications caused by prolonged immobility. A continuously rotating surface, similar in concept and design to that of the KCI Pediatric RotoRest P-30 product (510(k) No. K822402), automatically turns the patient 40° (maximum) on one side of the body, to lying on his/her back, to 40° (maximum) on the opposite side of the body. The side support cushions, which automatically inflate when Modified PediKair is in use, and the bed's side rails keep the patient from falling out of the bed while in a rotated position, or while being rotated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
CONFIDENTIAL
K 954320
Summarv
JUL 1 8 1997
Introduction
Modified PediKair is a critical care bed with an air mattress for supporting bedridden pediatric patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. The air mattress consists of a series of transverse, inflatable cushions that can be alternately inflated and deflated to provide pulsation therapy (as on the predicate device), an air bladder beneath the patient's chest region to provide vibration/percussion therapy, and left and right turning bladders to rotate the patient side to side. Inflatable support cushions on each side of the patient's head and body keep the patient positioned properly during rotation. PediKair includes the collapsible side rails and removable head and foot rails of the predicate device for maximum and immediate access to the patient-CPR can be performed without the hindrance of rails and without removing the patient from the bed.
Summary
As with the predicate device, the re-designed PediKair mattress is also a lowpressure air mattress. Low-pressure support mattresses are effective in preventing or reducing the incidence of decubitus ulcers in immobile patients by lowering the pressure on any portion of the body to below capillary pressure (25-35 mmHg).
Modified PediKair also provides kinetic therapy, which is effective in the care management and prevention of decubitus ulcers and in the treatment or mitigation of pulmonary complications caused by prolonged immobility. A continuously rotating surface, similar in concept and design to that of the KCI Pediatric RotoRest P-30 product (510(k) No. K822402), automatically turns the patient 40° (maximum) on one side of the body, to lying on his/her back, to 40° (maximum) on the opposite side of the body. The side support cushions, which automatically inflate when Modified PediKair is in use, and the bed's side rails keep the patient from falling out of the bed while in a rotated position, or while being rotated.
1
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 image of three human profiles facing right, stacked on top of each other to create a sense of depth. These profiles are enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William H. Quirk ·Director, Regulatory Affairs Kinetic Concepts, Incorporated P.O. Box 659508 San Antonio, Texas 78265
K954320 Re: Modified Pedikair Trade Name: Requlatory Class: II Product Code: FNM Dated: June 12, 1997 Received: June 13, 1997
JUL 1 8 1997
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 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 of the Act. The qeneral 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 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. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation 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.
2
Page 2 - Mr. Quirk
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtrious in four equivalence of your device to a legally marketed predicate device results in a classification for your marice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Also, please note rolloy Bearl (1) 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) 630-2041 or at (301) 443-6597.
Sincerely yours,
Ulatowski
Timothy A. Ulatowskı Diredtor
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health