(210 days)
Not Found
No
The device description explicitly states the system uses "basic, simple mechanical and electrical components" and there is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is described with "Intended Use / Indications for Use" that include "Prevention and treatment of decubitus ulcers" and "treatment of burns, flaps and grafts," which are therapeutic applications.
No
The device description and intended use indicate that the product is a therapeutic surface for the prevention and treatment of decubitus ulcers, burns, flaps, and grafts, and to aid circulation, which are all treatment functions, not diagnostic ones.
No
The device description explicitly details physical components like a low airloss surface, positioning base, plastic support plates, accordion bladders, and mechanical and electrical components, indicating it is a hardware-based medical device.
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 decubitus ulcers, treatment of burns, flaps and grafts, and to aid circulation. These are all therapeutic applications directly applied to the patient's body.
- Device Description: The device is a low airloss therapy system with positioning capabilities. It is a physical device that interacts with the patient's body surface.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic or other health-related information. This device is a therapeutic device that interacts with the body.
N/A
Intended Use / Indications for Use
The SILKAIR™ Low Airloss Therapy is intended for medical purposes to treat or prevent pressure ulcers, to treat severe or extensive burns, or to aid in circulation. This bed system will be an ideal support for patients who have advanced pressure ulcers, flaps or grafts and require frequent transfers or variable head and leg elevation. SILKAR will permit easy positioning and egress, thereby enhancing the independence of patients. Low airloss beds have been used for comfort and therapy for individuals who could not move themselves. Low airloss therapy has been demonstrated to reduce the risk of pressure ulcers caused by loss of capillary circulation as well as an aid in the treatment of pressure ulcers. Low airloss therapy maintains patient's peripheral circulation by distributing the patient's weight over cushions filled with air. The even distribution of pressure on the skin limits capillary closure. thereby helping maintain tissue viability around bony prominence such as the sacrum and heels. The fabrics used in the design of the SILKAIR™ cushion and coverlet help to decrease shear and friction against the skin by moving freely of one another.
Indications for Use: Prevention and treatment of decubitus ulcers, treatment of burns, flaps and grafts and to aid circulation.
Product codes
IOQ
Device Description
This product provides the therapeutic surface features and leg elevation bed features of the Flexicair® Low Airloss Therapy Unit while eliminating the hospital bed frame. The intent of the design of the SILKAIR™ Low Airloss Therapy is to provide a zoned low airloss surface with the capabilities of head and leg elevation for non articulating bed frames or mattress box springs. SILKAIR attaches the low airloss surface to a positioning base which provides the head and leg articulation features. This positioning base can be attached to any flat surface such as a box spring, converting a regular bed into a hospital bed. The SILKAIR™ Low Airloss Therapy System is a zoned low airloss surface. The system distributes different pressures in different zones relative to the main air manifold pressure. This system uses basic, simple mechanical and electrical components. In order to achieve this feature the unit is electrically double insulated. Head and leg articulation required by many patients in the home is achieved through the use of a positioning base. This positioning base consists of plastic support plates and accordion bladders to raise and lower the head and leg sections of the surface.
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
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5170 Powered flotation therapy bed.
(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(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.
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510(k) Summary
JUL - 3 1997
Submitter Information 1. Hill-Rom®, Inc.
4349 Corporate Road Charleston, SC 29405
- Contact: Edwin L. Bills Manager, Quality Services and Regulatory Affairs (803)740-8380
- Establishment Registration Number 2.
For 4349 Corporate Road: 1045510
-
- Device Information
| Trade Name: | SILKAIR™ Low Airloss Therapy |
|---|---|
| Classification: | IOQ (21CFR Part 890.5170) |
| Class II Device |
-
- Predicate Device
| Trade Name: | Flexicair® Low Airloss Therapy Unit |
|---|---|
| Classification: | IOQ (21CFR Part 890.5170) |
| Class II Device | |
| 510(k) Number: | K863047 |
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5. General Description
This product provides the therapeutic surface features and leg elevation bed features of the Flexicair® Low Airloss Therapy Unit while eliminating the hospital bed frame. The intent of the design of the SILKAIR™ Low Airloss Therapy is to provide a zoned low airloss surface with the capabilities of head and leg elevation for non articulating bed frames or mattress box springs. SILKAIR attaches the low airloss surface to a positioning base which provides the head and leg articulation features. This positioning base can be attached to any flat surface such as a box spring, converting a regular bed into a hospital bed. The primary care setting for this product will be the home. This product eliminates the need for a hospital bed which often is difficult to bring in the home and may clutter small bedrooms.
Indications for Use 6.
The SILKAIR™ Low Airloss Therapy is intended for medical purposes to treat or prevent pressure ulcers, to treat severe or extensive burns, or to aid in circulation. This bed system will be an ideal support for patients who have advanced pressure ulcers, flaps or grafts and require frequent transfers or variable head and leg elevation. SILKAR will permit easy positioning and egress, thereby enhancing the independence of patients. This intended use is the same as the predicate device, Flexicair® Low Airloss Therapy Unit (K863047) also manufactured by Hill Rom Company.
Low airloss beds have been used for comfort and therapy for individuals who could not move themselves. Low airloss therapy has been demonstrated to reduce the risk of pressure ulcers caused by loss of capillary circulation as well as an aid in the treatment of pressure ulcers. Low airloss therapy maintains patient's peripheral circulation by distributing the patient's weight over cushions filled with air. The even distribution of pressure on the skin limits capillary closure. thereby helping maintain tissue viability around bony prominence such as the sacrum and heels. The fabrics used in the design of the SILKAIR™ cushion and coverlet help to decrease shear and friction against the skin by moving freely of one another.
7. Safety and Efficacy
The safety characteristics of this product compare to those of the predicate devices. No significant changes have been made which impact the safety and efficacy of the SILKAR™ Low Airloss Therapy System as compared to the predicate device. There are no performance standards established for this classification.
2
Technological Characteristics 8.
The SILKAIR™ Low Airloss Therapy System is a zoned low airloss surface. The system distributes different pressures in different zones relative to the main air manifold pressure. This system uses basic, simple mechanical and electrical components
One of the most important aspects of equipment designed for home is to have the ability to use two prong electrical outlets found in older homes. In order to achieve this feature the unit is electrically double insulated.
Head and leg articulation required by many patients in the home is achieved through the use of a positioning base. This positioning base consists of plastic support plates and accordion bladders to raise and lower the head and leg sections of the surface.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Edwin L. Bills Official Correspondent Hill-ROM®, A Hillenbrand Industry ------4349 Corporate Road Charleston, South Carolina 29405-7445
JUL - 3 1997
Re: K964873 Trade Name: Silkair™ Low Airloss Therapy Regulatory Class: II Product Code: IOQ Dated: April 1, 1997 Received: April 3, 1997
Dear Mr. Bills:
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 of the Act. The general 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , 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 action. In addition, FDA may publish further announcements concerning your device in the
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Page 2 - Mr. Edwin L. Bills
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.
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 vour 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,
Celia 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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510(k) Number:
・・
SILKAIR™ Low Air Loss Therapy
Indications for Use:
Prevention and treatment of decubitus ulcers, treatment of burns, flaps and grafts and to aid circulation.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
alin
(Division Sign-Off)
Division of Lamorsi Restorative Devices
510(k) Number