← Product Code [IOQ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ) · K964873 # SILKAIR LOW AIRLOSS THERAPY (K964873) _Hill-Rom, Inc. · IOQ · Jul 3, 1997 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K964873 ## Device Facts - **Applicant:** Hill-Rom, Inc. - **Product Code:** [IOQ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ.md) - **Decision Date:** Jul 3, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5170 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## 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. SILKAIR will permit easy positioning and egress, thereby enhancing the independence of patients. ## Device Story SILKAIR™ Low Airloss Therapy is a zoned low airloss surface system designed for home use. It provides therapeutic support and head/leg elevation by attaching to a positioning base placed on flat surfaces like box springs, eliminating the need for a full hospital bed frame. The system uses air-filled cushions to distribute patient weight, maintaining peripheral circulation and limiting capillary closure to prevent tissue damage. Fabrics in the cushion and coverlet reduce shear and friction. The device is operated by the patient or caregiver to facilitate positioning and egress, enhancing patient independence. It functions as a support surface to aid in the treatment of pressure ulcers and burns. ## Clinical Evidence No clinical data provided. The submission relies on the established therapeutic principles of low airloss therapy for pressure ulcer prevention and treatment, comparing the device's safety and efficacy to the predicate device. ## Technological Characteristics Zoned low airloss surface; uses air-filled cushions and a positioning base with plastic support plates and accordion bladders for articulation. Electrically double-insulated for use with two-prong home outlets. Mechanical and electrical components only; no software or complex algorithms. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Flexicair® Low Airloss Therapy Unit ([K863047](/device/K863047.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K964873 # 510(k) Summary JUL 3 1997 1. Submitter Information Hill-Rom®, Inc. 4349 Corporate Road Charleston, SC 29405 Contact: Edwin L. Bills Manager, Quality Services and Regulatory Affairs (803)740-8380 2. Establishment Registration Number For 4349 Corporate Road: 1045510 3. Device Information Trade Name: SILKAIR™ Low Airloss Therapy Classification: IOQ (21CFR Part 890.5170) Class II Device 4. Predicate Device Trade Name: Flexicair® Low Airloss Therapy Unit Classification: IOQ (21CFR Part 890.5170) Class II Device 510(k) Number: K863047 1 of 3 {1} 2 of 3 # 5. General Description This product provides the therapeutic surface features and the head 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. # 6. 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. SILKAIR 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 SILKAIR™ Low Airloss Therapy System as compared to the predicate device. There are no performance standards established for this classification. {2} 3 of 3 # 8. Technological Characteristics 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 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 {4} 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 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, ![img-0.jpeg](img-0.jpeg) 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 {5} 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) ![img-1.jpeg](img-1.jpeg) OR Over-The-Counter Use ☑ Prescription Use (Per 21 CFR 801.109) --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K964873](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K964873) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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