(66 days)
926411
Not Found
No
The device description details a purely mechanical system for lifting patients using air chambers. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML.
No
The HoverJack™ is described as a device that lifts a patient from the floor to bed height for transfer and provides a surface for procedures, without therapeutic claims.
No
The device description and intended use clearly state that the HoverJack™ is for lifting and transferring patients. There is no mention of it being used to diagnose diseases or conditions.
No
The device description clearly details a physical medical device made of nylon air chambers, valves, straps, and requiring an external air supply. It is not software-only.
Based on the provided information, the HoverJack™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to lift a patient from the floor to a bed height for transfer. This is a physical manipulation of the patient's body.
- Device Description: The device is a system of inflatable air chambers designed for lifting and supporting a patient. It does not interact with biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The HoverJack™ does not perform any of these functions.
N/A
Intended Use / Indications for Use
The HoverJack™ lifts a patient in a supine position, from the floor to the approximate height of a bed for a subsequent lateral patient transfer.
Product codes (comma separated list FDA assigned to the subject device)
FNG
Device Description
The HoverJack™ is made of four connected nylon air chambers, each measuring 32" x 70". When inflated, each chamber is 7" high. Each chamber has a dump valve for safety purposes. Each of these chambers has an air entry valve through which an external air supply is used to inflate the chamber against the floor is to be inflated first, then the other three chambers are inflated, in an upward succession, until the device is fully inflated. When fully inflated, the HoverJack™ feels hard and substantially supports the patient atop it, also providing a surface upon which emergency patient procedures can be performed, if necessary. Also in an emergency, dump valves are available to use for quick deflation. The HoverJack™ is constructed using 200 denier Nylon Oxford. Seams are RF welded (heat-sealed) to limit infection control issues. The bottom of the HoverJack™ has strips of a non-skid material attached for safety purposes. Fill-valves are self-sealing AND have caps that also screw on for additional closure. The HoverJack™ has two patient safety straps to buckle over the patient. The HoverJack™ does require the use of the Air Supply that is available as a separate unit.
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)
Non-Clinical, Volunteer, Safety Testing: HoverTech International has tested the HoverJack™ on numerous occasions, both in the manufacturer's warehouse setting and in public trade show venues and in a hospital behavioral health department. Findings and feedback from all scenarios have resulted in safety and comfort improvements ultimately ending in the final design of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
926411
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5500 AC-powered patient lift.
(a)
Identification. An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient.(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
AUG 1 2 2004
pg 172
K041503
510(k) SUMMARY 6/04/04 D.T. Davis Enterprises, Ltd.
Premarket Notification Summary
| Classification Name: | Lift, Patient, Ac-Powered |
|---|---|
| Regulation Number | 21CFR 880.5500 |
| Class II Device | |
| Product Code: | FNG |
| Trade Name: | HoverJack™ |
| Common Name: | Air Patient Lift |
| Registration #: | 2531468 (D.T. Davis Enterprises, Ltd.) |
| Reason for Submission: | New Technology |
| 510(k) Number: | K041503 |
| Office Correspondent: | David T. Davis, President |
| D.T. Davis Enterprises, Ltd. | |
| t/a HoverTech International | |
| 513 S. Clewell St. | |
| Bethlehem, Pa. 18015 | |
| 610-694-9600 | |
| 800-471-2776 | |
| 610-694-9601 (fax) | |
| hovermatt@earthlink.net | |
| Predicate Device: | Arjo-Century, Inc. |
| Saf-Lift/Saf-Kary | |
| 510(k) #926411 1993 |
Intended Use:
The HoverJack™ lifts a patient in a supine position, from the floor to the approximate height of a bed for a subsequent lateral patient transfer.
Description:
The HoverJack™ is made of four connected nylon air chambers, each measuring 32" x 70". When inflated, each chamber is 7" high. Each chamber has a dump valve for safety purposes. Each of these chambers has an air entry valve through which an external air supply is used to inflate the chamber against the floor is to be inflated first, then the other three chambers are inflated, in an upward succession, until the device is fully inflated. When fully inflated, the HoverJack™ feels hard and substantially supports the patient atop it, also providing a surface upon which emergency patient procedures can
1
Pg 212
K041523
be performed, if necessary. Also in an emergency, dump valves are available to use for quick deflation.
The HoverJack™ is constructed using 200 denier Nylon Oxford. Seams are RF welded (heat-sealed) to limit infection control issues. (Details are attached) The bottom of the HoverJack™ has strips of a non-skid material attached for safety purposes. Fill-valves are self-sealing AND have caps that also screw on for additional closure. The HoverJack™ has two patient safety straps to buckle over the patient.
The HoverJack™ does require the use of the Air Supply that is available as a separate unit. The Air Supply is CSA approved, meeting UL Standard #544. This Air Supply is also used to inflate other equipment such as the HoverMatt® which is an optional accessory to the HoverJack™.
Comparison to Saf-Lift/Saf-Kary: (Currently Penner Patient Care/Superior Series)
The reason for utilization of both the HoverJack™ and the SL/SK is to lift a patient in a safe, secure manner without risk of injury to the caregiver. While the lift provided by the SL/SK is for the intended purpose of transferring the patient into a bath, the significance is first and foremost for the comfortable, injury-free patient move. Both of these devices require the use of an AC power source. And, both devices are stationary while the lift is being performed.
However, the technology that powers the lift is different with these devices. The HoverJack™ lift is operated via air that inflates four connected chambers beneath the patient. The "energy" source provides the air that provides the lift. The lift of the SL/SK is accomplished by mechanical action, utilizing moving parts. The "energy" literally powers the lift itself.
See attached Matrix of comparisons.
Non-Clinical, Volunteer, Safety Testing:
HoverTech International has tested the HoverJack™ on numerous occasions, both in the manufacturer's warehouse setting and in public trade show venues and in a hospital behavioral health department. Findings and feedback from all scenarios have resulted in safety and comfort improvements ultimately ending in the final design of the product.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2004
Mr. David T. Davis President D.T. Davis Enterprises, Limited T/A HoverTech International 513 South Clewell Street Bethlehem, Pennsylvania 18015
Re: K041503
Trade/Device Name: HoverJack™ Air Patient Lift Device Regulation Number: 880.5500 Regulation Name: AC-Powdered Patient Lift Regulatory Class: II Product Code: FNG Dated: August 2, 2004 Received: August 4, 2004
Dear Mr. Davis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the relevenced above and he managere) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to arrived Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin approvisions of the Act. The general controls provisions of the Act include eonerols provisions of 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K041503
Device Name: HoverJack™ Air Patient Lift Device
Indications For Use:
The HoverJack™ lifts a patient in a supine position, from the floor to the approximate height of a bed for a subsequent lateral patient transfer.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Randolph. Shuy for ADW August 12, 04
(Division Sign-Off) Division of Anesthesiology, Infection Control, Dent
510(k) Number
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