(156 days)
The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.
The HT-Wedge is an inflatable wedge with square headrest and two intake appendages, one for the head and one for the chest. An inflation/deflation valve is found in each appendage. There is also a tongue attached to the wedge that lies under the patient's buttocks. The inflatable portion of the product is 22" wide and 31 1/4" long. There are four attachment straps, two located on each side of the wedge in order for it to be secured to the OR table. The tongue adds an additional 20" in length. The wedge is constructed of polyurethane coated nylon with 2 one-way, inflation/deflation valves.
This document is a 510(k) summary for a medical device (HT-Wedge), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific quantitative acceptance criteria typically seen for diagnostic AI/ML devices.
Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.
The document indicates that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications," but it does not provide the specific specifications or the results of these tests. It relies on citing compliance with voluntary standards (ISO 10993) for biocompatibility rather than performance metrics related to lifting and positioning.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (from document) |
|---|---|
| Functional Equivalence: Device must perform the same intended function as the predicate device. | "The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting." "The HoverTech International® HT-Wedge is substantially equivalent to the HoverJack air patient lift... in function and intended use." "The basic technology is exact since they both require the same UL Listed air supply and make use of the same one-way inflation valve." "The basic technology and performance characteristics of these systems are the same." |
| Safety: Device must not raise new issues of safety compared to the predicate device. | "The differences described in the submission between the HoverTech International® HT-Wedge and that of the predicate devices do not raise any new issues of safety or effectiveness." "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications. These reports are maintained as required by 21 CFR 820, Quality Systems Regulations." "An assessment of known and reasonable hazards has been conducted to ensure that any risk associated with the device as of the date of product release is as low as reasonably possible." Compliance with ISO 10993 (biocompatibility) standards (Part 5: Cytotoxicity, Part 10: Irritation and Sensitization, Part 1: Evaluation & testing within a risk management process) is stated as voluntary standards adhered to. This addresses material safety from patient contact. |
| Effectiveness: Device must be as effective as the predicate device for its intended use. | "The differences described in the submission between the HoverTech International® HT-Wedge and that of the predicate devices do not raise any new issues of safety or effectiveness." The overall conclusion is "The HT-Wedge and its predicate device included in this submission are substantially equivalent." |
| Compliance with Regulations/Standards: Device must meet applicable regulatory requirements and voluntary standards. | "These reports [Safety Testing and performance characteristics] are maintained as required by 21 CFR 820, Quality Systems Regulations." "The device will comply with the following voluntary standards: ISO 10993-5, ISO 10993-10, ISO 10993-1." Compliance with regulations for medical devices (e.g., annual registration, listing, good manufacturing practice, labeling, medical device reporting) is mentioned in the FDA letter. |
| Mechanical Performance (e.g., lift capacity, inflation time, durability): (Implicit for a patient lift) | The document states "Safety Testing and performance characteristics have been conducted and successfully completed to ensure compliance with specifications," but does not detail these specifications or the results. It implies equivalence to the predicate in "basic technology and performance characteristics" but provides no quantitative data. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided. This summary is for a physical patient lift, not an AI/ML device relying on a test set of data (e.g., images). The "testing" referred to is likely engineering and safety testing on the device itself, not a dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable / Not Provided. Ground truth establishment by experts is relevant for diagnostic AI/ML algorithms. For this physical device, "ground truth" would relate to its engineering specifications and safety, verified through manufacturing processes and compliance with standards. "Design review has been conducted by a cross-functional team, including but not limited to regulatory, quality, engineering and manufacturing," but detailed qualifications or number of individuals are not specified.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided. This applies to expert review of data, not physical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is a physical patient lift, not a diagnostic AI assistance system. MRMC studies are used to evaluate human reader performance with and without AI assistance in diagnostic tasks.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not Applicable. This is not an algorithm. Performance relates to its mechanical and functional specifications.
7. The Type of Ground Truth Used:
- For this device, "ground truth" would be internal engineering specifications, safety standards (e.g., biocompatibility standards like ISO 10993), and the performance characteristics of the legally marketed predicate device. The document implies that the device performs as designed and meets safety standards, and that its performance is equivalent to the predicate.
- The document explicitly mentions "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." These specifications are the "ground truth" the device was tested against, but the detailed specifications themselves are not provided in this 510(k) summary.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided. (See point 8)
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Image /page/0/Picture/0 description: The image shows the logo for Hovertech International. The logo consists of a stylized wave pattern on the left, followed by the word "HOVERTECH" in bold, uppercase letters. Below "HOVERTECH" is the word "International" in a smaller, non-bold font. The wave pattern is made up of several parallel lines that curve and overlap to create a sense of movement.
< 121287
OCT
Э 2012
"510(k) SUMMARY" as required by section 807.92(c)
Submitter Information:
D.T. Davis Enterprises, LTD T/A HoverTech International 513 S. Clewell Street Bethlehem, PA 18015 Phone: (610)-694-9600 Fax: (610)694-9601
Contact Person: ·
Susan Pavelko Quality Manager D. T. Davis Enterprises, LTD
Date Summary Prepared:
Trade Name:
Lift, Patient, AC Powered
April 24, 2012
HT-Wedge
Common Name:
Classification Name:
AC-powered patient lift (21 CFR 880.5500, Product Code FNG)
Legally Marketed Device: HoverTech International HoverJack Air Patient Lift 510(k)#: K041503
Device Description: The HT-Wedge is an inflatable wedge with square headrest and two intake appendages, one for the head and one for the chest. An inflation/deflation valve is found in each appendage. There is also a tongue attached to the wedge that lies under the patient's buttocks. The inflatable portion of the product is 22" wide and 31 1/4" long. There are four attachment straps, two located on each side of the wedge in order for it to be secured to the OR table. The tongue adds an additional 20" in length. The wedge is constructed of polyurethane coated nylon with 2 one-way, inflation/deflation valves.
The HT-Wedge is similar in use and function to the HoverJack Air Patient Lift, registered by D. T. Davis Enterprises, LTD., which is a Class II Device with Product Code FNG.
513 S. Clewell Street Bethlehem, PA 18015
Phone 800.471,2776 Fax 610.694.9601
www.HoverMatt.com info@HoverMatt.com
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Image /page/1/Picture/0 description: The image shows the logo for Hovertech International. The logo consists of two curved lines, one above the other, with several parallel lines running along each curve. To the right of the curved lines is the text "HOVERTECH" in bold, uppercase letters, with the word "International" in a smaller font size below it.
Indications for Use: The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.
Device Comparison: The HoverTech International® HT-Wedge is substantially equivalent to the HoverJack air patient lift, reaistered by D. T. Davis Enterprises, LTD. in function and intended use. The differences described in the submission between the HoverTech International® HT-Wedge and that of the predicate devices do not raise any new issues of safety or effectiveness. The intended use for each system is the same. The basic technology is exact since they both require the same UL Listed air supply and make use of the same one-way inflation valve. The power source is only attached to device during inflation, once the device has reached it desired firmness the air supply is removed and the one-way valve is in a closed position. The basic technology and performance characteristics of these systems are the same.
The subject device is intended to be used in any clinical environment where patient care is administered. Health facilities ordinarily used AC powered lifts to place patients in the proper position for ancillary procedures, while reducing the risk of injury to the caregiver and patient.
The labels and labeling (Information Sheet) provide information for the safe operation by the caregiver/user and the intended operation features.
No performance standards or special controls have been promulgated for patient positioning supports under sections 513 and 514 of the FD&C Act.
Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications. These reports are maintained as required by 21 CFR 820, Quality Systems Regulations.
An assessment of known and reasonable hazards has been conducted to ensure that any risk associated with the device as of the date of product release is as low as reasonably possible. Design review has been conducted by a cross-functional team, including but not limited to regulatory, quality, engineering and manufacturing.
.HoverMatt.com
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The device will comply with the following voluntary standards:
-
ISO 10993-51SO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices-- Part 10: Tests for Irritation and Sensitization
-
ISO 10993-1:2009/Cor1:2010(E) Biological evaluation of medical devices -- Part 1 Evaluation & testing within a risk management process
Conclusion:
The HT-Wedge and its predicate device included in this submission are substantially equivalent.
w.HoverMott.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
3 2012
D.T. Davis Enterprises, Limited
T/A HoverTech International
Ms. Susan Pavelko
Quality Manager
513 South Clewell Street
Bethlehem, Pennsylvania 18015
Re: K121287
Trade/Device Name: HT-Wedge Regulation Number: 21 CFR 880.5500 Regulation Name: AC-Powered Patient Lift Regulatory Class: II Product Code: FNG Dated: September 14, 2012 Received: September 21, 2012
Dear Ms. Pavelko:
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 indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Pavelko
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Fo?
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: HT-Wedge
Indications For Use:
The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.
X Prescription Use (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)
e Sta for Richards CHAPMAN
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K121287
§ 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.