(101 days)
The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.
The provided text describes a 510(k) summary for the HoverTech International® Transformer, a battery-powered patient transport device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets them.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: The document states that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." However, it does not list what those specific specifications or acceptance criteria are, nor does it provide the results or reported performance of the device against them. It only mentions compliance with voluntary standards like IEC and UL for safety and biocompatibility. These are general standards, not specific performance metrics for this particular device.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set: All of these data points are typical for studies evaluating diagnostic or predictive algorithms/devices, especially in fields like medical imaging. Since the HoverTech International® Transformer is a physical patient transport device (a powered wheeled stretcher), these types of studies (MRMC, standalone algorithm performance, training/test sets for AI, ground truth establishment by experts/pathology) are not applicable to this device's regulatory submission as described.
Summary of missing information:
- Table of acceptance criteria and reported device performance: Not provided. The document generally states "compliance with specifications" and "safety testing," but no specific metrics or results are reported.
- Sample size used for the test set and data provenance: Not applicable in the context of this physical device.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What is present in the document is a declaration of compliance with general safety and electrical standards:
- Voluntary Standards the device will comply with:
- IEC 60601-1 (General Requirements for Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- IEC 60601-2-38 (Safety of Electrically Operated Hospital Beds - applicable parts only for loading and pinch points)
- UL 2601-1 (Standard for Medical Electrical Equipment)
- CAN/CSA C22.2 No. 601.1-M90 (Standard for Medical Equipment)
- ISO 10993-5 (Biocompatibility - In Vitro cytotoxicity)
- ISO 10933-10 (Biocompatibility - irritation and sensitization, delayed type hypersensitivity)
The document concludes that the device is "substantially equivalent" to a predicate device (Transmotion Medical Model TMM6 Power Drive Chair) based on "intended use, basic technology, and performance characteristics." The "performance characteristics" are implied to be met through the safety testing and compliance with the listed voluntary standards, but no specific performance data is disclosed in this summary.
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Image /page/0/Picture/0 description: The image shows the text "K102236" at the top. Below that is the logo for Hovertech International. The logo includes a stylized graphic of curved lines, with the text "HOVERTECH" in bold, uppercase letters. Below that, the word "International" is written in a smaller, non-bold font.
"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
NOV 1 9 2010
Susan Pavelko Quality Manager D. T. Davis Enterprises, LTD
Date Summary Prepared:
Trade Name:
Contact Person:
Common Name:
Classification Name:
March 17, 2010
HoverTech International® Transformer
Stretcher, Wheeled, Powered
Powered wheeled stretcher (21CFR 890.3690, Product Code INK)
Legally Marketed Device: Transmotion Medical Model TMM6 Power Drive Chair
Device Description: The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.
Intended use: This device is a motorized device intended for medical purposes to assist in the transport of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles. The FDA has classified the device as a Class II device.
513 S. Clewell Street Bethlehem, PA 18015
Phone 800.471.2776 Fax 610.694.9601
www.HoverMatt.com info@HoverMall.c
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Image /page/1/Picture/0 description: The image shows the logo for Hovertech International. The logo consists of a stylized graphic of curved lines, resembling air currents or waves, on the left side. To the right of the graphic is the company name, "HOVERTECH," in bold, uppercase letters. Below "HOVERTECH" is the word "International" in a smaller, regular font.
HoverMatt.com
Device Comparison: The HoverTech International® Transformer is substantially equivalent to the Transmotion Medical Model TMM6 Power Drive Chair in function and intended use. Any minor differences described in the submission between the HoverTech International® Transformer and that of the predicate devices does not raise any new issues of safety or effectiveness. The intended use, basic technology, and performance characteristics of the system are the same.
The subject device is intended to be used in any clinical environment where patient care is administered. Health facilities ordinarily used stretchers for patient treatment, recovery and for transportation to and from treatment modalities, i.e. physical therapy, diagnostic radiology, etc.
The labels and labeling (Operator's and Maintenance Manuals) 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 powered patient transport devices 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 An associated with the device as of the date of product release is as low as reasonably nossible. Design review has been conducted by a cross-functional team, including but not limited to regulatory, quality, engineering and manufacturing.
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HOVERTECH
International
The device will comply with the following voluntary standards:
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IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988 (General), Amendment 1, 1991-11, Amendment 2, 2 1995-03
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IEC 60601-1-2. (First Edition, 1993-04), Medical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility -Requirements and Tests (General)
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IEC 60601-2-38 Issue: 1996/10/01 Ed: 1 Medical Electrical Equipment -Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital Beds; Amd. 1: 12-1999- Applicable parts only (loading and pinch points)
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UL 2601-1 (2nd Edition) Standard for Medical Electrical Equipment, Part 1: General Reguirements for Safety - Issued: 2003/04/24 Edition 1, Revision: 2006/04/26
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CAN/CSA C22.2 No. 601.1-M90 Standard for Medical Equipment
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ISO 10993-5: 1999, Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility)
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ISO 10933-10: 2002, Biological evaluation of medical devices- Part 10: Tests for irritation and Sensitization pp. 6 - 10, 21 (Biocompatibility)
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ISO 10933-10: 2002, Biological evaluation of medical devices- Part 10: Tests for irritation and delayed type hypersensitivity pp. 18-20. (Biocompatibility)
The Transformer and predicate powered patient transport included in this submission are substantially equivalent.
HoverMatt.com
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
D.T. Davis Enterprises, LTD % HoverTech International Ms. Susan Pavelko Quality Manager 513 South Clewell Street Bethlehem, Pennsylvania 18015
NOV 1 9 2010
Re: K102236
Trade/Device Name: The HoverTech International HoverTrans™ Transformer Regulation Number: 21 CFR 890.3690 Regulation Name: Powered wheeled stretcher Regulatory Class: Class II Product Code: INK Dated: August 5, 2010 Received: August 25, 2010
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.
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.
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
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Page 2 - Ms. Susan Pavelko
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/ReportalProblem/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.hum.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K10236.
Section 4:
Indications for Use
NOV 18 2 12
510(k) Number (if known):
Device Name: The HoverTech International HoverTrans™ Transformer
Indications For Use: The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
Prescription Use (Part 21 CFR 801 Subpart D)
. (*--
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Counter Use
(21 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102236
Page 1 of 1
§ 890.3690 Powered wheeled stretcher.
(a)
Identification. A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).(b)
Classification. Class II (performance standards). The powered wheeled stretcher is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9, and the following conditions for exemption:(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable;
(9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device;
(10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and
(11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.