(213 days)
The bed mover is intended to assist a single operator in the moving of wheeled beds and stretchers from one location to another within a healthcare facility.
Examples of usage include:
- a single operator may move empty beds to staging or storage areas within the healthcare facility.
- a single operator may move patient-laden beds from one location to another within the healthcare facility.
The IRSG i-mover for beds is a battery-powered, temporary accessory to most wheeled hospitals beds and stretchers. It is unit operated by a single caregiver to assist in the movement of most wheeled hospital beds and stretchers commonly used within a healthcare facility.
Only the caregiver, not the patient, can control this powered assistive device.
This device is not permanently attached to or made a part of the stretcher or bed.
The FDA has classified this device as an accessory to the wheeled bed or stretcher which the device will assist in moving. These beds and stretchers are Class I (hydraulic or manual beds) and Class II (powered adjustable beds and wheeled stretchers). The FDA has classified this device as a Class I device when used with non-patient laden beds and a Class II device when assisting in movement of a patient-laden bed.
The provided text describes a 510(k) summary for the IRSG Bed Mover, a device intended to assist a single caregiver in moving hospital beds and stretchers. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically expected for a medical device with performance metrics (e.g., accuracy, sensitivity, specificity, or improvement in human performance).
The submission focuses on establishing substantial equivalence to predicate devices based on intended use, basic movement technology, and performance characteristics, but it does not detail specific performance studies with quantitative acceptance criteria.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- Table of acceptance criteria and reported device performance: This information is not present. The document focuses on regulatory classification, intended use, device description, and comparison to predicate devices, asserting "substantial equivalence" rather than reporting distinct performance metrics against predefined acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable in this context. There isn't a "test set" of data in the sense of a machine learning or diagnostic device that requires data for evaluation. The device is a bed mover, and its evaluation relies on comparison to existing devices and compliance with safety standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant to a bed mover.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool, so there are no "human readers" in this context, nor an AI component to compare against. Its purpose is mechanical assistance, not diagnostic improvement.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a human-operated mechanical aid, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. The device is a hardware product, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
What is present in the document related to "acceptance criteria" and "study":
The "acceptance criteria" for this type of device, as per the 510(k) summary, are primarily centered around substantial equivalence to predicate devices and compliance with voluntary standards for safety.
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Acceptance Criteria (Implicit - based on 510(k) requirements):
- Substantial Equivalence: The IRSG Bed Mover must be substantially equivalent in intended use, technological characteristics, and performance to legally marketed predicate devices.
- Safety Standards: Compliance with relevant voluntary safety standards, specifically IEC 60601-1 (Medical Electrical Equipment – Part 1: General Requirements for Safety).
- No New Issues of Safety or Effectiveness: The minor differences from predicate devices should not raise new concerns.
- Biocompatibility: Not applicable since the device does not contact the patient.
- Labeling and Instructions: Provision of clear labels and manuals for safe operation.
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"Study" (as described):
The document doesn't describe a formal clinical study or a quantitative performance validation study with specific metrics. Instead, the "study" is implicitly the 510(k) submission process itself, which argues for substantial equivalence based on:- Device Comparison: Directly comparing the IRSG Bed Mover to two predicate devices:
- Stryker Powered Wheeled Stretcher with Zoom™ Drive Wheel (K022309)
- Paramed Systems Paraglyde™ DCS TM-1 (FPO, 880.6910, Class II, 510k exempt)
The comparison asserts that the IRSG bed mover is "substantially equivalent... in function, technological characteristics and intended use."
- Safety Standard Compliance: A statement that "The bed mover will comply with the following voluntary standards IEC 60601-1..." This implies that the device was designed to meet these standards, and presumably evidence of this compliance was provided in the full 510(k) submission (though not detailed in the summary).
- Risk Assessment (Implicit): Discussion points address potential safety concerns, stating that "The IRSG i-mover for beds does not contact the patient, so biocompatibility is not a concern," and that labeling addresses safe operation.
- Device Comparison: Directly comparing the IRSG Bed Mover to two predicate devices:
In summary, for the IRSG Bed Mover, the "acceptance criteria" were met by demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards, rather than through a performance study with quantitative metrics for the device itself.
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510(k) Submission, Traditional: IRSG Bed Mover section 5: 510(k) Summary
APR 1 4 2008
page 5-1
510(k) Summary Pertaining to the Safety and Effectiveness of the IRSG Bed Mover
| Date Summary Prepared: | August 28, 2007 |
|---|---|
| Submitter: | International Retail Services Group, LLC12230 NE Woodinville Dr., Suite AWoodinville, WA 98072 USAContact: Karen M. Russell, Business DevelopmentTel: (425) 398-1875Fax: (425) 398-1675e-mail: karenr@irsg.com |
| Name of Device: | IRSG Bed Mover |
| Common name of device: | Bed mover |
| Classification name device: | "AC powered Adjustable Bed 21 CFR 880.5100, Class II, FNL"and "Wheeled Stretcher" 21 CFR 880.6910, Class II, FPO |
| Predicate Device (s): |
Stryker Powered Wheeled Stretcher with Zoom™ Drive Wheel AND Paramed Systems Paraglyde™ DCS TM-1
Device Description:
The IRSG i-mover for beds is a battery-powered, temporary accessory to most wheeled hospitals beds and stretchers. It is unit operated by a single caregiver to assist in the movement of most wheeled hospital beds and stretchers commonly used within a healthcare facility.
Only the caregiver, not the patient, can control this powered assistive device.
This device is not permanently attached to or made a part of the stretcher or bed.
The FDA has classified this device as an accessory to the wheeled bed or stretcher which the device will assist in moving. These beds and stretchers are Class I (hydraulic or manual beds) and Class II (powered adjustable beds and wheeled stretchers). The FDA has classified this device as a Class I device when used with non-patient laden beds and a Class II device when assisting in movement of a patient-laden bed.
Intended Use
The IRSG bed mover is intended to assist a single caregiver in the moving of wheeled beds and stretchers from one location to another within the healthcare facility. The bed mover may be used with both patient-laden or non patient-laden beds / stretchers.
Device Comparison:
The IRSG bed mover is substantially equivalent to the Stryker Zoom™ Motorized Stretchers (i.e. with the Stryker Powered Wheeled Stretcher with a drive option)K022309 and the Paramed Systems Paraglyde 10 DCS - TM1 (FPO, 880.6910, Class II, 510k exempt) in function, technological characteristics and intended use.
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The minor differences described in the submission between the IRSG bed mover and the predicate devices do not raise any new issues of safety or effectiveness. The intended use, basic movement technology and performance characteristics of the devices are the same.
The IRSG i-mover for beds does not contact the patient, so biocompatibility is not a concern.
The subject assistive device is intended for use in the same clinical environment where patient care is administered. Health facilities ordinarily use powered stretchers or beds for patient transportation to and from treatment modalities i.e. physical therapy, diagnostic radiation, etc.)
The labels and labeling (operators and maintenance manuals) provide information for the safe operation by the caregiver / user and the intended operation features.
The bed mover will comply with the following voluntary standards
IEC 60601-1, medical Electrical Equipment - Part 1 : General Requirements for Safety, 1988 (General), Amendment 1, 19991-11, Amendment 2, 1995-03.
The subject bed mover and the optional integrated bed moving technology of the predicate device and the externally attached bed moving technology of the other predicate device included in this submission are substantially equivalent.
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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen M. Russell Business Development International Retail Services Group, LLC 12230 NE Woodinville Drive, Suite A Woodinville, Washington 98072
Re: K072598
Trade/Device Name: IRSG Bed Mover Regulation Number: 21 CFR 880.6910 Regulation Name: Wheeled Stretcher Regulatory Class: II Product Code: FPO Dated: March 26, 2008 Received: March 27, 2008
Dear Ms. Russell:
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.
APR 1 4 2008
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 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
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Page 2 - Ms. Russell
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
C.A.R.S.
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
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page 4-1
Indications for Use
510(k) Number (if known): Device Name:
K072598
IRSG Bed Mover
Indications for Use:
The bed mover is intended to assist a single operator in the moving of wheeled beds and stretchers from one location to another within a healthcare facility.
Examples of usage include:
- a single operator may move empty beds to staging or storage areas within the healthcare facility.
- a single operator may move patient-laden beds from one location to another within the healthcare facility.
Prescription Use ____________
AND /OR
Image /page/4/Picture/12 description: The image contains the text "Over-the-counter Use" in a simple, sans-serif font. A large, bold "X" is drawn next to the text. The text and the "X" are both in black, contrasting with the white background.
(part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Am
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K472548 510(k) Number:
§ 880.6910 Wheeled stretcher.
(a)
Identification. A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.(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.