(126 days)
The Prime Series® Stretcher with Zoom® Motorized Drive is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications, such as short-term outpatient clinical evaluation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to critically ill. The Prime Series® Stretcher with Zoom® Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility.
The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.
The Prime Series® Stretcher with Zoom® Motorized Drive, is a powered wheeled stretcher that consists of a platform mounted on a wheeled frame that is designed to transport patients in a substantially horizontal position within the interior of a healthcare facility by health professionals and/or trained representatives of the user facility. The electric-drive system, called the Zoom Drive System, assists the health professional and/or trained representative by assisting stretcher movement and maneuverability in various healthcare facilities. The device can be manually pushed by the user in the event of power loss to the Zoom Drive System. The device has siderails, supports for fluid infusion equipment, and various options and accessories that assist with the transport of the patient. The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.
The provided text describes the Stryker Prime Series® Stretcher with Zoom® Motorized Drive, and its acceptance criteria are primarily demonstrated through substantial equivalence to a predicate device and verification and validation (V&V) testing to ensure safety and effectiveness.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the format of defined thresholds with corresponding "device performance" results. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and passing functional, performance, safety, and efficacy specifications through V&V testing. The reported device performance is largely a direct comparison to the predicate device, indicating that the new device performs at least as well as the predicate and meets relevant standards.
Here's an attempt to extract and present the closest information to your request, focusing on comparative aspects and testing outcomes:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "The Prime Series® Stretcher with Zoom® Motorized Drive is substantially equivalent to and as safe and effective as that of the predicate device." |
| Functional, Performance, Safety, and Efficacy Specifications | "Stryker Medical has verified and validated that the Prime Series® Stretcher with Zoom® Motorized Drive meets its functional, performance, safety, and efficacy specifications and requirements." |
| Physical and Mechanical Testing Results | "Physical and mechanical testing has been performed on individual components and on the system... Test results demonstrate that both the individual units and system meet specified performance requirements." |
| Software Testing Results | "Software testing that has been completed... The Prime Series Stretcher with Zoom Motorized Drive has successfully passed bench and software testing, Test results demonstrate that both the individual units and system meet specified performance requirements." |
| Adherence to Recognized Standards | The device was designed and evaluated according to AAMI/ANSI/ISO 10993 series (biological evaluation), AAMI/ANSI ES 60601-1 (basic safety and essential performance), IEC 60601-1-2 (EMC), IEC 60601-1-3 (radiation protection for X-ray), IEC 60601-2-52 (medical beds), and IEC 60601-2-54 (X-ray equipment). |
| No New Issues of Safety or Effectiveness due to Differences | "Any differences described between the Prime Series® Stretcher with Zoom® Motorized Drive and the predicate device does not raise any new issues of safety or effectiveness." |
| Intended Use Supported by Predicate | "The Prime Series with Zoom Motorized Drive's intended uses are substantially supported by the previously cleared predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Physical and mechanical testing has been performed on individual components and on the system" and "bench and software testing." However, it does not specify the sample size for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a physical medical device like a stretcher, the testing would be considered prospective as it's conducted specifically for demonstrating compliance before market approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes a physical medical device (a stretcher), not an AI/diagnostic software. "Ground truth" in the context of expert consensus is typically relevant for evaluating diagnostic accuracy, which is not the primary concern for a patient transport stretcher. The "truth" in this context is defined by engineering specifications and recognized performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in diagnostic studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a motorized stretcher, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and effect size in improving human reader performance with AI is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. There is no algorithm in the sense of an AI or diagnostic software being evaluated. The "Zoom Motorized Drive" is an electromechanical system that assists a human caregiver. Its performance is always "human-in-the-loop" as it requires a caregiver to operate it.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" is established by engineering specifications, performance standards (e.g., IEC, ISO, AAMI), and predefined functional requirements. These are generally objective, measurable parameters rather than subjective expert consensus, pathology, or outcomes data. For example, the "ground truth" for patient capacity (700 lbs max) would be determined by structural integrity tests and engineering calculations.
8. The sample size for the training set
This is not applicable. This is a physical electromechanical device, not a machine learning model that requires a "training set" of data.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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140095
SECTION 5 - 510(k) SUMMARY or 510(k) STATEMENT
MAY 2 0 2014
510(k) Summary
Stryker Corporation - Medical Division
Prime Series® Stretcher with Zoom® Motorized Drive
SUBMITTER/510(K) HOLDER
Date Prepared:
| Name: | Stryker Corporation - Medical Division |
|---|---|
| Address: | 3800 East Centre Ave.Portage, MI 49002 |
| Contact Person: | Brian L. Orwat |
| Telephone: | 269 389 6817 |
DEVICE NAME
| Proprietary Name: | Prime Series® Stretcher with Zoom® Motorized Drive |
|---|---|
| Catalog Numbers: | 1125 |
| Common/Usual Name: | Patient Transport Stretcher |
| Classification Name: | Powered Wheeled Stretcher |
| Classification: | 21 CFR 890.3690 |
| Product Code: | INK |
| Classification Panel: | Physical Medicine |
11 March 2014
PREDICATE DEVICES
Stryker Medical ("Stryker") claims substantial equivalence to: 1. Stryker Powered Wheeled Stretcher (K022309)
DEVICE DESCRIPTION
The Prime Series® Stretcher with Zoom® Motorized Drive, is a powered wheeled stretcher that consists of a platform mounted on a wheeled frame that is designed to transport patients in a substantially horizontal position within the interior of a healthcare facility by health professionals and/or trained representatives of the user facility. The electric-drive system, called the Zoom Drive System, assists the health professional and/or trained representative by assisting stretcher movement and maneuverability in various healthcare facilities. The device can be manually pushed by the user in the event of power loss to the Zoom Drive System. The device has siderails, supports for fluid infusion equipment, and various options and accessories that assist with the transport of the patient. The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.
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INTENDED USE
The Prime Series Stretcher with Zoom Motorized Drive is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications such as short-term outpation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to crime Series® Stretcher with Zoom Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility.
The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Substantial equivalence is based on one predicate device, Stryker Power Wheeled Stretcher (K022309). The referenced predicate device is a powered wheeled stretcher as defined in 21 CFR § 890.3690. The product code of the cleared predicate device is INK.
Like the predicate device, the Prime Series Stretcher with Zoom Motorized Drive is a DC powered wheeled stretcher that operates as an electromechanical stretcher which provides a method of transporting patients within healthcare facilities. The Prime Series® Stretcher with Zoom® Motorized Drive may be used for minor procedures and short-term stay, typical of existing stretcher applications. The drive-assist Zoom system professional and/or trained representative greater manewerability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is equivalent in operational characteristics to the predicate device in that the mobility, drive-assist Zoom system, and caregiver input for patient transport operate in the same manner. Both devices have a four (4) caster brake system, side rails, hydraulic lift system for height adjustment, support, and trendelenburg features of the patient surface. Both devices also feature similarities in construction materials and surface mattresses.
The Prime Series® Stretcher with Zoom® Motorized Drive includes an available option that allows for a full-length articulating radiographic patient support surface and platform. A dual-deck design of the patient platform allows for the positioning of x-ray cassettes at any point under the patient, from head to side to side. With an open architecture design, this design will accommodate the majority of sizes of commercially available x-ray cassette receptors. The predicate device featured an optional x-ray cassette holder behind the fowler portion of the patient platform. Verification and validation of design and performance for the Prime Series® Stretcher with Zoom® Motorized Drive demonstrates that these technology differences do not adverselv affectiveness of the device when used as labeled, as the device has been fully tested for use and performance to demonstrate its safe and effective use.
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| Table 5-1 Side-by-Side Comparison of | ||
|---|---|---|
| Prime Series® Stretcher with Zoom® Motorized Drive with Predicate Device | ||
| Category | Subject Device: Prime Series® Stretcher with Zoom® Motorized Drive | Predicate Device: Stryker Powered Wheeled Stretcher K022309 |
| Indications for Use | The Prime Series® Stretcher with Zoom® Motorized Drive is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications, such as short-term outpatient clinical evaluation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to critically ill. The Prime Series® Stretcher with Zoom® Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility.The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system. | The Stryker Powered Wheeled Stretcher is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications. The drive-assist Big Wheel provides the healthcare caregiver greater maneuverability in steering and moving the stretcher with significantly less force. |
| Product Weight | 416 – 483 lbs. | Less than 450 lbs. |
| Patient Capacity | 700 lbs. max | 500-700 lbs. max |
| Overall Dimensions | Length: 86"Width: 31" to 34" | Length: 84"Width: 31" to 34" |
| Patient Surface Dimensions | Length: 75.25"Width: 26" or 30" | Length: 75.5"Width: 26" to 29" |
| Height Range (to litter top) |
.
Table 5-1 Side-by-Side Comparison of Predicate
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| - High | 37.25" | 35.5" - 36" |
|---|---|---|
| - Low | 26.25" | 21" - 22" |
| Trendelenburg/ReverseTrendelenburg | +/- 16 degrees | +/- 16 degrees |
| Articulation:- Fowler(electric) | Available option, not in conjunctionwith Prime X option | None |
| - Fowler(manual) | 0-90 degrees | 0 - 90 degrees |
| - Knee Gatch | 0-40 degrees, not in conjunction withPrime X option | 0 - 35 degrees |
| Siderails- Length | Glideaway collapsible siderails54" | Glideaway collapsible siderails54" |
| - Height | 12" (Prime X Option); 14" | 14" |
| - In-Rail Controls | Available option, not in conjunctionwith Prime X option | None |
| - Patient Lock-out | Available option, not in conjunctionwith Prime X option | None |
| Lift System | Manual Hydraulic pedestal jacks | Manual Hydraulic pedestal jacks |
| Brake and Steer | Located at head/foot end4 caster brake system | Located at head/foot end4 caster brake system |
| Mobility- Zoom Drive | Drive-assisted "Big Wheel" –controlled by the caregiver | Drive-assisted "Big Wheel" - controlled by thecaregiver |
| - Push ControlHandles | Electrical push handles used tomaneuver loaded/unloaded stretcher | Electrical push handles used to maneuverloaded/unloaded stretcher |
| - Performance onRamps (Grades) | Drive-assisted "Big Wheel" will aid thehealthcare user | Drive-assisted "Big Wheel" will aid the healthcareuser |
| Zoom DriveSpeed | Healthcare user sets the speed of thestretcher using the push control handles | Healthcare user sets the speed of the stretcher usingthe push control handles |
| Casters- Diameter | 8" | 8" |
| - Casters | Covered | Covered/Uncovered available |
| Mattress | 3" h (standard), 4", & 5" h optional (5"not available in conjunction with PrimeX option) | 3" h (standard), 4" & 5" h (optional) |
| Energy Source -Charging System | 120 V, 60Hz, 4 A | 120 V, 60Hz, 4 A |
| Energy Source -Battery | 2 x 12 V, 31Ah Battery | 2 x 12 V, 31Ah Battery |
| Materials- Stretcher | Cold Rolled Steel, Hot Rolled Steel,HDPE Plastic, Glass FilledPolypropylene Plastic, ABS Plastic,Rigid PU Foam, Aluminum,Powdercoat paint | Low Carbon Steel, Fiber-Resin or Low Carbon SteelLitter Panels, Siderails are chrome-plated lowcarbon steel with plastic or low carbon steel toprail. |
| - Mattress | Polyurethane foam with vinyl or | Polyurethane foam with vinyl or polyurethane- |
:
.
(
{4}------------------------------------------------
| polyurethane-coated nylon covering. | coated nylon covering. | |
|---|---|---|
| ManualOverrides | All manual overrides | All manual overrides |
| StandardOperatingConditions | ||
| - Storage | Temp: -4°F to +140°F, Rel Humidity –Up to 95% | Temp: -32°F to +140°F, Rel Humidity – Up to100% (non-condensing) |
| - Operation | Temp: 50°F to 100°F, Rel Humidity –30% to 75% RH | Temp: 60°F to 100°F, Rel Humidity – 0% to 60%RH (non-condensing) |
| Sterility | Device is not intended to be sterilized | Device is not intended to be sterilized |
| X-Ray Surface | Articulating radiographic patientsupport surface and platform | Optional radiolucent surface via X-Ray CassetteHolder (Fowler) |
SUMMARY
Stryker Medical has verified and validated that the Prime Series® Stretcher with Zoom® Motorized Drive meets its functional, performance, safety, and efficacy specifications and requirements. Physical and mechanical testing has been performed on individual components and on the system, including Software testing that has been completed. The Prime Series Stretcher with Zoom® Motorized Drive has successfully passed bench and software testing, Test results demonstrate that both the individual units and system meet specified performance requirements.
The Prime Series Stretcher with Zoom Motorized Drive has been designed and evaluated according to the following FDA Recognized and international Standards:
- AAMI/ANSI/ISO 10993-1: 2009; Biological Evaluation of Medical Devices -- Part 1: Evaluation and . Testing within a Risk Management Process
- ISO 10993-2: 2006; Biological Evaluation of Medical Devices -- Part 2: Animal Welfare Requirements .
- AAMI/ANSI/ISO 10993-5: 2009; Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro . Cytotoxicity
- AAMI/ANSI/ISO 10993-10: 2010; Biological Evaluation Of Medical Devices Part 10: Tests For Irritation . And Skin Sensitization
- ISO 10993-11: 2006; Biological Evaluation Of Medical Devices Part 11: Tests For Systemic Toxicity .
- AAMI/ANSI ES 60601-1: 2005/(R)2012 and C1:2009(R)2012 and A2:2010/(R)2012 ; Medical Electrical . Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- . IEC 60601-1-2 Edition 3:2007-03; Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
- . IEC 60601-1-3 Edition 2.0 2008-01, Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment
{5}------------------------------------------------
- IEC 60601-2-52 Edition 1.0 2009-12, Medical Electrical Equipment Part 2-52: Particular Requirements . For Basic Safety And Essential Performance Of Medical Beds
- . IEC 60601-2-54 Edition 1.0 2009-06, Medical Electrical Equipment - Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Radiography And Radioscopy
Based on the Prime Series® Stretcher with Zoom Motorized Drive and predicate design, operational and technical characteristics and completed bench testing, the Prime Series® Stretcher with Zoom® Motorized Drive is substantially equivalent to and as safe and effective as that of the predicate device. The Prime Series with Zoom Motorized Drive's intended uses are substantially supported by the previously cleared predicate device. Any differences described between the Prime Series® Stretcher with Zoom® Motorized Drive and the predicate device does not raise any new issues of safety or effectiveness. The Prime Series® Stretcher with Zoom Motorized Drive's indication for use statement includes all of the same indications as the previously cleared predicate device.
CONCLUSION
In summary, Stryker Medical has demonstrated that the Prime Series® Stretcher with Zoom® Motorized Drive is as safe and effective as and is substantially equivalent to the predicate device.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2014
Stryker Corporation - Medical Division c/o Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K140095
Trade/Device Name: Prime Series® Stretcher with Zoom® Motorized Drive Regulation Number: 21 CFR 890.3690 Regulation Name: Powered Wheeled Stretcher Regulatory Class: Class II Product Code: INK Dated: March 19, 2014 Received: March 28, 2014
Dear Mr. Job:
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.
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
{7}------------------------------------------------
Page 2 - Mr. Mark Job
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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
•
{8}------------------------------------------------
Indications for Use
510(k) Number (if known) K140095
Device Name
Prime Series® Stretcher with Zoom® Motorized Drive
Indications for Use (Describe)
The Prime Series® Stretcher with Zoom® Motorized Drive is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications, such as short-term outpation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to critically ill. The Prime Series® Stretcher with Zoom® Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility.
The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
ം Date: 2014.05.20 15:38:03
2014.05.2014.05.20 15:38:03
2014.05.2014.05.20 15:38:03
2014.05.2014.05.2014.05.2014.00
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§ 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.