(83 days)
the device is a motorized device intended for medical purposes to assist in transfer of patient to and from beds, chairs, treatment facilities. wheelchairs or transport vehicles.
the Savion Industries "Medi-Cruiser" model MS777 Stretcher is a motorized patient transport stretcher / trolley. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
The provided text is for a 510(k) summary for a "Motorized Patient Transport Stretcher" (Savion Industries "Medi-Cruiser" Model MS777). This type of device is a physical medical instrument, not a software device or an AI model, and therefore the concepts of acceptance criteria, study data, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable in the way they would be for an AI/ML medical device.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and compliance with safety standards for electrical and electromagnetic compatibility, as well as quality systems regulations.
Here's how to interpret the provided information in the context of a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
For this device, "acceptance criteria" and "reported device performance" are primarily related to compliance with recognized medical device standards and demonstrating equivalence to existing legally marketed devices, rather than statistical performance metrics like sensitivity or specificity.
| Acceptance Criterion (Compliance Objective) | Reported Device Performance (Demonstrated Compliance) |
|---|---|
| Substantial Equivalence: To predicate devices (Stryker ZOOM® Motorized Stretchers / Hausted POWERTRAN series stretcher) in function, intended use, basic technology, and performance characteristics. | The submission explicitly states: "The Savion Industries "Medi-Cruiser" MS777 Stretcher is substantially equivalent to the ZOOM® Motorized Stretchers and to The Hausted® POWERTRAN M Series Stretcher in function and intended use." "Any minor differences described in the submission between the Savion Industries "Medi-Cruiser" MS777Stretcher 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 systems are the same." The FDA's 510(k) clearance letter confirms this finding: "We have... determined the device is substantially equivalent...". |
| Electrical Safety: Compliance with general requirements for safety of medical electrical equipment. | The device is designed to assure compliance with IEC 60601-1 (Electrical Safety). Electrical testing is certified by an accredited testing facility. The stretcher will comply with voluntary standard IEC 60601-1 (1988, Amendment 1 1991-11, Amendment 2 1995-03) and UL 2601-1 (2nd Ed.) and CAN/CSA C22.2 No. 601.1-M90. |
| Electromagnetic Compatibility (EMC): Compliance with EMC requirements and tests. | The device is designed to assure compliance with IEC 60601-1-2 (Electromagnetic Compatibility). The stretcher will comply with voluntary standard IEC 60601-1-2 (First Edition, 1993-04). |
| Quality System Compliance: Adherence to established quality management standards for medical devices. | 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 ISO 9001:2000 and ISO 13485 Quality Systems Regulations. Design controls have been applied in accordance with FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. An assessment of known and reasonable hazards has been conducted to ensure that any risk is as low as reasonably possible. |
| Risk Management/Hazard Assessment: Identification and mitigation of known and reasonable hazards. | 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. |
| Labeling and Manuals: Provision of clear and safe operation information. | The labels and labeling (Operator's and Maintenance Manuals) provide information for the safe operation by the caregiver/user and the intended operation features. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. For a physical device like a stretcher, performance is evaluated through engineering tests (e.g., electrical safety, EMC, mechanical load testing) rather than a "test set" of data points. These tests typically involve a specific number of units from the production line or prototypes to verify compliance with standards. The document doesn't specify the number of units tested.
- Data Provenance: Not applicable in the context of an AI/ML device. The "data" here refers to test results from physical device testing, which would be generated in a lab setting, likely in Israel (where Savion Industries is located) or by an accredited international testing body. It's a prospective testing process on physical devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts & Qualifications: Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on images) is not relevant for this device. The "truth" is established by adherence to engineering performance standards and regulatory requirements. The "experts" involved would be the engineers performing the tests, the quality assurance team, and the regulatory affairs personnel ensuring compliance. A design review was conducted by a "cross-functional team, including but not limited to regulatory, quality, engineering, technical writing and manufacturing."
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There is no ambiguous "ground truth" that requires adjudication. Tests either pass or fail based on objectively defined criteria in the standards (e.g., leakage current levels, mechanical stability).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Study: Not applicable. MRMC studies are used to evaluate the performance of diagnostic devices, often AI-assisted, by comparing human reader performance with and without AI assistance across multiple cases. This is a motorized stretcher, a therapeutic/transport device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: Not applicable. This is a physical medical device. There is no algorithm or AI component to assess for standalone performance. The "device" itself operates with human interaction (caregivers).
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable in the AI/ML sense. For this device, the "ground truth" is defined by:
- Regulatory Standards: (e.g., IEC 60601-1, IEC 60601-1-2, UL 2601-1, CAN/CSA C22.2 No. 601.1-M90, FDA 21 CFR 820.30, ISO 9001:2000, ISO 13485).
- Predicate Device Performance: The "truth" of what is safe and effective is established by the existing, legally marketed predicate devices to which the new device demonstrates substantial equivalence.
- Engineering Specifications: Internal design and performance specifications against which the device is tested.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. There is no "training set" for a physical medical device in the AI/ML context. The design and manufacturing process are informed by engineering principles, industry best practices, and regulatory standards, not by machine learning training data.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As there's no training set, there's no associated ground truth to establish.
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9/28/05
510(k) Summary for the Savion Industries "Medi-Cruiser" Model MS777
Date: April 13, 2011
510(k) SUMMARY PERTAINING TO THE SAFETY AND EFFECTIVENESS OF the Savion Industries "Medi-Cruiser" Model MS777 Submitter Information:
..............................................................................................................................................................................
Savion Industries (1987) Ltd P.O.B 4076. Ashdod Israel 77140 Date Summary Prepared: May 22 2005 Name of the device: the Savion Industries "Medi-Cruiser" Model MS777
Common or usual name of the device: Motorized Patient Transport Stretcher Classification name of the device: Powered Patient Transport Predicate Device: Stryker ZOOM® Motorized Stretchers /Hausted
POWERTRAN series stretcher
Device Description: the Savion Industries "Medi-Cruiser" model MS777 Stretcher is a motorized patient transport stretcher / trolley. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
The FDA has classified powered patient transports as a Class II device.
The Savion Industries "Medi-Cruiser" MS777 Stretcher is designed to assure compliance with IEC 60601-1
(Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
The device will also carry the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings.
Electrical testing is certified by the accredited testing facility shown at the end of this certification.
Software testing is being certified by .......................................................................................................................................
Intended Use: This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
The FDA has classified the device as a Class IL device.
Device Comparison: the Savion Industries "Medi-Cruiser" MS777Stretcher is substantially equivalent
to the ZOOM® Motorized Stretchers and to The Hausted® POWERTRANI M Series Stretcher in function and intended use.
Any minor differences described in the submission between the Savion Industries "Medi-Cruiser" MS777Stretcher 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 systems are the same.
The device does not contact the patient, so biocompatibility is not a concern.
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The subject stretcher is intended to be used in any clinical environment where patient care is administered. Health facilities ordinarily use stretchers for patient treatment, recovery and for transportation to and from treatment modalities, i.e., physical therapy, diagnostic radiography, 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 ISO 9001:2000 and ISO 13485 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 controls have been applied in accordance with FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001.
Design review has been conducted by a cross-functional team, including but not limited to
regulatory, quality, engineering, technical writing and manufacturing.
The stretcher will comply with the following voluntary standards:
- IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.
1988 (General), Amendment 1, 1991-11, Amendment 2, 1995-03
U IEC 60601-1-2. (First Edition, 1993-04), Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests (General)
m UL 2601-1
(2nd Ed.) Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
U CAN/CSA C22.2 No. 601.1-M90 Standard for Medical Electrical Equipment
The subject stretcher and predicate stretcher included in this submission are substantially equivalent.
Prepared by:
Mr. Steli Loznen. M.Sc. Head of Medical Devices Safety Branch Savion Industries, LTD. P.O. Box 4076, Ashdod Israel 77140
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" arranged in a circular fashion around the emblem.
Public Health Service
SEP 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steli Loznen, M.Sc. Head of Medical Devices Safety Branch Savion Industries, LTD. P.O. Box 4076, Ashdod Israel 77140
Re: K051861
Trade/Device Name: The SAVION INDUSTRIES "MEDI-CRUISER" MODEL MS777 Regulation Number: 21 CFR 890.3690 Regulation Name: Powered wheeled stretcher Regulatory Class: II Product Code: INK Dated: September 12, 2005 Received: September 12, 2005
Dear Mr. Loznen:
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 cnactment 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. Iisting 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 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); 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.
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Page 2 - Mr. Steli Loznen, M.Sc.
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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may chtain 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/dsmamoin/html
Sincerely yours,
Mark A. Millburn
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Att. 4
Intended Use
510(k) Number (if known):
Device Name:THE SAVION INDUSTRIES "MEDI-CRUISER" MODEL MS777
Indications For Use: the device is a motorized device intended for medical purposes to assist in transfer of patient to and from beds, chairs, treatment facilities. wheelchairs or transport vehicles.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
| (Division Sign-Off)Division of General, Restorative,and Neurological Devices | |||
|---|---|---|---|
| Page 1 of 1 | 510(k) NumberK051861 | 510(k) Number | K051861 |
| 510(k) Number | K051861 |
రా
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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.