(28 days)
The TransMotion Medical Model TMM6 Power Drive Chair is intended to provide a method of transporting patients within health care facilities.
The TransMotion Medical TMM6 Power Drive Chair is designed for use in short term (≤ 23 hours) health care facilities. Its' intended use is to provide a method of transporting patients within the facility.
The TransMotion Medical, Inc. TMM6 Power Drive Chair (TMM6) is a battery powered device designed for use in short term (≤ 23 hours) patient care facilities. Its intended function and use is to transport patients within the confines of the facility, where patient function and use is to transport patient used to support the patient during examinations, care is boing administer clinical activity which may take place in the facility.
The TMM6 is unique in that it can support and transport patients in either a supine The TMMO is unique in that it can supportures 1 and 2 below). This enhances patient (laying) poregivers and also provides for greater patient comfort.
The provided 510(k) Premarket Notification for the TransMotion Medical TMM6 Power Drive Chair does not contain the detailed information necessary to complete most of the requested table and study details. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria and specific test results from a clinical trial.
Here's an analysis of what information can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Compliance with IEC 60601-1 (General Requirements for Safety) | Stated compliance with IEC 60601-1. No specific test results or pass/fail thresholds are provided. |
| EMC: Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | Stated compliance with IEC 60601-1-2. No specific test results or pass/fail thresholds are provided. |
| Intended Use: Transporting patients within health care facilities for short-term use (≤ 23 hours), supporting and transporting patients in supine or seated positions. | Device description states it is "designed for use in short term (≤ 23 hours) patient care facilities" and "can support and transport patients in either a supine (laying) or seated position." This reflects the intended use, but no specific performance metrics (e.g., transport distance, speed, stability) are given. |
| Substantial Equivalence: To predicate device Stryker Powered Wheeled Stretcher (K022309). | Submitted for classification as substantially equivalent to the predicate. This is the primary "performance" being demonstrated for regulatory purposes. |
Missing from the document concerning acceptance criteria and performance:
- Quantitative performance metrics: The document lacks specific, measurable acceptance criteria for aspects like battery life, weight capacity, maneuverability, braking effectiveness, stability, patient comfort scores, or reliability data.
- Actual test results: While it states "compliance" with standards, detailed results demonstrating this compliance (e.g., EMC emission levels, safety test outcomes) are not provided.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/not provided. This 510(k) submission primarily relies on demonstrating compliance with voluntary standards and substantial equivalence to a predicate device, not on clinical performance data from a specific test set of patients or users.
- Data provenance: Not applicable/not provided. There is no mention of country of origin or whether data would be retrospective or prospective because a clinical study with a test set as commonly understood for AI/diagnostic devices was not performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of a test set requiring ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is mentioned.
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
- No. This device is a powered patient transport chair, not an AI-assisted diagnostic or operative device that would involve human "readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. This device does not generate diagnostic output that requires ground truth validation. The "truth" in this context is the chair's ability to safely and effectively perform its stated functions, which would be assessed through engineering and safety testing against defined specifications.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device and Approval Process:
The TransMotion Medical TMM6 Power Drive Chair is a battery-powered device designed for transporting patients within healthcare facilities for short durations (≤ 23 hours). It can support patients in both supine and seated positions. The 510(k) submission primarily establishes substantial equivalence to a predicate device, the Stryker Powered Wheeled Stretcher (K022309), and states compliance with IEC 60601-1 (General Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) standards. The FDA's letter confirms that based on the provided information, the device is substantially equivalent, permitting its marketing. The approval process for such a device would heavily rely on engineering testing to confirm safety, electrical performance, mechanical integrity, and functional performance against its design specifications and relevant voluntary standards. Clinical trials or performance studies with patient outcomes data, as might be seen for novel diagnostic or therapeutic devices, are not typically required for this type of device seeking 510(k) clearance based on substantial equivalence.
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TransMotion
MEDICAL INC
MAY 1 1 2009
510(k) Premarket Notification
TMM6 Series Power Drive Chair
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
TransMotion Medical, Inc. 1441 Wolf Creek Trail Sharon Center, Ohio 44274 Phone: (866) 860-8447 Fax: (330) 239-4465
Contact Person: Ralph Rogers General Manager TransMotion Medical, Inc.
April 5, 2009 Date Prepared:
Name of Device
TMM6 Power Drive Chair
Common or Usual Name
Stretcher
Classification Name
Powered Wheeled Stretcher
Predicate Device
Stryker Powered Wheeled Stretcher (K022309)
Intended Use
The TransMotion Medical Model TMM6 Power Drive Chair is intended to provide a method of transporting patients within health care facilities
Device Description
The TransMotion Medical, Inc. TMM6 Power Drive Chair (TMM6) is a battery powered device designed for use in short term (≤ 23 hours) patient care facilities. Its intended
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Image /page/1/Picture/0 description: The image shows the logo for TransMotion Medical Inc. The logo features a stylized "T" formed by a curved line and a straight line, enclosed within a partial circle. To the right of the "T" is the text "TransMotion" in a bold, sans-serif font, with "MEDICAL INC" in a smaller font below it.
510(k) Premarket Notification
TMM6 Series Power Drive Chair
function and use is to transport patients within the confines of the facility, where patient function and use is to transport patient used to support the patient during examinations, care is boing administer clinical activity which may take place in the facility.
The TMM6 is unique in that it can support and transport patients in either a supine The TMMO is unique in that it can supportures 1 and 2 below). This enhances patient (laying) poregivers and also provides for greater patient comfort.
Substantial Equivalence
The TransMotion Medical, Inc. TMM6 Power Drive Chair is substantially equivalent to The TransModon Mcarable type that are currently being legally marketed within the other devices of computable type ubstantially equivalent to the Stryker Powered Wheel Stretcher (K022309).
Performance Data
The TMM6 Power Drive Chair will comply with the following voluntary standards;
- Medical Electrical Equipment Part 1: General Requirements for IEC 60601-1 Safety 1: Safety Requirements for Medical Electrical Systems
- Medical Electrical Equipment Part 1: General Requirements for IEC 60601-1-2 Safety 2: Electromagnetic Compatibility -- Requirements and Tests
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAY 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
TransMotion Medical, Inc. % Mr. Ralph Rogers General Manager 1441 Wolf Creek Trail Sharon Center, Ohio 44274
Re: K091043
Trade Name: TransMotion Medical, Inc. Model TMM6 Power Drive Chair Regulation Number: 21 CFR 890.3690 Regulation Names: Powered wheeled stretcher Regulatory Class: II Product Code: INK Dated: April 6, 2009 Received: April 13, 2009
Dear Mr. Rogers:
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 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. Ralph Rogers
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
For Peter m.
Dep D.e
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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Indications for Use
510(k) Number (if known): TBD
Device Name: TransMotion Medical, Inc. Model TMM6 Power Drive Chair
Indications for Use:
The TransMotion Medical TMM6 Power Drive Chair is designed for use in short term (≤ 23 hours) health care facilities. Its' intended use is to provide a method of transporting patients within the facility.
Prescription Use (Part 21 CFR 801 Subpart D)
、 %.
Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C)
X(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091043
§ 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.