(35 days)
To assist persons who have difficulty rising from a seated position to a standing position.
The EasyStand Evolv is a modular standing frame for indoor use that allows users with various degrees of physical disability to be supported in a standing, weight-bearing position. The device is modular and is configured around a centralized seat. It incorporates pivot points that allow a user to rise from a fully seated to a fully standing position. Pivot action is such that shear the user, seat and seat back is minimized. Device is modular in that multiple uses of the device can be accommodated depending on the overall configuration of the device. Current modules allow for passive standing (Basic), workstation use at an elevated or seated position (Shadow Support Tray) and standing with leg exercise (Glider). Elevation action is provided by one of two means. The standard device utilizes a user controlled hydraulic pump. The optional electrical version uses a low voltage motor-driven linear actuator that is powered by two 12-Volt batteries and actuated by a hand held control pendant. On the electrical version, the patient or a care provider activates the hand held control pendant to change the position of the seat. The electric version also provides an emergency release. Recharge of batteries is accomplished by connection of an external battery charger to the control pendant. The EasyStand Evolv is designed for indoor use and will accommodate individuals ranging in height from 5' to 6'2" (152cm - 188 cm) and up to 280lbs (127kg)
The provided text describes a 510(k) summary for the EasyStand Evolv, an electric positioning chair. It details the device's functionality, intended use, and its substantial equivalence to predicate devices, in addition to performance standards it was tested against. However, the document does not contain information about a study proving the device meets specific acceptance criteria in the way typically associated with AI/ML medical devices (e.g., performance metrics based on sensitivity, specificity, accuracy, or comparative effectiveness studies with human readers).
Instead, the "acceptance criteria" here refer to compliance with established safety and electrical standards for medical devices and demonstrating substantial equivalence to legally marketed predicate devices.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent or not applicable in this context:
Acceptance Criteria and Device Performance (Based on Regulatory Compliance)
| Acceptance Criteria | Reported Device Performance (Compliance) |
|---|---|
| Safety Standards Compliance: - BS EN 12182:1999 Part 1 - IEC/EN 60601-1: 1998; A1:1991; A2:1995 Part 1 - UL 60601-1:2003 First Edition - CAN/CSA 22.2 No. 601.1-M90 | The manufacturer "has chosen to test the EasyStand Evolv against these standards." The FDA's 510(k) clearance implies successful adherence to these standards for safety. |
| Substantial Equivalence to Predicate Devices: - Altimate Medical StandEX (K885343) - Invacare Lift Chair (K002171) | The FDA determined the device is "substantially equivalent" to the predicate devices for its intended use, construction, and functionality, particularly regarding the power lift feature and supporting a person in a standing position. Key differences (e.g., battery vs. AC power, seat material, exercise functionality) were acknowledged but did not preclude substantial equivalence. |
| Intended Use: To assist persons who have difficulty rising from a seated position to a standing position. | Functionality description supports this intended use, allowing users to rise from seated to standing with minimal shear. |
| Weight Capacity: 280 lbs. (127kg) | Device is designed to accommodate individuals up to 280 lbs. |
| Height Accommodation: 5' to 6'2" (152cm - 188 cm) | Device is designed to accommodate individuals within this height range. |
Study Details (Information Not Provided for AI/ML-style studies)
The provided text describes a regulatory submission for a physical medical device (an electric positioning chair), not an AI/ML algorithm or software as a medical device. Therefore, many of the requested details about statistical studies (sample size for test/training, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable or not present in this type of document.
- Sample size used for the test set and the data provenance: This information is not provided. The "testing" referred to is against safety and electrical standards, not performance against a diagnostic or predictive ground truth using a clinical test set.
- 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 "ground truth" establishment in a clinical evaluation sense for this device.
- 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device affecting human reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device with direct user interaction.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic/predictive performance. The "ground truth" for this device would be its ability to physically perform its described functions safely and effectively (e.g., lift a person of a certain weight, meet electrical safety standards), which is assessed through engineering and compliance testing rather than clinical data comparison to a true diagnosis.
- The sample size for the training set: Not applicable. There is no "training set" for this type of physical device.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) summary focuses on demonstrating the EasyStand Evolv's safety and effectiveness through compliance with recognized standards and substantial equivalence to existing predicate devices. It is not an AI/ML device, and thus, typical performance study metrics and methodologies for AI are not found in this document.
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510(K) SUMMARY FOR ALTIMATE MEDICAL'S EASYSTAND EVOLV
This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
The assigned 510(k) number is
Date: August 15, 2006
Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190
Manufacturer: Altimate Medical Registration No. 2183634 262 West First St. Morton, MN 56270
Telephone: 440-326-3115 Fax: 440-326-3607
Contact Person: Mr. Ronald Clines
Trade Name: EasyStand Evolv
Common Name: Electric lift chair
Classification Name: Chair, positioning, electric per 21 CFR 890.3110
Legally Marketed Predicate Device(s): Altimate Medical StandEX; K885343, May 1, 1989 Invacare Lift Chair; K002171, August 10, 2000
Device Description: The EasyStand Evolv is a modular standing frame for indoor use that allows users with various degrees of physical disability to be supported in a standing, weight-bearing position. The device is modular and is configured around a centralized seat. It incorporates pivot points that allow a user to rise from a fully seated to a fully standing position. Pivot action is such that shear the user, seat and seat back is minimized. Device is modular in that multiple uses of the device can be accommodated depending on the overall configuration of the device. Current modules allow for passive standing (Basic), workstation use at an elevated or seated position (Shadow Support Tray) and standing with leg exercise (Glider).
Elevation action is provided by one of two means. The standard device utilizes a user controlled hydraulic pump. The optional electrical version uses a low voltage motor-driven linear actuator that is powered by two 12-Volt batteries and actuated by a hand held control pendant. On the electrical
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version, the patient or a care provider activates the hand held control pendant to change the position of the seat. The electric version also provides an emergency release. Recharge of batteries is accomplished by connection of an external battery charger to the control pendant.
The EasyStand Evolv is designed for indoor use and will accommodate individuals ranging in height from 5' to 6'2" (152cm - 188 cm) and up to 280lbs (127kg)
Models available EasyStand Evolv - Basic EasyStand Evolv - Glider EasyStand Evolv- Shadow Support Tray
Supporting these three basic models are additional seating, postural supports and positional attachments that allow proper fit of the device to accommodate a patients particular medical condition. The powered lift feature (Pow'r Up) can be added to any of the three basic models. Fit of the device is to be determined only by a qualified therapist or physician.
Intended Use: To assist persons who have difficulty rising from a seated position to a standing position.
Substantial Equivalence: Products that are substantially equivalent to the Altimate Medical EasyStand Evolv are the Altimate Medical StandEx (K885343, May 1, 1989) and the Invacare Lift Chair (K002171, August 10, 2000).
The EasyStand Evolv is comparable to both the Invacare Lift Chair and the StandEx. It is comparable to the StandEx device in its intended use, construction and functionality. The intended use of providing support for a person in a standing position, providing a means for a person to rise from a seated to a fully standing position and offering a method of exercising the body (the Glider model) remains the same between the two devices. The difference between the two devices is the addition of the power lift feature. This power lift feature is comparable to the lift feature in the Invacare Lift Chair in that they both use an electrically powered, low voltage DC, linear mechanical worm drive actuated via a hand held pendant to adjust the seat. Both devices also have the same intended use. The differences between the EasyStand Evolv and the Invacare Lift Chair are that the main electrical power input needed to operate the actuators comes from a battery for the EasyStand Evolv, but for the Invacare Lift Chair, it comes from AC power converted to low voltage DC power; the fact that the EasyStand Evoly seat is covered with Dartex (a polyurethane transfer coating on weft knitted fabric) and the Invacare Lift Chair has a fabric upholstered seat; that the Invacare Lift Chair offers no method of exercise; and that the EasyStand Evolv supports the user to allow for passive standing.
Performance Standards: Although no performance standards or special controls have been developed under Section 514 of the FDC Act for electric positioning chairs, Altimate Medical has chosen to test the EasyStand Evolv against the following standards:
BS EN 12182:1999 Part 1 Medical Electrical Equipment General Requirements for Safety IEC/EN 60601-1: 1998; A1:1991; A2:1995 Part 1 Medical Electrical Equipment General Requirements for Safety
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UL 60601-1:2003 First Edition and CAN/CSA 22.2 No. 601.1-M90 Standard for Electrical Medical Equipment Part 1: General Requirements for Safety
| Features | EasyStand Evolv | Invacare Lift Chair | StandEx |
|---|---|---|---|
| Manufacturer | Altimate Medical | Invacare Corporation | Altimate Medical |
| 510(k) Number | TBD | K002171 | K885343 |
| Classification/Product Code | 890.3110 / INO | 890.3110 / INO | 890.5370 / ION |
| Date Cleared | TBD | August 10, 2000 | May 1, 1989 |
| Class | Class II | Class II | Class I |
| Intended Use | To assist persons who have difficulty rising from a seated position to a standing position | To assist persons who have difficulty rising from a seated position to a standing position | To assist persons to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. |
| Basic Construction | Steel Tubing / Plastic / Vinyl | Steel Tubing/Wood/Fabric | Steel Tubing / Plastic / Vinyl |
| Energy Requirements | Standard: Manual pump actionElectrical option: 24 Volt Battery (2) | AC-Power converted to low voltage DC | Manual pump action |
| Weight Capacity | 280 lbs. | 350 lbs. | 300 lbs. |
| Mechanical Action | Standard: hydraulic oil cylinderElectrical option: DC linear mechanical worm drive | AC linear mechanical worm drive | Hydraulic oil cylinder |
Substantial Equivalence Discussion
The EasyStand Evolv is comparable to the StandEx device in its intended use, construction and functionality. The intended use of providing support for a person in a standing position, providing a means for a person to rise from a seated to a fully standing position and offering a method of exercising the body (the Glider model) remains the same between the two devices. The difference between the two devices is the addition of the power lift feature. This power lift feature is comparable to the lift feature in the Invacare Lift Chair in that they both use an electrically powered, low voltage DC, linear mechanical worm drive actuated via a hand held pendant to adjust the seat. Both devices also have the same intended use. The differences between the EasyStand Evolv and the Invacare Lift Chair are that the main electrical power input needed to operate the actuators comes from a battery for the EasyStand Evolv, but for the Invacare Lift Chair, it comes from AC power converted to low voltage DC power; the fact that the EasyStand Evolv seat is covered with Dartex (a polyurethane transfer coating on weft knitted fabric) and the Invacare Lift Chair has a fabric upholstered seat; that the Invacare Lift Chair offers no method of exercise; and that the EasyStand Evolv supports the user to allow for passive standing.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement around the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2006
Ivacare Corporation % Mr. Ronald Clines One Invacare Way Elyria, Ohio 44035
Re: K062402
Trade/Device Name: EasyStand Evolv Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: August 15, 2006 Received: August 17, 2006
Dear Mr. Clines:
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. Ronald Clines
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 obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers; International and Gonsumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Raibara Buemp
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: EasyStand Evolv
Indications for Use: To assist persons who have difficulty rising from a seated position to a standing position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Barbara Pouend
(Division Si: Off) Division of Ceueral, Restorative, anu Neurological Devices
Page 1 of _
510(k) Number K062472
Altimate Easy Stand Evolv 510k Submission Page 9
§ 890.3110 Electric positioning chair.
(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair 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 non-clinical 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 non-clinical 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 non-clinical 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 non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.