(156 days)
ThyssenKrupp Accessibility's Battery Operated Stair Lift LEVANT is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down straight stairs, indoors and outdoors.
Levant/ HomeGlide is a stair lift for transport of one person up and down straight stairs. The system consist of a drive unit, a foldable footrest and an aluminum rail that is fixed on the stairs. The system can be fixed on either sides of the stairs. It is available standard with a manual swivel for easy getting on and off the seat. It comes with a padded seat. A hinged rail, a heavy duty drive and a intermediate park position are available as options. The Comfort Option provides a premium positioned chair lift with extra options: straight or curved armrests, luxurious seat, fabric- vinyl- or leather upholstery, adjustable seat height, and a powered swivel. The Outdoor Option provides a stair lift for outdoor use in both cold and warm climates. The Outdoor option is created by adding a waterproof control, a waterproof cover, coated electronics, coated switches, waterproof charging contacts and a step up transformer.
The provided text is a 510(k) summary for a medical device called the "LEVANT/HOMEGLIDE" Battery Operated Stair Lift for Straight Stairs. This document does not describe a study to prove the device meets acceptance criteria, but rather a comparison to a predicate device to establish substantial equivalence.
Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert involvement, and statistical analyses) are not applicable to the information provided. The document outlines a product comparison rather than a performance study with specific acceptance criteria that would typically be described for software or AI-driven medical devices.
Here's how to address the questions based on the provided text, noting its limitations:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) premarket notification focusing on substantial equivalence to a predicate device rather than a study with defined acceptance criteria and performance against those criteria, a direct "acceptance criteria" table as typically seen in performance studies is not present. Instead, the document compares the technical characteristics of the proposed device to a predicate device to demonstrate equivalence.
Here’s a summary of the comparative characteristics, which implicitly serve as the basis for "performance" from an equivalence standpoint:
| Characteristic | Predicate Device (Bruno SRE-3000/SRE-2000) Performance | Proposed Device (ThyssenKrupp Accessibility Levant) Reported Performance | Discussion / Equivalence |
|---|---|---|---|
| Standards | ASME 18.1 | ASME 18.1 | Equivalent |
| Application | Straight stairs | Straight stairs | Equivalent |
| Rated Load (max) | 181 kg | 146 kg | Both exceed minimum standards; close enough for equivalence |
| Passengers | 1 | 1 | Equivalent |
| Power | 2 pieces 7AH 12 Battery | 2 pieces 7AH 12 Battery | Equivalent |
| Charger | 24VDC/ 2A | Ind: 24VDC/ 1700 mA; Outd: 6 VAC | Different, but considered equivalent based on function |
| Drive | Direct drive worm gear motor | Direct drive worm gear motor | Equivalent |
| Final Drive | 8dp gear rack with spur gear | 8dp gear rack with spur gear | Equivalent |
| Braking | Dynamic, worm gear, el/mech brake | Dynamic, worm gear, el/mech brake | Equivalent |
| Call & Send | IR | IR | Equivalent |
| Control | 3-position momentary rocker switch | 3-position momentary rocker switch | Equivalent |
| Supports | Anchored to stair thread | Anchored to stair thread | Equivalent |
| Angle (max) | 22 to 45 degrees, specials up to 52 | 28 to 53 degrees, heavy duty to 45 | Small difference, caused by design, considered equivalent |
| Speed | 0.08 m/s | 0.12 m/s | Both below standards max; Proposed device is 50% faster but still acceptable |
| Track length (max) | 6.1 meters max | 7.5 meters max | Proposed device offers more length, but both meet implicit needs |
| Construction Rail | Aluminum extrude rail (Indoor), Exterior grade powder coated steel rail (Outdoor) | Anodized aluminum extrude rail (Indoor/Outdoor) | Different materials, but both fulfill safety requirements |
| Safety devices | Multiple | Multiple | Equivalent |
| Footrest | Folding type | Folding type | Equivalent |
| Seat | Folding type | Folding type | Equivalent |
| Indoor use | Yes | Yes | Equivalent |
| Outdoor use | Yes | Yes | Equivalent |
| Temp Range Indoor | Not specified | +5°C to +40°C (41°F to 104°F) | Information provided for proposed device |
| Temp Range Outdoor | -5°C to +50°C (25°F to 125°F) | -15°C to +60°C (5°F to 140°F) | Differences discussed, but considered acceptable |
| Construction Chair | Stainless steel (Outdoor) | ABS Synthetic material (Outdoor) | Different materials, but considered equivalent |
| Electrical Enclosure | IPx3 | IPx5 | Proposed device meets higher standard (EN 81-40 requirement), considered acceptable |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a premarket notification for substantial equivalence, not a clinical or performance study involving a test set of data. The "comparison" is based on the technical specifications of the devices themselves, not on collected data from a test set.
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)
Not applicable. There is no test set or ground truth established by experts described in this document. The assessment is based on a technical review by the manufacturer and subsequently the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or related adjudication method is described.
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
Not applicable. This device is a mechanical stair lift, not an AI or imaging device that would involve human readers or comparative effectiveness studies of this nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth, as this document focuses on substantial equivalence based on technical specifications and adherence to standards (like ASME 18.1 and EN 81-40), rather than a diagnostic or analytical performance study.
8. The sample size for the training set
Not applicable. There is no training set mentioned or relevant for this type of mechanical device submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth described.
{0}------------------------------------------------
NOV. 1
510(k) SUMMARY as required by section 807.92(c)
| Submitted by: | ThyssenKrupp Accessibility BVVan Utrechtweg 992921 LN Krimpen aan den IjsselThe Netherlands |
|---|---|
| Contact: | Arnold van der HeidenMail: avanderheiden@tkacc.nlTel: +31 180 530900Fax: +31 180 530901 |
| Date prepared: | 10/05/2012 |
| Trade Names: | LEVANT/HOMEGLIDE |
| Common Device Name: | Battery Operated Stair Lift for Straight Stairs |
| Regulation Number | 890.5150 |
| Class | II |
| Product Code: | ILK |
| Submission | K121560 |
| Predicate Devices: | Stair Lift BRUNO Independent Living Aids INCK113308, K033438CER 890.5150 |
Promotional Product Description
Levant/ HomeGlide is a stair lift for transport of one person up and down straight stairs. The system consist of a drive unit, a foldable footrest and an aluminum rail that is fixed on the stairs. The system can be fixed on either sides of the stairs.
It is available standard with a manual swivel for easy getting on and off the seat. It comes with a padded seat. A hinged rail, a heavy duty drive and a intermediate park position are available as options.
The Comfort Option provides a premium positioned chair lift with extra options: straight or curved armrests, luxurious seat, fabric- vinyl- or leather upholstery, adjustable seat height, and a powered swivel.
The Outdoor Option provides a stair lift for outdoor use in both cold and warm climates. The Outdoor option is created by adding a waterproof control, a waterproof cover, coated electronics, coated switches, waterproof charging contacts and a step up transformer.
1 2017
{1}------------------------------------------------
Intended Use
ThyssenKrupp Accessibilty's Battery Operated Stair Lift Levant is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down straight stairs, indoors and outdoors.
Product Comparison Tables
Equivalent Technological Characteristics
| Bruno SRE-3000/ SRE-2000 | ThyssenKrupp Accessibility Levant | |
|---|---|---|
| Standards | ASME 18.1 | ASME 18.1 |
| Application | Straight stairs | Straight stairs |
| Rated Load | 181 kg | 146 kg |
| Passengers | 1 | 1 |
| Power | 2 pieces 7AH 12 Battery | 2 pieces 7AH 12 Battery |
| Charger | 24VDC/ 2A | Ind:24VDC/ 1700 mA Outd: 6 VAC |
| Drive | Direct drive worm gear motor | Direct drive worm gear motor |
| Final Drive | 8dp gear rack with spur gear | 8dp gear rack with spur gear |
| Braking | Dynamic, worm gear, el/mech brake | Dynamic, worm gear, el/mech brake |
| Call & Send | IR | IR |
| Control | 3-position momentary rocker switch | 3-position momentary rocker switch |
| Supports | Anchored to stair thread | Anchored to stair thread |
| Angle | 22 to 45 degrees, specials up to 52 | 28 to 53 degrees, heavy duty to 45 |
| Speed | 0.08 m/s | 0.12 m/s |
| Track length | 6.1 meters max | 7.5 meters max |
| Construction | Aluminum extrude rail | Anodized aluminum extrude rail |
| Rail Indoors | ||
| Safety devices | Multiple | Multiple |
| Footrest | Folding type | Folding type |
| Seat | Folding type | Folding type |
| Indoor use | Yes | Yes |
| Outdoor use | Yes | Yes |
Non Equivalent Technological Characteristics
| Bruno SRE-3000/ SRE-2000 | ThyssenKrupp Accessibility Levant | |
|---|---|---|
| Temperaturerange Indoors | SRE-3000 (Bruno ref ILS-01024):not specified | Levant Standard + Comfort option:+5°C to +40°C (41°F to 104°F) |
| Temperaturerange Outdoors | SRE-2000 (Bruno ref ISO-404.88)-5°C to +50°C (25°F to 125°F) | Levant Outdoor option:-15°C to +60°C (5°F to 140°F) |
| ConstructionRail Outdoors | Exterior grade powder coated steelrail | Anodized aluminum extrude rail |
| ConstructionChair Outdoors | Stainless steel | ABS Synthetic material |
| Electricalenclosure | IPx3 | IPx5 |
{2}------------------------------------------------
Product Comparison Discussion
Bruno's SRE-3000/ SRE-2000 and ThyssenKrupp Accessibility's Levant show substantial equivalence on most features and characteristics.
- Both products offer a higher rated load then the minimum requested by standards (EN . Doth products offer a mights offers a maximum of 181 kg, where ThyssenKrupp Accessibility offers a maximum of 146 kg.
- Both product offer the possibility to install the rail at the maximum angle of . inclination (EN 75°, ASME 45°). There is a small difference in the angle range, caused by differences in the design.
- Both products a travelling speed that is below the maximum allowed by standards (EN . 0,15 m/s, ASME 0,4 m/s). Bruno specifies a speed of 0,08 m/s where ThyssenKrupp Accessibility offers a speed that is 50% higher.
- Standards do not specify a maximum track length. Bruno offers a maximum track . length of 6,1 meters, where ThyssenKrupp Accessibility offers a maximum track length of 7,5 meters.
- Regarding the temperature range of the outdoor chair versions (Bruno SRE-2000 . stainless steel, Levant Outdoor ABS Synthetic material) there is a difference. Where Bruno offers a minus temperature of 25°F, ThyssenKrupp Accessibility offers a Diano Chero a lemperature of 59F. Where Bruno offers a maximum temperature of 1259F, ThyssenKrupp Accessibility offers a maximum temperature of 140°F.
Small differences as listed above are subject to analysis of specific customer demands by the sales person.
Bruno's SRE-3000/ SRE-2000 and ThyssenKrupp Accessibility's Levant show less substantial equivalence on the features and characteristics listed below.
- ThyssenKrupp Accessibility offers anodized aluminium as rail material, where Bruno t offers exterior grade coated steel. Although substantially different, both materials fulfil the requirements regarding the requested safety factors by the standards. The choice of material is subject to the taste of the end user.
- Bruno offers as protection against spraying water class IPx3, where IPx5 is offered by . ThyssenKrupp Accessibility. IP55 is required by EN 81-40 referenced according IEC Friyssellicrapp Feesssive a required IP level. The substantial difference can be explained by the fact that Levant is a European design, that has to meet EN 81-40. The explained by the fact than be subject of analysis of specific customer demands by the sales person.
Bruno's SRE-3000/ SRE-2000 and ThyssenKrupp Accessibility's Levant show minor Differences in features and characteristics. From the point of view from ThyssenKrupp Technical Advisor, both products can be considered as substantially equal where the I venined frames, or adaption to specific customer demands, creating a bigger chance for mobility impaired persons to find suitable solution.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread and body formed by curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV
Thyssenkrupp Accessibility B.V. % Mr. Arnold Heiden Technical Advisor Van Utrechtweg 99 Krimpen aan den Ijssel Zuid-Holland, Netherlands 2921 LN
Re: K121560
Trade/Device Name: LEVANT Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: ILK Dated: October 24, 2012 Received: October 25, 2012
Dear Mr. Heiden:
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 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 (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.
1 2012
{4}------------------------------------------------
Page 2 - Mr. Arnold Heiden
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -5 2012.11.01 14:50:25 -04'00'
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): _K121560
Device Name: LEVANT
Indications for Use:
ThyssenKrupp Accessibility's Battery Operated Stair Lift LEVANT is intended to ThyssellRrupp Accessibility S Buttery Opered or son in a fold-down seat, up and down straight stairs, indoors and outdoors.
Prescription Use NO (Part 21 CFR 801 Subpart D)
Over-The-Counter Use YES AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K121560
§ 890.5150 Powered patient transport.
(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair lift 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:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.