(125 days)
No
The summary describes a manually propelled wheelchair with a gas-spring-system for positioning, with no mention of AI or ML technologies.
No.
The device is a standup wheelchair for mobility, not a device that directly treats or diagnoses a medical condition.
No
Explanation: The device description clearly states it is a "manually propelled standup wheelchair" for mobility. There is no mention of it being used to diagnose diseases or conditions. The "Intended Use" section also describes it as providing mobility to users with impairments, not for diagnostic purposes.
No
The device description clearly states it is a "manually propelled standup wheelchair," which is a physical hardware device. The summary also mentions "two back wheels," "front castors," and a "gas-spring-system," all indicative of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device for providing mobility to individuals with ambulatory impairments. This is a physical aid, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a manually propelled standup wheelchair with mechanical components. This aligns with a physical mobility device, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The LSA Helium does not fit this description.
N/A
Intended Use / Indications for Use
The LSA Helium offers manually operated seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifibia, cerebral palsy, multiple sclerosis, muscular dystrophy, polio. rheumatism. etc.
The LSA Helium offers seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.
Product codes
IPL
Device Description
The LSA Helium is a manually propelled standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the chair and allow indirect steering through the turning back wheels. A gas-spring-system supports the customer in putting the seat manually into a seating or standing position.
Maximum end-user weight : 100 kg
Wheelchair width 36/38/40/42/44/46cm
Wheelchair seat depth 40 to 50 every 2 cm
Frame Rigid, in magnesium, epoxy paint
Seat Depth adjustable, with sore proof cushion
Backrest Inclinable. Folds down for transport
Upholstery Polyester fireproof material (M4), washable
Foot-rests Height adjustable
Front wheels Ø 125mm x 29mm, solid
Rear wheels Ø 600mm x 25mm, 1000kPa
Brakes Hand, by pushing
Propulsion Manual
Elevation Manual assisted by gas-powered springs, adjustable according to the user's weight.
Rear stabilization Anti-tip wheels (optional).
Idle weight 17,9kg
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To approve the performance of the LSA Helium, tests according to current applicable standards where performed at test-laboratories of European notified bodies:
EN 12182: 1999 Technical aids for disabled persons. General requirements and test methods
EN 12183: 1999 Manually propelled wheelchairs. Requirements and test methods
ISO 7176-1: 1999 Wheelchairs. Determination of static stability
ISO 7176-3: 1988 Wheelchairs. Determination of effectiveness of brakes
ISO 7176-5: 1986 Wheelchair tests. Methods for determination of overall dimensions, mass and turning space
ISO 7176-7: 1998 Measurement of seating and wheel dimension
ISO 7176-8: 1998 Wheelchairs. Requirements and test methods for static. impact and fatigue strengths
ISO 7176-15: 1996 Wheelchairs. Requirements for information disclosure. documentation and labeling
ISO 10993-5: 1999 Biological evaluation of medical devices. Tests for in vitro cytotoxicity
NFP 92503: flammability
NFP 92505: flammability
ISO 6941: 2003 Textile fabrics. Burning behavior. Measurement of flame spread properties of vertically oriented specimens
Clinical tests were not performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo with three vertical lines. The line on the right is thick, while the other two lines are thinner. The two thinner lines are connected by a horizontal line at the top and a diagonal line in the middle. The word "STAND" is written below the logo.
LifeStand "Vivre-Debout" Rond-point de Rosarge 40, rue Palverne F 01700 LES ECHETS-FRANCE Tel : +33(0)4 37 26 27 28 Fax : +33(0)4 37 26 27 29 VAT :FR 23 312 906 613 00079
EXHIBIT #1
JAN 2 6 2005
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
-
- Submitter's Identification:
Lifestand Rond-point de Rosarge 40, rue Palverne F 01700 LES ECHETS-FRANCE
- Submitter's Identification:
Date Summary Prepared: September 06", 2004
-
- Name of the Device: LSA Helium
-
- Common or Usual Name: manually propelled standup wheelchair
Device Description: 4.
The LSA Helium is a manually propelled standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the chair and allow indirect steering through the turning back wheels. A gas-spring-system supports the customer in putting the seat manually into a seating or standing position.
| Maximum end-user weight : | 100 kg |
|---|---|
| Wheelchair width | 36/38/40/42/44/46cm |
| Wheelchair seat depth | 40 to 50 every 2 cm |
| Frame | Rigid, in magnesium, epoxy paint |
| Seat | Depth adjustable, with sore proof cushion |
| Backrest | Inclinable. Folds down for transport |
| Upholstery | Polyester fireproof material (M4), washable |
| Foot-rests | Height adjustable |
| Front wheels | Ø 125mm x 29mm, solid |
| Rear wheels | Ø 600mm x 25mm, 1000kPa |
| Brakes | Hand, by pushing |
| Propulsion | Manual |
| Elevation | Manual assisted by gas-powered springs, adjustable according to the user's weight. |
| Rear stabilization | Anti-tip wheels (optional). |
| Idle weight | 17,9kg |
1
Image /page/1/Picture/0 description: The image shows a logo with the word "LIFESTAND" at the bottom. Above the text, there are three vertical lines of varying thicknesses. The lines are arranged in a way that they appear to be connected, forming an abstract shape.
Intended Use:
The I.S.A Helium offers manually operated seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifibia, cerebral palsy, multiple sclerosis, muscular dystrophy, polio. rheumatism. etc.
Comparison to Predicate Devices: 6.
The LSA Helium is substantially equivalent to the standup wheelchair LAE (LEVO Active Easy) by LEVO, K971873
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
To approve the performance of the LSA Helium, tests according to current applicable standards where performed at test-laboratories of European notified bodies:
| EN 12182: 1999 | Technical aids for disabled persons. General
requirements and test methods |
|-------------------|---------------------------------------------------------------------------------------------------------------|
| EN 12183: 1999 | Manually propelled wheelchairs. Requirements and test
methods |
| ISO 7176-1: 1999 | Wheelchairs. Determination of static stability |
| ISO 7176-3: 1988 | Wheelchairs. Determination of effectiveness of brakes |
| ISO 7176-5: 1986 | Wheelchair tests. Methods for determination of overall
dimensions, mass and turning space |
| ISO 7176-7: 1998 | Measurement of seating and wheel dimension |
| ISO 7176-8: 1998 | Wheelchairs. Requirements and test methods for static.
impact and fatigue strengths |
| ISO 7176-15: 1996 | Wheelchairs. Requirements for information disclosure.
documentation and labeling |
| ISO 10993-5: 1999 | Biological evaluation of medical devices. Tests for in
vitro cytotoxicity |
| NFP 92503: | flammability |
| NFP 92505: | flammability |
| ISO 6941: 2003 | Textile fabrics. Burning behavior. Measurement of
flame spread properties of vertically oriented specimens |
8. Discussion of Clinical Tests Performed:
Clinical tests were not performed
9. Conclusions:
Lifestand believes that the LSA Helium is substantially equivalent to the predicate and is safe and effective for it's intended use.
2
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 € 2005
Ms. Stephanie D. Bankston Official Correspondent for Lifestand Lifestand 10925 Beamer #290 Houston, Texas 77089
Re: K042596
Trade/Device Name: LSA Helium Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: January 11, 2005 Received: January 14, 2005
Dear: Ms. Stephanie D. Bankston
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.
3
Page 2 - Ms. Stephanie D. Bankston
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witification. 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 Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Celia M. Witten, PH. D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit #3
Page 1 of 1
510(k) Number (if known): KO4 2596
Device Name: LSA Helium
Indications For Use:
The LSA Helium offers seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.
Prescription Use × (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFT 807 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
510(k) Number.