(18 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The LERADOTECH Scooter, SB is an indoor / outdoor Electrical Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided 510(k) summary for the LERADOTECH Scooter, SB details a submission for a power mobility device, like an electric scooter, and therefore does not have acceptance criteria or associated studies in the way that an AI/ML medical device would. The information provided heavily focuses on demonstrating "substantial equivalence" to a predicate device, as is customary for 510(k) submissions.
Here's why the requested information cannot be fully provided from the given document:
- Type of Device: The LERADOTECH Scooter, SB is a physical medical device (an electric scooter), not an AI/ML algorithm or software. The concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," and "training set" are primarily relevant to the evaluation of AI/ML-based medical devices or diagnostic tools.
- Regulatory Pathway (510(k)): The 510(k) pathway for traditional medical devices primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This involves comparing technical characteristics, indications for use, and performance data to show the new device is as safe and effective as the predicate. It does not typically involve the rigorous clinical performance studies (like multi-reader multi-case studies or standalone algorithm performance) that are common for AI/ML devices.
However, I can extract and interpret the information related to performance testing as described for this type of device, which serves a similar function to demonstrating that the device meets certain standards.
Interpretation and Information Extraction Based on the Provided Document:
Given the context of a 510(k) for an electric scooter, the "acceptance criteria" can be interpreted as compliance with relevant industry standards and safety certifications. The "study" refers to the performance testing conducted to meet these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance / Compliance |
|---|---|
| EMC Report | Passed (Implied by listing) |
| CISPR 11: 1990 (Industrial, scientific and medical equipment) | Passed (Implied by listing) |
| EN61000-3-2: 1995 (Harmonic current emissions) | Passed (Implied by listing) |
| IEC61000-3-3: 1995 (Voltage fluctuations and flicker) | Passed (Implied by listing) |
| ANSI/RESNA WC/Vol.2-1998 (Wheelchairs and transport devices) | Passed (Implied by listing) |
| Electrical Scooters, controller, and their chargers requirements | Passed (Implied by listing) |
| UL certificated electronic systems (for new and predicate device) | All passed by UL certificated |
| Resistance ignition test (back upholstery material) | Passed by SGS |
| Maximum speed | 6.0 mph (new device, within 6 miles/hr limit) |
| Cruising range | 36 km (new device) |
Explanation of Substantial Equivalence and Performance Aspects (Not "Acceptance Criteria" in the AI/ML sense):
The document primarily focuses on demonstrating substantial equivalence to the COMFORT Scooter LY-EW415 (K063032). Key comparisons made include:
- Intended Uses: Same.
- Warranty Period: Same.
- Electronic Systems: Both passed UL certification; same controller and switching power supplier.
- Back Upholstery: Same material, passed resistance ignition test by SGS.
- Differences (Agreed Not to Affect Safety/Effectiveness):
- Tire size
- Weight limit
- Weight capabilities
- Smaller/more agile dimensions (leads to smaller turning radius and safe climbing angle)
- Maximum speed: New device 6.0 mph vs. predicate 5.0 mph (both under 6 mph limit, speeds adjustable).
- Cruising range: New device 36 km vs. predicate 75 km (due to smaller batteries, real range depends on environment, deemed substantially equivalent).
Regarding the remaining specific questions (2-9), these are not applicable to the provided document for the following reasons:
- 2. Sample sized used for the test set and the data provenance: Not applicable. Performance testing for an electric scooter involves physical testing against standards, not a "test set" of data in the AI/ML context. Physical testing would be conducted on a representative sample of the manufactured device. Data provenance (country of origin, retrospective/prospective) is typically for clinical data used in studies, which is not described here.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context would be whether the device physically meets a standard (e.g., does it emit less than X radiation per CISPR 11). This is determined by instrumental measurement and trained technicians/engineers, not clinical experts establishing diagnostic "ground truth."
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations, which is not part of an electric scooter's performance testing for regulatory submission.
- 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 is specific to AI/ML devices that assist human interpretation or diagnosis.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is specific to AI/ML algorithms.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be the physical properties and functionality measured against engineering and electrical safety standards.
- 8. The sample size for the training set: Not applicable. There is no "training set" for a physical device like an electric scooter.
- 9. How the ground truth for the training set was established: Not applicable, as there is no training set.
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APR 1 3 2007
Image /page/0/Picture/1 description: The image shows a logo with the word "LERADO" in large, bold letters. A stylized image of a tree is placed between the letters "R" and "D". Below the word "LERADO" is the text "LERADO GROUP" in a smaller font. Below that is some text in a different language.
LERADO CHINA LIMITED
No. 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Tahwan, ROC. Tel: 886-5-2475629 Fax: 886-5-2379672 E-mail:edwardlaglerado.com tw http:// www.lerado.com
510(k) SUMMARY " દ્ધ
Submitter's Name: LERADO CHINA LIMITED
Dong Sheng Road North Zhong Shan, CHINA
Date summary prepared:
Device Name:
March 17, 2007
Proprietary Name: Common or Usual Name: Classification Name:
Electrical Scooter Motorized 3-Wheeled Vehicle, Class II, 21 CFR 890.3800
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
LERADOTECH Scooter, SB
Description of the device:
The LERADOTECH Scooter, SB is an indoor / outdoor Electrical Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Electrical Scooters, controller, and their chargers requirements and test methods)
Legally marketed device for substantial equivalence comparison: COMFORT Scooter LY-EW415 (K063032)
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Image /page/1/Picture/0 description: The image shows the logo for LERADO Group. The logo is in black and white and features the company name in a stylized font. Above the company name is a triangular shape that resembles a mountain. Below the company name are some Chinese characters.
LERADO CHINA LIMITED No. 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: 886-3-2475629 · Fax: 886-5-2379672 E-mail edwardl@lerado.com tw http:// www.lerado.com
Summary for substantial equivalence comparison:
The new device SB and the predicate device LY-EW415 are the same intended uses and warranty period, and the electronic systems between the two devices are all passed by the UL certificated. Except the recharger of the electronic systems, the two devices are the same suppliers. Especially, the two devices use the same controller and switching power supplier. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.
The major difference existing for the two devices are tires size, weight limit, weight capabilities, and the dimensions for the new device are more agile and smaller than those of the predicate device. Thus the new device can drive smaller turning radius and safe climbing angle. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
The maximum speed is 6.0 mph for the new device and 5.0 mph for the predicate device that are also under the 6 miles maximum speed limited. The speeds can be continuous adjusted by the throttle tiller. The operators can set the adequate speed according to their feeling and need, and the maximum speed differences do not mean any performance differences. They are substantially equivalent.
The cruising range of the new device is 36 km and 75 km for the predicate device. This is mainly due to the fact that the batteries for the new device are smaller. Certainly the real range depends on the practice environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
Based on the above the information and the analysis, we know that the subject device and the predicate devices have the same intended use, the same technological aspects and only minor dimensions or data differences exist. Thus the subject device and the predicate device are substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lerado China Limited % Republic of China Chinese-European Industrial Research Society Dr. Ke-Min Jen Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan) 30067
APR 1 3 2007
Re: K070817
Trade/Device Name: LERADOTECH Scotter, SB Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: March 17, 2007 Received: March 26, 2007
Dear Dr. Jen:
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
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Page 2 – Dr. Ke-Min Jen
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. 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 Consumer 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,
Mark N. Melkerson
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 ): __ K
Device Name: LERADOTECH SCOOTER, SB
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 16070817
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).