(42 days)
The Zip'r PC powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The Zip'r PC powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
The provided text is a 510(k) summary for the Zip'r PC powered wheelchair. It describes the device and claims substantial equivalence to a predicate device (CWD01). However, it does not include information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth establishment, expert adjudication, or sample sizes for testing or training sets that would be expected for a diagnostic or AI-driven device.
The document primarily focuses on demonstrating that the Zip'r PC powered wheelchair is substantially equivalent to an existing device (CWD01) based on its intended use, design, and performance specifications. This type of submission relies on comparing physical and operational parameters rather than statistical performance against a defined ground truth using a clinical study.
Therefore, many of the requested details are not present in the provided text.
Here's a breakdown of the information that can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance (Table)
The document lists performance specifications for the Zip'r PC and compares them to the predicate device, CWD01. While these are performance characteristics, they are presented as part of a substantial equivalence claim rather than formal acceptance criteria for a clinical study. The acceptance criteria for a physical medical device typically revolve around safety standards and functional equivalence to predicate devices, which is what this document addresses through comparison.
Note: For a device like a wheelchair, acceptance criteria are generally established through adherence to recognized standards (e.g., ISO standards for wheelchairs) and comparison to a predicate device's safety and functional output, rather than clinical efficacy studies with specific performance metrics against a "ground truth" as might be seen with diagnostic AI.
| Acceptance Criteria (Implied by Comparison) | Reported Zip'r PC Performance | Reported CWD01 (Predicate) Performance |
|---|---|---|
| Net weight w/battery | 68 kg (150 lbs) | 83.5 kg (183.7 lbs) |
| Slope grade ability | 8 degree | 12 degree |
| Per-charge distance | Up to 40 km (25 miles) | 40 km (24 miles) |
| Maximum speed | Up to 6.4 km/hr (4 mph), variable | 5 km/h (3.2 mph) |
| Turning radius | 0.51 m (20") | Not specified |
| Maximum curb height | 25 mm (1") | Not specified |
| Armrest | Fixed | Removable |
| Brake system | Intelligent regenerative electromagnetic brake | Not specified |
| Braking distance | Forward: 1.4 m (56") at max speed | Not specified |
| Suspension | Front: No, Rear: No | Cross brace |
| Horn | Yes | Yes |
| Anti-tip wheels | Yes | Yes |
| Intended Use | Provides mobility to disabled or elderly persons limited to a seated position. | Provides mobility to disabled or elderly persons limited to a seated position. |
| Power Source | Lead-Acid 12V x 33AH x 2 | Lead-Acid 12V x 35AH x 2 |
| Motor Output | DC 24V, 320 W, 2 Pcs | 60W x DC24V x 2Pc |
| Front Wheel | PG Solid tire x 2 | Numatic tire x 2 |
| Rear Wheel | PG Solid tire x 2 | U foaming tire x 2 |
| Weight Capacity | 136 kg (300 lbs) | 136 kg (300 lbs) |
Note: The document states, "There are minor differences in performance specifications of the powered wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." This statement implies that the differences observed in the table are within acceptable limits for substantial equivalence.
Missing Information Regarding a Study Proving Acceptance Criteria
The provided text does not contain any information about a specific study designed to "prove the device meets acceptance criteria" in the sense of a clinical trial or performance study against a defined ground truth, as would be conducted for a diagnostic or AI-enabled device. The submission relies on a comparison to a predicate device to establish substantial equivalence.
Therefore, the following information cannot be provided from the given text:
- Sample size used for the test set and the data provenance: Not applicable/Not provided. The submission is not a clinical study on a test set; it's a comparison to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No "ground truth" in the diagnostic sense is established or used.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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/Not provided. This is a medical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" here is arguably the performance and safety profile of the predicate device and adherence to relevant standards.
- The sample size for the training set: Not applicable/Not provided. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable/Not provided.
Summary of what the document IS:
This is a 510(k) Premarket Notification for a Class II powered wheelchair. The manufacturer claims substantial equivalence to a predicate device (CWD01) already on the market. The "evidence" provided consists of a comparison table of specifications and a statement that minor differences do not affect safety or effectiveness. This is a common pathway for demonstrating safety and effectiveness for many medical devices that are functionally similar to existing ones, rather than requiring new clinical trials that establish performance against a defined ground truth like diagnostic devices.
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SEP 2 1 2007
Global FabTech Wheelchair (Shanghai) Co., Ltd.
No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China TEL: +86-21- 6763-2308 FAX: +86-21- 6763-2309
510(k) Summary
Device
Trade name: Zip'r PC powered wheelchair Common name: Powered wheelchair Classification name: Powered wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3860 Product Code: ITI Classification: Class II
Predicate devices
CWD01 (K062888) / EMG Technology Co. Ltd.
Intend use of device
Zip'r PC powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The Zip'r PC powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
Substantial equivalence:
The Zip'r PC powered wheelchair is substantially equivalent to the CWD01 (K062888) manufactured by EMG Technology Co. Ltd..
There are minor differences in performance specifications of the powered wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Global FabTech Wheelchair (Shanghai) Co., Ltd. believes that the Zip'r PC powered wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.
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l FabTech Wheelchair (Shanghai) Co.,
18, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China
TEL: +86-21- 6763-2308 FAX: +86-21- 6763-2309
intended for medical purposes to provide
ility to persons restricted to a sitting posi CWD01 (K0628 ad-Acid 12V×35AH×2 'U foaming tire × 2 60W x DC24V × 2Pc numatic tire × 2 4V 5A, off-bo 6 kg ( 300 lb 30 mm (44.5 00 mm ( 35.4 50 mm ( 25.6 Dynamic Shar direct drive ﺔ ﺍﻟ ealed transaxle bled or elderly persons limited to a seated pos notor driven, indoor and outdoor transport 5 AMP (Automatic Type) off-b s with the intended use to provide mob 12V × 33AH × 2PG Solid tire × 2 P Solid tire × 2 Po Zip'r PC ad-Acid 6 kg (35 lbs)
OC 24V, 320 W, 2 Pcs 6 kg (300 lbs 020 mm (40) 30 mm (24" 90 mm (39" 70 mm (23 620mm (21' 609mm (24 PG VRI at overall weigl t overall heigl at overall dept t overall widt iximum loadi Rear wheel driv verall heigh verall lengt verall widt tended use lotor outpu Front whee Rear whee ontrolle Charge Batter
ubstantial equivalence comparison of the Zip'r PC and CW
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| Continuous) | The substantial equivalence comparison of the Zip'r PC and CWD01 | Zip'r PC | CWD01 (K062888) |
|---|---|---|---|
| Armrest | Fixed | Removable | |
| Break system | Intelligent regenerative electromagnetic brake | ||
| Braking distance | Forward: 1.4 m(56") at max speed | ||
| Net weight wbattery | 68 kg (150 lbs) | 83.5kg (183.7 lbs) | |
| Slope grade ability | 8 degree | 12 degree | |
| Per-charge distance | Up to 40 km (25 miles) | 40 km (24 miles) | |
| Maximum speed | Up to 6.4 km/hr (4 mph), variable | 5 km/h (3.2 mph) | |
| Turning radius | 0.51 m (20") | ||
| Maximum curbheight | 25 mm (1") | ||
| Suspension | Front: No, Rear: No | Cross brace | |
| Horn | Yes | Yes | |
| Anti-tip wheels | Yes | Yes |
Global FabTech Wheelchair (Shanghai) Co., Ltd.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
L ISEF 2 1 7007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Global FabTech Wheelchair (Shanghai) Co., Ltd. % Mr. Edward Dong No. 318, TianFu Rd. Jiuting Songjiang Shanghai, 201615, China
K072224 Trade/Device Name: Zip'r PC Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 7, 2007 Received: August 10, 2007
Dear Mr. Dong:
Re:
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. Edward Dong
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Zip'r PC
Indications for Use:
The Zip'r PC powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Over-The-Counter Use _ X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K672224
(Posted November 13, 2003)
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).