The Shanghai Phoenix Mechanical Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the resistant to ignition source smouldering cigarette. and match flame equivalent.

AI/ML Overview

The provided document K130848 describes the Shanghai Phoenix Mechanical Wheelchair and its substantial equivalence to a predicate device, as well as the performance tests conducted to meet relevant international standards.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards. This means the acceptance criteria are defined by these standards. The device's reported performance is its successful compliance with these standards.

Acceptance Criteria (from ISO 7176 / EN 12183 standards)	Reported Device Performance
ISO 7176-1: Determination of Static Stability	Met standard requirements
ISO 7176-3: Determination of effectiveness of brakes	Met standard requirements
ISO 7176-5: Determination of overall dimensions, mass and maneuvering space	Met standard requirements
ISO 7176-7: Measurement of seating and wheel dimensions	Met standard requirements
ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths	Met standard requirements
ISO 7176-11: Test dummies	Relevant methodologies followed
ISO 7176-13: Determination of coefficient of friction of test surfaces	Met standard requirements
ISO 7176-15: Requirements for information disclosure, documentation and labelling	Met standard requirements
ISO 7176-16: Resistance to ignition of upholstered parts	Met standard requirements
ISO 7176-22: Set-up procedures	Relevant methodologies followed
EN 12183: Manually propelled wheelchairs Requirements and test methods	Met standard requirements
EN 1021-1 /-2: Assessment of the ignition of upholstered furniture	Met standard requirements
Weight Capacity	100 Kgs / 220 lbs
Flammability (upholstery fabric)	Meets resistance to ignition source smouldering cigarette and match flame equivalent

Note: The document states "Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards". This implies that the device successfully passed all tests outlined in these standards, thus demonstrating compliance. Specific numerical results for each test were not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size (number of wheelchairs) used for the performance testing.
The testing is described as "Literature for Performance Testing," which typically refers to laboratory testing of physical samples, not clinical data.
Data Provenance: The tests relate to international and European standards (ISO and EN). The manufacturer is based in Shanghai, China, suggesting the testing was likely conducted in accordance with these international standards, potentially in specialized testing facilities in China or elsewhere. It is a prospective evaluation of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For engineering performance standards like those referenced (ISO 7176, EN 12183), "ground truth" is typically established by the standard itself and verified by accredited testing laboratories and their qualified engineers/technicians. These tests are objective measurements (e.g., static stability, brake effectiveness, dimensions, strength, flammability) against predefined criteria, rather than subjective expert consensus on medical images or diagnoses. Therefore, the concept of "experts establishing ground truth" in the clinical sense doesn't directly apply here. The "experts" would be the personnel at the testing lab who execute and interpret the standard tests.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are characteristic of clinical studies involving subjective assessments (e.g., radiologists reviewing images). For objective engineering performance tests against international standards, there is no "adjudication method" in this sense. The test results are either within the acceptable range specified by the standard or they are not. If a deviation occurs, the device fails the test for that criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in tasks like image interpretation, which is not applicable to the performance testing of a mechanical wheelchair.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm-only) performance study was not done. This concept applies to AI algorithms, and this document pertains to a mechanical medical device, not an AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is the objective, quantifiable criteria defined by the referenced international and European engineering standards (ISO 7176 series, EN 12183, EN 1021-1/-2). These standards specify test methods, measurement procedures, and acceptable ranges or thresholds for various performance aspects (e.g., static stability angles, brake force, material ignition resistance, strength under load).

8. The Sample Size for the Training Set

This document describes the performance testing of a physical medical device (mechanical wheelchair). The concept of a "training set" is relevant for machine learning algorithms. Therefore, a training set sample size is not applicable in this context.

9. How the Ground Truth for the Training Set was Established

As mentioned above, the concept of a "training set" is not applicable to the performance testing of this mechanical device. Ground truth for the performance of the wheelchair is established by the engineering standards themselves and their specified test methodologies.

Summary

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Image /page/0/Picture/0 description: The image shows a black and white drawing of a figure that appears to be a stylized bird or creature perched on a rectangular base. The creature has a flowing, almost ethereal quality, with lines suggesting feathers or fur. The base is marked with what looks like symbols or writing, adding to the image's enigmatic nature. The overall impression is one of a symbolic or heraldic emblem.

Shanghai Phoenix Medical Equipment CO., LTD. NO.188 Zhongfa Road.Zhujing Industrial Park.Jinshan District,Shanghai China Tel: 086-021-67221555 - Fax:086-021-67221999 E-mail:ph(@phoenixmed.com.cn

510(k) SUMMARY "

K130848

Submitter's Name: Shanghai Phoenix Medical Equipment Co., Ltd. No. 188 Zhongfa Road,Zhujikng Industrial Park, Jinshan District, Shanghai, China, 201500

Date summary prepared:

Device Name:

Proprietary Name: Model name:

Common or Usual Name:

Classification Name:

Regulation Number:

Product Code:

Shanghai Phoenix Mechanical Wheelchair PHW954LGC for Aluminum Framework PHW902BC for Steel Framework Mechanical Wheelchair Mechanical Wheelchair, Class I. 21 CFR 890.3850 IOR

Contact person:

Dr. JEN. KE-MIN

FAX: +886-3-5209783 TEL: +886-3-5208829

Email: ceirs.jen@msa.hinet.net

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Description of the device:

Literature for Performance Testing:

Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards including:

· ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
· ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003.
· ISO7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008.

NOV 1 2 2013

March 18. 2013

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Image /page/1/Picture/0 description: The image shows a black and white drawing of a figure. The figure appears to be a person sitting on a platform. The person is hunched over, and their head is tilted down. The platform has a rectangular shape with some markings on it. The drawing is simple and lacks detail.

1SO7176-7 Wheelchairs Part 7: Measurement of seating and wheel dimensions, 0 1998.
· ISO7176-8 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths, 1998.
· ISO7176-11 Wheelchairs Part 11: Test dummies, 1992.
@ ISO7176-13 Wheelchairs Part 13:Determination of coefficient of friction of test surfaces, 1989.
· ISO7176-15 Wheelchairs Part 15:Requirements for information disclosure, documentation and labelling, 1996.
. ISO7176-16 Wheelchairs - Part 16:Resistance to ignition of upholstered parts --Requirements and test methods, 1997.
· ISO7176-22 Wheelchairs Part 22:Set-up procedures, 2000.
· EN 12183 Manually propelled wheelchairs Requirements and test methods, 1999.
· EN 1021-1 /-2 Assessment of the ignition of upholstered furniture, 2006.

Materials used in the main supporting features of the device:

· 7000 series aluminum for PHW954LGC Aluminum Framework.
@ High-Quality SPCC Steel Pipe for PHW902BC Steel Framework.

Material in contact with patients:

PVC Leather for seat.
Legally marketed device for substantial equivalence comparison:

KAIYANG Aluminum Wheelchair (K101998)

Summary for substantial equivalence:

All of the features, except for the sizes and supporting material, are the same. The small differences of the sizes between the two devices do not affect the safety or effectiveness. Furthermore, the steel material for the subject device shows more strength than the aluminum material used for the predicate device. Thus the subject device is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows a black and white drawing of a crest or emblem. The emblem features a stylized bird-like figure perched atop a rectangular base. The base appears to have some markings or symbols on it, although they are not clearly legible due to the image quality. The overall design is simple and somewhat abstract.

Shanghai Phoenix Medical Equipment CO., LTD.
NO.188 Zhongfa Road.Zhujing Industrial Park.Jinshan District.Shanghai China
Tel: 086-021-672215555 | Fax:086-021-672215999
E-mail:ph@phocnixmed.com.cn

Comparison Table

ITEMS	PREDICATE DEVICE	SUBJECT DEVICE
BRAND NAME	KAIYANG	Shanghai Phoenix
MANUFACTURER	Guangdong Kaiyang MedicalTechnology Co., Ltd.	Shanghai Phoenix MedicalEquipment Co., Ltd.
MODEL NO	KAIYANG Aluminum Wheelchair	Mechanical WheelchairPHW954LGC Aluminum FrameworkPHW902BC Steel Framework
510K NO	K101998	K130848
INTENDED USE	The device is intended formedical purposes to providemobility to persons restrictedto a sitting position.	SAME
FRAME
Seat width	18.1"~25.1"	18.1"
Cross brace	YES	SAME
Seat height	16.2"	20.0"
Full length	1050 mm	1180 mm
Full width	650 mm	670 mm
Full height	920 mm	920 mm
Backrest height	un-adjustable	SAME
Reclining backrest	fixed	SAME
Seat sling	padded nylon	SAME
Frame colors	Black, Blue	Silver white
ARMREST
Arm pad	Padded	SAME
Flip back	YES, detachable	SAME
Height-adjustable	adjustable	SAME
HANGERS
Swing-away	YES	SAME
Elevating leg rest	YES	SAME
Articulating leg rest	YES	SAME
Footplate style	Padded	SAME
Heel loop	No	SAME
Footrest angle	10°	SAME
REAR AXLE
Offset axle	YES	SAME
Quick release axle	YES	SAME
ITEMS	PREDICATE DEVICE	SUBJECT DEVICE
REAR WHEELSizeTire typeHandrim material	7.5"PneumaticAluminum composite	24"PneumaticAluminum composite
CASTERSSizeTire type	5~8"Solid	7"Solid
WHEEL LOCK	Pull-to-Lock	SAME
WEIGHT CAPACITY	100 Kgs / 220 lbs	SAME
WEIGHT OF CHAIR	17.5~21 kgs	SAME(19.0 kgs / 41.8 lbs )
STABILITY TEST	ISO 7176 series standards	SAME
WARRANTY	12 months for the main parts( The chair side frames areguaranteed for 5 years fromthe date of purchase. )	SAME
OPTIONAL ACCESSORIESAnti-tipper	YES

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Image /page/3/Picture/0 description: The image shows a black and white drawing of a figure standing on top of a platform. The figure appears to be wearing a robe or gown, and it has a small head with a hat. The platform has a rectangular shape with some geometric designs on the front. The drawing is simple and lacks detail, but it is clear and easy to understand.

Shanghai Phoenix Medical Equipment CO., LTD.
NO.188 Zhongfa Road.Zhujing Industrial Park.Jinshan District Shanghai China Tel: 086-021-67221555 - Fax:086-021-67221999 E-mail:ph(@phoenixmed.com.cn

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 12. 2013

Shanghai Phoenix Medical Equipment Co., Ltd. Ke-Min Jen. Official Correspondent No. 188 Zhonfga Road Zhujing Industrial Park Jinshan District, Shanghai China 201500

Re: K130848

Trade/Device Name: Shanghai Phoenix Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 15, 2013 Received: September 24, 2013

Dear Ke-Min Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to tegary manatinent date of the Medical Device American Drug commerce prior to May 20, 1976, the chaonnene 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. You may, interefore, market the active, subject to and growinements for annual registration, listing of I he general controls provisions of the Hordan 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), If your device is classified (SCC above) into entire) major regulations affecting your device can be If may be subject to additional controls. Bittlems, 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 Please be advised fill I DA 3 issuation of a succession of the requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decertifications administered by other Federal agencies. You must or any Federal statutes and regulations administer or of career in the firsting (21

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Page 2 - Ke-Min Jen

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Joyce M. Whang -S

for

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130848

Device Name: Shanghai Phoenix Mechanical Wheelchair

Indications For Use:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

X Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).