(123 days)
No
The description details a standard electric mobility scooter with manual controls and an automatic electromagnetic brake. There is no mention of AI, ML, image processing, or any features that would suggest autonomous decision-making or learning capabilities. The performance studies and metrics are related to the physical function and safety of the scooter, not algorithmic performance.
Yes.
The device is intended to provide mobility to a disabled or elderly person with mobility limitations, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition or disability.
No
The device is described as a mobility scooter intended to provide transportation for disabled or elderly individuals, not to diagnose any condition.
No
The device description clearly outlines numerous hardware components including a base, wheels, seat, motor, battery, and brakes. It is a physical mobility scooter, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical aid for transportation, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical and electrical device for transportation, not equipment used for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition through in vitro testing.
- Performance Studies: The performance studies focus on the physical and electrical safety and functionality of the scooter, not the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This mobility scooter does not fit that definition.
N/A
Intended Use / Indications for Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Product codes
INI
Device Description
The subject device, Model HS186B Mobility Scooter, is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller, a control panel, an electric motor, an electromagnetic brake, a rechargeable Lithium-lon Battery with a charger. The movement of the scooter is controlled by the rider who operates the throttle Control Lever, speed knob and hand grips.
The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter is suitable for use indoors and on flat roads near buildings.
Folding design: To fold the scooter pull out the fold knob, at the same time gently lower the seat back down into its folded position, Now with the seat folded, loosen off the tiller adjuster knob and gently lower the tiller into the folded position. The tiller handles should be able to rest between the chassis. Re-tighten the tiller knob to hold the tiller into position. This will then allow you to pull the scooter on its rear tip wheels, the folding is completed.
Hold the straight handle, push the right throttle control lever forward with the right thumb, and the scooter will move forward. Push the left throttle control lever forward with the left thumb, the scooter will move backwards. The horn will sound a warning sound when the scooter is moving backwards.
When the throttle control lever is fully released, it will automatically stop in the "center" position, and the electromagnetic brake will automatically brake the scooter.
The motor of the Scooter is DC24V 120W; the battery is 24V 10AH, Li-ion battery; the charger is 24V/2A.
Max. loading can not be over than 120Kgs.
Max. distance of travel on the fully charged battery is 15.8km and Max. speed forward is 7km/h.
The braking time is about 1.6s, and the braking distance is
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 9, 2023
Suzhou Master Machinery Manufacturing Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K222711
Trade/Device Name: HS186B Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: October 10, 2022 Received: October 11, 2022
Dear Boyle Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222711
Device Name HS186B Scooter
Indications for Use (Describe)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's information
Name: Suzhou Master Machinery Manufacturing Co.,Ltd. Address: No.48,Binjiang Road,Zhangpu Town, Kunshan,Jiangsu, China 215321 Tel: 86-512-57452882 Fax: 86-512 - 57452992 Contact: Siqi.Shangguan Date of Preparation: Jul.08,2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
HS186B Scooter Trade name: Common name: Scooter Classification name: Motorized Three-Wheeled Vehicle Model(s): HS186B
3.0 Classification
Production code: INI Regulation number: 21 CFR 890.3800 Classification: Class II Panel: Physical Medicine
4.0 Predicate device information
Nanjing Jin Bai He Medical Apparatus Co., Ltd. Manufacturer: Trade/Device: Scooter (Model: FDB01) 510(k) number: K201196
5.0 Indication for Use Statement
4
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
6.0 Device description
The subject device, Model HS186B Mobility Scooter, is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller, a control panel, an electric motor, an electromagnetic brake, a rechargeable Lithium-lon Battery with a charger. The movement of the scooter is controlled by the rider who operates the throttle Control Lever, speed knob and hand grips.
The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter is suitable for use indoors and on flat roads near buildings.
Folding design: To fold the scooter pull out the fold knob, at the same time gently lower the seat back down into its folded position, Now with the seat folded, loosen off the tiller adjuster knob and gently lower the tiller into the folded position. The tiller handles should be able to rest between the chassis. Re-tighten the tiller knob to hold the tiller into position. This will then allow you to pull the scooter on its rear tip wheels, the folding is completed.
Hold the straight handle, push the right throttle control lever forward with the right thumb, and the scooter will move forward. Push the left throttle control lever forward with the left thumb, the scooter will move backwards. The horn will sound a warning
sound when the scooter is moving backwards.
When the throttle control lever is fully released, it will automatically stop in the "center" position, and the electromagnetic brake will automatically brake the scooter.
The motor of the Scooter is DC24V 120W; the battery is 24V 10AH, Li-ion battery; the charger is 24V/2A.
Max. loading can not be over than 120Kgs.
Max. distance of travel on the fully charged battery is 15.8km and Max. speed forward is 7km/h.
The braking time is about 1.6s, and the braking distance is ≤1m.
7.0 Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
5
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11: 2012 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-16:2012 Wheelchairs -- Part 16: Resistance to ignition of postural support devices
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 12184 :2014 Electrically powered wheelchairs, scooters and their chargers-Requirements and test methods
Biocompatibility of patient-contacting parts
Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including:
Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
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Irritation and Skin Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
8.0 _Summary of Clinical Testing
No clinical study implemented for the scooter.
9.0 Technological Characteristic Comparison Table
7
| Item | Subject device | Predicate device | Remark |
|---|---|---|---|
| Product Code | INI | INI | Same |
| Regulation No. | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Class | II | II | Same |
| Product name | Scooter (Model: HS186B) | Scooter (Model: FDB01) | - |
| 510(k) No. | K222711 | K201196 | - |
| Intended | |||
| Use/Indication for | |||
| Use | It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. | It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. | Same |
| Use environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| Patient | |||
| Population | This product is suitable for disabled people with mobility difficulties and elderly people. | This product is suitable for disabled people with mobility difficulties and elderly people. | Same |
| Product structure | It has a base with frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller, a control panel, an electric motor, an electromagnetic brake, a rechargeable Lithium-Ion Battery with a charger. | It has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, 2 rechargeable Lithium-Ion Battery with an off-board charger. | Similar |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of | |||
| wheels | 4 | 4 | Same |
| Main frame | |||
| material | Aluminium alloy | Aluminium alloy | Same |
| Motor | Brushless motor, DC24V* 120W*1 pcs | brush differential rear axle. 24V *180W | Minor differences in the |
| Battery | DC 24V 10Ah Lithium-ion, 1 pcs | 24V 6AH Lithium-ion, 2 pcs | dimensions will not |
| Battery charger | Off-board charger Input: 100-240 VAC Output: DC 24V, 2A | Off-board charger Input: 100-240 VAC Output: DC 24V, 6 Amp | impact the safety and effectiveness of the substantial equivalence. |
| Item | Subject Device | Predicate Device | |
| K201196 | Remark | ||
| Dimensions | |||
| (mm) | 1016x560x914 | 1050 X 550 X 870 | Minor differences in the |
| dimensions will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Folded | |||
| dimensions | |||
| (mm) | 950x560x460 | 480 x550 x790 | Minor differences in the |
| folded dimensions will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Weight, w/ | |||
| Battery | 42.1lbs. /19.1kg | 63.1lbs. /29 kg | The difference will |
| not raise any new safety | |||
| and effectiveness | |||
| concerns. | |||
| Frame design | Foldable/ | ||
| The scooter is driven by electricity | |||
| scooter, is a transportation tool and | |||
| auxiliary tools for the purpose of | |||
| walking, without removing the | |||
| battery can be folded, easy to carry | |||
| and storage. | Foldable/ | ||
| Electric scooter is driven by | |||
| electricity scooter, is a | |||
| transportation | |||
| tool | |||
| and | |||
| auxiliary tools for the | |||
| purpose of walking, without | |||
| removing the battery can be | |||
| folded, easy to carry and | |||
| storage. | Same | ||
| Seating | |||
| Design | To fold the scooter pull out the fold | ||
| knob, at the same time gently lower | |||
| the seat back down into its folded | |||
| position, Now with the seat folded, | |||
| loosen off the tiller adjuster knob | |||
| and gently lower the tiller into the | |||
| folded position. The tiller handles | |||
| should be able to rest between the | |||
| chassis. Re-tighten the tiller knob to | |||
| hold the tiller into position. This will | |||
| then allow you to pull the scooter on | |||
| its rear tip wheels, the folding is | |||
| completed. | One-click folding | ||
| intelligent electric scooter, | |||
| with a sensitive remote | |||
| control, gently press, the | |||
| car automatically | |||
| completed folding | |||
| contraction, folding volume | |||
| small, electromagnetic | |||
| automatic brake, the overall | |||
| simple design, convenient | |||
| and practical, Travel does not | |||
| have to consume physical | |||
| force to do folding, poor | |||
| physical strength and the | |||
| elderly the best walking | |||
| tool. | The difference will | ||
| not raise any new safety | |||
| and effectiveness | |||
| concerns. | |||
| Seating | |||
| Attachment | Without any seat | ||
| accessories (integrated, power | Without any seat | ||
| accessories (integrated, | Same | ||
| integrated, | |||
| power | |||
| base, specialty | |||
| power | base, dedicated power supply) | power base, dedicated | |
| power supply) | |||
| Folding | |||
| mechanism | A foldable seat frames | ||
| (The backrest could be folded to | |||
| seat) | Seat can be folded; battery | ||
| can be dismantled; The | |||
| frame can be folded back | |||
| and forth | Same | ||
| Front | |||
| wheel(inch) | 6 | ||
| (Solid tire) | 7 | ||
| (Solid tire) | Smaller size of the front | ||
| wheel. | |||
| The difference will not raise | |||
| any new safety and | |||
| effectiveness concerns. | |||
| Rear tire (inch) | 10 | ||
| (Solid tire) | 8 | ||
| (Solid tire) | Larger size of rear wheels | ||
| bring steadier pivoting | |||
| function than predicate | |||
| device. | |||
| Anti-tip Wheels | |||
| (inch) | 2.5 | 2.5 | Same |
| Cruising | |||
| Range(km) | 15.8 | Not Publicly Available | The difference will not raise |
| any new safety and | |||
| effectiveness concerns. | |||
| Obstacle | |||
| climbing(mm) | 50 | 60 | The smaller height in the |
| obstacle climbing will not | |||
| impact the safety and | |||
| effectiveness of the subject | |||
| device. | |||
| Ground | |||
| clearance | 75mm | 50mm | The device has been tested |
| according to ISO7176 series | |||
| standards and the test | |||
| records support its safety and | |||
| effectiveness. | |||
| Static stability | |||
| forward | 25° | 30° | Both of the devices are |
| evaluated according to | |||
| standard ISO 7176-1:2014, | |||
| Static stability | |||
| rearward | 14.2° | 20.1° | standard ISO 7176-1:2014, |
| so the different static stability | |||
| will not impact the safety and | |||
| effectiveness | |||
| Static stability | |||
| sideways | 12.6° | 15.3° | will not impact the safety and |
| effectiveness | |||
| Max. loading | |||
| (kg) | 265lbs(120kg) | 265lbs (120kg) | Same |
| Maximum safe | |||
| operational | |||
| incline | Maximum safe operational incline | ||
| for posteriorly is >25 | Maximum safe operational | ||
| incline for posteriorly is 20.1° | Larger safe operational | ||
| incline of subject brings more | |||
| convenient for the use | |||
| for anteriorly is 14.2° | |||
| Maximum safe operational incline | |||
| for sideways is 14.2° | incline for anteriorly is 30° | ||
| Maximum safe operational | |||
| incline for sideways is 15.3° | environment | ||
| Min. Turning | |||
| radium | 1225mm | 1200mm | The little difference in the |
| turning radius will bring more | |||
| convenience when it turns. | |||
| The difference will not raise | |||
| any new safety and | |||
| effectiveness concerns. | |||
| Minimum | |||
| braking | |||
| distance | 1.0m for the speed of 7km/h | ||
| 1.6s | 1.1 m for the speed of 6km/h | ||
| 1s | Similar | ||
| Max | |||
| Speed | |||
| Forwards | 1.88m/s (7 km/h) | 1.67m/s (6 km/h) | The devices are evaluated |
| according to standard ISO | |||
| 7176-6:2018, so the different | |||
| will not impact the safety | |||
| and effectiveness | |||
| Max. | |||
| Speed | |||
| Backward | 0.58 m/s (2 km/h) | 0.83m/s (3 km/h) | The devices are evaluated |
| according to standard ISO | |||
| 7176-6:2018, so the different | |||
| will not impact the safety and | |||
| effectiveness | |||
| Controller | Yangzhou Feya Electronic | ||
| Technology Co., Ltd. | |||
| FY0-7 FULL | British PG Controller PG45A | Although different controller | |
| is used, both the control | |||
| system, including the | |||
| electromagnetic brakes and | |||
| the user interface are similar. | |||
| Both devices have the same | |||
| user interface, the patient | |||
| uses the foldable tiller | |||
| handle/handlebar for steering | |||
| and a thumb operated | |||
| potentiometer throttle control | |||
| lever located at the top of the | |||
| tiller to engage and | |||
| disengage the scooter motion | |||
| in both the forward and | |||
| reverse directions. When the | |||
| throttle control lever is | |||
| released, the electromagnetic | |||
| brake will be actuated and | |||
| the scooter is slow to stop. | |||
| The speed mode of the both | |||
| devices was single mode and | |||
| the speed control dial can | |||
| control the maximum speed. | |||
| Both of the control systems | |||
| are evaluated according to | |||
| standard ISO 7176-14:2008 | |||
| and software validation | |||
| requirement and there are no | |||
| new safety and effectiveness | |||
| concerns due to the | |||
| difference. | |||
| Wheel | |||
| (type) | Lock | Electromagnetic brake | Same |
| Electromagnetic brake |
Table1-General Comparison
8
Table2 Performance Comparison
9
10
11
Table3 Safetv Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materials | |||
| contacting | |||
| user | Armrest: TRP | ||
| Backrest: Terylene | |||
| Seat: Leather | Armrest: PU Foamed; | ||
| Backrest/seat: Leather package | |||
| Footplates: ABS plastics | Biocompatibility | ||
| evaluation has | |||
| been carried out | |||
| per ISO 10993-1. | |||
| There are no new | |||
| safety and | |||
| effectiveness | |||
| concerns due to the | |||
| difference. | |||
| Biocompatibility of materials | |||
| contacting | |||
| user | Comply with ISO 10993-1, FDA | ||
| Guidance, Tests included | |||
| Cytotoxicity (ISO 10993-5:2009), | |||
| Sensitization and Intracutaneous | |||
| Reactivity (ISO 10993-10:2010) | Comply with ISO 10993-1, FDA | ||
| Guidance, Tests included | |||
| Cytotoxicity (ISO 10993-5:2009), | |||
| Sensitization and Intracutaneous | |||
| Reactivity (ISO 10993-10:2010) | Same |
Summary of substantial equivalence discussion:
Despite of the above differences, the two devices all completed the performance tests in accordance with ISO 7176 series standards. There are no safety and effectiveness aspects concerned. In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
Conclusion 10.0
The conclusions drawn from the comparison and analysis above demonstrate that the
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subject device is as safe, as effective, and performs as well as the legally marketed predicated device in K201196 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.