(140 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on mechanical and sensor-based control.
Yes
The device is described as enabling individuals with spinal cord injuries to perform ambulatory functions, which directly addresses a health condition and aims to restore or improve a physical function.
No
The device is an exoskeleton designed to assist individuals with spinal cord injuries in performing ambulatory functions, not to diagnose medical conditions.
No
The device description explicitly states it is composed of an "external, powered, motorized frame" and includes hardware components like gears, motors, a remote controller, exoskeleton, battery charger, and a laptop. This indicates it is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ReWalk™ P6.0 is an external, powered, motorized exoskeleton that fits to the lower limbs and part of the upper body. It is designed to enable individuals with spinal cord injuries to perform ambulatory functions.
- Intended Use: The intended use is to enable individuals with spinal cord injury to walk, not to perform diagnostic tests on biological samples.
The description clearly indicates that the ReWalk™ P6.0 is a physical assistive device for mobility, not a diagnostic tool that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory function of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
Product codes
PHL
Device Description
The ReWalk™ P6.0 is a prescription device which enables individuals with spinal cord injuries to perform ambulatory functions and composed of an external, powered, motorized frame fits to the lower limbs and part of the upper body.
Control of the device is achieved through a wrist-worn user-operated wireless remote controller (RC), tilt sensor and specific body movements. The gait movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk™ P6.0 system includes Remote control (RC) Communicator, Exoskeleton (Inc. Rigid Frames, Waistpack and Straps), Battery charger and Laptop (GUI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs and part of the upper body (specifically spinal cord injury at levels T7 to L5 and T4 to T6)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Specially trained companion, rehabilitation institutions. Home environment: any environment outside a professional healthcare facility.
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)
Review of non-clinical performance testing as well as comparison of the device classification, indication for use, operating principles, technological characteristics demonstrate that the subject device is substantially equivalent to the predicate. Any differences between the subject and the predicate device do not raise new questions of safety or effectiveness.
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
§ 890.3480 Powered lower extremity exoskeleton.
(a)
Identification. A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how to program the device;
(D) Instructions and explanation of all controls, input, and outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
e.g., EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a caduceus, a symbol associated with medicine and healthcare. The FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
May 26, 2020
ReWalk Robotics Ltd. Ofir Koren General Manager, VP R&D, and Regulatory Affairs 3 Hetnufa St., POB 161 Yokneam, 2069203 Israel
Re: K200032
Trade/Device Name: ReWalk P6.0 Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: February 25, 2020 Received: February 26, 2020
Dear Ofir Koren:
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 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
1
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,
Heather Dean, PhD Acting 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200032
Device Name ReWalk™ P6.0
Indications for Use (Describe)
The ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory function of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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3
Image /page/3/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo has the word "ReWalk" in large letters, with "Re" in gray and "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in gray. There are gray lines to the left of the word "Robotics".
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92
1. Submission Sponsor
ReWalk Robotics Ltd. 3 Hatnufa St. Yokneam, Israel 2069203, POB: 161 Establishment Registration: 3007615665
2. Submission Correspondent
Ofir Koren, General Manager, VP R&D and Regulatory Affairs
| Phone: | (+972) 54-52-25-792 |
|---|---|
| Fax: | (+972) 4-95-90-125 |
| E-mail: | Ofir@rewalk.com |
3. Date Prepared: May 25, 2020
Device Identification 4.
| Name of Device: | ReWalk™ P6.0 |
|---|---|
| Classification Name: | Powered Exoskeleton |
| Regulation: | 21 CFR §890.3480 |
| Regulatory Class: | Class II |
| Product Classification Code: | PHL |
| Classification panel: | Neurology |
5. Legally Marketed Predicate Device
| Predicate Manufacturer: | ReWalk Robotics Ltd. |
|---|---|
| Predicate Trade Name: | ReWalk™ P6.0 |
| Predicate 510(k): | K160987 |
6. Device Description
The ReWalk™ P6.0 is a prescription device which enables individuals with spinal cord injuries to perform ambulatory functions and composed of an external, powered, motorized frame fits to the lower limbs and part of the upper body.
Control of the device is achieved through a wrist-worn user-operated wireless remote controller (RC), tilt sensor and specific body movements. The gait movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk™ P6.0 system includes Remote control (RC) Communicator, Exoskeleton (Inc. Rigid Frames, Waistpack and Straps), Battery charger and Laptop (GUI).
4
Image /page/4/Picture/1 description: The image shows the logo for ReWalk Robotics. The logo is split into two parts, with "Re" in gray and "Walk" in yellow. Below the word "Walk" is the word "Robotics" in gray with a series of lines to the left of the word.
7. Intended Use / Indication for Use
The ReWalk™ P6.0 orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
8. Substantial Equivalence Discussion
The following table compares the ReWalk™ P6.0 to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance. The comparison of the devices in Table 1 below provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new or different questions of safety or effectiveness based on the similarities to the predicate device.
5
Image /page/5/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo features the word "ReWalk" in a stylized font, with the "Re" in gray and the "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in gray, with a series of vertical lines to the left of the word. The logo is simple and modern, and it effectively communicates the company's focus on robotics and mobility.
| Table 1: (Substantial Equivalence Discussion) | ||
|---|---|---|
| Characteristic | The ReWalk™ P6.0 (K200032) by ReWalk Robotics | The ReWalk™ P6.0 (K160987) by ReWalk Robotics |
|---|---|---|
| 510(k) number | K200032 | K160987 |
| Product Code | PHL | Same |
| Regulation Name | Powered Exoskeleton | Same |
| Regulation No. | 890.3480 | Same |
| Indication for Use | The ReWalk™ P6.0 orthotically fits to the lower limbs and part | |
| of the upper body and is intended to enable individuals with | ||
| spinal cord injury at levels T7 to L5 to perform ambulatory | ||
| functions with supervision of a specially trained companion in | ||
| accordance with the user assessment and training certification | ||
| program. The device is also intended to enable individuals with | ||
| spinal cord injury at levels T4 to T6 to perform ambulatory | ||
| functions in rehabilitation institutions in accordance with the user | ||
| assessment and training certification program. | ||
| The ReWalk™ P6.0 is not intended for sports or stair climbing. | Same | |
| Indications | Before using the device, confirm that the following prerequisites | |
| are met by the user: | ||
| • Hands and shoulders can support crutches or a walker | ||
| • Healthy bone density, meaning sufficient bone density | ||
| according to the judgement of the prescribing physician after | ||
| clinical examination of the patient - including radiological | ||
| proof if needed. | ||
| • Skeleton does not suffer from any fractures | ||
| • Able to stand using a device such as Easy Stand | ||
| • In general good health | ||
| • Height is between 160 cm and 190 cm (5' 3" - 6' 2") | ||
| • Weight does not exceed 100 kg (220 lbs.) | Before using the device, confirm that the following prerequisites | |
| are met by the user: | ||
| • Hands and shoulders can support crutches or a walker | ||
| • Healthy bone density | ||
| • Skeleton does not suffer from any fractures | ||
| • Able to stand using a device such as Easy Stand | ||
| • In general good health | ||
| • Height is between 160 cm and 190 cm (5' 3" - 6' 2") | ||
| • Weight does not exceed 100 kg (220 lbs.) | ||
| Characteristic | The ReWalk™ P6.0 (K200032) by ReWalk Robotics | The ReWalk™ P6.0 (K160987) by ReWalk Robotics |
| Contraindications | People with the following conditions should not use the | |
| ReWalk™: | ||
| • History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc.) | ||
| • Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores | ||
| • Severe spasticity (Modified Ashworth 4) | ||
| • Unstable spine or unhealed limbs or pelvic fractures | ||
| • Heterotopic ossification that impair joint mobility. | ||
| • Significant contractures (plantar flexion > 0°, knee > 10°, hip flexion >0°) | ||
| • Psychiatric or cognitive situations that may interfere with proper operation of the device | ||
| • Pregnancy | ||
| Warning: Crutches are required when using ReWalk™ | Same | |
| Patient Population | Individuals with spinal cord injury at levels T7 to L5 and levels T4 to T6 | Same |
| Device construction and | ||
| materials | The ReWalk™ P6.0 device is composed of rigid supporting framework and textile strapping providing body weight support to | |
| the patient | Same | |
| SW | Release 4.2 | |
| Two minor software feature modifications for sit-to-stand transition, and additional new software feature for stand-to-sit transition. | Release 4.1 | |
| Body Coverage | Worn over legs and around hips and lower torso | Same |
| Size of Components | Modular small, medium, large paretic leg component, control unit integrated into adjustable waist belt | Same |
| Mobility Aid | Off- the- shelf forearm crutches | Same |
| Ability of User Mobility | Sit, Stand and Walk | Same |
| Walking Speed | 2.3 km/Hr. (1.43 MPH) | Same |
| Patient height/weight | 160 to 190 cm (63 inches to 75 inches) | |
| 100 kg max. (220 lbs.') | Same | |
| Characteristic | The ReWalk™ P6.0 (K200032) by ReWalk Robotics | The ReWalk™ P6.0 (K160987) by ReWalk Robotics |
| Range of Motion | Hip: 34 degrees extension; 104 degrees flexion | |
| Knee: 110 degrees flexion; 2 degrees extension | Same | |
| Use environment | Healthcare facility environment including hospital rehabilitation centers. Home environment: any environment outside a | |
| professional healthcare facility. The ReWalk™ is not intended for sports or stair climbing. | Same | |
| Type of surface | Use the device on paved surfaces or on dry, even surfaces. | Same |
| Device weight | Total: 30 kg (66 lbs.) | Same |
| Maximum Speed | 2.3 km/Hr. (1.43 MPH) | Same |
| Training and | ||
| Certification Program | ||
| (Clinical Use) | A thorough training program providing certification is required | |
| for clinicians before using ReWalk™ P6.0 with patients | Same | |
| User/companion training | A training program providing certification is required for User & | |
| Companion before using ReWalk™ P6.0 | Same | |
| Expected Useable Life | 5 years with proper servicing | Same |
| Operating Temperature | +5°C to +40°C (+41°F to + 104°F) | Same |
| Operating Humidity | 15 % to 90%, non-condensing, but not requiring a water vapor | |
| partial pressure greater than 50 hPa | Same | |
| Electrical Safety Testing | IEC 60601-1/ IEC 60601-11 | Same |
| Electromagnetic | ||
| Compatibility Testing | IEC 60601-1-2 | Same |
| Laptop | Laptop is used for controlling and configuring through USB | |
| communication | Same | |
| Alignment (between user | ||
| and device) | Alignment of hip, knee and ankle joints with strap mechanism | |
| attached to device frame | Same | |
| Assistance method | Motors/gears moving rigid supporting framework to power knee | |
| and hip movement | Same | |
| System modes | Sit, Stand and Walk | Same |
| Battery specifications | Two rechargeable batteries: | |
| Main (Li-Ion) with capacity of 10.4 AH | ||
| and Auxiliary (Li-Polymer) 2 AH | Same | |
| Battery Life Cycle | Life Cycle > ~300 for standard charge/discharge cycles | Same |
| Battery charge time | Minimum 4 hours | Same |
| Failsafe feature | When battery is fully depleted or a power loss occurs, the | |
| Graceful Collapse feature is activated supporting the user's weight | ||
| while slowly lowering the user to a seat or the ground | Same |
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Image /page/6/Picture/0 description: The image shows the logo for ReWalk Robotics. The word "ReWalk" is written in a stylized font, with the "Re" in gray and the "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in gray. The logo is simple and modern, and it conveys the company's focus on robotics and mobility.
7
Image /page/7/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo is in two colors, gray and yellow. The word "ReWalk" is in large letters, with "Re" in gray and "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in smaller gray letters. There are also several gray lines to the left of the word "Robotics".
8
Image /page/8/Picture/0 description: The image shows the text "ReWalk™ P6.0 – K200032" on the first line and "510(k) Summary" on the second line. The text is centered and in a clear, readable font. The image appears to be a title or heading for a document or presentation.
Image /page/8/Picture/1 description: The image shows the logo for ReWalk Robotics. The word "ReWalk" is displayed in two colors, with "Re" in gray and "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in gray, with a series of gray lines to the left of the word. The logo is simple and modern, and the use of color helps to make it stand out.
9. Conclusions
The subject ReWalk™ P6.0 and the ReWalk™ P6.0 (K160987) - the predicate device have the same intended use and indications for use. In addition, both have same technological characteristics, and use very similar principles of operation. The only differences between the ReWalk™ and its predicate are two (2) minor software modifications for sit-to-stand transition, and the addition of one (1) new software feature for stand-to-sit transition. These minor differences do not present any new or different questions of safety or effectiveness as confirmed by completed testing also discussed in further detail below. Thus, the subject ReWalk™ P6.0 is substantially equivalent to the ReWalk™ P6.0 (K160987).
10. Conclusion on SE based on Technical Comparison & Performance Data
The subject device is designed to fulfill the requirements of the following recognized standards:
- IEC 60601-1-11:2015 (2nd Ed) /ANSI AAMI HA60601-1-11:2011 ●
- . IEC 60601-1-2 Edition 4.0 2014-02
- ANSI AAMI ES 60601-1:2005/(R)2012 And A1:2012, .
- . ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06 Software life cycle processes .
Review of non-clinical performance testing as well as comparison of the device classification, indication for use, operating principles, technological characteristics demonstrate that the subject device is substantially equivalent to the predicate. Any differences between the subject and the predicate device do not raise new questions of safety or effectiveness.
11. Summary
Utilizing FDA's Substantial Equivalence Decision Tree we conclude the following:
- The subject device has the same Intended use and Indications for use as the predicate ●
- · The subject device the same technological characteristics as the predicate device
- . The different characteristics do not raise new or different types of safety or effectiveness questions
- . Acceptable scientific methods exist for assessing the new characteristics
- . Performance data are available to assess the effects of the new characteristics
- . Performance data (along with descriptive characteristics) demonstrate substantial equivalence.