(410 days)
The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.
The Vivally System is a wearable, non-invasive, bladder control therapy with a mobile application to treat patients with the conditions of urge urinary incontinence and urinary urgency, without the need for surgery, implants, drugs, or needle-electrodes. The Vivally System utilizes neuromodulation to deliver electrical signals to the tibial nerve. The tibial nerve is a mixed (motor and sensory) peripheral nerve that feeds into the sacral plexus which contains the nerves that innervate the detrusor muscle surrounding the urinary bladder. The Vivally System also includes an analog input that measures the electromyogram (EMG) signal from the patient's foot via three additional EMG electrodes embedded on the Garment. The system operates in a combination of closed-loop using EMG as the physiological feedback, as well as in open-loop when the feedback signal is unreliable or unreadable. The main components of the Vivally System include a rechargeable-controller (Stimulator) powered by a rechargeable lithium-ion battery, an ankle worn Garment designed to be used on the left or right ankle, Gel Cushions and charging accessories. The Vivally System also includes a mobile application on the patient's personal device and a HIPAAcompliant cloud database. The Vivally Mobile Application allows the patient to start and manage a therapy session and provides access to condition support tools such as an electronic bladder diary to record symptoms, fluid intake and other factors impacting their condition and a record of therapy compliance. The HIPAA-compliant Vivally Cloud Database collects patient therapy statistics, therapy compliance and symptom tracking over time and can be accessed by the patient and physician as a tool to monitor and manage treatment.
Here is a summary of the acceptance criteria and study information for the Vivally System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the clinical study in the form of numerical thresholds for responder rates or symptom reduction required for clearance. Instead, it describes what was reported from the study. The FDA's conclusion indicates that the study demonstrated clinically meaningful improvement in UUI and urinary urgency symptoms.
| Effectiveness Metric | Acceptance Criteria (Not explicitly stated as numeric thresholds for clearance, but implied by FDA's conclusion of "clinically meaningful improvement") | Reported Device Performance (12 Weeks) | Reported Device Performance (6 Months) | Reported Device Performance (12 Months) |
|---|---|---|---|---|
| UUI (Urinary Incontinence Events, ≥ 50% improvement) Responder Rate | Implied to be a clinically meaningful percentage | 61.8% | 62.8% | 62.9% |
| Urges (Urinary Urgency Events, ≥ 50% improvement) Responder Rate | Implied to be a clinically meaningful percentage | 55.4% | 69.4% | 69.0% |
| Voiding Frequency (Voiding Events, ≥ 30% improvement) Responder Rate | Implied to be a clinically meaningful percentage | 34.8% | 34.1% | 27.8% |
| Quality of Life (QOL) Assessments | Exceed threshold validated for minimal clinically important difference | All QOL domains exceeded threshold | Not explicitly broken down | Not explicitly broken down |
| Safety | Favorable safety profile, low incidence of severe adverse events | 12 device/procedure related AEs (all mild/moderate), no severe | 1 device-related AE (mild), no severe | Not explicitly detailed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- Intent-to-Treat (ITT) population: 96 subjects
- Evaluable population: 94 subjects
- Per Protocol (PP) population: 73 subjects
- 6-month follow-up: 47 subjects
- 12-month follow-up: 39 subjects
- Data Provenance: Prospective, multi-center study conducted at nine centers within the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes a clinical study where subjects reported their symptoms using a 3-day bladder diary. There is no mention of external experts establishing the ground truth for the test set. The patients themselves provided the data on their symptoms (UUI, urges, voids) which served as the "ground truth" for assessing effectiveness, as measured by symptom reduction and responder rates against their baseline.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The symptom data was derived from patient-recorded 3-day bladder diaries.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study was a single-arm clinical trial evaluating the device in a cohort of patients, not comparing human readers' performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the effectiveness outcomes presented are for the device (Vivally System) as a standalone treatment used by the patient at home. While personalization of therapeutic range was set by a physician, and a mobile application and cloud database are part of the system for therapy management and patient/physician access, the effectiveness results are based on the device's direct therapeutic action. The study assessed the device's ability to reduce symptoms and improve QOL.
7. The Type of Ground Truth Used
The ground truth for effectiveness outcomes was based on patient-reported symptoms recorded in a 3-day bladder diary at baseline and various follow-up periods. Quality of Life (QOL) assessments were also patient-reported using validated questionnaires (OAB-q, I-QoL, IIQ-7, PGIC, and OHG).
8. The Sample Size for the Training Set
The document describes a clinical study for product evaluation, not an AI/algorithm development study with distinct "training" and "test" sets in the typical machine learning sense. Therefore, there is no specified "training set" sample size for an algorithm in this context. The clinical study enrolled 96 subjects who served as the study population for evaluating the device's effectiveness.
9. How the Ground Truth for the Training Set Was Established
As there is no distinct "training set" in the context of an AI algorithm, this question is not applicable based on the provided text. The clinical study evaluated the device's performance directly using patient-reported outcomes as the "ground truth."
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April 3, 2023
Avation Medical, Inc. Manish Vaishya Chief Technical Officer 1375 Perry Street Columbus, OH 43201
Re: K220454
Trade/Device Name: Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application Regulation Number: 21 CFR§ 876.5310 Regulation Name: Nonimplanted, peripheral electrical continence device Regulatory Class: II Product Code: NAM Dated: March 2, 2023 Received: March 3, 2023
Dear Manish Vaishya:
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.
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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,
Angel A. Soler-garcia -S
for Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220454
Device Name
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
Indications for Use (Describe)
The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.
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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Image /page/3/Picture/1 description: The image contains the logo for Avation Medical. The logo consists of a circular design on the left and the company name on the right. The circular design is made up of green and blue curved lines that intersect to form a flower-like shape. The company name is written in black, with the word "AVATION" on top and the word "MEDICAL" below it in a smaller font.
510 (k) Summary
Submitter Information 1.
| 510 (k) submitter | Avation Medical, Inc. |
|---|---|
| Address | 1375 Perry St, Suite 13-150Columbus, OH 43201 |
| Contact Person | Manish Vaishya, PhD |
|---|---|
| Chief Technology Officer Phone | |
| 614.591.4201 | |
| Email : Manish@Aviation.com |
Preparation date March 31, 2023
2. Device Name
| Trade Name of the Device | Vivally System Wearable, Non-Invasive NeuromodulationSystem and Mobile Application |
|---|---|
| Common Name | Non-implanted peripheral nerve stimulator for incontinence |
| Classification Name | Nonimplanted, Peripheral Electrical Continence Device |
| Classification Regulation | 21 CFR 876.5310 |
| Device Class | II |
| Panel | Gastroenterology/Urology |
| Product Code | NAM |
Predicate and Reference Devices 3.
| Predicate | Reference | |
|---|---|---|
| 510(k) Number | K192731 | K132561 |
| Trade Name of theDevice | ZIDA WearableNeuromodulation System | NURO NeuromodulationSystem |
Device Description 4.
The Vivally System is a wearable, non-invasive, bladder control therapy with a mobile application to treat patients with the conditions of urge urinary incontinence and urinary urgency, without the need for surgery, implants, drugs, or needle-electrodes.
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The Vivally System utilizes neuromodulation to deliver electrical signals to the tibial nerve. The tibial nerve is a mixed (motor and sensory) peripheral nerve that feeds into the sacral plexus which contains the nerves that innervate the detrusor muscle surrounding the urinary bladder. The Vivally System also includes an analog input that measures the electromyogram (EMG) signal from the patient's foot via three additional EMG electrodes embedded on the Garment. The system operates in a combination of closed-loop using EMG as the physiological feedback, as well as in open-loop when the feedback signal is unreliable or unreadable.
The main components of the Vivally System include a rechargeable-controller (Stimulator) powered by a rechargeable lithium-ion battery, an ankle worn Garment designed to be used on the left or right ankle, Gel Cushions and charging accessories.
The Vivally System also includes a mobile application on the patient's personal device and a HIPAAcompliant cloud database. The Vivally Mobile Application allows the patient to start and manage a therapy session and provides access to condition support tools such as an electronic bladder diary to record symptoms, fluid intake and other factors impacting their condition and a record of therapy compliance. The HIPAA-compliant Vivally Cloud Database collects patient therapy statistics, therapy compliance and symptom tracking over time and can be accessed by the patient and physician as a tool to monitor and manage treatment.
ર. Indications For Use
The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.
| Device & PredicateDevice(s): | K220454 | K192731 (Predicate) | K132561(Reference) |
|---|---|---|---|
| Device Name | Vivally | ZIDA WearableNeuromodulation System | Nuro NeuromodulationSystem |
| Indications for Use | The Vivally® System is awearable neuromodulationsystem to treat patients withthe bladder conditions ofurge urinary incontinenceand urinary urgency. | ZIDA WearableNeuromodulation Systemis a neuromodulationsystem that is intended totreat patients with anoveractive bladder (OAB)and associated symptomsof urinary urgency, urinaryfrequency, and urgeincontinence | The Nuro neuromodulationsystem (stimulator modelNuro 100) is intended totreat patients withoveractive bladder (OAB)and associated symptoms ofurinary urgency, urinaryfrequency, and urgeincontinence. |
| Prescription or OTC | Prescription | Prescription | Prescription |
| Operating Principle | It is a non-invasivewearable bladder controltherapy system utilizingneuromodulation to treatpatients with bladderconditions of the urgeurinary incontinence andurinary urgency bystimulating the tibial nerve. | It is a non-invasivewearable device whichprovides transcutaneouselectrical stimulation ofthe posterior tibial nerve totreat OAB. | It is designed as apercutaneous tibial nervestimulation system (PTNS)to deliver retrograde accessto the sacral nerve plexusthrough percutaneouselectrical stimulation of theposterior tibial nerve treatoveractive bladder (OAB)and associated symptoms. |
| For closed loop operationEMG electrodes areembedded on the Garment | No EMG electrodes arepresent | No EMG electrodes arepresent | |
| Power source | Rechargeable Battery | 1x AAA Battery (non-rechargeable) | Rechargeable Battery |
Comparison of the Technological Characteristics with primary Predicateand Reference Devices 6.
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| 240-mAh, 3.7V Li-Ion | 130-mAh, 3.7V Li-Ion | ||
|---|---|---|---|
| Number of OutputModes | 4 modes: Calibration,therapy, test therapy, anddiary | 2 modes: Therapy andtesting | 2 modes: Calibration andTherapy |
| Therapy schedule | 30 minutes per session, 1xor 3x per week or asprescribed by clinician | 30 minutes per session, 1xper week | 1x per week |
| Therapy sessionduration | 30 minutes | 30 minutes | 30 minutes |
| WirelessTechnology | Bluetooth | Not present | Not present |
| Electrodedimension (each) | 22 X 50 mmEstimated surface area of996 mm² | 20 X 40 mmEstimated surface area of800 mm² | 34 gaugeAcupuncture needleelectrode |
| StimulationFrequency | 20 Hz | 20 Hz | 20 Hz |
| Pulse width | 40 – 600 us | 200 µs, fixed | 200 us |
| Current amplitude | 20 mA fixed | 0-156 mA, adjustable | 0 - 9 mA pk-to-pk |
| Electrode material | Silver ink coating | 80% nylon 20%silver | Needle: stainless steel |
As evidenced by the above table, both the subject and the predicate devices have similar intended use, but the subject and predicate devices have different technological characteristics. However, performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.
7. Non-Clinical Testing
Below is a list of the tests that have been performed and successfully completed for the subject device per the below guidance and standards:
- Biocompatibility testing according to ISO 10993-1:2018 Biological evaluation of medical O devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- O Electrical Safety testing according to IEC 60601-1: 2020 - Medical electrical equipment -Basic safety and essential performance
- Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 General O requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- IEC 60601-2-10:2016 Particular requirements for the basic safety and essential o performance of nerve and muscle stimulators
- 0 IEC 60601-1-10 Ed 1.2 :2020 General Requirements for Basic Safety And Essential Performance - Collateral Standard: Requirements For The Development Of Physiologic Closed-Loop Controllers
- o IEC 62366-1 Ed 1.1: 2020 Medical devices Part 1:Application of Usability Engineering to Medical Devices
- o Software Verification and Validation Testing according to FDA's Guidance for
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the Content of Premarket Submissions for Software Contained in Medical Devices"
Additionally, performance bench data was submitted for device performance and durability of the subject device. This data included:
- o Stimulation performance and closed-loop functionality tests.
- o Testing for Medical Devices Home Use, including environmental, operating, shock and vibration.
- o System and component durability and cycle testing.
- o Use case testing for comfort, safety and tolerability.
- o Cybersecurity testing
All predetermined acceptance criteria were met.
Clinical Study Summary 8.
To confirm the safety, effectiveness of the subject device. Avation Medical conducted a prospective, multi-center study which evaluated the safety and effectiveness of the Vivally System for thirty minutes per session one to three times per week for 12 weeks , and then once every other week in the long-term follow up. After 12 weeks, subjects who met additional inclusion/exclusion criteria, such as completion of the 12 weeks of study with a minimum compliance of 90% for diary entries were able to continue in the long-term follow-up (24 months) portion of the study to assess the sustainability of therapeutic effect provided by the subject device. However, only 12 month follow-up data were submitted to support this 510(k).
Nine centers within the United States screened and enrolled subjects that met the inclusion and exclusion criteria. 96 subjects, confirmed to suffer from one or more symptoms of OAB as measured by a baseline 3-day bladder diary, and who met the other inclusion criteria, were enrolled into the study. 88.5% subjects in the study were female. 80.2% study subjects were white and 10.4% were black. Mean age of the subjects was 60.8 years. Objective confirmation of the activation of the subject's tibial nerve (via EMG signal feedback) was achieved, and a personalized therapeutic range was set for each subject by their physician. Therapy sessions were performed by the subject at-home for 30 minutes per session, one to three times per week for 12 weeks, and twice per month during the long-term follow up portion. 96 subjects were enrolled and included in the Intent-to-Treat (ITT) population, 94 were deemed evaluable and 73 were deemed per protocol (PP). 47 subjects continued in the long-term follow-up phase of the study and completed the 6 month follow-up, followed by 39 for 12 months follow-up.
Baseline Symptoms - Daily average events per day:
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| ITT (N=96) | PP (N=73) | |||
|---|---|---|---|---|
| OAB Symptom | Number of SubjectsReporting Symptom(%) | Average Daily ofSymptom Events atBaseline(Mean ± SD;Median [Min, Max]) | Number of SubjectsReporting Symptom(%) | Average DailySymptom Events atBaseline(Mean ± SD;Median [Min, Max]) |
| UUI(Urinary Incontinenceevents) | 76 (79.1%) | 4.82 ± 4.133.67 [0.33, 16.0] | 58 (79.5%) | 4.92 ± 4.133.83 [0.33, 15.67] |
| Urges(Urinary urgencyevents) | 74 (77.1%) | 6.94 ± 5.856.0 [0.33, 28.0] | 54 (74.0%) | 6.99 ± 6.066.67 [0.33, 28.0] |
| Voids (Voidingfrequency) | 89 (92.7%) | 13.34 ± 4.1312.0 [8.67, 38.33] | 73 (100%) | 13.28 ± 3.1312.0 [10.0, 28.0] |
Effectiveness Outcome:
Effectiveness results were measured using responder rate, where a responder is a subject with an improvement of 50% or greater over baseline symptoms for UUI and urinary urgency events, and 30% improvement over baseline for voiding events. The responder rates at 12 weeks, 6 months and 12 months are listed in the table below-
| Treatmentduration | Effectiveness Metric | UUI (IncontinenceEvents, ≥ 50%improvement) | Urges (UrgencyEvents, ≥ 50%improvement) | VoidingFrequency(Voiding Events,≥ 30%improvement) |
|---|---|---|---|---|
| 12 Weeks(N = 94) | # with symptoms at baseline (Y) | 76 | 74 | 89 |
| # of responders (X) | 47 | 41 | 31 | |
| Responder Rate (X/Y)*100% | 61.8% | 55.4 % | 34.8 % | |
| Symptom Event Reduction(Mean ± SD;Median [Min, Max]) | 1.91 ± 3.101.33 [-8.67, 11.67] | 3.10 ± 3.852.33 [-3.0, 23.0] | 2.92 ± 2.533.0 [-3.67, 10.33] | |
| 6 months(N = 47) | # with symptoms at baseline (Y) | 43 | 36 | 44 |
| # of responders (X) | 27 | 25 | 15 | |
| Responder Rate (X/Y)*100% | 62.8 % | 69.4 % | 34.1 % | |
| Symptom Event Reduction(Mean ± SD;Median [Min, Max]) | 2.13 ± 3.031.67 [-9.0, 10.0] | 3.97 ± 5.222.17 [-4.0, 23.0] | 2.67 ± 2.502.50 [-4.67, 7.0] | |
| 12 months(N = 39) | # with symptoms at baseline (Y) | 35 | 29 | 36 |
| # of responders (X) | 22 | 20 | 10 | |
| Responder Rate (X/Y)*100% | 62.9 % | 69.0 % | 27.8 % | |
| Symptom Event Reduction(Mean ± SD;Median [Min, Max]) | 1.29 ± 3.851.67 [-10.67, 10.33] | 2.84 ± 4.871.33 [-5.0, 21.0] | 1.85 ± 2.802.33 [-6.33, 5.33] |
Responder Rates and Daily Average Symptom Event Reduction
Safety Outcome:
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The sponsor reported a total of 77 adverse events throughout the first 12 weeks of the study among which 61 were mild. The sponsor reported 12 device/procedure related adverse events which were all mild or moderate. No device-or procedure related severe adverse events were reported. The device or procedure related adverse events were foot pain (02), foot contusion (01), frequent urination (03), skin irritation (01), mild thermal burn (01) and urinary incontinence (01). One subject exited the study due to frequent urination. All the other adverse events were resolved either by reducing the stimulation parameters or replacing the device components (e.g., gel cushion replacement resolved the adverse event related to mild thermal burn).
In the long-term follow up to 12 months, 12 additional adverse events were recorded, all listed as mild (10) to moderate (2) and only one noted as possibly related to the device. That adverse event was recorded as prominent varicose veins. No treatment was needed for the adverse event.
Quality of Life (QOL):
5 QOL (OAB-q, I-QoL, IIQ-7, PGIC, and OHG) assessments were conducted as part of the clinical study. Outcomes for all QOL domains exceeded the threshold validated for the minimal clinically important difference confirming that the Vivally System has a positive impact on Quality of Life.
Assessment of Clinical Data:
The statistical analysis of the clinical data was not pre-specified and post-hoc in nature. Therefore, all the clinical data presented in this summary are descriptive.
The clinical data submitted in this 510(k) demonstrate the subject device provides a clinically meaningful improvement in UUI and urinary urgency symptoms. While the lack of pre-specified statistical analyses increases the uncertainty around the clinical data, considering the favorable safety profile of the device, the non-invasive nature of the treatment, the potential for the device to increase accessibility of the treatment, and the percent of responders for UUI and urinary urgency, the benefits of the device in treating the specific symptoms of UUI and urinary urgency outweigh the risks.
9. Conclusions
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.
§ 876.5310 Nonimplanted, peripheral electrical continence device.
(a)
Identification. A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.(b)
Classification. Class II, subject to the following special controls:(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.