K201539 · B-Temia, Inc. · PHL · Sep 9, 2020 · Physical Medicine
Device Facts
Record ID
K201539
Device Name
Keeogo Dermoskeleton System
Applicant
B-Temia, Inc.
Product Code
PHL · Physical Medicine
Decision Date
Sep 9, 2020
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.3480
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Keeogo is robotic exoskeleton that fits orthotically on the user's waist, thigh, and shin, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for the following population: Individuals with stroke who have gait deficient hip (MMT Hip ≥ 3) and knee strength (MMT Knee ≥ 2) and who are capable of standing and initiating gait movement without assistance. The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.
Device Story
Keeogo is a powered lower extremity exoskeleton worn on the waist, thigh, and shin. It provides computer-controlled assistance to the knee joint, supporting knee flexion/extension during swing phase and eccentric control/extension during weight-bearing. Unlike pre-programmed exoskeletons, it integrates with user-initiated movements, providing assistance based on detected activity. Used in rehabilitation settings under supervision of a trained healthcare professional. Clinicians use a tablet-based mobile application to fit the device and tune software settings to individual patient needs. The device benefits patients by improving gait quality and assisting ambulatory function. It features a failsafe mode where motor torque disables, rendering the device passive.
Clinical Evidence
Interventional, single-arm clinical trial (NCT03986320) with 48 subjects (stroke patients). Primary endpoint: Gait Quality Assessment (Wisconsin Gait Scale). Results showed statistically significant improvement in WGS scores (Baseline 20.36 vs. Device 17.76; p < 0.001). 75% of participants showed improvement in >50% of effectiveness assessments. No serious adverse events reported.
Technological Characteristics
Powered lower extremity exoskeleton; 2 knee motors (up to 40 Nm torque). Materials biocompatible per ISO 10993. Connectivity: Tablet-based mobile app for clinician tuning. Standards: IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), IEC 60601-1-11 (vibration), IEC 62366 (usability), IEC 62133 (battery). Rechargeable Li-Ion battery (39.6V).
Indications for Use
Indicated for individuals with stroke, aged 58±11 years, with gait deficits, hip strength (MMT Hip ≥ 3), and knee strength (MMT Knee ≥ 2), capable of standing and initiating gait without assistance.
Regulatory Classification
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.
Special Controls
In combination with the general controls of the FD&C Act, the Powered Exoskeleton is subject to the following special controls:
*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).
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September 09, 2020
B-Temia Inc. % Kristin Davenport Of Counsel Covington & Burling LLP 850 10th St NW Washington, DC 20001
Re: K201539
Trade/Device Name: Keeogo Dermoskeleton System Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: May 31, 2020 Received: June 9, 2020
Dear Kristin Davenport:
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.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 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
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## Indications for Use
510(k) Number (if known) K201539
Device Name Keeogo Dermoskeleton System
#### Indications for Use (Describe)
The Keeogo is robotic exoskeleton that fits orthotically on the user's waist, thigh, and shin, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for the following population:
Individuals with stroke who have gait deficient hip (MMT Hip ≥ 3) and knee strength (MMT Knee ≥ 2) and who are capable of standing and initiating gait movement without assistance.
The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
| General<br>Information: | Sponsor's Name: | B-Temia, Inc. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | Address: | 4780, rue St-Félix - unité 105<br>St-Augustin-de-Desmaures (QC) G3A 2J9<br>Canada |
| | Contact Person: | Alexandre Jokic<br>VP Regulatory, Clinical Affairs and Quality<br>Assurance, B-Temia Inc. |
| | Address: | 4780, rue St-Félix - unité 105<br>St-Augustin-de-Desmaures (QC) G3A 2J9<br>Canada |
| | Telephone: | 418-653-1010 ext. 248 |
| | Fax Number: | 418 653-0155 |
| | Date Prepared: | May 31, 2020 |
| Subject Device: | Trade Name: | Keeogo™ Dermoskeleton System |
| | Common Name: | Powered Exoskeleton |
| | Product Code: | PHL |
| | FDA Regulation: | 21 CFR 890.3480 Powered lower extremity<br>exoskeletons |
| | Device Classification: | Class II |
| Predicate Device: | Trade Name: | Honda Walking Assist Device |
| | Common Name: | Powered Exoskeleton |
| | Product Code: | PHL |
| | FDA Regulation: | 21 CFR 890.3480 Powered lower extremity<br>exoskeletons |
| | Device Classification: | Class II |
| | Premarket Notification: | K181294 |
| Indications for<br>Use: | The Keeogo™ Dermoskeleton System is robotic exoskeleton that fits<br>orthotically on the user's waist, thigh, and shin, outside of clothing. The<br>device is intended to help assist ambulatory function in rehabilitation<br>settings under the supervision of a trained healthcare professional for the<br>following population:<br><br>Individuals with stroke who have gait deficits and sufficient hip<br>(MMT Hip $≥$ 3) and knee strength (MMT Knee $≥$ 2) and who are capable<br>of standing and initiating gait movement without assistance. | |
| Description of<br>device: | KeeogoTM Dermoskeleton System is an ambulatory assistive device that is<br>fitted to the lower body, and is powered at the knee. This computer-<br>controlled orthosis provides complementary force to the knee joint to<br>assist with: (1) knee flexion and extension in the swing phase of gait, and<br>(2) eccentric knee control and extension in the weight bearing phase. | |
| | KeeogoTM Dermoskeleton System does not move through a pre-<br>determined pattern of movement, but rather integrates seamlessly with<br>movements initiated by the user themselves, and provides assistance based<br>on the detected activity. | |
The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.
{4}------------------------------------------------
Several performance tests were conducted with the Keeogo™ Non-Clinical Performance Data Dermoskeleton System to demonstrate safety, effectiveness, and usability: Add here
- Durability
- Vibration IEC 60601-1-11
- Electrical Safety IEC . 60601-1
- . Electromagnetic Compatibility (EMC) IEC 60601-1-2
- . Usability IEC 62366
- . Battery Safety IEC 62133:2012
- . Sensor accuracy
- . Biocompatibility testing in accordance with ISO 10993-1:2009, ISO 10993-5 & ISO 10993-10)
| Clinical<br>Performance | Trial<br>Registration | URL: http://www.clinicaltrials.gov<br>Identifier: NCT03986320 | | |
|-------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------|
| | Trial Design | Interventional, comparative, single-arm trial | | |
| | Trial Sites | • The Shirley Ryan AbilityLab (Chicago, Illinois, USA) | | |
| | | • Human Performance and Engineering Research<br>(HPER) (West Orange, New Jersey, USA) | | |
| | | • James J Peters VA Medical Center - Center for the<br>Medical Consequences of Spinal Cord Injury (Bronx,<br>New York, USA) | | |
| | | • Assistive Technology Clinic (ATC) (Toronto, Ontario,<br>Canada) | | |
| | | | | |
| | Condition | Stroke | | |
| | Test Groups | Keeogo – Intervention | | |
| | Intervention | • Week 1: 3 baseline sessions<br>• Week 2: 3 device familiarization sessions<br>• Week 3: 3 Keeogo testing sessions | | |
| | Total Subjects | Population | Safety Population<br>Visit 1 | Effectiveness<br>Population |
| | | N | 55 | 48 |
| | | Age | $58 \pm 11$ | $58 \pm 11$ |
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| | Gender | 26 female, 29<br>male | 23 female, 25<br>male |
|------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------|
| | Hemiparesis | 25 left-side, 30<br>right-side | 23 left-side, 25<br>right-side |
| | Stroke<br>Legacy | $70 \pm 81$ months | $74 \pm 84$ months |
| | | Hip: MMT ≥ 3+<br>(flexors &<br>extensors), | Hip: MMT ≥ 3+<br>(flexors &<br>extensors), |
| | MMT | Knee: MMT ≥ 2<br>(flexors &<br>extensors) | Knee: MMT ≥ 2<br>(flexors &<br>extensors) |
| Clinical<br>Outcome<br>Assessments | | ● Baseline (each of three baseline test visits) | |
| | | ● Intervention (each of three device test visits) | |
| | | ● Post (after 9 visits) | |
| Results | | Gait Quality Assessment, Wisconsin Gait Scale | |
| | | Units: scalar | |
| | | Scale Range: [13.35, 42] = [healthy gait, max gait<br>disability] | |
| | | Mean (SD) | |
| | | Baseline: 20.36 (3.22) | |
| | | Gait with Device: 17.76 (2.54) | |
| | Change from Baseline (Paired test) | | |
| | Minimum Clinically Important Difference: 2.25 | | |
| | Improvement: 2.60 (1.71) | | |
| | 95% Confidence interval for Improvement: $2.60 \pm$ 0.55 | | |
| | Significance: P-Value = p < 0.001 | | |
| | Safety results: | | |
| | No Serious Adverse Event was reported either for the | | |
| | participant (primary outcome) or physical therapist / | | |
| | clinician (secondary outcome). | | |
| | Effectiveness results: | | |
| | Participant group showed a statistically significant | | |
| | improvement in the WGS (secondary outcome) with the | | |
| | use of the Keeogo™ (p < 0.001) | | |
| | All the participants showed an improvement with one | | |
| | effectiveness assessment (WGS, 30SCT, TST-up, TST- | | |
| | down, ClinRO, PRO; assessments described under | | |
| | secondary and tertiary outcomes). Seventy-five percent | | |
| | showed an improvement with more than 50% of the | | |
| | effectiveness assessments. | | |
### Substantial Equivalence
| CATEGORY | KEEOGO™ | HONDA WALKING<br>ASSIST DEVICE (HWA) | Substantial Equivalence<br>Comments | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBA | K181294 | N/A | |
| Product Code | PHL | PHL | [SAME] | |
| CATEGORY | KEEOGOTM | HONDA WALKING<br>ASSIST DEVICE (HWA) | Substantial Equivalence<br>Comments | |
| Sub-Product Code | N/A | N/A | [SAME] | |
| Regulation Name | Powered Lower<br>Extremity Exoskeleton | Powered Lower<br>Extremity Exoskeleton | [SAME] | |
| Device Class | Class II | Class II | [SAME] | |
| Regulation | 21 CFR 890.3480 | 21 CFR 890.3480 | [SAME] | |
| Indications for Use | The Keeogo<br>Dermoskeleton System<br>is a robotic exoskeleton<br>that fits orthotically on<br>the user's waist, thigh,<br>and shin, outside of<br>clothing. The device is<br>intended to help assist<br>ambulatory function in<br>rehabilitation settings<br>under the supervision of<br>a trained healthcare<br>professional for the<br>following population:<br><br>Individuals with stroke<br>who have gait deficits<br>and sufficient hip (MMT<br>Hip $\geq$ 3) and knee<br>strength (MMT Knee $\geq$<br>2) and who are capable<br>of standing and initiating<br>gait movement without<br>assistance.<br><br>The trained healthcare<br>professional must<br>successfully complete a<br>training program prior to<br>fitting and tuning the<br>device. The device is not<br>intended for sports | The Honda Walking<br>Assist Device is a<br>robotic exoskeleton that<br>fits orthotically on the<br>user's waist and thigh,<br>outside of clothing. The<br>device is intended to<br>help assist ambulatory<br>function in rehabilitation<br>institutes under the<br>supervision of a trained<br>healthcare professional<br>for the following<br>population:<br><br>Individuals with stroke<br>who have gait deficits<br>and exhibit gait speeds<br>of at least 0.4m/s and are<br>able to walk at least 10<br>meters with assistance<br>from a maximum of one<br>person.<br><br>The trained healthcare<br>professional must<br>successfully complete a<br>training program prior to<br>use of the device. The<br>devices are not intended<br>for sports. | [SIMILAR]<br>- The patient population<br>is the same<br><br>- The Keeogo indication<br>defines the necessary<br>physical characteristics<br>of the patient population<br>in terms of minimum<br>hip and knee strength,<br>while the predicate<br>describes the patient<br>characteristics in terms<br>of minimum gait speed<br><br>- Hip and knee strength<br>correlate to gait speed,<br>as supported by data<br>reported in literature<br><br>- The difference in how<br>minimum physical<br>characteristics are<br>described and<br>determined does not<br>raise different questions<br>of safety or<br>effectiveness | |
| CATEGORY | KEEOGO™ | HONDA WALKING<br>ASSIST DEVICE (HWA) | Substantial Equivalence<br>Comments | |
| Device Weight | 15 lbs (6.8 kg) | 5.95 lbs (2.7 kg) | [SIMILAR]<br>- Difference in weight is<br>due to the Keeogo's<br>design (covers area<br>between hip and shin)<br>compared to the<br>predicate that covers the<br>area between the hip<br>and above the knee.<br>This difference in<br>weight does not raise<br>different questions of<br>safety or effectiveness | |
| Body Coverage and<br>Area of Assistance | Worn around the waist<br>& legs; assistance<br>provided to knee joint | Worn around the waist<br>& thighs; assistance<br>provided at hip | [SIMILAR]<br>- As described above, the<br>Keeogo covers the area<br>between the hip and<br>shin and provides<br>assistance at the knee.<br>The Honda device<br>covers the area between<br>hip and above the knee<br>and provides assistance<br>at the hip.<br>- The differences in body<br>coverage and area to<br>which assistance is<br>applied do not raise<br>different questions of<br>safety or effectiveness | |
| Mobility Aid | Optional (e.g., walker,<br>cane) | Optional (e.g., walker,<br>cane) | [SAME] | |
| Patient Population | • Individuals with<br>stroke who have gait<br>deficits and sufficient<br>hip (MMT Hip $\geq$ 3) and<br>knee strength (MMT<br>Knee $\geq$ 2) and who are<br>capable of standing and<br>initiating gait movement<br>without assistance. | • Individuals with<br>stroke who have gait<br>deficits and exhibit gait<br>speeds of at least 0.4m/s<br>and are able to walk at<br>least 10 meters with<br>assistance from a<br>maximum of one person. | [SAME]<br>- The patient population<br>is the same, i.e.,<br>individuals with stroke<br>who have gait deficits<br>- The difference in how<br>minimum physical user<br>characteristics are<br>described and measured<br>does not raise different<br>questions of safety or<br>effectiveness | |
| Device limit on<br>user's gait speed | None | None | [SAME] | |
| Type of Surface for<br>Training | Smooth, cement, carpet | Smooth, cement, carpet | [SAME] | |
| CATEGORY | KEEOGO™ | HONDA WALKING<br>ASSIST DEVICE (HWA) | Substantial Equivalence<br>Comments | |
| Device Range of<br>Motion (ROM) | Hips: 150° flexion to 40° extension Knee: 166° flexion to 4° extension | - Hips: 113° flexion to<br>47° extension | [SIMILAR]<br>- Keeogo hip joint ROM<br>is comparable to<br>predicate<br><br>- Keeogo also has a knee<br>ROM because it<br>provides assistance at<br>the knee<br><br>- Minor differences in hip<br>ROM, and additional<br>knee ROM, do not raise<br>different questions of<br>safety or effectiveness | |
| | User Height<br>Requirement | 1.52 m to 1.88 m (~60<br>in to ~74 in) | 1.4 m to 2.0 m (~55 in<br>to ~79 in) | [SIMILAR]<br>- This minor…
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What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
