K221859 · Wandercraft SAS · PHL · Dec 29, 2022 · Physical Medicine
Device Facts
Record ID
K221859
Device Name
Atalante
Applicant
Wandercraft SAS
Product Code
PHL · Physical Medicine
Decision Date
Dec 29, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.3480
Device Class
Class 2
Attributes
Therapeutic, Real-World Evidence
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K221859 · Dec 29, 2022
Atalante
Wandercraft SAS
Real-world usage data from over 250 patients
The sponsor utilized real-world evidence from over 250 patients to support the clinical findings regarding the safety and effectiveness of the Atalante exoskeleton in patients with CVA.
CVA; Exoskeleton; Real-world usage
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Real-world evidence of use; Not specified (Real-world usage data)
Patients with cerebrovascular accident (CVA); Sample Size: >250
Not applicable for this study
Safety and effectiveness
Indications for Use
The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator. The operator must complete a training program prior to use of the device. The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position. The device is not intended for sports or stair climbing.
Device Story
Atalante is a fully powered, self-balancing hip-knee-ankle lower body exoskeleton; 12 actuated degrees of freedom. Device enables hands-free ambulatory functions and mobility exercises for hemiplegic patients in rehabilitation centers. Operated by trained clinicians; requires mandatory certification training. System utilizes dynamic-walking control for natural gait and power efficiency. Input includes patient physical parameters; output provides mechanical assistance for sit, stand, walk, turn, and exercise. Feedback provided via handheld controller, physio interface, and auditory signals. Device must be used with safety rails. Benefits include improved functional ambulation and balance during early rehabilitation.
Clinical Evidence
Two clinical studies involving 43 patients with CVA due to stroke; all subjects completed performance outcome measures. Real-world evidence from >250 patients. Five non-serious adverse events reported. Results indicate safe and effective use, with improvements in functional ambulation and balance during early rehabilitation.
Technological Characteristics
Powered lower extremity exoskeleton; 12 actuated degrees of freedom. Rechargeable lithium-ion battery (46.8 V, 9 Ah). Materials biocompatibility per ISO 10993-5/10. Electrical safety per ANSI/AAMI ES60601-1; EMI per IEC 60601-1-2. Software validated per IEC 62304. Features dynamic-walking control algorithm. Dimensions include adjustable upper/lower leg components.
Indications for Use
Indicated for adolescents (18+) and adults with hemiplegia due to cerebrovascular accident (CVA) capable of tolerating a stand-up position. Not indicated for sports or stair climbing.
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).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
December 29, 2022
Wandercraft SAS % Andre Kindsvater Senior Consultant Emergo Global Consulting. LLC 2500 Bee Cave Road Building 1 Suite 300 Austin, Texas 78746
Re: K221859
Trade/Device Name: Atalante Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: June 22, 2022 Received: June 27, 2022
Dear Andre Kindsvater:
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 L. Dean -S
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 Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
### Indications for Use
510(k) Number (if known) K221859
Device Name Atalante
Indications for Use (Describe)
The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation under the supervision of a trained operator. The operator must complete a training program prior to use of the device.
The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position.
The device is not intended for sports or stair climbing.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
## 510(k) Summary Atalante
#### 1. Submission Sponsor
Wandercraft SAS 88 rue de Rivoli 75004 Paris France
Contact: Matthieu Masselin Title: Chief Executive Officer
#### 2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com
Contact: André Kindsvater Title: Senior Consultant RA & QA
#### 3. Date Prepared
June 22nd, 2022
#### 4. Device Identification
| Trade/Proprietary Name: | Atalante |
|-------------------------|---------------------------------------------------|
| Common/Usual Name: | Powered Exoskeleton |
| Classification Name: | Powered lower extremity exoskeleton |
| Regulation Number: | 890.3480 |
| Product Code: | PHL |
| Class: | II |
| Classification Panel: | Neurological and Physical Medicine Devices (OHT5) |
#### 5. Legally Marketed Predicate Devices
| | Primary Predicate | Reference Device |
|---------------|-------------------|-----------------------------------------|
| Device name | Indego® | EksoTM (v.1.1) and<br>Ekso GTTM (v.1.2) |
| 510(K) number | K173530 | K143690 |
{4}------------------------------------------------
| Regulation Number | 21 CFR 890.3480 | 21 CFR 890.3480 |
|-------------------|----------------------|---------------------|
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton |
| Product code | PHL | PHL |
| Review Panel: | Neurology | Neurology |
| Manufacturer | Parker Hannifin Corp | Ekso Bionics Inc. |
#### 6. Indication for Use Statement
The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator must complete a training program prior to use of the device.
The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position.
The device is not intended for sports or stair climbing.
#### 7. Device Description
The Atalante is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante is self-balancing and includes dynamic-walking control. Dynamic-walking allows the Atalante to consume significantly less power and have a more natural gait.
#### 8. Substantial Equivalence Discussion
The following table compares the Atalante to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
#### Table 5A - Comparison of Characteristics preliminary
| | Subject Device | Predicate | Reference Device |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE | Atalante | Indego® | Ekso<br>Ekso™ (v.1.1) and<br>Ekso GT™ (v.1.2) |
| 510(k) Number | K221859 | K173530 | K143690 |
| Manufacturer | Wandercraft SAS | Parker Hannifin Corp. | Ekso Bionics Inc. |
| Product Code | PHL | PHL | PHL |
| Regulation | 890.3480 | 890.3480 | 890.3480 |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Powered Exoskeleton |
| | Subject Device | Predicate | Reference Device |
| FEATURE | Atalante | Indego® | Ekso<br>Ekso™ (v.1.1) and<br>Ekso GT™ (v.1.2) |
| Indications for Use | The Atalante exoskeleton is<br>intended to enable<br>individuals with hemiplegia<br>due to cerebrovascular<br>accident (CVA) to perform<br>ambulatory functions and<br>mobility exercises, hands-<br>free, in rehabilitation<br>institutions under the<br>supervision of a trained<br>operator.<br>The operator must<br>complete a training program<br>prior to use of the device.<br>The Atalante system is<br>intended to be used on<br>adolescents of 18 years<br>and older and adults able to<br>tolerate a stand-up position.<br>The device is not intended<br>for sports or stair climbing. | The Indego® orthotically fits<br>to the lower limbs and the<br>trunk; the device is intended<br>to enable individuals with<br>spinal cord injury at levels<br>T3 to L5 to perform<br>ambulatory functions with<br>supervision of a specially<br>trained companion in<br>accordance with the user<br>assessment and training<br>certification program. The<br>device is also intended to<br>enable individuals with<br>spinal cord injury at levels<br>C7 to L5 to perform<br>ambulatory functions in<br>rehabilitation institutions in<br>accordance with the user<br>assessment and training<br>certification program.<br>Finally, the Indego® is also<br>intended to enable<br>individuals with hemiplegia<br>(with motor function of 4/5<br>in least one upper<br>extremity) due to<br>cerebrovascular accident<br>(CVA) to perform<br>ambulatory functions in<br>rehabilitation institutions in<br>accordance with the user<br>assessment and training<br>certification program. The<br>Indego is not intended for<br>sports or stair climbing. | The Ekso™ (version 1.1)<br>and Ekso GT™ (version<br>1.2) are intended to perform<br>ambulatory functions in<br>rehabilitation institutions<br>under the supervision of a<br>trained physical therapist<br>for the following population<br>with upper extremity motor<br>function of at least 4/5 in<br>both arms:<br>Individuals with hemiplegia<br>due to stroke,<br>Individuals with spinal cord<br>injuries at levels T4 to L5,<br>and Individuals with spinal<br>cord injuries at levels of C7<br>to T3 (ASIA D).<br>The therapist must<br>complete a training program<br>prior to use of the device.<br>The devices are not<br>intended for sports or stair<br>climbing. |
| | Subject Device | Predicate | Reference Device |
| FEATURE | Atalante | Indego® | Ekso<br>Ekso™ (v.1.1) and<br>Ekso GT™ (v.1.2) |
| Population | Adolescents of 18 years<br>and older, and adults | Adults over age of 18 | Adults over age of 18 |
| Environment | Rehabilitation centers | CVA population cleared<br>only for use in<br>Rehabilitation centers | Rehabilitation centers |
| Body Coverage | Worn over legs and upper<br>body with rigid torso | Worn over legs and around<br>hips with lower torso | Worn over legs and upper<br>body with rigid torso |
| Size of Components | Adjustable upper leg, lower<br>leg. Non adjustable hip<br>width; | Modular Small, Medium and<br>Large upper leg, lower leg<br>and hip components; | Adjustable upper leg, lower<br>leg, and hip width; |
| Mobility Aid | None | Walker, Crutches, Cane | Walker, Crutches, Cane |
| User Mobility | Sit, stand, walk, turn,<br>exercise (weight shift,<br>squat), repositioning | Sit, stand, walk, and turn | Sit, stand, walk, exercises<br>(weight shift) and turn |
| Walking Speed | ~2km/hr | ~2 km/hr | ~2 km/hr |
| Type of Surface | Smooth | Smooth, cement, carpet | Smooth, cement,carpet |
| Range of Motion | Hip: 90° flexion,<br>5° extension;<br>17° abduction,<br>10° adduction;<br>10° medial rotation,<br>20° lateral rotation | Hips: 110° flexion<br>to 30° extension | Hips: 135° flexion<br>to 20° extension |
| | Knee: 110° flexion<br>to -5° extension<br>(flexum). | Knees: 110° flexion<br>to 10° extension | |
| | Ankle: 0 dorsiflexion,<br>9° plantar flexion,<br>18° pronation and<br>supination | | Ankles: 0° dorsiflexion<br>to 25° plantar extension |
| Rechargeable<br>Battery | Rechargeable lithium-ion<br>battery 46.8 V, 9 Ah | Rechargeable lithium ion.<br>33.3 V, 36A peak current,<br>12A continuous current. | Rechargeable lithium<br>ion batteries 48.1V,<br>30A peak current, |
| | Usage duration: 2 hours of<br>continuous usage per<br>charge | 159Wh fully charged; | |
| | | Usage duration: 1.5 hours<br>of continuous usage per<br>charge | 1 hour of continuous<br>usage per charge |
| Battery Charge<br>Time | 4 hours | 4 hours | 1 hour |
| Training Program | Yes | Yes | Yes |
| | Subject Device | Predicate | Reference Device |
| FEATURE | Atalante | Indego®…
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
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.
