The ZeroWire Mobile, Radiance Ultra series ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures. The ZeroWire Mobile, Radiance Ultra series, and ZeroWire G2 wireless video systems are non-sterile reusable devices not intended for use in the sterile field.
Device Story
ZeroWire Mobile is a battery-powered, mobile 5-wheel stand designed to hold a display monitor (up to 32"/33 lbs) in clinical settings like ORs or Endo/GI procedure rooms. It functions as an accessory to the ZeroWire G2 wireless video system, eliminating power cords and associated trip hazards or biohazard contamination risks. The system includes two hot-swappable power modules and a DC-DC converter to regulate output voltage (24V +/- 5%) for the monitor. Firmware allows users to interface with and monitor battery status. The device is used by clinical staff to provide a mobile secondary display for medical imaging. It benefits patients and staff by improving OR mobility and safety through cord-free operation.
Clinical Evidence
Bench testing only. No clinical data presented. Safety and effectiveness were demonstrated through design verification testing against recognized standards including IEC 60601-1 (electrical safety), IEC 62133 (battery safety), and EN 60601-1-2 (EMC).
Technological Characteristics
Mobile 5-wheel mechanical stand; adjustable height (55-71 inches); tiltable VESA mount; 5-inch locking castors. Power system: 2 hot-swappable DC power modules; DC-DC converter for 24V output. Connectivity: Wireless video link (via ZeroWire G2 system). Firmware for battery status monitoring. Compliant with IEC 60601-1, IEC 62133, and FCC Part 15B.
Indications for Use
Indicated for use in endoscopic and general surgical procedures for the delivery of medical video signals from a source (e.g., endoscopy camera/processor) to a display for review and analysis of medical images. Not intended for use in the sterile field.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
ZeroWire G2 Duo Wireless HD Video Transfer System G2 (K151609)
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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
#### April 7, 2017
NDS Surgical Imaging, LLC. % Ms. Shelley Trimm RCQ Consulting Services 1152 Navarro Street Santa Rosa, California 95401
Re: K170598
Trade/Device Name: ZeroWire Mobile Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: February 23, 2017 Received: March 1, 2017
Dear Ms. Trimm:
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. 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 801); medical device reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
K170598
Device Name ZeroWire Mobile
#### Indications for Use (Describe)
The ZeroWire Mobile, Radiance Ultra series ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures.
The ZeroWire Mobile, Radiance Ultra series, and ZeroWire G2 wireless video systems are non-sterile reusable devices not intended for use in the sterile field.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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[Type here]
Image /page/3/Picture/1 description: The image shows the logo for NDS. The logo consists of a grid of blue squares on the left, followed by the letters NDS in blue. The grid of squares is arranged in a diagonal pattern, with the squares getting smaller as they move to the right. The letters NDS are in a bold, sans-serif font.
K170598
# 510(K) SUMMARY
| A. Manufacturer: | NDS Surgical Imaging, LLC<br>5750 Hellyer Avenue<br>San Jose, CA 95138<br>USA |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Submitted By: | Shala Famil<br>Sr. Director QA/RA, NDS Surgical Imaging, LLC |
| B1. Address: | NDS Surgical Imaging, LLC<br>5750 Hellyer Avenue<br>San Jose, CA 95138<br>USA |
| C. Date of Preparation: | February 23, 2017 |
| D. Contact Information: | Tel: 408-912-0528<br>Fax: 408-705-5521 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | Wireless Displays |
| G. Proprietary Name: | ZeroWire Mobile<br>Model Number: 90Z0160 |
| H. Classification number: | 21 CFR 876.1500 |
| I Product Code: | GCJ |
| J. Substantial Equivalence: | Predicate device: K151609 Model ZeroWire G2 Duo<br>Predicate device: Special K161228 Model ZeroWire<br>Radiance Ultra Series Display Monitors |
| K. Device Description: | ZeroWire Mobile is a medical grade, battery powered pole<br>stand that eliminates the need for a power cord. It will be<br>used as an accessory, secondary monitor display in<br>Endo/GI procedure rooms, surgical operating rooms, or<br>other clinical settings. ZeroWire Mobile is a cordless stand<br>with a wireless monitor solution that provides the<br>procedure or operating room with a mobile second display<br>monitor eliminating the risk of biohazard contamination of<br>cords and cables, and cable/cord trip hazards. The |
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Image /page/4/Picture/1 description: The image shows the logo for NDS. The logo consists of a grid of blue squares on the left, followed by the letters "NDS" in blue. The letters are large and bold, and they have a slight gradient effect.
K170598
| | ZeroWire Mobile is the second accessory to ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo (K151609). The first accessory to be approved was the Radiance Ultra ZeroWire Embedded (Special K161228). |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| L. Indications for Use: | The ZeroWire Mobile, the Radiance Ultra Series ZeroWire Embedded, and ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures. |
| | The ZeroWire Mobile, Radiance Ultra Series and ZeroWire G2 Duo wireless video systems are non- sterile reusable devices not intended for use in the sterile field. |
| M. Technological Characteristics: | The ZeroWire Mobile consists of a 5-wheel mechanical stand to hold a display monitor, up to 32" in size and / or < 33 lbs in weight, with 2 mounted power modules as DC power supply source for the monitor. The system is completed with a 4-bay wall-mount charger, allowing to charge 4 power modules simultaneously. |
| | Three keys elements of the ZeroWire Mobile stand are the mechanical stand it-self, the DC -DC converter plus battery hot-swap monitoring circuitry, and the firmware allowing the user to interface and monitor the battery status. |
| | Since the power module supply output can vary from 20V to 25V and a 24V +/- 5% output is required to power the monitor, there is a need for a DC-DC converter to regulate the DC output voltage. The system can run with either one or both power modules mounted and replacement of the drained power module shall not affect the voltage output of the running power module. |
| | Characteristics:<br><ul><li>ZeroWire Mobile stand column has an adjustable height from 55 inches to 71 inches. </li></ul> |
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N. Performance:
### K170598
- Tiltable Vesa mount supporting a display up to 32" in size and / or 33 lbs of weight.
- 5-leg wheel base to provide maximum stability.
- Castors of 5-inch diameter and with an individual lock. ●
The performance standards reports that the ZeroWire Mobile, Power Module, and 4-Bay charger are compliant to are available in Tab 11. The ZeroWire Mobile, ZeroWire G2 Duo Wireless Video System (K151609) and the Radiance Ultra ZeroWire Embedded monitor displays (Special K161228) as a system has successfully passed design verification testing to further demonstrate safety and effectiveness.
The following is a summary of standards have been tested to and passed:
#### ZeroWire Mobile
Standards IEC 60601-1:2005=Corr.1(2006) + Corr.2 (2007) EN 60601-1:2006
IEC60601-1 3rd Edition (2005)
CAN/CSA-C22.2 No. 60601-1-08 (R2013) ANSI/AAMI ES60601-1:2005+A2 (R2012)
EN 60601-1-2:2007/AC:2010; FCC Part 15B Class B
### ZeroWire Power Module
| Document Type |
|-------------------------|
| Test Report - Batteries |
| IEC 62133:2012 |
| EN 62133:2013 |
IEC 62133:2012 EN 62133:2013
File MH61123, Vol. 1
IEC 62133(ed.2) EN 62133:2013
#### 4 Bay Charger
Standards
IEC 60601-1:2005+ CORR.
1:2006+ CORR. 2:2007 + AM1:2012 (or UEC 60601-1:2012 reprint)
IEC 60601-1:2005+ CORR.
1:2006+ CORR. 2:2007 + AM1:2012 (or UEC 60601-1:2012 reprint)
{6}------------------------------------------------
K170598
CAN/CSA-C22.:2007 2 No.60601-1:14 ANSI/AAMI ES60601- 1:2005+A2 (R2012)+A1
IEC 60601-1:2005+A1 IEC 60601-6:2010+A1 IEC 62366-2007+A1
EN60601-1-2: 2007/AC: 2010 Class B, FCC Part 15 Subpart B
### Radiance 27" Embedded Display Monitor with ZeroWire Mobile
Standards IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), EN 60601-1:2006
IEC 60601-1, 3rd Edition (2005)
ANSI/AAMI ES60601- 1:2005+A2 (R2012) CAN/CSA-C22.2 No. 60601-1-08 (R2013)
EN 301 489-1 V1.9.2 (2011-09) EN 301 489-3 V1.6.1 (2013-06)
EN 60601-1-2: 2007/AC: 2010 FCC SubPart 15B Class B
## Radiance 32" Embedded Display Monitor with ZeroWire Mobile
| Standards |
|------------------------------------------------------------------------|
| IEC 60601-1: 2005 + CORR. 1<br>(2006) + CORR. 2 (2007) EN 60601-1:2006 |
| IEC 60601-1, 3rd Edition (2005) |
| ANSI/AAMI ES60601- 1:2005+A2 |
| CAN/CSA-C22.2 No. 60601-1-08 |
| EN 301 489-1 V1.9.2 (2011-09) |
| EN 301 489-3 V1.6.1 (2013-06) |
| EN 60601-1-2: 2007/AC: 2010 |
| FCC SubPart 15 B Class B |
The ZeroWire Mobile is an accessory to K151609: O. Summary Changes ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo and K161228: Radiance Ultra Embedded. As an accessory, ZeroWire Mobile did not require any technology or labeling changes to K151609 or K161228 to be compatible. The ZeroWire Mobile is substantially equivalent to the P. Substantial Equivalency: safety and effectiveness of K151609: ZeroWire Duo
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K170598
Wireless HD Video Transfer System G2/ ZeroWire G2 Duo and K161228: Radiance Ultra Embedded as proven in the safety, performance, and verification reports sited in Section N: Performance.
Q. Conclusion: Based upon the safety, performance, and verification reports, ZeroWire Mobile accessory stand demonstrates safety and effectiveness that is equivalent to the predicate devices: K151609, ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo and K161228, Radiance Ultra Embedded.
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Learn the FDA Browser
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.
