K103312 · Olympus Medical Systems Corporation · FDF · May 12, 2011 · Gastroenterology, Urology
Device Facts
Record ID
K103312
Device Name
UPD-Y0003
Applicant
Olympus Medical Systems Corporation
Product Code
FDF · Gastroenterology, Urology
Decision Date
May 12, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
Device Story
The UPD-Y0003 is an endoscope position detecting unit used with Olympus endoscope systems to visualize endoscope shape during procedures. It consists of a main unit and a receiver dish. The system drives magnetic coils located in the endoscope/probe, a hand coil, and a reference plate. The receiver dish detects the resulting magnetic fields. The unit processes these signals to calculate spatial coordinates for each coil, then reconstructs and displays the endoscope's shape on a monitor. The reference plate establishes a standard plane, and the hand coil provides an independent reference point. Used in clinical settings by physicians, the device assists in navigating the colonoscope by providing real-time visual feedback of the scope's configuration within the patient, potentially improving procedural efficiency and patient comfort.
Clinical Evidence
Bench testing only. No clinical data provided. Device safety and performance were verified through design verification testing, risk analysis, and adherence to international standards including IEC 60601-1, IEC 60601-2-18, and IEEE Std C95.1.
Technological Characteristics
Magnetic field-based position detection system. Components: UPD-Y0003 unit, receiver dish, source coils (in endoscope/probe), hand coil, reference plate. Connectivity: RS232C, video output (Y/C, SD-SDI, XGA). Power: 100-240V AC. Standards: IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEEE Std C95.1. Software: Minor level of concern.
Indications for Use
Indicated for patients requiring colonoscopy. Contraindicated in patients with pacemakers and pregnant women.
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.
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# 510(k) SUMMARY
MAY 1 2 2011
# ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003
### May 11, 2011
#### 1 General Information
- l OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047
- . Stacy Abbatiello Kluesner, M.S., RAC Official Correspondent: Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy kluesner@olympus.com 를
- Shirakawa Olympus Co., Ltd. Manufacturer: 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No .: 3002808148
### 2 Device Identification
| Device Trade Name: | UPD-Y0003 |
|-----------------------|-----------------------------------|
| Common Name: | ENDOSCOPE POSITION DETECTING UNIT |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class: | II |
| Classification Panel: | Gastroenterology/Urology |
| Product Code: | FDF |
#### . 3 Legally Marketed Device to which Substantial Equivalence is Claimed
The following table shows the primary component (part of this submission) of the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 and the device to which we claim substantial equivalence (predicate device).
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## Table 12-1 Primary Component & Predicate Device of the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003
| Subject Device<br>(Part of this Submission) | Predicate Device | PD's<br>510(k)<br>No. |
|------------------------------------------------|---------------------------------------------|-----------------------|
| ENDOSCOPE POSITION DETECTING<br>UNIT UPD-Y0003 | Endoscope Contour Detection Device<br>3DX45 | K002749 |
#### ঞ্চ Device Description
<Device Description Summary>
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
The device detects the magnetic field generated by magnetic coils built directly into the endoscope or the probe inserted into the endoscope's instrument channel.
#### < Operating Principle of the subject device>
This device consists of the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) and a RECEIVER DISH (MAJ-1868). The RECEIVER DISH is connected to the UPD-Y0003 via a RECEIVER DISH CABLE (MAJ-1875 or MAJ-1927).
The ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) supplies "driving" signals to the source coils in 1) the endoscope or probe, 2) the Hand Coil and 3) the Reference Plate. The endoscope and probe have plural source coils. The Hand Coil has one source coil. The Reference Plate has plural source coils. The driving signals are sent to each source coil. The driving signal is delivered to the endoscope or probe through a UPD CABLE (MAJ-1881). The driving signal is delivered to the Hand Coil through an integrated cable and the Reference Plate through an integrated cable.
When the source coils receive the driving signal, a magnetic field is generated. The magnetic field is then detected by the sense coils built into the RECEIVER DISH. The signals detected by each sense coil are processed in the UPD-Y0003. The UPD-Y0003 calculates the spatial coordinates for the specific source coil. This calculation is repeated for every source coil built into the endoscope or probe. The UPD-Y0003 then creates the visual image of the endoscope on the monitor, by then putting the spatial coordinates of the multiple source coils in order (distal to proximal) and connects them.
Akin to the methodology described above, the same process takes place for the reference plate and hand coil. The spatial coordinates data obtained from the source coils in the reference plate are used to create the standard plane of endoscope's position. The source coil in the "hand coil" is used to create an independent reference point in the field of view, as displayed on the video monitor.
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<Fundamental technology modifications>
The following two modifications were made to the fundamental technology of the Subject
Device from the Predicate Device's:
1) The mechanism to drive the source coils
2) Calculation method of the spatial coordinate of each source coil
## 5 Indications for Use
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
<Patient population> Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women
## 6 Comparison of Technological Characteristics
ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 is basically identical to its predicate device in intended use, and similar in specifications. Comparison between the subject and predicate devices is shown in Table 12-2.
### Table 12-2 Comparison of Specifications
Subject Device: ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 Predicate Device: Endoscope Contour Detection Device Olympus 3DX45 (K002749) Main unit
| Specifications | Subject Device<br>ENDOSCOPE POSITION<br>DETECTING UNIT UPD-Y0003 | Predicate Device<br>System Controller Unit<br>X301811 |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Rated voltage | Voltage: 100-240V AC ±10%<br>Frequency: 50/60Hz ±1Hz | Voltage: 120V AC ±10%<br>Frequency: 50/60Hz ±1Hz |
| Power consumption | 110VA | 480VA |
| Unit composition | Monitor and receiver dish are<br>separated. | Monitor, receiving unit and the main<br>unit are built in one unit. |
| Dimensions | 370(W) x 482(D) x 81(H)mm | 490(W) x 500(D) x 1820(H) mm |
| Weight | 9kg | 59kg |
| Specification for Scope<br>Model display | -The Display now shows the<br>insertion portion even where a<br>source coil is not installed, areas<br>outside the detection area, and<br>areas in which a source coil is<br>broken, | -Displayed in a shaft shape or in a<br>polygonal line graph.<br>-The part of The insertion portion<br>where source coil is not installed is<br>not displayed. |
| Display of overlapping<br>intersection area | Available | Not available |
| Scope/probe/reference<br>plate/hand marker<br>Connection Indicator | Available | Not available |
| Viewpoint indicator display | Select from the following:<br>-Operating image model<br>-Figure image model | Select from the following:<br>-Operating table model<br>-Coordinate axis model<br>-Simultaneous display of Operating<br>table model and Coordinate axis<br>model |
| Patient data display | Patient ID, patient name, age and<br>sex. | Patient ID |
| Error message display | Available | Not available |
| Display rotation | -Scope model is rotated by 90<br>degrees to left and right by one<br>push of the switch.<br>-Depending on the setting on the<br>menu, scope model is rotated by<br>every 2.5 degrees vertically and<br>horizontally. | -Scope model is rotated by every<br>2.5 degrees vertically and<br>horizontally. |
| Setting for the display start<br>position of the scope model<br>(Scope position) | -Setting method: Using external<br>marker or the position of the distal<br>end of the endoscope.<br>-Display start position: Bottom<br>center or top center of display. | -Setting method: Using external<br>marker.<br>-Display start position: Center of<br>display. |
| Marking | Available | Not available |
| Background color | The user can choose from three<br>predefined background colors. | -It is set by adjusting the RGB<br>density. |
| Display of the distal end of<br>scope model | The distal end of a scope model is<br>displayed in yellow. | -The user can choose whether to<br>display the distal end of a scope<br>model in yellow or not. |
| Detection of the source coil<br>wire break | Source coil wire break is detected<br>automatically and reflected on the<br>scope model display. | Manually input the number of the<br>broken source coil to reflect it on<br>the scope model display. |
| Change of the display mode | Display of the scope model can be<br>set by the user:<br>-Displayed from the bottom<br>(standard setting)<br>-Displayed from the top | Not available |
| Scope model thickness<br>setup | Adjustable.<br>The size of external marker<br>changes depending on the scope<br>model thickness. | Adjustable.<br>The size of external marker does<br>not change. |
| Show/hide information | Show/Hide various information<br>individually. | Show/Hide information cannot be<br>set individually. It is either show or<br>hide all information. |
| Saving and recalling the<br>setting | Save 20 presets. | Save only one preset. |
| Patient data | Input via a communication<br>connector via video system center.<br>And patient data is displayed. | Input with Ten-key pad. And patient<br>data is displayed. |
| Video signal output | -Y/C: 1<br>-SD-SDI: 1<br>-XGA: 1 | VGA: 1 |
| Communication terminal | RS232C: 1 | Not available |
| Receiving antenna input<br>terminal | One. | Not available |
| Driving signal output<br>terminal for external marker | Two. | One. |
| Driving signal output<br>terminal for reference plate | Two. | One. |
| Safety standards | IEC 60601-1 Ed.2<br>IEEE Std C95.1, 2005 +<br>Amendment 1:2010 | IEC 60601-1<br>IEEE Std C95.1, 1999 |
| EMC compliance | Class B | Class A |
| Plate cover | REFERENCE PLATE COVER<br>MAJ-1880 is provided | Not provided |
| Installation on the patient: | Fasten the reference plate with a<br>belt on the patient (body surface). | Attach the reference place on the<br>patient's body (over the gown) with<br>surgical tape. |
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#### 7 Summary of non-clinical testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
The following standards have been applied to the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003):
-IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995 -IEC 60601-1-1: 2000 -IEC 60601-2-18: 1996, Amendment 1: 2000 -IEC 60601-1-2: 2007 -ISO 14971: 2007 -IEEE Std C95.1: 2005+ Amendment 1: 2010
## 8 Conclusion
When compared to the predicate device, the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002
MAY 1 2 2011
Olympus Medical Systems Corporation c/o Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K103312
Trade/Device Name: ENDOSCOPE POSITION DETECTION UNIT UPD-Y0003 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: April 12, 2011 Received: April 14, 2011
Dear Ms. Kluesner:
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-related
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Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Hubert H Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known):
K103312
Device Name: ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003
Indications for Use:
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
<Patient population> Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH/Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---------------------|
|---------------------|
| Page |
|------|
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Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K1033/2
Page 1 of 1
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.
