MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
K082988 · Medivators Reprocessing Systems · FEB · Feb 13, 2009 · Gastroenterology, Urology
Device Facts
Record ID
K082988
Device Name
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
Applicant
Medivators Reprocessing Systems
Product Code
FEB · Gastroenterology, Urology
Decision Date
Feb 13, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Real-World Evidence
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K082988 · Feb 13, 2009
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
Medivators Reprocessing Systems
Clinically used endoscopes
In-use testing was performed on clinically used endoscopes to demonstrate the efficacy of the Rapicide PA High Level Disinfectant in a real-world reprocessing environment.
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system. Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions: High Level Disinfection, 5 minutes, 30(℃), 850ppm Minimum Recommended Concentration of Peracetic Acid (MRC).
Device Story
Advantage Plus is an electro-mechanical automated endoscope reprocessor (AER) for flexible fiberoptic and video endoscopes. System performs automated leak testing, blockage detection, channel connectivity verification, washing, high-level disinfection, rinsing, and drying. Operates by mixing two-part Rapicide PA (peracetic acid-based) with water in the basin for a 5-minute contact time at 30°C. System processes two scopes asynchronously. Safety features include cycle alarms for failure modes and printed records of disinfection results. Healthcare personnel operate the system in clinical settings. Output is a reprocessed, high-level disinfected endoscope ready for clinical use. Benefits include standardized, validated disinfection process, reducing risk of cross-contamination between patients.
Clinical Evidence
Bench testing only. Efficacy validated via sporicidal, tuberculocidal, virucidal, fungicidal, and use-dilution testing achieving total kill or complete inactivation. Simulated-use testing demonstrated >6 log reduction of Mycobacterium terrae. In-use testing on clinically used scopes confirmed total kill. Material compatibility and biocompatibility studies confirmed no significant deterioration of endoscopes or AER components and no harmful residues.
Technological Characteristics
Electro-mechanical AER system. Uses peracetic acid-based chemistry (Rapicide PA). Features automated leak, blockage, and connectivity sensors. Includes water filtration system. Connectivity: prints records by serial number. Sterilization/Disinfection: High-level disinfection via chemical immersion. Software: embedded control system for cycle monitoring and alarm management.
Indications for Use
Indicated for high-level disinfection of heat-sensitive, semi-critical flexible fiberoptic and video endoscopes between patient uses in healthcare facilities. Requires manual pre-cleaning prior to automated reprocessing. Not for use with rigid endoscopes.
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
Medivators MDS Endoscope Reprocessing System (K063876)
Advanced Sterilization Products' EvoTech™ Integrated Endoscope Disinfection System (K061899)
Acecide High Level Disinfectant and Sterilant (K041984)
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## Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant
FEB 1 3 2009
## 510(k) Summary of Safety and Effectiveness
| Manufacturer: | Medivators Reprocessing Systems, a Division of Minntech<br>Corporation |
|---------------|------------------------------------------------------------------------|
| Address: | 14605 28th Avenue North<br>Mpls., MN 55447<br>USA |
Lynn Lueders Official Contact: Director, Regulatory Affairs
Medivators has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalence of the Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant to other endoscope reprocessors and high level disinfectants currently marketed in the U.S.
#### 1. Device Description
The Advantage Plus AER is an electro-mechanical system intended to test, wash, and high level disinfect flexible fiberoptic and video endoscopes between uses. It is not intended for reprocessing rigid endoscopes. The Advantage is capable of asynchronously reprocessing two scopes at a time.
The Advantage Plus system uses the peracetic acid based Rapicide PA High Level Disinfectant. The Advantage Plus is a single use system in that it mixes the Part A and Part B of the Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused.
Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to placing in the system for reprocessing.
After the scopes are connected to the AER, the system tests the endoscopes for blockages in the channels and leaks in the outer skin, and then proceeds to the washing step. The system also includes an optional channel connectivity test to verify proper connection of the fluid channels for reprocessing. If the endoscopes pass the blockage and leak tests and
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the washing cycle has been completed, the system proceeds to rinse the instruments and begins the disinfection cycle.
For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC and then the disinfectant is emptied from the basin into the drain from the machine. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use.
The machine has many built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product.
The machine also prints records by endoscope serial number indicating the results of testing, disinfection, number of disinfections, etc. which are required for permanent records.
Rapicide PA High Level Disinfectant is a peracetic acid based, two part disinfectant. Part A contains the active ingredients and Part B contains anticorrosive agents and surfactants. Part A and Part B are mixed in the machine and diluted with water. The Minimum Recommended Concentration (MRC) of Rapicide PA is 850 ppm of peracetic acid. A test strip is used to ensure that the use solution is above the MRC.
#### Intended Use 2.
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes.
Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use.
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Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle.
Rapicide PA should be used under the following contact conditions:
| Claim | Time | Temperature | Minimum Recommended<br>Concentration of<br>Peracetic Acid<br>(MRC) |
|----------------------------|-----------|-------------|--------------------------------------------------------------------|
| High Level<br>Disinfection | 5 minutes | 30(°C) | 850ppm |
#### 3. Comparison to Another Device in Commercial Distribution Within the United States
The Advantage Plus is equivalent in function and indications to the Medivators MDS Endoscope Reprocessing System (K063876) and the Advanced Sterilization Products' EvoTech™ Integrated Endoscope Disinfection System (K061899). All of the machines have the same indications for use and the same methods of providing disinfection.
Rapicide PA High Level Disinfectant is equivalent in indications and usage to Acecide High Level Disinfectant and Sterilant (K041984) and Peract 20 Liquid Sterilant (K960513). All of the products are peracetic acid based germicides labeled for providing high level disinfection to flexible endoscopes.
#### Summary of Testing 4.
Medivators has provided testing to show that the Advantage Endoscope Reprocessing system and Rapicide PA are safe and effective for their intended use following the requirements listed in the FDA's Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (dated August 1993) and the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants (January 3, 2000).
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The efficacy testing for Rapicide PA is summarized in the table below:
| Tests | Organisms | Results |
|----------------------------|----------------------------------------------------------------------------|-----------------------|
| Sporicidal | Clostridium sporogenes and<br>Bacillus subtilis spores | Total Kill |
| Confirmatory<br>Sporicidal | Clostridium sporogenes and<br>Bacillus subtilis spores | Total Kill |
| Tuberculocidal | Mycobacterium bovis (BCG) | Total Kill |
| Virucidal | Polio virus type 2 | Complete Inactivation |
| Virucidal | Herpes simplex virus type 1 | Complete Inactivation |
| Virucidal | Human Immunodeficiency Virus<br>type 1 | Complete Inactivation |
| Fungicidal | Trichophyton mentagrophytes | Total Kill |
| Use-Dilution | Pseudomonas aeruginosa<br>Staphylococcus aureus Salmonella<br>choleraesuis | Total Kill |
| Simulated-Use | Mycobacterium terrae | >6 log Reduction |
| In-Use | Clinically Used Scopes | Total Kill |
## Efficacy Testing Summary Table
#### Material Compatibility
The effect of disinfectant on the materials used in endoscopes and in the AER system was evaluated and showed that the endoscopes and AER materials showed no significant deterioration over time. Studies were also presented to show that the filters used in the water filtration system were compatible with Rapicide PA.
### Biocompatibility
The amount of disinfectant residue left on endoscopes after the disinfection and rinsing cycles was evaluated and compared to determined safe levels. The results of the testing showed that any remaining residues would not have an effect on patients or users.
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### Performance Data
Data was provided to the FDA to show that the machine performs as required. This evaluation included testing to show that the leak check, blockage check, connectivity checks, washing cycle, disinfection cycle, rinse cvcles, and drying cycles performed correctly. Any error messages were tested to ensure they function properly to notify users of any possible failure modes. Testing was performed to show that all critical parameters of the machine function correctly.
Testing was provided that showed that the disinfectant remained at its required temperature for the length of time required for high level disinfection.
Testing was completed that showed that the Advantage Plus self disinfection cycle works properly by disinfecting all areas of the machine, including the water filtration system.
Studies were performed to show that the water filtration system will function appropriately over time and that the machine will alarm if water filters are plugged to a point which will lower the water pressure below required input. This study also showed that the filters remained bacterial retentive even when plugged to a point that causes the machine to alarm.
#### Summary of Substantial Equivalence 5.
Medivators has provided the above information in the form of a 510(k) to support the claim that the Advantage Plus Endoscope Reprocessing System and Rapicide PA are safe and effective when used in accordance with the device labeling.
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The logo is simple and recognizable, representing the department's role in providing health and human services to the United States.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## FEB 1 3 2009
Medivators Reprocessing Systems C/o Ms. Lynn Lueders Director, Regulatory Affairs Minntech Corporation 14605 28th Avenue North Minneapolis, Minnesota 55447-4822
Re: K082988
> Trade/Device Name: Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB
Dated: January 28, 2009
Received: January 29, 2009
Dear Ms. Lueders:
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 Ford, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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## Page 2 - Ms. Lueders
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Òffice of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony D. Matosian
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
#### Enclosure
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# Indications for Use
510(k) Number (if Known):
Device Name:
Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant
Indications for Use:
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system.
Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions:
| Claim | Time | Temperature | Minimum<br>Recommended<br>Concentration of<br>Peracetic Acid<br>(MRC) |
|----------------------------|-----------|-------------|-----------------------------------------------------------------------|
| High Level<br>Disinfection | 5 minutes | 30(℃) | 850ppm |
Over-the Counter Use X AND/OR Prescription Use (21-EFR-801 Subpart-C) >(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
K082988
Concurrence of CDRH, Office of Device Evaluation (ODE)
GCT fa SSM
(Division Sign-Off) (Division of Anasthesiology, General Hospital infection Schrol, Dental Devices
510(k) Number:
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.
