The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and divert surgical debris during minimally-invasive surgery while maintaining visualization of the surgical site.
Device Story
Disposable, sterile, multi-lumen sheath assembly; mounts over laparoscope shaft (5mm or 10mm diameters). Connects to existing CO2 insufflation circuit via pre-connected tube set. Principle of operation: redirects portion of CO2 across laparoscopic lens to prevent condensation; continuous gas flow creates laminar 'wind shear' to divert smoke/debris. Includes controlled vent accessory. Used in OR during minimally-invasive surgery; operated by surgical staff. Output is clear visualization of surgical site; benefits patient by reducing need for scope removal/cleaning, maintaining surgical workflow efficiency.
Clinical Evidence
Bench testing only. Evidence includes biocompatibility (ISO 10993: cytotoxicity, sensitization, reactivity, pyrogenicity, toxicity), functional testing (defogging, air flush, manifold attachment, trocar insertion), and mechanical testing (bond/insertion/holding forces, mechanical/tip bond strength). No clinical data provided.
Technological Characteristics
Multi-lumen sheath assembly; 5mm and 10mm configurations for standard laparoscopes. Materials: biocompatible polymers (ISO 10993). Energy source: external CO2 insufflation. Connectivity: pneumatic connection to insufflator. Sterilization: gamma irradiation. No software/electronics.
Indications for Use
Indicated for adult patients undergoing minimally-invasive laparoscopic surgery to facilitate intra-operative lens defogging and divert surgical debris while maintaining visualization.
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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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 11, 2026
FloShield, Inc.
% Trudie Seeger
CEO
Advance BioReg, Inc.
4170 Bowmansroot Court
Hilliard, Ohio 43026
Re: K260710
Trade/Device Name: FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: March 4, 2026
Received: March 4, 2026
Dear Trudie Seeger:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260710 - Trudie Seeger
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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K260710 - Trudie Seeger
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(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Colin Chen, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K260710 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | | | |
| Please provide your Indications for Use below. | | | ? |
| The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and divert surgical debris during minimally-invasive surgery while maintaining visualization of the surgical site. | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |
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510(k) #: K260710
# 510(k) Summary
Prepared on: 2026-06-08
# Contact Details
21 CFR 807.92(a)(1)
Applicant Name
FloShield, Inc
Applicant Address
1013 Cactus Rio Drive Weatherford TX 76087 United States
Applicant Contact Telephone
650-823-5559
Applicant Contact
Laird Cagan
Applicant Contact Email
Laird@cmcp.com
Correspondent Name
Advance BioReg, Inc.
Correspondent Address
4170 Bowmansroot Court Hilliard OH 43026 United States
Correspondent Contact Telephone
614-519-1591
Correspondent Contact
Trudie Seeger
Correspondent Contact Email
tseeger@advancebioreg.com
# Device Name
21 CFR 807.92(a)(2)
Device Trade Name
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
Common Name
Endoscope lens cleaning and defogging device
Classification Name
Endoscope and Accessories
Regulation Number
21 CRF 876.1500
Product Code(s)
GCJ
# Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
Predicate #
Predicate Trade Name (Primary Predicate is listed first)
Product Code
K080613
Clear-Vu System
OCT
# Device Description Summary
21 CFR 807.92(a)(4)
1. Device Description
The FloShield Air System is disposable, gamma irradiated laparoscopic accessory device delivered sterile to the hospital and assembled to the laparoscope prior to surgery. The system requires secondary connections to compressed CO2. The device has two (2) configurations: 1) the 5mm device will accommodate a 5mm laparoscope (outside diameter) of standard length (~31cm) and fit inside a 7mm or 8mm optical trocar (inside diameter) and; 2) the 10mm device will accommodate a 10mm laparoscope (outside diameter) of standard length (~31mm) and fit inside a 12mm optical trocar (inside diameter).
1
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K260710
1.1. Principle of Operation
The Air Only FloShield System consists of a multi-lumen sheath assembly (device) that mounts over the shaft of the laparoscope. A pre-connected tube set connects the device to the existing CO2 insufflation circuit. To prevent fogging, a small portion of CO2 supplied by the interface with the insufflation circuit is redirected through the FloShield device and across the laparoscopic lens, thereby preventing significant accumulation of condensation. Additionally, the continuous flow and velocity of gas across the lens creates a laminar flow or "wind shear," which serves to divert smoke and surgical debris away from the laparoscopic lens during surgery. A portion of the CO2 gas is released through a controlled vent that is provided with the FloShield System (accessory).
1.2. Intended Use
The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and divert surgical debris during minimally-invasive surgery while maintaining visualization of the surgical site.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and divert surgical debris during minimally-invasive surgery while maintaining visualization of the surgical site.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The FloShield Air System (proposed device) and the Clear-Vu Air System (predicate device: K080613) both are intended to facilitate intraoperative defogging and divert surgical debris of the distal lens of a rigid laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site. Both devices have the same intended use.
Technological Comparison
21 CFR 807.92(a)(6)
Comparison of Technological Characteristics with the Predicate device
Minimally invasive laparoscopic surgery is the technological principle for both the subject and predicate devices. It is based on laparoscopy being used to diagnose and/or treat inside the abdomen as well as other closed spaces. The subject and predicate device facilitate laparoscopy by ensuring the camera lens used to guide the laparoscope remain clear and free of debris. At a high level, the subject and predicate devices as based on the following same technological elements:
- Multi-lumen Sheath Assembly – mounts over shaft of the laparoscopes with 0°, 30° and 45° angled tips and protects the camera
- Preconnected Tube Set – connects device to existing CO2 insufflation circuit which is redirected though the device and across the laparoscopic lens to prevent fogging
- Use of insufflator CO2 provides a continuous flow and velocity of gas across the lens creates a laminar flow or "wind shear" which serves to divert smoke and surgical debris
The following technological differences exist between the subject device and predicate devices:
- Use of existing surgical irrigation system (saline) – Predicate
- Use of a Handle Assembly to control the use of CO2 and saline – Predicate
- Use of FloVent (accessory) to allow release of CO2 gas through a controlled vent – Subject device
These technological difference are only related to the removal of the surgical irrigation system from the FloShield Air System and do not impact the intended use nor the safety or effectiveness of the FloShield Air System.
Performance Data
For all the design changes made to the FloShield Air System underwent verification and validation to ensure that the device still meant its Product Specifications. After the manufacturing of the FloShield Air System was transferred to the Tianymed facility in Ningbo, China, some additional design changes were made due to availability of materials and the manufacturing process. The current FloShield Air System has undergone full testing to show that it still meets all of it's specifications (See Performance Testing) as follows:
Biocompatibility Testing
The biocompatibility evaluation of FloShield Air System was conducted in accordance with the Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process,' September 2023 as recognized by FDA. The battery of testing included the following tests:
- Chemical Characterization and Toxicological Risk Assessment
- Cytotoxicity
- Sensitization
- Intravenous Reactivity
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity
- Reproductive/development Toxicity
The FloShield Air System body contact is classified as external communicating (tissue/bone/dentin) with a limited duration of contact (≤
2
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K260710
24hr).
Functional Testing
- Scope Removal for Defogging/Cleaning
- Air Flush to prevent Fogging
- Devices Provides Vent
- Manifold to Sheath Attachment
- Insertion/Removal into Trocar
- Alignment Guide
Mechanical Testing
- Bond Force
- Insertion Force
- Holding Force
- Mechanical Strength
- Tip Bond Strength
Animal Studies
FloShield has conducted numerous animal studies to verify the initial design of the FloShield System and subsequently, to verify the performance of design changes and line extension.
# Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following performance data were provided to support of that the FloShield Air System substantial equivalence determination.
Biocompatibility Testing:
The biocompatibility evaluation of FloShield Air System was conducted in accordance with the Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process,' September 2023 as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Intravenous Reactivity
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity
- Reproductive/development Toxicity
The FloShield Air System body contact is classified as external communicating (tissue/bone/dentin) with a limited duration of contact (≤ 24hr).
Functional Testing:
- Scope Removal for Defogging/Cleaning
- Air Flush to prevent Fogging
- Devices Provides Vent
- Manifold to Sheath Attachment
- Insertion/Removal into Trocar
- Alignment Guide
Mechanical Testing:
- Bond Force
- Insertion Force
- Holding Force
- Mechanical Strength
- Tip Bond Strength
"Not Applicable"
The biocompatibility, functional and mechanical testing show that the FloShield Air System manufactured by FloShield, Inc. meets all its specifications and performs as well as (equivalent to) its predicate device, Clear-Vu Air System.
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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.
