The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Device Story
RedEx is a sterile, single-use contained extraction system for laparoscopic surgery. It consists of a polyurethane specimen bag with a nitinol opening ring, a bag tether, and a polyethylene guard component. The device is preloaded in an introducer and deployed into the abdominal cavity via a 12mm trocar. The nitinol ring maintains the bag's shape for specimen encapsulation. Once the specimen is inside, the tether is pulled to close the bag, which is then exteriorized through the incision. The guard is inserted into the bag mouth and actuated via a rolling ring to protect the incision and bag material during manual morcellation using standard surgical instruments (graspers/scalpels). The guard is removed after morcellation, followed by the bag. The device is operated by surgeons in an OR setting. It benefits patients by isolating tissue during removal, reducing the risk of inadvertent tissue spread or incision trauma.
Clinical Evidence
Bench testing only. Evidence includes bag material/seal strength, puncture resistance, microbial barrier testing, component durability, simulated use (with post-use leak testing), human factors, packaging, and stability testing. Biocompatibility testing (MTT cytotoxicity, intracutaneous injection, Kligman maximization) confirmed all materials are biocompatible.
Technological Characteristics
Materials: Polyurethane (PU) film bag, nitinol opening ring, polyethylene (PE) film guard. Energy: None (manual). Form factor: Introducer-based deployment, 6000mL bag capacity. Connectivity: None. Sterilization: Gamma radiation (VDmax 25 per ANSI/AAMI/ISO 11137-2).
Indications for Use
Indicated for containment and isolation of tissue during or prior to surgical removal and/or extracorporeal manual morcellation. Contraindicated for use with laparoscopic power and manual morcellators, powered cutting devices (e.g., electrosurgical, laser instruments), or when physician judgment deems use contrary to patient interest.
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
Applied Medical Tissue Containment System (K142427) a/k/a Alexis CES
Submission Summary (Full Text)
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September 17, 2021
Advanced Surgical Concepts Ltd % Jonathan Kahan Partner Hogan Lovells US LLP Columbia Square, 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K211234
Trade/Device Name: RedEx Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 20, 2021 Received: August 20, 2021
Dear Jonathan Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. 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
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510(k) Number (if known)
K211234
Device Name
#### RedEx
Indications for Use (Describe)
The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
RedEx is contraindicated for use with laparoscopic power and manual morcellators.
RedEx is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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#### 510(k) SUMMARY
### Advanced Surqical Concepts Ltd's RedEx
### Submitter
| Advanced Surgical Concepts Ltd | |
|--------------------------------|--|
| Unit 4 Sunnybank Center | |
| Upper Dargle Road | |
| Bray | |
| County Wicklow | |
| A98 E339 | |
| Ireland | |
| Phone: | +353 1 286 4777 |
|------------|-----------------|
| Facsimile: | +353 1 286 4776 |
| Contact Person: | Edward Hyland |
|-----------------|---------------|
|-----------------|---------------|
| Date Prepared: | August 20, 2021 |
|----------------|-----------------|
|----------------|-----------------|
| Name of Device: | RedEx |
|-----------------------|--------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Tissue Bag |
| Classification: | 21 CFR 876.1500, Accessory to Endoscope |
| Regulatory Class: | Class II |
| Product Code: | GCJ |
| Predicate Devices: | Applied Medical Resources Corporation's Applied Medical Tissue Containment System (K142427) a/k/a Alexis CES |
#### Device Description
The Advanced Surgical Concepts Ltd, RedEx, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ.
The device is provided sterile for single use.
The RedEx consists of a flexible specimen containment Baq, with an integrated Opening Ring and Bag Tether and a separate Guard component to protect the Bag and incision.
The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any FDA cleared 12mm trocar may be used as an accessory for device deployment. This is a standard sized trocar for use in laparoscopic surgery. A blue arrow on the Introducer provides the user with the correct orientation for insertion of the Introducer to ensure the Bag is correctly deployed.
After the Baq is ejected from the Introducer into the abdominal cavity, the mouth of the Bag returns to its original circular shape. The nitinol wire Opening Ring facilitates placement of the specimen in the Bag. When the specimen is encapsulated and ready for removal or extracorporeal manual morcellation the Bag Tether is pulled, closing the Bag. The Bag Tether and Opening Ring exit through the 12mm trocar, indicating the Bag is fully closed. The incision is then increased to the required size, 2.5-6cm, prior to removal of the trocar is removed, and the mouth of the Bag is opened outside the abdomen. The free end of the Guard. which includes the Guard Petals and is opposite the end with the Guard Ring, is then inserted
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through the mouth of the Bag followed by the Anchor Ring. The Guard is actuated by flipping the Rolling Ring inward until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap and conform to the incision; protecting the incision and Bag material from inadvertent scalpel strikes and from the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.
The physician then performs extracorporeal manual morcellation using manual surgical instruments (e.g., a grasper and a scalpel). When the tissue specimen has been removed, the surgeon flips the Rolling Ring in the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.
# Intended Use / Indications for Use
The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
RedEx is contraindicated for use with laparoscopic power and manual morcellators.
RedEx is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
# Comparison of Technological Characteristics with the Predicate Device:
The subject and predicate devices are both tissue containment bags intended to retrieve and contain specimens during manual morcellation. Both devices are wholly inserted into the abdominal or pelvic cavity prior to specimen placement in the bag. If the specimen requires morcellation, both bags are brought up to the incision prior to manual morcellation.
The subject and predicate devices are based on the following identical technological elements:
- . A specimen bag with an attached ring that opens once deployed in the abdominal cavity to aid encapsulation of the specimen for removal and/or extracorporeal manual morcellation at the incision site.
- o A baq tether, attached to the bag and which remains external to the abdominal cavity, for exteriorization of the mouth of the bag to facilitate extracorporeal manual morcellation.
- A guard that maximizes the incision to allow for removal and/or extracorporeal manual morcellation at the incision site.
The following technological differences exist between the subject and predicate devices:
- . The method of insertion of the bag into the abdominal cavity
- . The quard technology; although the purpose of both quards is the same, the technology is different
- Use of different materials as described in the substantial equivalence information table. ●
### Performance Data
Substantial Equivalence Testing
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Side-by-side testing was carried out on both the subject and predicate devices to demonstrate substantial equivalence. The tests primarily focused on the durability of the containment bags and the performance of the guard components. Testing included:
- Bag material and seal strength
- o Baq material puncture-resistance
- Guard puncture-resistance ●
- Guard coverage and security
- Simulated use
# Functionality Testing
Additional testing was carried out on the subject device its performance. Testing included:
- Microbial barrier testing .
- . Component durability testing
- Bench-top simulated use (with post-use leak testing) ●
- Simulated clinical use (with post-use leak testing)
- Human factors testing
- Packaging performance testing ●
- Stability testing o
### Biocompatibility
The subject device is a device that is in contact with tissue for a period of less than 24 hours. Evaluation of the biocompatibility of RedEx was carried out as per IS EN ISO 10993-1 Biological Evaluation of Medical Devices. The following biocompatibility testing was carried out by an independent laboratory (Toxikon):
- MTT Cytotoxicity test
- Intracutaneous Injection Test
- Kligman Maximization Test o
All materials were found to be biocompatible.
### Sterilization
ASC completed a sterilization validation using the standard VDmax 25 gamma radiation method as per ANSI/AAMI/ISO 11137-2: Sterilization of Health Care Products – Radiation – Establishing the sterilization dose - Method VDmax
In all instances, the RedEx functioned as intended and the results observed were as expected.
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| Substantial Equivalence Information | | | | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | RedEx<br>K211234 | Applied Medical<br>Tissue<br>Containment<br>System<br>K142427 | Comparison | Testing |
| Clinical<br>Function | Specimen<br>containment Bag | Specimen<br>containment Bag | | Simulated use<br>testing |
| | Guard to protect<br>bag and incision | Guard to protect<br>bag and incision | Same | |
| Sterility | Sterile, for Single<br>use | Sterile, for Single<br>Use | Same | Validated using<br>VDmax25 |
| Packaging | Device provided in a<br>Tyvek/Polymer<br>pouch | Device provided in<br>a Tyvek/Polymer<br>pouch | Same | Testing carried out<br>following transit<br>simulation:<br>Bubble-leak testing<br>Functionality testing<br>Packaging seal<br>testing |
| Physical Characteristics | | | | |
| Bag Size | Volume: 6000mL<br>Dimensions: 25cm x<br>36cm<br>Opening Ring<br>Diameter: 17.5cm | Volume: 3400mL<br>Dimensions: 22cm<br>x 30cm<br>Opening Ring<br>Diameter: 14cm<br>Volume: 6500mL<br>Dimensions: 27cm<br>x 38cm<br>Opening Ring<br>Diameter: 17cm | Larger<br>Opening Ring<br>diameter<br>Larger Bag<br>capacity | Simulated use<br>testing |
| Bag<br>Composition | Polymer film<br>material<br>Nitinol ring at the<br>mouth to open Bag<br>Fabric tether<br>attached to ring | Polymer film<br>material<br>Polymer ring at the<br>mouth to open bag<br>String tether<br>attached to ring | Different<br>Ring, Bag and<br>retrieval<br>tether<br>materials | Bag seal strength<br>testing (standalone<br>& comparative)<br>Bag puncture-<br>resistance testing<br>(comparative)<br>Tether strength<br>testing<br>Biocompatibility<br>testing<br>Bacterial<br>penetration testing |
| Guard | Guard with anchor<br>ring, sleeve and<br>adjustable petals<br>Actuated/retracted<br>by rolling down the<br>Rolling Ring | Ratcheted guard<br>strip<br>Actuated by<br>pulling open the<br>guard | Different<br>overall Guard<br>design<br>Both intended<br>to maximize<br>and protect | Simulated use<br>testing (standalone<br>& comparative)<br>Post-use Bag leak-<br>testing<br>Guard puncture<br>resistance<br>(standalone & |
| Substantial Equivalence Information | | | | |
| | RedEx<br>K211234 | Applied Medical<br>Tissue<br>Containment<br>System<br>K142427 | Comparison | Testing |
| | | | the incision<br>area | comparative)<br>Guard security<br>(comparative)<br>Guard coverage<br>(comparative) |
| Opening Ring | Composed of nitinol<br>Welded inside a<br>pocket at the mouth<br>of the Bag that<br>allows for closure<br>Facilitates<br>specimen<br>encapsulation | Composed of thick<br>polymer<br>Welded directly to<br>the bag and does<br>not close<br>Facilitates<br>specimen<br>encapsulation | Different<br>materials<br>Ring welded<br>into a pocket<br>to allow Bag<br>closure. | Simulated use<br>testing (standalone<br>& comparative)<br>Ring strength<br>testing |
| Use | | | | |
| Manual<br>Morcellation<br>Process | Opening ring<br>exteriorized through<br>incision<br>Guard placed in<br>mouth of Bag<br>Manual morcellation<br>undertaken | Opening ring<br>exteriorized<br>through incision<br>Guard placed in<br>mouth of bag<br>Manual<br>morcellation<br>undertaken | Same | Simulated use |
| Bag<br>Introduction<br>Process | Bag provided pre-<br>loaded in Introducer<br>with Plunger.<br>Delivered through a<br>12mm trocar<br>accessory.<br>Pneumoperitoneum<br>maintained. | Bag folded before<br>insertion<br>Deployed through<br>open incision.<br>Pneumoperitoneu<br>m re-established<br>after deployment. | Provided pre-<br>rolled in an<br>Introducer | Simulated use<br>(standalone &<br>comparative) |
| Incision size | 2.5-6cm | 2.5-4cm | Larger<br>incision length<br>range | Guard coverage<br>testing<br>(comparative)<br>Guard security<br>testing<br>(comparative)<br>Simulated use |
| Tissue<br>Encapsulation | Tissue introduced<br>into open mouth of<br>Bag. | Tissue introduced<br>into open mouth of<br>bag.<br>Bag cannot be<br>closed | Bag is closed<br>before<br>exteriorization | Simulated use<br>(standalone &<br>comparative) |
| Substantial Equivalence Information | | | | |
| | RedEx<br>K211234 | Applied Medical<br>Tissue<br>Containment<br>System | Comparison | Testing |
| | | K142427 | | |
| | RedEx Bag can be<br>fully closed by<br>pulling on the tether | | | |
| Bag Removal | IFU instructs<br>surgeon to pull<br>upwards on<br>Opening Ring | IFU instructs<br>surgeon to pull<br>upwards on<br>Opening Ring and<br>tether | No use of<br>tether when<br>removing | Simulated use<br>testing (standalone<br>& comparative) |
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# Conclusions
RedEx is as safe and effective as the Applied Medical Tissue Containment System/Alexis CES. RedEx has the same intended use and indications, and similar technological characteristics and principles of operation as its predicate device. In addition, the minor technological differences between RedEx and its predicate device raise no new issues of safety or effectiveness. Thus, RedEx is substantially equivalent.
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.
