Use in laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to manipulate tubing and to generally assist with the placement of a gastric band.
Device Story
LogiFlex is a sterile, single-use, laparoscopic blunt dissection instrument. It features a shaft with a distal articulating tip containing a slot/hook for capturing suture threads and tubing. The device connects to a reusable, ratchet handle (from Logic Monopolar Laparoscopic Scissors) to enable tip articulation. Operated by a surgeon during laparoscopic procedures, the device assists in tissue layer separation and gastric band placement. It is not designed for electrocautery. The articulating tip allows for positioning around the esophagus. Benefits include precise manipulation of sutures and tubing during bariatric surgery.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including distal tip pull testing (load > 2.6kg), sideway force testing (≥ 0.54kg), crimped nipple pull-out testing (5.23kg), tip deflection testing (0° to 90°), lifecycle testing (50 actuations), drop testing (ASTM D4169-1996), accelerated shelf-life testing (ASTM F1980-07), sterilization validation (ISO 11137-2:2006), and biocompatibility testing (ISO 10993-1:2002, ISO 10993-10:2002).
Technological Characteristics
Sterile, single-use, laparoscopic blunt dissector. Features articulating distal tip with suture/tubing hook. Connects to reusable ratchet handle. Materials biocompatible per ISO 10993. Sterilized via gamma radiation (25kGy, SAL 10^-6) per ISO 11137-2. Mechanical actuation via handle linkage. No electrocautery capability.
Indications for Use
Indicated for use in laparoscopic procedures requiring blunt dissection between tissue layers, suture thread manipulation, tubing manipulation, and assistance with gastric band placement.
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.
Goldfinger Blunt Dissector – Obtech Medical SARL (Class I, 510(k) exempt: 21 CFR 878.4800)
Submission Summary (Full Text)
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k 100/09
# SECTION 5:
# 510(k) SUMMARY
: **JUL** 1 5 2019
| Submitter: | Surgical Innovations plc.<br>Clayton Wood House<br>6 Clayton Wood Bank<br>Leeds<br>LS16 6QZ<br>United Kingdom<br>Tel.: +44 113 230-7597<br>Fax: +44 113 230-7598 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike White<br>Product Development Director |
| Date Summary<br>Prepared: | 08 January 2010 |
| Trade Name: | LogiFlex Laparoscopic Band Positioning Device |
| Common Name: | Endoscope and accessories |
| Classification Name: | Laparoscope, General and Plastic Surgery<br>(21 CFR 876.1500, Product Code GCJ). |
| Equivalent to: | Logic Monopolar Laparoscopic Scissors – Surgical Innovations plc<br>(K063485).<br>Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors<br>and Needle Holders – Allegiance Healthcare Corporation (K991928).<br>Goldfinger Blunt Dissector – Obtech Medical SARL<br>(Class I, 510(k) exempt: 21 CFR 878.4800) |
11
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k 100109
The LogiFlex Laparoscopic Band Positioning Device is a sterile, single-use, Device Description: laparoscopic, blunt dissection instrument. It comprises a shaft with a distal articulating tip incorporating a slot that forms a hook for capturing suture threads and tubing. The LogiFlex Laparoscopic Band Positioning Device is designed to be connected to and used with the reusable, ratchet handle of the Logic Monopolar Laparoscopic Scissors in order to effect articulation of the distal tip. The LogiFlex Laparoscopic Band Positioning Device is not designed to be used with an electrocautery connection.
The LogiFlex Laparoscopic Band Positioning Device is indicated for use in Intended Use: laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to pull tubing and to generally assist with the placement of a gastric band.
Substantial Determination of substantial equivalence for the LogiFlex Laparoscopic Equivalence: Band Positioning Device was based on comparison to the predicate devices in terms of intended use, indications for use and device technological characteristics, such as design features, materials of composition, principle of operation and presentation. The LogiFlex Laparoscopic Band Positioning Device is substantially equivalent to the Logic Monopolar Laparoscopic Scissors and the Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders in terms of modularity of construction and intended use. The LogiFlex Laparoscopic Band Positioning Device is substantially equivalent to the single use insert components of the Logic Monopolar Laparoscopic Scissors in terms of the design, materials of construction, and principle of operation of the handle connection mechanism and the actuation mechanism. The LogiFlex Laparoscopic Band Positioning Device is substantially equivalent to the Goldfinger Blunt Dissector in terms of the indications for use and the design, materials of construction and principle of operation of the articulating distal tip.
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K100109
#### Nonclinical tests summary
## 1. Bench Testing
#### Distal Tip Pull Testing
For this test the input criteria was determined to be:
- . A tensile axial load > 2kg when pulling suture.
- Product straightens to -5° to 0° for cannula introduction / removal. �
- Product articulates to ≥ 90° to allow positioning around the esophagus. ●
The pass results in TN100309 (Exhibit 12) show that the pre-production LogiFlex laparoscopic band positioning device passes the input criteria, achieve a load of 2.96kg and articulating from 0° to 90°.
In TN100341 (Exhibit 16), further testing was carried out on production standard product (13 samples). The results show that the product has achieved a load of 2.6kg and articulating from 0° to 90°.
#### Sideway force testing
For this test the input criteria was determined to be:
- . A sideway force ≥ 0.54kg when pulling suture.
- . Product straightens to -5° to 0° for cannula introduction / removal.
- . Product articulates to ≥ 90° to allow positioning around the esophagus.
The pass results in TN100310 (Exhibit 11) show that the LogiFlex laparoscopic band positioning device passes the input criteria, achieve a sideway force of 0.54kg (same as Goldfinger Blunt Dissector) and articulating from 0° to 90°.
#### Crimped nipple pull out testing
For this test the input criteria was determined to be:
- Crimped nipple to withstand 5kg amount of force. .
The pass result in TN100341 (Exhibit 16) shows that the LogiFlex laparoscopic band positioning device passes the input criteria, achieving an average force of 5.23kg.
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k100109
## Tip deflection testing
For this test the input criteria was determined to be:
- Product straightens to -5° to 0° for cannula introduction / removal. ●
- Product articulates to ≥ 90° to allow positioning around the esophagus. ●
The pass results in TN100341 (Exhibit 16) show that the LogiFlex laparoscopic band positioning device passes the input criteria to articulate from 0° to 90°.
## Lifecycle testing
For this test the input criteria was determined to be:
- All 10 specimens to survive 2 irradiation cycles and 50 actuations (articulating from 0° to . 90°) without any mechanical defects.
The pass results in TN100326 (Exhibit 14) show that the LogiFlex laparoscopic band positioning device passes the input criteria to survive 2 irradiation cycles and 50 actuations without any mechanical defects.
## Drop testing
For this test the input criteria was determined to be:
- Pass in accordance with pass criteria ASTM D4169-1996. After 100% inspection of . product after dropping there should be no visible defects found in the product and the package seal should be intact.
The pass results in TN 100311 (Exhibit 15) show that the LogiFlex laparoscopic band positioning device passes the input criteria where the packaging is capable of maintaining the device in a sterile condition and free from damage during transit.
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Image /page/4/Picture/0 description: The image shows the text "Page 5 of 6" and "k100109" written in black ink on a white background. The number 6 is circled. The text appears to be handwritten.
## 2. Shelf life: LogiFlex Accelerated Ageing Testing
A 5 year accelerated shelf life study is completed with the LogiFlex Laparoscopic Band Positioning Device. The study has been performed in accordance with ASTM F1980-07 and involves ageing of packed, sterilized devices at 53°C ± 4°C, under which conditions, 6 weeks storage duration is equivalent to 12 months storage at ambient temperature. Thirty test samples at each time point are subjected to visual inspection of the seals (in accordance with ASTM F1886-98(2004)); 15 of these are subjected to burst strength testing (in accordance with ASTM F1140-07) and 15 to dye penetration testing (in accordance with ASTM F1929-98(2004)). The full report of this testing (ref. Technical Note 100312) is provided at Exhibit 9.
## 3. Sterilization Validation
The gamma radiation sterilization process used for sterilization of the Logic Laparoscopic Band Positioning Device has been validated in accordance with ANSI / AAMI / ISO 11137-2:2006, using the VDmax2 method, and is subject to quarterly re-validation. To achieve a SAL of 10° a sterilization dose of 25kilogray must be applied to this product.
The full report of this testing (ref. Technical Note 100313) is provided at Exhibit 7.
### 4. Materials Biocompatibility
From ISO 10993-1:2002, LogiFlex is an external communicating device with duration < 24 hours, therefore initial tests for consideration are:
- 1. Cytotoxicity
- 2. Sensitization
- ന് Intracutaneous reactivity.
#### 1. Cytotoxicity Test
The result has showed that the extract of the negative control (polypropylene filters) was noncytotoxic to 1929 cells under the conditions of this test. The extract of the positive control (rubber bands) was cytotoxic to L929 cells under the conditions of this test. Therefore, LogiFlex has been indicated to be non-cytotoxic.
The full report of this testing (ref. Technical Note 100314) is provided at Exhibit 10.
#### 2. Local Lymph Node Assay in the mouse
The result has showed that a stimulation of less than 3 was recorded for the polar and non-polar extract of the test item. Therefore, the polar and non-polar extracts of LogiFlex were considered to be a non-sensitiser under the conditions of the test.
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k100109.
## 3. Intracutaneous Reactivity test in the rabbit
The result has showed that the average reaction to the polar and non-polar test item extracts was considered not to be greater than the average reaction for the corresponding control at any observation period. Therefore, polar and non-polar extracts of the LogiFlex meet the requirements of ISO 10993-10:2002 Intracutaneous (Intradermal) Reactivity Test in the Rabbit; and considered to be non-irritant under the conditions of the test. .
{6}------------------------------------------------
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The overall design is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 5 2010
Surgical Innovations Plc. % Mr. Mike White Product Development Director Clayton Wood House 6 Clayton Wood Bank Leeds LS16 60Z United Kingdom
Re: K100109
Trade/Device Name: LogiFlex Laparoscopic Band Positioning Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: July 07, 2010 Received: July 12, 2010
Dear Mr. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{7}------------------------------------------------
### Page 2 - Mr. Mike White
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its voll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of ①
t 100109
## SECTION 4:
### INDICATIONS FOR USE STATEMENT
510{k) Number (if known): Not known
Device Name:
LogiFlex Laparoscopic Band Positioning Device
Indications for Use:
Use in laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to manipulate tubing and to generally assist with the placement of a gastric band.
Prescription Use___X
AND/ OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concerns of the Region of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_
10
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
