K040048 · Fujinon, Inc. · FDA · Jun 7, 2004 · Gastroenterology, Urology
Device Facts
Record ID
K040048
Device Name
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
Applicant
Fujinon, Inc.
Product Code
FDA · Gastroenterology, Urology
Decision Date
Jun 7, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.
Device Story
Fujinon Double Balloon Enteroscopy System facilitates visualization and treatment of the upper GI tract, specifically the small intestine. System components include a G5 endoscope (EN-450P5/20), over-tube (TS-12140), balloons (BS-1), and a balloon pump controller (PB-10). The device operates by using balloons and an over-tube to ensure complete positioning of the enteroscope within the small intestine, allowing the tip to reach the area of diagnosis. It connects to a Series 400 processor and various peripherals (light source, monitor, video printer, electrosurgical instruments). Used in clinical settings by physicians, the system provides real-time optical visualization to the clinician via a monitor. This enables direct observation of the GI tract, facilitating diagnostic procedures and therapeutic interventions. The balloon-assisted mechanism allows for deeper access into the small intestine compared to standard enteroscopy, potentially improving diagnostic yield and therapeutic access for patients with small bowel pathology.
Clinical Evidence
Bench testing only. The device underwent electrical safety, thermal, EMC, and biocompatibility testing. No clinical data was provided.
Technological Characteristics
Endoscope: Interline color CCD chip, 411,988 pixels, 120-degree FOV, 8.5mm diameter. Materials: Natural rubber (balloon), polyvinylpyrrolidone hydromer coating (overtube). Energy: 120V/230V power supply for pump. Connectivity: Compatible with Fujinon Series 400 processor. Sterilization: Compatible with standard endoscopic reprocessing methods. G5 upgrade features external/removable check valves and updated cleaning adaptors (CA-500).
Indications for Use
Indicated for optical visualization, observation, diagnosis, and endoscopic treatment of the upper gastrointestinal tract, including the esophagus, stomach, duodenum, and small bowel in patients requiring GI endoscopy.
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.
{0}------------------------------------------------
K 040048 pg ' of 4
# 510 (k) Summary
JUN - 7 2004
Date Prepared [21 CFR 807.92(a)(1)]
January 9, 2004
# Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary C/o Fujinon Inc. 543 Long Hill Avenue Shelton, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor Fujinon Inc. 10 High Point Drive, Wayne, NJ 07470, Establishment Registration# 2431293.
# Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are: Fujinon Double Balloon Enteroscopy System Common Name: Enteroscope Classification: Class II, 21 CFR 876.1500, FDA
#### Predicate Device [21 CFR 807.92(a)(3)]
- Fujinon Enteroscope EN-410WM K993704 ●
The subject device have the same indications for use, material composition, viewing direction, image size, bending, reprocessing/sterilization method, and working dimensions as the predicate. The subject device uses the same processor and peripherals as the predicate device.
The main differences between the subject device and predicate device are as follows:
- Minor differences with observation range, field of view, diameter, and length. .
- Subject device includes an overtube, balloons, and a balloon pump. ●
- The subject device includes the G5 upgrade, which is characterized by the following minor differ-. ences:
- The L-Port has been eliminated. The L-port functioned as a lens wash port . Doctors had o the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons.
- The J-Port was repositioned. The J-Port is used as a jost water wash port. The J-Port was 0 repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eligainate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
{1}------------------------------------------------
K040.48 pg 2 of 4
- A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber O cap. The smaller port and rubber cap help increase suction and reduce leakage.
- The jet wash line check valve was removed. Internal check valves were removed to elimio nate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable.
- The suction and air/water cylinders and valves were upgraded. They were updated to ac-0 commodate the new valves. The function of the valves is the same.
- Addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a wa-O tertight seal when the endoscope is used.
- Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be con-0 nected to tubes for cleaning.
#### Description of the Device [21 CFR 807.92(a)(4)}
The small intestine is one of the most difficult organs to access in gastro-intestinal (GI) tract endoscopy. The Fujinon double balloon enteroscopy system facilitates diagnosis and treatment of the upper GI tract including the small intestine.
The Fujinon double balloon enteroscopy system utilized balloons and over-tube to ensure complete positioning of the enteroscope in the small intestine. The tip of the scope can be smoothly inserted to reach the area of diagnosis.
The Fujinon double balloon enteroscopy system includes the following:
- G5 endoscope / enteroscope (EN-450P5/20) .
- Over-Tube (TS-12140) .
- Balloon (BS-1) .
- Balloon Pump Controller (PB-10) .
The subject device is used with the Fujinon Series 400 processor, the same processor used with the predicate device.
The Fujinon double balloon enteroscopy system is used in conjunction with other peripherals specified in the Operation Manual such as:
- Light Source .
- . Processor
- Cart .
- Data Keyboard
- Foot Switch .
- Monitor .
- Video Printer .
- Camera and Hard Copy Unit .
- VCR .
- ElectroSurgical Tastruments .
{2}------------------------------------------------
\$\qquad K^{v}4\quad 0048\quad B_{y}\quad ^{3}g\quad 4\$
# Specifications Chart:
| | EN-450P5/20 | |
|---------------------------|--------------|--|
| Viewing Direction | Forward | |
| Observation Range | 5~100mm | |
| Field of view | 120 | |
| Image size | 130% (super) | |
| Distal end diameter | 8.5mm | |
| Flexible portion diameter | 8.5mm | |
| Bending capability | See below | |
| Up | 180 | |
| Down | 180 | |
| Left | 160 | |
| Right | 160 | |
| Forceps channel diameter | 2.2mm | |
| Working length | 2000mm | |
| Total length | 2300mm | |
| Lens diameter | 2.1mm |
|----------------------------|----------------------|
| # of pixels | 411,988 pixels |
| Pixels per square mm | 83, 892 |
| Pixel size (H x V) | .0032 x .003725 |
| Active area of CCD (H x V) | 2.458 x 1.840 |
| Type of CCD chip | Interline color chip |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-----------------------------------------------------------------------------------------------------------<br>NAL R BLOGARIA<br>Door | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Book Book Child Child Child Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Ch<br>A-4-4-4-4-4<br>Section of the country of the closed on the controlled to the contribution of the comments of the comments of the comments of the comments of the comments of the comments of<br>A more. I cost and consisted com accession of<br>FEE A<br>REER CRIMINATION COLUMN AN<br><br><br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>-----------------------------------<br>Access the contributed to the contributed to the contributed to the contributed to the contributed to the contributed to the contributed to the contributed to the contributed<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>and the collection of the desires the first the first the first the first the<br>Acres of the Council A children and consider and any and<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Advertising the<br>.<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| SELL CLEAN I LAND OR BALL BOOK OF<br>and the most of the property of the continued any and changes and the considered and the contribution of the concesses<br>CAR COLOR COLLECT OF COLLECTION<br>Company Controller Comments of<br>Company of the call of the collection | | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Company of Canada Cases of Children Company Company Company Company Comments of Children Comments of Children<br>.<br>.<br>AND LI & A R ANNUA MOND SHOULD STATUS CONSULER | | |
| <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br><br>AND LA BREAD LE LANDRED<br>-------------------------------------------------------------------------------------------------------------- | <br>FIR IN IN MINNERALING A<br><br>.<br>AN LAND CANDREAL CONNECT COLLEGION<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A has and a comments a che all can and a comments of the first and<br>Company of Concession Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company | |
# Over-Tube Specifications
| .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Specificant program and a che consisted and a set a superior contract<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br><br>ARE E ME RE LEBERT<br>----------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | LE MILE II DAME<br>AND AND A COLLEGION FOR<br>- Status Support For Children Comments a<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Company of the county of the comments of the promote on<br><br><br> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CO CALL COLLECTION<br>1<br>Carl Property Concession Come<br>Can Beach and Child A company a<br>.<br>.<br>.<br><br>CON EL LAND - NA AN AND AND AND AND | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>.<br>.<br><br><br>. |
Balloon Pump Controller with Remote Switch PB-10 Specifications
| Set Pressure of Balloon | 3.6 kpa - 7.6 kpa (5.6 kpa +/- 2 kpa) |
|---------------------------|---------------------------------------|
| Maximum flow rate of pump | 170 ml/10 sec |
| Power Supply | 120V / 230V |
| Dimensions | 300 (W) x 200(H) x 300(D) mm |
| Weight | 8.7 kg |
The balloon is composed of natural rubber, which has been subjected to and passed biocompatibility I his banding vertube is composed of polyvinylpyrolidone hydromer coating, which has been subjected to and passed biocompatibility testing.
> Fujinon Inc. Double Balloon Enteroscopy 510(k) Page 5-3
{3}------------------------------------------------
K cttco48 Pg 4 of 4
### Intended Use [21 CFR 807.92(a)(5)]
The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.
# Technological Characteristics [21 CFR 807.92(a)(6)]
Fujinon, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device have the same indications for use, material composition, image size, bending, reprocessing/sterilization method, and working dimensions as the predicate. The subject device uses the same processor and peripherals as the predicate device.
The main technological difference is the balloon and overtube as a way to facilitate diagnosis and treatment of the upper GI tract including the small intestine, as well as the minor changes associated with the G5 upgrade.
#### Performance Data [21 CFR 807.92(b)(1)}
The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device. The balloon and overtube materials have been subjected to and passed biocompatibility testing.
### Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.
> Fujinon Inc. Double Balloon Enteroscopy 510(k) Page 5-4
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three horizontal lines above it, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Fujinon, Inc. c/o Mr. Joseph M. Azary Azary Technologies LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K040048
Trade/Device Náme: Fujinon Double Balloon Enteroscopy System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: 78 FDA Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Product Code: 78 KNT Regulatory Class: II Dated: May 5, 2004 Received: May 7, 2004
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications ferenced above and nave acterimes ally marketed predicate devices marketed in interstate for use slated in the enolosure) is regars and ment date of the Medical Device Amendments, or to commerce prior to way 20, 1976, the exaccidance with the provisions of the Federal Food, Drug, devices that have occh receired in asse equire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mance are as not include requirements for annual registration, listing of general controls provisions of the 1100 ling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (see above) into entire regulations affecting your device can be it may be subject to additional controller Life 21, Parts 800 to 898. In addition, FDA may round in the Code of Possients concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tease oc advised that FDF i robation a vour device complies with other requirements of the Act that I DA has made a decommandin an administered by other Federal agencies. You must of any I ederal Statutes and regulations, but not limited to: registration and listing comply with an the rice I requirements, in 201); good manufacturing practice requirements as set (21 CFR Part 807), labemg (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) . og (sections 531-542 of the Act); 21 CFR 1000-1050.
{5}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marteenig your ential equivalence of your device to a legally premarket notification. The PDA inding of backantal epical on thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice tor your device on one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the promote of the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Othice of Compliance at (501) 594-4057. Fab.) production of Super Bear the Division of Same by reference to premarket notification (21 OF Act may be obtained from the Division of Small
information on your responsibilities under the Act may be sitted from the 1800) 6 information on your responsionalities unec tales tales tales toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fremation htt Manufacturers, International and Colladmor i assistement of the main.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
5 10(k) Number (if known): // 04 00 48
Device Name: Fujinon Inc. Double Balloon Enteroscopy System
Indications For Use: The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Allin (Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Fujinon Inc. Double Balloon Enteroscopy 510(k) Page 4
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.
