(240 days)
The Fujifilm Endoscopes: EG-530CT, EG-530D, EC-530DL, and ES-530WE have the following indications for use:
Indications for Use (EG-530CT):
The EG-530CT Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for Use (EG-530D):
The EG-530D Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for Use (EC-530DL):
The EC-530DL Endoscope: This device is intended for the lower digestive tract, soecifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Indications for Use (ES-530WE):
The ES-530WE Endoscope: This device is intended for the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
The endoscopes are comprised of three general sections: an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/ight) of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water, provide suction, and a forceps channel. The forceps channels are used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and the light source.
The proposed models are used in combination with Fuilfilm's video processor, light source and peripheral devices (water tank, endoscope accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, and cart).
The minor modifications to the endoscopes were made for the purpose of overall product enhancement and general technological advancement.
The document describes the regulatory submission for several new endoscopes (EG-530CT, EG-530D, EC-530DL, and ES-530WE) from Fujifilm Medical Systems U.S.A., Inc. This is a 510(k) premarket notification, where the manufacturer demonstrates that the new devices are "substantially equivalent" to legally marketed predicate devices.
This submission does NOT involve a device that uses Artificial Intelligence (AI) or machine learning. Therefore, many of the requested criteria related to AI/ML device performance (like multi-reader multi-case studies, effect size of human improvement with AI, standalone performance, training set details, expert ground truth establishment for training data) are not applicable.
Instead, the acceptance criteria and proof of device performance are based on compliance with established medical device safety and performance international standards and engineering testing for physical and electrical characteristics.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Assurance |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | The subject devices (EG-530CT, EC-530DL, ES-530WE, EG-530D) "have been subjected to and passed electrical safety ... test requirements." |
| "Evaluation to ANSI/AAMI ES60601-1 ... was conducted for Fujifilm Endoscopes." | ||
| Electromagnetic Compatibility (EMC) | IEC60601-1-2:2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests) | The subject devices "have been subjected to and passed ... EMC test requirements." |
| "Evaluation to ... IEC60601-1-2 ... was conducted for Fujifilm Endoscopes." | ||
| Safety of Endoscopic Equipment | IEC60601-2-18:2009 (Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment) | "Evaluation to ... IEC60601-2-18 was conducted for Fujifilm Endoscopes." |
| Usability | IEC60601-1-6:2010 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability) | Devices were evaluated in accordance with this standard. |
| Usability Engineering | IEC62366:2007 (Medical devices - Application of usability engineering to medical devices) | Devices were evaluated in accordance with this standard. |
| Biocompatibility (General) | ISO10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | "Evaluation to ISO 10993-1 (Tested per ISO10993-10) was conducted for patient contact materials." Devices were evaluated in accordance with this standard. |
| Biocompatibility (In Vitro Cytotoxicity) | ISO10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity) | Devices were evaluated in accordance with this standard. |
| Biocompatibility (Irritation & Skin Sensitization) | ISO10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) | "Evaluation to ISO 10993-1 (Tested per ISO10993-10) was conducted for patient contact materials." Devices were evaluated in accordance with this standard. |
| Endoscope Optical Properties (General Requirements) | ISO8600-1:2013 (Optics and photonics - Medical endoscopes and endotherapy devices – Part 1: General requirements) | "Evaluation to ISO8600-1 (Tested per ISO8600-3 and ISO8600-4) was conducted for medical endoscopes and accessories." Devices were evaluated in accordance with this standard. |
| Endoscope Optical Properties (Field of View & Direction of View) | ISO8600-3:1997 (Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics) | "Evaluation to ISO8600-1 (Tested per ISO8600-3 and ISO8600-4) was conducted for medical endoscopes and accessories." Devices were evaluated in accordance with this standard. |
| Endoscope Physical Properties (Max Width of Insertion Portion) | ISO8600-4:1997 (Optics and Optical instruments – Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion) | "Evaluation to ISO8600-1 (Tested per ISO8600-3 and ISO8600-4) was conducted for medical endoscopes and accessories." Devices were evaluated in accordance with this standard. |
| Reprocessing/Cleaning Instructions | AAMI TIR 30:2011 and AAMI TIR12:2010 | "The reprocessing instructions were updated and validation was performed in conformance with AAMI TIR 30:2011 and AAMI TIR12:2010. A Reprocessing validation certificate is included with this premarket notification." |
| Sterilization | ISO 17665-1:2006 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices) | "Steam sterilization was validated per ISO 17665-1:2006." |
| Substantial Equivalence | Comparison to predicate devices (Fujinon G5 Gastroscope, EG-450WR5 (K042043) and Fujinon Colonoscopes, EC-530HL2 (K112391)) | Manufacturer concluded: "The Fujifilm EG-530CT, EG-530D, and ES-530WE Endoscopes are as safe and effective as the Fujinon G5 Gastroscope, EG-450WR5 (K042043) and the Fujinon Colonoscopes, EC-530HL2 (K112391). ... The minor technological differences ... raise no new issues of safety or effectiveness. Performance data demonstrate that the Fujifilm EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes are as safe and effective as the predicate devices." |
2. Sample size used for the test set and the data provenance
The document states, "No clinical testing was conducted." The testing was primarily engineering bench testing and compliance with standards. Therefore, concepts like "test set," "sample size," and "data provenance" in the context of patient data do not apply here. The performance was demonstrated through compliance with recognized standards using the actual devices, their components, and reprocessing methods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, no clinical testing in the form of a diagnostic performance study was conducted. The "ground truth" here is the adherence to established engineering and safety standards, assumed to be verified by qualified professionals within the testing labs and manufacturer's quality system (e.g., test engineers, biocompatibility specialists, electrical safety engineers).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There was no clinical ground truth established by multiple readers requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI/ML device. It is a traditional medical endoscope.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI/ML algorithm. It is a physical medical device requiring human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on:
- Compliance with recognized international and national consensus standards (e.g., IEC, ISO, ANSI/AAMI for safety, EMC, usability, biocompatibility, and reprocessing).
- Engineering test results confirming the physical, electrical, and optical properties of the devices meet the specified requirements of these standards.
- Substantial equivalence to previously cleared predicate devices, suggesting that the established safety and effectiveness profiles of the predicates are maintained or improved upon by the minor modifications of the new devices.
8. The sample size for the training set
Not applicable. There is no AI/ML model involved, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model involved.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.