AnQing Medical Flexible Choledochoscope has been designed to be used with the video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct. The Flexible Choledochoscope is designed for use in adults.

Device Description

The Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is a sterile single-use endoscope which is used with the video processor (Model: EOS-H-01. FDA cleared #K211169) produced by AnQing for providing endoscopic imaging within the bile duct for the purpose of diagnosis and treatment. The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version). The Flexible Choledochoscope is a single-use endoscope, which consists of Handle, Insertion Section, Distal Tip, and Endoscope Connector. The handle includes a deflection lever, a lever lock, an aspiration button, an aspiration connector, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA, specifically concerning a Flexible Choledochoscope. This type of document is for a medical device that does not rely on complex algorithms or AI for its primary function. Therefore, the concepts of "AI algorithm," "acceptance criteria for an AI model," "training dataset," "test set," "ground truth establishment," "MRMC studies," and "standalone performance" as they relate to AI are not applicable to this submission.

The acceptance criteria and performance data provided in this document are entirely related to the physical and functional characteristics of the choledochoscope itself, not an AI component.

Here's an analysis of the document in relation to the questions asked, noting where the questions are not applicable due to the nature of the device:

Acceptance Criteria and Device Performance (Non-AI Device)

Since this is a physical medical device (a choledochoscope), the "acceptance criteria" are related to its physical properties, safety standards, and functional performance compared to a predicate device.

1. A table of acceptance criteria and the reported device performance

The document presents a comparison table between the subject device (Flexible Choledochoscope, Models CS50H-20EU, CS50H-20US) and its predicate device (Olympus CHF TYPE V), showing "acceptance criteria" as functional and physical similarities and differences. The "reported device performance" is essentially that the subject device meets or is comparable to the predicate device in these aspects, and where there are differences, non-clinical tests were conducted to demonstrate equivalence without raising new safety/effectiveness concerns.

Feature / Criteria	Subject Device (CS50H-20EU, CS50H-20US)	Predicate Device (CHF TYPE V) (K081456)	Comparison / Performance Outcome
Indications for Use	Diagnosis & treatment within bile duct, for adults. Used with video processor, monitor, endotherapy accessories.	Diagnosis & treatment within bile duct. Used with Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories.	Equivalent (Note 1: Wording differences do not alter intended use or raise new safety/effectiveness questions).
Physical Characteristics
Type of Scope	Flexible	Flexible	Same
Outer diameter (mm)	Max. 5.0 mm	Max. 5.85 mm	Similar (Subject is smaller; Note 2: Differences evaluated via performance testing).
Inner diameter (mm)	Min. 2.0 mm	Min. 2.0 mm	Same
Working length	380 mm	380 mm	Same
Deflection	210° up, 180° down	160° up, 130° down	Similar (Subject has greater deflection; Note 2: Differences evaluated via performance testing).
Optical Characteristics
Type of Image sensor	CMOS	Color CCD	Different (Note 2: Differences evaluated via performance testing).
Field of View	110°	120°	Similar (Note 2: Differences evaluated via performance testing).
Direction of View	0°	0°	Same
Depth of Field	5mm~100mm	3mm~50mm	Similar (Note 2: Differences evaluated via performance testing).
Light Source	Internal LEDs	External light source	Different (Note 2: Differences evaluated via performance testing).
Patient Contacting Materials
General material type	Compliance with ISO10993-1	Compliance with ISO10993-1	Similar (Note 2: Differences evaluated via performance testing).
Duration and type of contact	"External communication medical device-Tissue" with a contact duration of "Limited (< 24 hours)"	"External communication medical device-Tissue" with a contact duration of "Limited (< 24 hours)"	Same
Sterilization Methods
Number of Users	Single-Use	Reusable	Different (Note 2: Differences evaluated via EO Sterilization validation).
Sterilization	EO Sterilized, SAL 10-6	Not provided sterile but intended for sterilization at Medical Facility.	Different (Note 2: Differences evaluated via EO Sterilization validation).
Technological Characteristics
Environment of use	Healthcare facility/hospital	Healthcare facility/hospital	Same
Energy source	Electricity	Electricity	Same

Summary of Non-Clinical Tests conducted to support equivalence for differences:

Electrical Safety and Electromagnetic Compatibility: Compliance with IEC 60601 series standards.
Photobiological safety: Compliance with IEC 62471:2006 for LEDs.
Mechanical and Optical Performance: Compliance with ISO 8600 standard parts for optical measurements, and testing of leakage tightness, bending, deflection endurance, withstand of channel. Comparative testing related to image quality parameters was also performed against the predicate.
Biocompatibility: Evaluation according to ISO 10993-1 and FDA Guidance, including Cytotoxicity, Sensitization, Material-mediated pyrogenicity, and Acute systemic toxicity.
Sterilization and shelf life testing: Validation to ISO 11135:2014, EO/ECH residual test to ISO 10993-7:2008, and accelerated aging to ASTM F1980-21.
Package Validation: Compliance with ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-21, ASTM F1929-15, and transport testing to ASTM D4169-22.

Regarding AI-specific questions (Not Applicable to this Device):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a physical device, not an AI algorithm. There is no "test set" of data in the AI sense. Testing involved laboratory and bench testing of the physical properties and performance of the device and its components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth, in the context of an AI algorithm, refers to verified labels for training/testing. For a physical medical device, "ground truth" is established through engineering specifications, international standards (ISO, IEC, ASTM), and validated manufacturing processes. Expert review in this context would be part of the design and quality control processes by engineers and manufacturing specialists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling of AI datasets. This does not apply to the testing of a physical endoscope.

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. MRMC studies are used to evaluate diagnostic imaging systems with human readers, often in the context of AI assistance. This device is an endoscope that provides the image, not an AI system that interprets it or assists in its interpretation. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. There is no AI algorithm to test in a "standalone" fashion.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable. See point 3. "Ground truth" for this device includes compliance with recognized standards, engineering specifications, and validated performance characteristics.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" to establish ground truth for.

In conclusion, the provided FDA 510(k) submission pertains to a conventional medical device, a Flexible Choledochoscope, and does not involve AI or machine learning algorithms. Therefore, the questions related to AI acceptance criteria, datasets, and ground truth establishment are not relevant to this specific document.

Summary

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October 17, 2023

Shanghai AnQing Medical Instrument Co., Ltd Shuwen Fan RA Manager 3 & 4 Floor, No.2 Building, 366 Huiging Rd East Zhangjiang High-Tech Park Shanghai, 201201 China

Re: K231105

Trade/Device Name: Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBN Dated: September 15, 2023 Received: September 15, 2023

Dear Shuwen Fan:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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).

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Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231105

Device Name

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image contains the logo for Innovax Anqing Medical. The logo is purple and white. The word "Innovax" is in large, bold, purple letters, and the words "Anqing Medical" are in smaller, purple letters below the word "Innovax".

510(k) Premarket Notification Submission Flexible Choledochoscope

510(k) Summary

Date Prepared:	Apr./17/2023
Manufacturer:	Shanghai AnQing Medical Instrument Co., Ltd.3 & 4 Floor, No.2 Building, 366 Huiqing Rd,East Zhangjiang High-Tech Park, 201201Shanghai, China

Contact Person:	Shuwen Fan
	RA Manager
	Shanghai AnQing Medical Instrument Co., Ltd.
	Tel: +86-21-61117375
	Fax: +86-21-61117374
	ra_dept@anqing-sh.com

Identification of the Device:

Proprietary/Trade Name:	Flexible Choledochoscope
Model:	CS50H-20EU, CS50H-20US
Common name:	Choledochoscope And Accessories, Flexible/Rigid
Classification Name:	Endoscope and accessories
Regulatory Number:	21 CFR Part 876.1500
Product Code:	FBN
Device Class:	Class II
Review Panel:	Gastroenterology/Urology

Identification of the Legally Marketed Predicate Device:

Trade Name:	CHF-V Choledocho Videoscope
Common name:	Choledochoscope And Accessories, Flexible/Rigid
Classification Name:	Endoscope and accessories
Regulatory Number:	21 CFR Part 876.1500
Product Code:	FBN
Device Class:	Class II
Review Panel:	Gastroenterology/Urology
Submitter/510(k) Holder:	OLYMPUS MEDICAL SYSTEMS CORP.
Clearance:	K081456 (cleared November 6, 2008)

This predicate has not been subject to a design-related recall.

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Device Description:

The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version).

The Flexible Choledochoscope is a single-use endoscope, which consists of Handle, Insertion Section, Distal Tip, and Endoscope Connector. The handle includes a deflection lever, a lever lock, an aspiration button, an aspiration connector, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

Mechanism of action:

The light emitted by the LED cold light source at the distal tip of the disposable Flexible Choledochoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.

Flexible Choledochoscope has the following physical and performance characteristics:

Maneuverable tip controlled by the user O
Flexible insertion cord
O Camera and LED light source at the distal tip
Sterilized by Ethylene Oxide
O For single use

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Image /page/6/Picture/0 description: The image shows the logo for Anqing Medical. The logo is purple and features the word "INNOVEX" in a sans-serif font with a curved line above it. Below the word "INNOVEX" is the text "ANQING MEDICAL" in a larger, bolder font. To the left of the word "INNOVEX" is a stylized image of a leaf.

Indications for Use:

The Flexible Choledochoscope is designed for use in adults.

Comparison with Predicate Device:

The Flexible Choledochoscope and its predicate device, the Olympus CHF TYPE V(K081456), have the same intended use, and similar physical characteristics, optical characteristics.

Substantial Equivalence:

The Flexible Choledochoscope employs the same fundamental scientific technology as its predicate device, as below table:

	Subject Device(CS50H-20EU,CS50H-20US)	Predicate Device,(CHF TYPE V)(K081456)	Comparison
Indications For Use
IndicationsFor Use:	AnQing Medical FlexibleCholedochoscope has beendesigned to be used withthe video processor,monitor, endotherapyaccessories and otherancillary equipment forendoscopic diagnosis andtreatment within the bileduct.The FlexibleCholedochoscope isdesigned for use in adults.	This instrument hasbeen designed to beused with an Olympusvideo system center,light source,documentationequipment, monitor,EndoTherapyaccessories, and otherancillary equipmentfor endoscopicdiagnosis andtreatment within thebile duct.	EquivalentSee Note1.
Physical Characteristics
Type ofScope	Flexible	Flexible	Same
Outerdiameter(mm)	Max. 5.0 mm	Max. 5.85 mm	SimilarSee Note2.
Innerdiameter	Min. 2.0 mm	Min. 2.0 mm	Same
	Subject Device(CS50H-20EU,CS50H-20US)	Predicate Device,(CHF TYPE V)(K081456)	Comparison
(mm)Working length	380 mm	380mm	Same
Deflection	210°up, 180°down	160° up, 130° down	SimilarSee Note2.
Optical Characteristics
Type ofImage sensor	CMOS	Color CCD	DifferentSee Note2.
Field of View	110°	120°	SimilarSee Note2.
Direction ofView	0°	0°	Same
Depth ofField	5mm~100mm	3mm~50mm	SimilarSee Note2.
Light Source	Internal LEDs	External light source	DifferentSee Note2.
Patient Contacting Materials
Generalmaterial typeof mainpatient-contact part	Compliance withISO10993-1	Compliance withISO10993-1	SimilarSee Note2.
Duration andtype ofcontact	"External communicationmedical device-Tissue"with a contact duration of"Limited (< 24 hours)"	"External communicationmedical device-Tissue" with acontact duration of"Limited (< 24 hours)"	Same
Sterilization Methods
Number ofUsers	Single-Use	Reusable	DifferentSee Note2
Sterilization	EO Sterilized,SAL 10-6	Not provided sterilebut intended forsterilization at theMedical Facility.	DifferentSee Note2
Technological Characteristics
Environment	Healthcare facility/hospital	Healthcare	Same
	Subject Device(CS50H-20EU,CS50H-20US)	Predicate Device,(CHF TYPE V)(K081456)	Comparison
of use		facility/hospital
Energysource	Electricity	Electricity	Same

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Note:

The indications for use statement for the subject Choledochoscope is very similar to that of the predicate device. A slightly different is wording description. The differences do not alter the intended use of the device nor do they raise different questions of safety and effectiveness of the device relative to the predicate.
The subject and predicate device have the same fundamental technology, type of scope, Working length, Direction of View, Inner diameter, contact duration and contact type, and environment of use.

The subject Choledochoscope differs from the predicate in Outer diameter, Type of Image Sensor, Light source, Deflection, Field of View, Depth of Field, Sterilization method, Number of uses and patient-contacting materials. These differences do not raise different questions of safety and effectiveness as compared to the predicate, and can be evaluated through performance testing and EO Sterilization validation.

Summary of Testing:

Summary of Non-Clinical Tests:

Electrical Safety and Electromagnetic Compatibility Summary

The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & . A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] ●
IEC 60601-2-18 Edition 3.0 2009-08
IEC/TR 60601-4-2 Edition 1.0 2016-05 .

Bench Testing Summary

Photobiological safety

The LEDs in submitted Choledochoscope were tested according to the following FDA recognized standards:

IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps . and lamp systems

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Image /page/9/Picture/0 description: The image shows the logo for Innovax Anqing Medical. The logo is purple and features a stylized wave-like design above the word "INNOVEX" with a registered trademark symbol. Below "INNOVEX" is the text "ANQING MEDICAL" in a larger, bolder font.

Mechanical and Optical Performance

The Flexible Choledochoscope was designed to comply with applicable parts of ISO Optical measurements were performed according to applicable part of ISO 8600. 8600 standard.

Mechanical characteristics were tested and include leakage tightness, bending, deflection endurance, withstand of channel.

In addition, comparative testing related to image quality parameters was performed for submitted Flexible Choledochoscope and the predicate device to support substantial equivalence.

Biocompatibility Summary

The biocompatibility evaluation for the patient contacting components of the Flexible Choledochoscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact category of "External communication medical device -Tissue" with a contact duration of "Limited (< 24 hours):

· Cytotoxicity: ISO 10993-5:2009
· Sensitization. Intracutaneous reactivity/irritation: ISO 10993-10:2010
· Material-mediated pyrogenicity: ISO 10993-11:2017
· Acute systemic toxicity: ISO 10993-11:2017

Sterilization and shelf life testing

The sterilization method has been validated to ISO 11135:2014, which has thereby determined the routine control and monitoring parameters.

EO/ECH residual test was performed according to ISO 10993-7:2008.

The shelf life of the Flexible Choledochoscope is determined based on stability study which includes ageing test according to ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier.

Package Validation

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F88/F88M-21, ASTM F1929-15. Transport and shipping testing as per ASTM D4169-22.

Summary of Clinical Tests:

The subject of this premarket submission, did not require clinical studies to support substantial equivalence.

Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible Choledochoscope is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.