(111 days)
AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.
The Flexible Cystoscope is intended for use in a hospital environment or medical office environment. The Flexible Cystoscope is designed for use in adults.
The Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) 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 of the lower urinary tract, including the bladder and urethra for the purpose of diagnosis and treatment.
The CY50H-20 and CY55H-24 difference is the size of Distal End Outer Diameter and Working Channel Inner Diameter. The US and EU model are identical except the deflection versions, which is opposite from each other (EU version or US version).
The Flexible Cystoscope 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, 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.
The provided document does not describe the acceptance criteria and study proving device meets acceptance criteria in the format requested. Specifically, it does not include a table of acceptance criteria vs. device performance, or details regarding sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document is a 510(k) premarket notification for a Flexible Cystoscope, primarily focusing on demonstrating substantial equivalence to a predicate device (Ambu aScope 4 Cysto) through non-clinical testing.
Here's a breakdown of the information that is available in relation to your request, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided in the requested format. Instead, the document provides a "Comparison with Predicate Device" table (pages 5-6) which compares various physical, optical, and technological characteristics of the subject device to the predicate device. However, this table lists characteristics and indicates "Same" or "Similar" for comparison, rather than specific acceptance criteria and quantitative performance results for each criterion.
- "Summary of Testing" (page 8-9) lists the types of non-clinical tests performed (Electrical Safety, EMC, Photobiological safety, Mechanical and Optical Performance, Biocompatibility, Sterilization, Shelf life, Package Validation) and the standards they comply with, but does not provide specific acceptance criteria or performance values for the subject device against these criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The document describes non-clinical bench testing, but does not specify sample sizes for these tests or the origin of any data (as it's physical device testing, not data collection from patients).
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/Not provided. This type of information is typically relevant for AI/ML-based devices where expert-labeled datasets are used to establish ground truth. The Flexible Cystoscope is a physical medical device, and its performance is evaluated against engineering specifications and standards, not against expert-established ground truth on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. As above, this is relevant for AI/ML evaluation, not for the direct performance 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
- No, not done. The document explicitly states under "Summary of Clinical Tests" (page 9): "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means no human-in-the-loop or MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not done. The device is a physical cystoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. The "ground truth" for this device's performance relies on established engineering standards (e.g., ISO 8600 for optical measurements, IEC 62471 for photobiological safety, ISO 10993 for biocompatibility) and direct physical measurements and tests of the device's characteristics (e.g., outer diameter, working length, deflection, depth of field).
8. The sample size for the training set
- Not applicable/Not provided. There is no AI/ML component, so no training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. There is no AI/ML component, so no training set or ground truth for it.
In summary, the provided document details the non-clinical testing and comparison of a flexible cystoscope to a predicate device to demonstrate substantial equivalence, rather than providing the specific AI/ML-related performance evaluation details requested.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
November 9, 2022
Shanghai AnQing Medical Instrument Co., Ltd Shuwen Fan RA Manager 3 & 4 Floor, No.2 Building, 366 Huiging Road, East Zhangjiang High-Tech Park Shanghai, 201201 China
Re: K222162
Trade/Device Name: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: October 11, 2022 Received: October 11, 2022
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device 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).
Sincerely.
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222162
Device Name
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
Indications for Use (Describe)
AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.
The Flexible Cystoscope is intended for use in a hospital environment or medical office environment. The Flexible Cystoscope is designed for use in adults.
| 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/3/Picture/1 description: The image contains the logo for Innovex Anqing Medical. The logo features a purple graphic on the left side, with the word "INNOVEX" in a sans-serif font to the right of the graphic. Below "INNOVEX" is the text "Anqing Medical" in a larger, bolder font. A curved line is above the word "INNOVEX".
Device Class:
Review Panel:
510(k) Premarket Notification Submission Flexible Cystoscope
| 510(k) Summary | |
|---|---|
| Date Prepared: | July 8, 2022 |
| Manufacturer: | Shanghai AnQing Medical Instrument Co., Ltd.3 & 4 Floor, No.2 Building, 366 Huiqing Rd, EastZhangjiang High-Tech Park, 201201Shanghai, China |
| Contact Person: | Shuwen FanRA ManagerShanghai AnQing Medical Instrument Co., Ltd.Tel: +86-21-61117375Fax: +86-21-61117374ra_dept@anqing-sh.com |
| Identification of the Device: | |
| Proprietary/Trade Name: | Flexible Cystoscope |
| Model: | CY50H-20EU, CY50H-20US, CY55H-24EU,CY55H-24US |
| Common name: | Flexible Cystoscope |
| Classification Name: | Endoscope and Accessories |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | FAJ |
rketed Predicate Devic
| Identification of the Legally Marketed Predicate Device: | ||||
|---|---|---|---|---|
| Trade Name: | Ambu aScope 4 Cysto | |||
| Common name | Flexible Cystoscope | |||
| Classification Name: | Cystoscope And Accessories, Flexible/Rigid | |||
| Regulatory Number: | 21 CFR Part 876.1500 | |||
| Product Code: | FAJ | |||
| Device Class: | Class II | |||
| Review Panel: | Gastroenterology/Urology | |||
| Submitter/510(k) Holder: | Ambu A/S. | |||
| Clearance: | K193095 (cleared April 2, 2020) | |||
| This predicate has not been subject to a design-related recall. |
Class II
Gastroenterology/Urology
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Image /page/4/Picture/1 description: The image contains a logo for Innovex Anqing Medical. The logo features the word "INNOVEX" in a bold, sans-serif font, with the registered trademark symbol to the right. Below that is the text "ANQING MEDICAL" in a slightly smaller, bold font. To the left of the text is a purple graphic with a white leaf design.
Device Description:
The Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, is a sterile single-use endoscope which is used with the video CY55H-24US) processor (Model: EOS-H-01, FDA cleared #K211169) produced by AnQing for providing endoscopic imaging of the lower urinary tract, including the bladder and urethra for the purpose of diagnosis and treatment.
The CY50H-20 and CY55H-24 difference is the size of Distal End Outer Diameter and Working Channel Inner Diameter. The US and EU model are identical except the deflection versions, which is opposite from each other (EU version or US version).
The Flexible Cystoscope 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, 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 Cystoscope 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 Cystoscope has the following physical and performance characteristics:
- O Maneuverable tip controlled by the user
- Flexible insertion cord
- Camera and LED light source at the distal tip
- O Sterilized by Ethylene Oxide
- For single use O
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Image /page/5/Picture/1 description: The image contains a logo for a company called "Innovex Anqing Medical". The logo features a stylized purple graphic on the left, with the text "Innovex" in a larger font size and "Anqing Medical" in a smaller font size below it. There is a curved line above the text "Innovex".
Indications for Use:
AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.
The Flexible Cystoscope is intended for use in a hospital environment or medical office environment.
The Flexible Cystoscope is designed for use in adults.
Comparison with Predicate Device:
The Flexible Cystoscope and its predicate device, the Ambu aScope 4 Cysto (K193095), have the same intended use, sterilization Methods and similar physical characteristics, optical characteristics.
Substantial Equivalence:
The Flexible Cystoscope employs the same fundamental scientific technology as its predicate device, as below table:
| Subject Device(CY50H-20EU,CY50H-20US,CY55H-24EU,CY55H-24US) | Predicate Device,Ambu aScope 4 Cysto(K193095) | Comparison | |
|---|---|---|---|
| Indications For Use | |||
| IndicationsFor Use: | AnQing Medical SingleUse Flexible Cystoscope isused to providevisualization and operativeaccess during diagnosticand therapeutic endoscopicprocedures of the lowerurinary tract, including thebladder and urethra.The Flexible Cystoscope isintended for use in ahospital environment ormedical officeenvironment. | Ambu® aScope™ 4Cysto is a sterile,single-use, flexiblecystoscope intended tobe used for endoscopicaccess to andexamination of thelower urinary tract.The Ambu® aScope™4 Cysto is intended toprovide visualizationvia Ambu®displaying unit andcan be used withendoscopic | EquivalentSee Note1. |
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Image /page/6/Picture/1 description: The image shows the logo for Innovex Anqing Medical. The logo consists of a purple square with a white leaf design on the left, and the word "INNOVEX" in purple on the right. Below the word "INNOVEX" is the phrase "Anqing Medical" also in purple. There is a registered trademark symbol next to the word Innovex.
| 510(k) Premarket Notification Submission |
|---|
| Flexible Cystoscope |
| Subject Device(CY50H-20EU,CY50H-20US,CY55H-24EU,CY55H-24US)The Flexible Cystoscope isdesigned for use in adults. | Predicate Device,Ambu aScope 4 Cysto(K193095)accessories.Ambu® aScope™ 4Cysto is intended foruse in a hospitalenvironment ormedical officeenvironment.Ambu® aScope™ 4Cysto is designed foruse in adults. | Comparison | |
|---|---|---|---|
| Physical Characteristics | |||
| Type ofScope | Flexible | Flexible | Same |
| Outerdiameter(mm) | Max. 5.0 mm(CY50H-20EU,CY50H-20US)Max. 5.5 mm(CY55H-24EU,CY55H-24US) | Max. 6.0 mm | SimilarSee Note2. |
| Innerdiameter(mm) | Min. 2.0 mm(CY50H-20EU,CY50H-20US)Min. 2.4 mm(CY55H-24EU,CY55H-24US) | Min. 2.2 mm | SimilarSee Note2. |
| Workinglength | 380 mm | 390 mm (15.4") | SimilarSee Note2. |
| Deflection | 210°up, 180°down | 210° up, 120° down | SimilarSee Note2. |
| Optical Characteristics | |||
| Type ofImager | CMOS | CMOS | Same |
| Field of View | 110° | 120° | SimilarSee Note2. |
| Direction of | 0° | 0° | Same |
| Subject Device(CY50H-20EU,CY50H-20US,CY55H-24EU,CY55H-24US) | Predicate Device,Ambu aScope 4 Cysto(K193095) | Comparison | |
| View | |||
| Depth of Field | 5mm~100mm | 3mm~100mm | SimilarSee Note2. |
| Light Source | Internal LED | Internal LED | Same |
| Patient Contacting Materials | |||
| General material type of main patient-contact part | Compliance withISO10993-1 | Compliance withISO10993-1 | SimilarSee Note2. |
| Duration and type of contact | "Surface –Mucosal Membrane" with a contact duration of “Limited (< 24 hours)” | "Surface -Mucosal Membrane" with a contact duration of “Limited (< 24 hours)” | Same |
| Sterilization Methods | |||
| Number of Users | Single-Use | Single-Use | Same |
| Sterilization | EO Sterilized,SAL 10-6 | EO Sterilized,SAL 10-6 | Same |
| Technological Characteristics | |||
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital | Same |
| Energy source | Electricity | Electricity | Same |
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Image /page/7/Picture/1 description: The image shows the logo for Innovex Anqing Medical. The logo is purple and white. The logo has a stylized image on the left and the words "INNOVEX" and "ANQING MEDICAL" on the right.
510(k) Premarket Notification Submission Flexible Cystoscope
Note:
-
The indications for use statement for the subject Cystoscope 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, type of imager, light source, Sterilization method, number of users and environment.
The subject Cystoscope differs from the predicate in Outer diameter, Inner diameter,
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Image /page/8/Picture/1 description: The image contains the logo for Anqing Medical. The logo features a purple square with a white leaf design inside. To the right of the square, the word "INNOVEX" is written in a sans-serif font, with a registered trademark symbol next to it. Below the logo, the words "Anqing Medical" are written in a larger, bolder font.
510(k) Premarket Notification Submission Flexible Cystoscope
| Subject Device | Predicate Device, | |
|---|---|---|
| (CY50H-20EU,CY50H-20US,CY55H-24EU,CY55H-24US) | Ambu aScope 4 Cysto(K193095) | Comparison |
Working length, Deflection, Field of View, Depth of Field, 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.
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 ES:60601-1:2005/A2:2010
- ·IEC 60601-2-18:2009: Part 2-18
- •IEC 60601-1-2:2014
Bench Testing Summary
Photobiological safety
The LEDs in submitted Cystoscope were tested according to the following FDA recognized standards:
· IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems
Mechanical and Optical Performance
The Flexible Cystoscope was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 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 Cystoscope and the predicate device to support substantial equivalence.
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Image /page/9/Picture/0 description: The image contains the logo for "Innovax Anqing Medical". The logo is purple and features a stylized leaf design on the left. The text "ANQING MEDICAL" is written in a larger, bolder font below the logo.
Biocompatibility Summary
The biocompatibility evaluation for the patient contacting components of the Flexible Cystoscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact category of "Surface -Mucosal Membrane" with a contact duration of "Limited (< 24 hours):
- · Cytotoxicity: ISO 10993-5:2009/(R) 2014
- · 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 Cystoscope is determined based on stability study which includes ageing test according to ASTM F1980-16, 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 F88/F88M-15, ASTM F 1929-15 Transport and shipping testing as per ASTM D4169-16.
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 Cystoscope is substantially equivalent to the predicate device.
§ 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.