(302 days)
The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment.
The Single-use Bronchoscope is a disposable device designed for use in adults.
The Bronchoscope System consists of Single-use Bronchoscope (Model: BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3) to be introduced within the airways or tracheobronchial tree and Monitor for Single-Use Endoscopy (Model: P1-A, P1-C, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E) for clinical image processing. The Single-use Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Monitor provides power and processes the images for medical electronic endoscope.
The Single-use Bronchoscope is a sterile single use flexible bronchoscope. The Monitor for Single-Use Endoscopy is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the disposable video Bronchoscope 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 Monitor for Single-Use Endoscopy via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals and outputs the processed video signal. The Monitor also controls the brightness of the LEDs on the endoscope.
The provided document is a 510(k) Premarket Notification and primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for a novel AI/ML-driven medical device. Therefore, it does not contain the specific information required to answer many of the questions about acceptance criteria, detailed study design, ground truth establishment, or human-in-the-loop performance.
This document describes a "Bronchoscope System," which includes a "Single-use Bronchoscope" and a "Monitor for Single-Use Endoscopy." The core technology described involves an optical system with a CMOS sensor to capture images for display, which is a common technology for endoscopes, not necessarily an AI/ML device in the sense of image analysis/decision support.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with reported quantitative performance metrics in the format usually seen for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating equivalence through various non-clinical tests compared to a predicate device.
The "Summary of Testing" section lists the types of tests performed. The acceptance criteria are implicitly that the device performs "as well as" the predicate or meets established ISO standards.
| Test Category | Acceptance Criteria (Implicit/Standard) | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-2-18 (safety), IEC 60601-1-2 (EMC) | "The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC." |
| Optical Performance | Compliance with ISO 8600 series standards. Performance comparable to predicate device. | "Optical performance testing according to ISO 8600 series." "The optical performance of the subject device was tested and the results met the ISO 8600 series..." |
| Mechanical Characteristics | Comparable to predicate device. | "Mechanical characteristics were performed compared with the predicate device." "All the performance was tested and the results met the standard requirements..." |
| Color/Photobiological Safety | Standard requirements met. | "Color feature separation and photobiological safety test." |
| Image Quality (Color, Res, DoF, SNR, Dynamic) | Comparable to predicate device. | "Color performance (color reproduction), optical performance (resolution, depth of view and image intensity uniformity), SNR and dynamic test compared with the predicate device." |
| Biocompatibility | Compliance with FDA guidance "Use of International Standard ISO 10993-1." No cytotoxicity, irritation, sensitization, pyrogen. | "Biocompatibility... was evaluated in accordance with the FDA guidance...", "No Cytotoxicity", "No Irritation to Skin", "No significant evidence of sensitization", "No pyrogen." |
| Sterilization & Shelf Life | Validated per ISO11135. Shelf life validated. | "Sterilization method has been validated according to ISO11135...", "The shelf life... is validated." |
| Software V&V | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software deemed "moderate" level of concern. | "Software verification and validation testing were conducted, and documentation was provided as recommended..." |
| Cybersecurity | Compliance with FDA's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." | "Cybersecurity was conducted according to FDA's Guidance..." |
| Package Validation | Compliance with ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-15, ASTM F 1929-15, ASTM D4169-16. | "Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F88/F88M-15, ASTM F 1929-15. Transport and shipping testing as per ASTM D4169-16." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Based on the similarities of the device specifications, intended use, indications for use between the Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification."
This means there was no clinical test set in the traditional sense for evaluating something like diagnostic accuracy of an AI/ML model. The evaluation was done through non-clinical bench testing, electrical safety, biocompatibility, and software V&V. Therefore, information on sample size, data provenance (country, retrospective/prospective) for a clinical test set is not applicable to this submission.
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)
Since no clinical studies were performed, no expert ground truth establishment for a clinical test set was required or conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical test set using expert adjudication was conducted.
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, as this is not an AI-assisted diagnostic device submission requiring MRMC studies. The device is a bronchoscope system for visualization.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an AI algorithm's performance. The Bronchoscope System is a hardware device for direct visualization, not an AI algorithm. Therefore, "standalone performance" in the AI sense is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods (e.g., ISO standards), and comparisons against the predicate device's established performance parameters. For example:
- Electrical Safety/EMC: Compliance to IEC standards.
- Optical Performance: Measurement against ISO 8600 series specifications.
- Biocompatibility: Results of standard biological tests (e.g., cytotoxicity, sensitization) against established safe thresholds.
8. The sample size for the training set
The document does not mention a "training set" because it is not an AI/ML device that requires machine learning training.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML model was used.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2024
Hunan Endoso Life Technology Co., Ltd. % Kyra Kang Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza 555 West Guangzhong Road Shanghai, 200072 China
Re: K231107
Trade/Device Name: Bronchoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: January 16, 2024 Received: January 17, 2024
Dear Kyra Kang:
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).
Sincerely.
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231107
Device Name Bronchoscope System
Indications for Use (Describe)
The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, endotherapy accessories and other ancillary equipment for endoscopy within the arways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment.
The Single-use Bronchoscope is a disposable device 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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510(k) Summary
| Date Prepared: | February 13, 2024 |
|---|---|
| Manufacturer: | Hunan Endoso Life Technology Co., Ltd.The 4th floor, Building 10, Innovation andEntrepreneurship Center, No. 31, Dongfeng Road,Economic and Technological Development Zone,Xiangtan, Hunan Province 411200, P. R. China |
| Contact Person: | Wang FuRA ManagerHunan Endoso Life Technology Co., Ltd.Tel: (86) 0731-52331999Email: services@endoso.com.cnOr wangfu@endoso.com.cn |
| Submission Correspondent: | Ms.Kyra KangLandlink Healthcare Technology (Shanghai) Co.,Ltd.Email: kyra.kang@landlink-health.com |
| Identification of the Device: | |
| Proprietary/Trade Name: | Single-use Bronchoscope, Monitor for Single-UseEndoscopy, Bronchoscope System |
| Model: | Single-use bronchoscope: BC12-1, BC12-2,BC20-1, BC20-2, BC22-1, BC22-2, BC22-3,BC28-1, BC28-2, BC28-3Monitor for Single-Use Endoscopy:P1-A, P1-B, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C,P2-D, P2-E |
| Common or Usual Name: | Bronchoscope (flexible or rigid) and accessories |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories(21 CFR 874.4680) |
| Product Code: | EOQ |
| Device Class: | Class II |
Identification of the Legally Marketed Predicate Device:
| Trade Name: | Vathin® Video Bronchoscope System |
|---|---|
| Classification Name: | Bronchoscope (flexible or rigid) and accessories(21 CFR 874.4680) |
| Product Code: | EOQ |
| Device Class: | Class II |
| Submitter/510(k) Holder: | Hunan Vathin Medical Instrument Co., Ltd. |
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Clearance:
K191828
This predicate has not been subject to a design-related recall.
Device Description:
The Bronchoscope System consists of Single-use Bronchoscope (Model: BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3) to be introduced within the airways or tracheobronchial tree and Monitor for Single-Use Endoscopy (Model: P1-A, P1-C, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E) for clinical image processing. The Single-use Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Monitor provides power and processes the images for medical electronic endoscope.
The Single-use Bronchoscope is a sterile single use flexible bronchoscope. The Monitor for Single-Use Endoscopy is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the disposable video Bronchoscope 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 Monitor for Single-Use Endoscopy via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals and outputs the processed video signal. The Monitor also controls the brightness of the LEDs on the endoscope.
Indications for Use:
The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment.
The Single-use Bronchoscope is a disposable device designed for use in adults.
Substantial Equivalence:
The Bronchoscope System employs the same fundamental scientific technology as its predicate device, as below table:
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| K Number | K231107 | K191828 | |
| Single-use Bronchoscope: | Vathin®H-SteriScope™ ISingle-use flexible VideoBronchoscope: | ||
| Model | BC12-1, BC12-2, BC20-1,BC20-2, BC22-1, BC22-2,BC22-3, BC28-1, BC28-2, | BCV1-01 BCV1-02BCV1-C1 BCV1-C2 | / |
| Subject Device | Predicate Device | Comparison | |
| K Number | K231107 | K191828 | |
| BC28-3 | BCV1-H1 BCV1-H2 | ||
| Monitor for Single-UseEndoscopy :P1-A, P1-B, P1-C, P1-D,P1-E, P2-A, P2-B, P2-C,P2-D, P2-E | BCV1-K1 BCV1-K2BCV1-M1 BCV1-M2BCV1-O1 BCV1-O2BCV1-S1 BCV1-S2BCV1-U1 BCV1-U2BCV1-W1 BCV1-W2Vathin®VisionCenter™ IDigital Video Processor:DVP-A1 | ||
| Manufacturer | Hunan Endoso LifeTechnology Co., Ltd. | Hunan Vathin MedicalInstrument Co., Ltd. | / |
| ClassificationName | Bronchoscope (flexible orrigid) and accessories | Bronchoscope (flexible orrigid) and accessories | / |
| Product Code | EOQ | EOQ | / |
| IndicationsFor Use: | The Single-useBronchoscope have beendesigned to be used with theMonitor for Single-UseEndoscopy, endotherapyaccessories and otherancillary equipment forendoscopy within theairways andtracheobronchial tree. TheBronchoscope System is foruse in a hospitalenvironment.The Single-useBronchoscope is adisposable device designedfor use in adults. | The Vathin®H-SteriScopeᵀM I Single-use flexibleVideo Bronchoscope havebeen designed to be usedwith the Vathin® VisionCenter™ I Digital VideoProcessor,endotherapy accessoriesand other ancillaryequipment for endoscopywithin the airways andtracheobronchial tree.The Vathin® VideoBronchoscope System isfor use in a hospitalenvironment. | Similar¹ |
| Workingplace/User | Use in a hospitalenvironment by trainedsurgical physicians who arefamiliar with endoscopicprocedures. | Use in a hospitalenvironment by trainedsurgical physicians whoare familiar withendoscopic procedures. | Same |
| Population | Adults | Adults | Same |
| Technology | The Single-use | The Flexible bronchoscope | Same |
| Subject Device | Predicate Device | Comparison | |
| K Number | K231107 | K191828 | |
| bronchoscope is insertedthrough the airways andtracheobronchial tree duringBronchoscopy. Anatomicalimages are transmitted to theuser by the Monitor forSingle-Use Endoscopy witha CMOS chip at the distalend of the endoscope andthe images showing on themonitor. | is inserted through theairways andtracheobronchial treeduring Bronchoscopy.Anatomical images aretransmitted to the user bythe video processor with aCMOS chip at the distalend of the endoscope andthe images showing on amonitor. | ||
| Physical Characteristics | |||
| Type of Scope | Flexible | Flexible | Same |
| Distal endouter diameter | ≤2.9mm (8.7 Fr) | ≤3.1mm (9.3 Fr) | Similar2 |
| InsertionSection length | 600mm | 600/700mm | Similar3 |
| Optical Characteristics | |||
| Type ofImager | CMOS | CMOS | Same |
| Direction ofView | forward | forward | Same |
| Depth of Field | 3mm~50mm | 3mm~30mm | Similar4 |
| Light Source | Internal LED | Internal LED | Same |
| Patient Contacting Materials | |||
| Generalmaterial typeof mainpatient-contactpart | Pebax, polyamide, StainlessSteel, Epoxy glue, glass,Polycarbonate, PTFE, PET | Pebax, PTFE, LCP, TPU,Fluoro elastomers,Epoxy glue, glass | Different5 |
| Duration andtype of contact | "Surface -MucosalMembrane" with a contactduration of "Limited (< 24hours)" | "Surface -MucosalMembrane" with a contactduration of "Limited (< 24hours)" | Same |
| Other information | |||
| Number ofUses | Single-Use | Single-Use | Same |
| Sterilization | EO Sterilized,SAL 10 | EO Sterilized,SAL 10-6 | Same |
| Subject Device | Predicate Device | Comparison | |
| K Number | K231107 | K191828 | |
| Video format inputs (Camera) | MIPI | DVI/USB | Different6 |
| Storage | Yes SD Card | Yes SD Card | Same |
| Image/Video Capture | Yes | Yes | Same |
| Single use/reusable | Single-use for bronchoscope/ reusable for Monitor for Single-Use Endoscopy | Single-use for bronchoscope/ reusable for Video Processor | Same |
| Biocompatibility | No Cytotoxicity | No Cytotoxicity | Same |
| No Irritation to Skin | No Irritation to Skin | Same | |
| No significant evidence of sensitization | No significant evidence of sensitization | Same | |
| No pyrogen | No pyrogen | Same |
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Analysis 1:
Only different expressions.
Analysis 2:
The thinner the outer diameter, the less damage it will cause to the patient after being inserted into the trachea; The thinner the outer diameter, the stronger the patient's comfort; The thinner the outer diameter, the easier it is for doctors to insert into the affected area of the trachea. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.
Analysis 3:
The insertion section length of subject device is covered by the predicate device.
Analysis 4:
The optical performance of the subject device was tested and the results met the ISO 8600 series, this difference will not raise any issues in safety and effectiveness.
Analysis 5:
Biocompatibility of the Single-use Bronchoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, this difference will not raise any issues in safety and effectiveness.
Analysis 6:
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MIPI, DVI, and USB are all intermediate formats for data transmission, which ultimately display images on the display screen. What users see is an image, so this difference is only a difference in data transmission format, not functional performance, and does not affect safety and effectiveness.
Summary of Testing:
Summary of Non-Clinical Tests:
Electrical Safety and Electromagnetic Compatibility Summary
Electrical safety and EMC testing were conducted on the Bronchoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.
Bench Testing Summary
The following bench tests were performed:
- Optical performance testing according to ISO 8600 series. 1.
- Mechanical characteristics were performed compared with the predicate device. 2.
- Color feature separation and photobiological safety test. 3.
- Color performance (color reproduction), optical performance (resolution, depth of 4. view and image intensity uniformity), SNR and dynamic test compared with the predicate device.
Biocompatibility Summary
Biocompatibility of the Single-use Bronchoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were performed, as recommended:
- · Cytotoxicity
- · Sensitization
- Intracutaneous reactivity/irritation
- Pyrogen
- · Acute systemic toxicity
The Single-use Bronchoscope is considered surface - mucosal membrane contacting for duration of less than 24 hours.
Sterilization and shelf life testing
The sterilization method has been validated according to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Single-use Bronchoscope is validated.
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Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Cybersecurity
Cybersecurity was conducted according to FDA's Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
Clinical Testing
Based on the similarities of the device specifications, intended use, indications for use between the Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.
Package Validation
Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F88/F88M-15, ASTM F 1929-15. Transport and shipping testing as per ASTM D4169-16.
Conclusion:
The non-clinical testing demonstrates that the subject device is as safe, as effective and performs as well as the predicate device. The Bronchoscope System is substantially equivalent to the predicate device.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.