The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.

Intended patient population: Adults

Device Description

The Disposable Cytology Brush is a sterile, single-use device as a kind of accessories for bronchial endoscopy. The Disposable Cytology Brush is intended to be used in conjunction with a bronchoscope to collect cells from the bronchi.

The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi.

The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/ pull rod.

The Disposable Cytology Brush has two different models depending on different design of the brush head. The WB series is a cytology brush with straight type of brush head and the XA series is a cytology brush with oval type of brush head. Each model has different specifications depending on different working length.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Disposable Cytology Brush) and primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic product. The document describes a traditional medical device (a cytology brush), not an AI/software device.

Therefore, many of the requested categories for AI/algorithm performance (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to non-clinical testing performed to demonstrate the device's performance and safety, which serves a similar purpose to meeting acceptance criteria for a physical device.

Here's the breakdown based on the provided text:

Device: Disposable Cytology Brush (AF series)

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

The document doesn't present a formal table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one would for an AI diagnostic. Instead, it lists performance tests conducted to verify the device meets design specifications and is substantially equivalent to a predicate. The "acceptance criteria" are implied to be "met all design specifications" and "demonstrated safety and essential performance" based on applicable standards. The "reported device performance" is summarized as the tests being successfully performed and demonstrating substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility in accordance with ISO 10993 standards	All specified biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity, Pyrogen) were performed and validated.
Sterilization validation (EO sterilization) per ISO 11135	EO sterilization validated according to ISO 11135, ISO 11737-2, ISO 10993-7, USP <85>.
Shelf Life and Sterile Barrier System validation	Validated per ASTM F1980, ISO11607-1, ISO11607-2, ASTM F 1929, ASTM D 3078, DIN 58593-6, ASTM F88/F88M-15, ASTM D4169-16.
Mechanical performance/design specifications	All specified performance tests (Appearance, Size and Dimension, Bronchoscope Compatibility, Brush Bond Strength, Tensile Strength, Push ability and Actuation, Tissue Sampling Performance) were performed on both subject and predicate devices, demonstrating substantial equivalence.
Safety and effectiveness (Substantial Equivalence to Predicate)	Non-clinical testing demonstrated that differences did not adversely affect performance and the device is substantially equivalent to the legally marketed predicate.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact number of devices/samples used for each non-clinical test (e.g., how many brushes were tested for tensile strength).
Data Provenance: The tests are described as "Non-clinical testing for Disposable Cytology Brush." The document's origin (Alton (Shanghai) Medical Instruments Co. Ltd in China) suggests the testing likely occurred there or was managed by them. The studies are bench (laboratory) tests and do not involve patient data in the typical sense of a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical medical device. Ground truth, in the AI/diagnostic sense, is not established by human experts for these mechanical/biocompatibility tests. The "ground truth" here is compliance with engineering specifications and recognized international standards.

4. Adjudication method for the test set:

Not Applicable. See point 3.

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 is not an AI/imaging device that would involve human readers.

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

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

For biocompatibility: Adherence to ISO 10993 standards (e.g., no cytotoxicity, no irritation).
For sterilization: Adherence to ISO 11135 standards (e.g., Sterility Assurance Level of 10-6).
For shelf life/sterile barrier: Adherence to ASTM and ISO 11607 standards (e.g., package integrity, product performance after aging).
For mechanical performance: Meeting internal design specifications and demonstrating performance comparable to the predicate device through side-by-side bench testing.

8. The sample size for the training set:

Not Applicable. This is not an AI device that requires a training set.

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

Not Applicable. See point 8.

In summary, this 510(k) pertains to a traditional medical device (a cytology brush) and not an AI or software-driven diagnostic tool. Therefore, the information provided in the document focuses on demonstrating substantial equivalence through non-clinical bench testing, biocompatibility, and sterilization validation, rather than the types of studies typically conducted for AI-powered diagnostic devices.

Summary

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March 4, 2025

Image /page/0/Picture/1 description: The image shows 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.

Alton (Shanghai) Medical Instruments Co. Ltd Wei Song Project Engineer No.24 Building Jinshao Rd.1688.Baoshan District Shanghai, Shanghai 200949 China

Re: K241679

Trade/Device Name: Disposable Cytology Brush (AF series) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: BTG Dated: January 27, 2025 Received: January 27, 2025

Dear Wei Song:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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).

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Sincerely,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241679

Device Name

Disposable Cytology Brush (AF series)

Indications for Use (Describe)

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.

Intended patient population: 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

I. SUBMITTER

Name: Alton (Shanghai) Medical Instruments Co. Ltd.

Address: No.24 Building, JinShao Rd. 1688, Baoshan District, 200949 Shanghai, P. R.

China

Name of contact person: Vivian Li

Position: Director of Quality Department

Tel: +86 21 56771811

Fax: +86 21 66307823

Mail: vivian@alton.com.cn

Date prepared: 2025-02-28

II. Identification of Subjective Device

Device trade name: Disposable Cytology Brush Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulation number: 21 CFR 874.4680 Regulation class: 2 Product Code Description: brush, biopsy, bronchoscope (non-rigid) Product code: BTG

III. Identification of Predicate device Primary predicate device

Predicate Submission Number: K190293 Trade/Device Name: Single Use Cytology Brush BC-205D Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulation Number: 21 CFR 874.4680 Regulatory Class: 2 Product Code Description: brush, biopsy, bronchoscope (non-rigid) Product Code: BTG

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Reference Device

Predicate Submission Number: K780872 Trade/Device Name: Cytology Brush Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulation Number: 21 CFR 874.4680 Regulatory Class: 2 Product Code Description: brush, biopsy, bronchoscope (non-rigid) Product Code: BTG

IV. Device description

The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi.

V. Indication for use

The disposable cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.

Intended patient population: Adults

VI. Comparison of technological characteristics with the predicate/reference device

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Attribute	Subject device	Predicative device (K190293)	Reference device (K780872)	Discussion/Conclusion
Manufacturer	Alton (Shanghai) Medical Instruments Co. Ltd	Olympus Medical Systems Corp.	COOPERVISION, INC.	/
Trade name	Disposable Cytology Brush	Single Use Cytology Brush BC-205D	CYTOLOGY BRUSH	/
Regulation name	Bronchoscope (Flexible Or Rigid) And Accessories	Bronchoscope (Flexible Or Rigid) And Accessories	Bronchoscope (Flexible Or Rigid) And Accessories	Same
Regulatory Class	II	II	II	Same
Product code	BTG	BTG	BTG	Same
Clinical characteristics
Indications for use	The disposable cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.	The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ 1.7mm or larger .	The device is intended to be used through endoscopes for the purpose of collecting sterile, non-contaminated specimens for microbiological analysis.	Same
General technological characteristics
Device composition	The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is	The main component of the proposed device is Brush Head, Outer Sheath and Handle.	Not publicly available	Same
Attribute	Subject device	Predicative device (K190293)	Reference device (K780872)	Discussion/Conclusion
	composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/pull rod.	The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/pull rod.
Principle of Operation	the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination.	the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination.	Same as predicate device	Same
Mechanics of action	Manual operated	Manual operated	Same as predicate device	Same
Mode of action	brush rotation	brush rotation	Same as predicate device	Same
Maximum insertion portion diameter	$φ$ 1.8 mm	$φ$ 1.4 mm	$φ$ 1.8 mm	Different, see discussion 1
Working length	1000 mm, 1200 mm	1150 mm	900 mm	Different, see discussion 2
Brush diameter	AF-D1810WB/AF-D1812WB	$φ$ 2 mm	$φ$ 1.0 mm	AF-D1810WB/AF-D18
Attribute	Subject device	Predicative device (K190293)	Reference device (K780872)	Discussion/Conclusion
	: φ 2 mmAF-D1810XA/AF-D1812XA:φ 4 mm			12WB: sameAF-D1810XA/AF-D1812XA: Different, seediscussion 3
Brush length	10 mm	10mm	Not publicly disclosed	Same
Componentsmaterial	Brush core: SUS304Bristles on brush head: NylonSheath (tube): PTFE (Teflon)Handle: ABS	Tube: single-layer high densitypolymerDistal tip/Wire: stainless steelBrush: nylonHandle: not identified	Tube: two-layer TefloncatheterPlug: non-toxic watersoluble waxDistal tip/Wire: notidentifiedBrush: not identified	Different, seediscussion 4
Sterilization	Method: Ethylene OxidesterilizationSAL: 10-6	Method: Ethylene OxidesterilizationSAL: 10-6	Same as predicate device	Same
Single use/reuse	For single use	For single use	For single use	Same
Shelf life	3 years	Not publicly disclosed	Not publicly disclosed	Different, seediscussion 5

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Attribute	Subject device	Predicative device (K190293)	Reference device(K780872)	Discussion/Conclusion
Mechanicalperformance	1) Dimension2) Brush Bond Strength3) Tensile Strength4) BronchoscopeCompatibility5) Push ability and Actuation6) Tissue SamplingPerformance	1) Brush operation with thecompatible endoscope2) Dimension of each part ofthe brush3) General durability4) Joint/tensile strength	Not publicly disclosed	Same
	Biocompatibility	CytotoxicitySkin SensitizationSkin Irritation TestAcute Systemic Toxicity TestPyrogen TestComply with ISO 10993standards	CytotoxicitySkin SensitizationSkin Irritation TestAcute Systemic Toxicity TestPyrogen TestComply with ISO 10993standards	Not publicly disclosed	Same

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Discussion on differences between the subject device and the predicate device

Discussion 1: there are difference on specification of maximum insertion portion diameter between both models, while considering specification of φ 1.8 mm on the subject device is same as the reference device cleared on K780872 manufactured by CooperVision, such differences will not affect clinical performance and safety of the subject device.

Discussion 2: there are two working length specification (1000 mm, 1200 mm) for the subject device, different from specification (1150 mm)for the predicate device, while considering specification of 900 mm is available on the reference device cleared on K780872 manufactured by CooperVision, specification of 1000 mm on the subject device is between the range of 1150 mm on the predicate device and 900 mm on the reference device, 1200 mm on the subject device is quite closer to 1150 mm on the predicate device. In addition, performance test comparison between the subject device and the predicate device is carried out according to specific product technical specification and the test results demonstrate substantial equivalence between subject device and predicate device. Therefore, such differences will not affect clinical performance and safety of the subject device.

Discussion 3: There are two specifications (φ2 mm and φ4 mm) related to brush for diameter AF-D1810WB/AF-D1812WB is φ 2 mm, same as specifications (φ2 mm) for the predicate device. while specification for models AF-D1810XA/AF-D1812XA φ 4 mm. while considering the mechanical performance tests were carried out on both the subject device and the predicate device according to specific product technical specification and the test results demonstrate substantial equivalence between subject device and predicate device. Therefore, such differences will not affect clinical performance and safety of the subject device.

Discussion 4: the tube material used in the subject device is Teflon, different from the tube material used in the predicate device (high density polymer). While considering the tube material used in the subject device is same as reference device cleared on K780872 manufactured by CooperVision, such differences will not affect clinical page 8 of 11

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performance and safety of the subject device.

Discussion 5: Although shelf life between the subject device and the predicate device is different, sterile process validation and shelf-life validation including performance test are performed on the subject device according to relevant standards, such differences will not affect the safety and effectiveness of the subject device.

VII. Summary of substantial equivalence discussion

Based on the above comparison table as well as discussion on differences, the subject device and the predicate device have similar design features and performance specifications. Although there are some differences on size specification parameters (e.g. maximum insertion portion diameter, brush diameter, working length and tube material) on the subject device and predicate device, such differences will not affect the effectiveness and safety of the subject device. In addition, a performance comparison testing between the subject device and the predicate device is implemented and all mechanical performances are verified to confirm the performance of the subject device is substantially equivalent to the predicate device. These technological differences between the subject device and the predicate device do not affect the safety and effectiveness of the subject device when used as labeled.

VIII. Summary of Non-clinical Data

Non-clinical testing for Disposable Cytology Brush was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed.

A Biocompatibility

The biocompatibility evaluation for the Disposable Cytology Brush was conducted 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" September 4, 2020, 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.

. MTT Cytotoxicity Test: ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity

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Skin Sensitization Test: ISO 10993-10:2021, Biological evaluation of ● medical devices - Part 10: Tests for irritation and sensitization
Skin Irritation Test: ISO 10993-23:2021. Biological evaluation of medical . devices - Part 23: Tests for irritation
Acute Systemic Toxicity Test and Pyrogen Test: ISO 10993-11:2017 . Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Sterilization Validation

The EO sterilization of the Disposable Cytology Brush has been validated according to the following applicable standards:

ISO11135:2014+A1:2018 Sterilization of medical device- validation and . routine control of ethylene oxide sterilization
. ISO 11737-2:2019 Sterilization of Medical Device-Microbiological methods-part 2: Tests of sterility performed in the validation of a sterilization process
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: . Ethylene oxide sterilization residuals
. USP <85> Bacterial endotoxins test
A Shelf Life and Sterile Barrier System

Shelf Life and Sterile Barrier System of the Disposable Cytology Brush has been validated according to the following applicable standards:

. ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
. ISO11607-1:2019 Packaging for terminally sterilized Medical Device Part 1: Requirement for materials, sterile barrier systems and packaging systems
. ISO11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process
ASTM F 1929-15: Standard Test Method for Detecting Seal Leaks in Porous ● Medical Packaging by Dye Penetration
ASTM D 3078-02(2013): Standard Test Method for Determination of Leaks . in Flexible Packaging by Bubble Emission page 10 of 11

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DIN 58593-6: 2016 Sterilization Sterile Supply Part 6: Microbial Barrier ● Testing of Packaging Materials for Medical Devices Which Are to Be Sterilized
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible . Barrier Materials
ASTM D4169-16 Standard practice for performance testing of shipping . containers and systems (DC-13, Level II)
A Performance Data – Bench

The performance tests were implemented on both the subject device (Alton Disposable Cytology Brush) and the predicate device (Olympus Single Use Cytology Brush BC-205D) to demonstrate substantial equivalence according to the specific product specification with the following test items:

Appearance
Size and Dimension
. Bronchoscope Compatibility
. Brush Bond Strength
. Tensile Strength
. Push ability and Actuation
. Tissue Sampling Performance
Performance Data – Animal

N/A, no animal studies are available for the subject device.

IX. Summary of Clinical Data

N/A, no clinical studies are available for the subject device.

X. Conclusions

In conclusion, intended use of the subject device substantially equivalent to the predicate device quoted above. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 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.