(59 days)
UE BRONCHO Single-Use Bronchoscope: The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment. The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.
UE Display: The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices.
The bronchoscope system consists of UE BRONCHO Single-Use Bronchoscopes and UE Display. The UE BRONCHO Single-Use Bronchoscopes (the bronchoscopes) are sterile, single-use flexible video bronchoscopes available in three sizes (Slim, Regular, Large). The bronchoscopes have been designed to be used with the UE Display (reusable, non-sterile), endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The bronchoscope system is designed for use by adults in a hospital environment.
The provided FDA 510(k) clearance letter details the clearance of the UE BRONCHO Single-Use Bronchoscopes and UE Display. However, it does not contain specific acceptance criteria or details of a clinical study that demonstrates the device's performance against such criteria. The document explicitly states "Clinical study: Not applicable."
The clearance is based on non-clinical data, specifically performance testing and compliance with voluntary standards, which demonstrates substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho, Ambu® aView™ Monitor - K173727).
Therefore, I cannot populate the requested table and answer questions 2-9 with the provided text. The document refers to "bench performance testing" which includes optical performance, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range, and frame rate, comparing these aspects with the predicate device. However, it does not specify quantitative acceptance criteria for these tests nor provide the reported device performance against such criteria in the detail requested.
Here's an attempt to populate the table and address the questions based only on the information available in the provided text. Where information is missing, it will be stated as "Not provided in the text."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected Value/Range) | Reported Device Performance | Comments from Text |
|---|---|---|---|
| Optical Performance | Not provided in the text (but implies compliance with ISO 8600 series) | Complies with ISO 8600 series | Bench testing performed according to ISO 8600. |
| Color Performance | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Color reproduction: compared with the predicate device. |
| Geometric Distortion | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Geometric distortion: compared with the predicate device. |
| Resolution | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Resolution: compared with the predicate device. |
| Depth of Field | 6-50 mm (same as predicate device) | 6-50 mm (same as predicate device) | Depth of view is 6-50 mm. |
| Image Intensity Uniformity | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Image intensity uniformity: compared with the predicate device. |
| Noise | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Noise: compared with the predicate device. |
| Dynamic Range | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Dynamic range: compared with the predicate device. |
| Frame Rate | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Frame rate: compared with the predicate device. |
| Field of View | Not provided in the text (Predicate: 85°) | 90° | Field of view (degree): 90° (subject device) vs 85° (predicate). Deemed "Similar". |
| Deflection Angle | Up: 180°, Down: 180° (for Slim/Regular sizes) | 180° up, 180° down | "Same" as predicate for Slim/Regular, "Similar" for Large (predicate Large is 160° down). |
| Insertion Tube Outer Diameter | Matches predicate (Slim: 3.8mm, Regular: 5.0mm, Large: 5.8mm) | EBS-380C: 3.8 mm, EBS-500C: 5.0 mm, EBS-600C: 5.8 mm | "Same". |
| Insertion Portion Maximum Diameter | Equivalent to predicate (Slim: 4.3mm, Regular: 5.5mm, Large: 6.3mm) | EBS-380C: 4.4 mm, EBS-500C: 5.5 mm, EBS-600C: 6.5 mm | "Equivalent". |
| Minimum Working Channel Diameter | Equivalent to predicate (Slim: 1.2mm, Regular: 2.0mm, Large: 2.6mm) | EBS-380C: 1.15 mm, EBS-500C: 2.15 mm, EBS-600C: 2.75 mm | "Equivalent". |
| Average Working Channel Diameter | Matches predicate (Slim: 1.2mm, Regular: 2.2mm, Large: 2.8mm) | EBS-380C: 1.2 mm, EBS-500C: 2.2 mm, EBS-600C: 2.8 mm | "Same". |
| Minimum ETT Inner Diameter Size | Matches predicate (Slim: 5.0mm, Regular: 6.0mm, Large: 7.0mm) | EBS-380C: 5.0 mm, EBS-500C: 6.0 mm, EBS-600C: 7.0 mm | "Same". |
| Minimum DLT Inner Diameter Size | Similar to predicate (Slim: 35 Fr, Regular: 41 Fr, Large: N/A) | EBS-380C: 35 Fr, EBS-500C: N/A, EBS-600C: N/A | "Similar". |
| Biocompatibility | Compliance with ISO 10993-1 | Evaluated and in accordance with ISO 10993-1 and FDA guidance. | Biocompatibility testing performed. |
| Sterilization Process | Compliance with ISO 11135:2014 | Validated in accordance with ISO 11135:2014. | Sterilization and shelf life testing performed. |
| EO/ECH Residual | Compliance with ISO 10993-7 | Test performed according to ISO 10993-7. | Sterilization and shelf life testing performed. |
| Shelf Life | 3 years (based on accelerated aging) | 3 years | Shelf life determined by accelerated aging (ASTM F1980). |
| Package Validation | Compliance with ISO 11607-1 and ISO 11607-2 | Conducted according to ISO 11607-1 and ISO 11607-2. | Package validation performed. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-18 | System complies with IEC 60601-1 and IEC 60601-2-18. | Electrical safety and EMC testing performed. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | System complies with IEC 60601-1-2. | Electrical safety and EMC testing performed. |
| Software Verification and Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" | Conducted and documentation provided as recommended by FDA guidance. | Software V&V testing performed. |
2. Sample size used for the test set and the data provenance
Not provided in the text. The document refers to "bench performance testing" which typically uses a limited number of physical units or simulated conditions, rather than a "test set" of patient data as might be relevant for AI/ML devices. No human patient data was used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or expert-based ground truth establishment for a test set is mentioned. The testing was non-clinical bench testing.
4. Adjudication method for the test set
Not applicable, as no clinical study involving expert interpretation or adjudication is mentioned.
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. The document explicitly states "Clinical study: Not applicable." Therefore, an MRMC study was not performed. This device is a bronchoscope system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bronchoscope system. While it has software and display capabilities, it is not an algorithm that performs a diagnostic or analytical function independently of a human operator, and no standalone performance study in this context was mentioned.
7. The type of ground truth used
For the non-clinical bench tests (e.g., optical performance, physical dimensions, electrical safety), the "ground truth" would be established by direct physical measurements, adherence to engineering specifications, and compliance with recognized international standards (e.g., ISO 8600, IEC 60601 series, ISO 10993 series). There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data, expert consensus) as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This device is a bronchoscope system and not an AI/ML device that requires a training set of data for model development.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
FDA 510(k) Clearance Letter - UE BRONCHO Single-Use Bronchoscopes
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 11, 2025
Zhejiang UE Medical Corp.
℅ Jie Yang
Consultant
Chonconn Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District
Shenzhen, Guangdong
China
Re: K251823
Trade/Device Name: UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)
Regulation Number: 21 CFR 874.4680
Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories
Regulatory Class: Class II
Product Code: EOQ
Dated: June 13, 2025
Received: June 13, 2025
Dear Jie Yang:
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.
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K251823 - Jie Yang
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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" (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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K251823 - Jie Yang
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assistance/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,
Joyce C. Lin -S
for 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
Enclosure
Page 4
Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251823 |
|---|---|
| Please provide the device trade name(s). |
UE BRONCHO Single-Use Bronchoscopes (EBS-380C);
UE BRONCHO Single-Use Bronchoscopes (EBS-500C);
UE BRONCHO Single-Use Bronchoscopes (EBS-600C);
UE Display (UE-M10S)
| Please provide your Indications for Use below. |
|---|
UE BRONCHO Single-Use Bronchoscope:
The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment.
The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.
UE Display:
The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices.
| Please select the types of uses (select one or both, as applicable). | ☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
UE BRONCHO Single-Use Bronchoscopes
Page 11 of 50
Page 5
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2025/6/13
1. Submission sponsor
Name: Zhejiang UE Medical Corp.
Address: No.8, Youyi Road, Baita Economic Development Zone, Xianju, Zhejiang 317300, China
Contact person: Carol He
Title: Regulatory Affairs Supervisor
E-mail: hejy@ueworld.com
Tel: +86 755 8977-4077
2. Submission correspondent
Name: Chonconn Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China
Contact person: Yang Jie
E-mail: yangjie@chonconn.com
Tel: +86-755 33941160
3. Subject Device Information
| Trade/Device Name | UE BRONCHO Single-Use Bronchoscopes, UE Display |
|---|---|
| Model | UE BRONCHO Single-Use Bronchoscopes (EBS-380C);UE BRONCHO Single-Use Bronchoscopes (EBS-500C);UE BRONCHO Single-Use Bronchoscopes (EBS-600C);UE Display (UE-M10S) |
| Common Name | Endoscope and accessories |
| Regulatory Class | Class II |
| Classification | 21CFR 874.4680 / Bronchoscope (Flexible Or Rigid) / EOQ |
| Submission type | Traditional 510(K) |
4. Predicate Device
510(k) number: K173727
Product name: Ambu® aScope™ 4 Broncho, Ambu® aView™ Monitor
Product code: EOQ
5. Device Description
The bronchoscope system consists of UE BRONCHO Single-Use Bronchoscopes and UE Display. The UE BRONCHO Single-Use Bronchoscopes (the bronchoscopes) are sterile,
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single-use flexible video bronchoscopes available in three sizes (Slim, Regular, Large). The bronchoscopes have been designed to be used with the UE Display (reusable, non-sterile), endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The bronchoscope system is designed for use by adults in a hospital environment.
6. Intended use & Indication for use
UE BRONCHO Single-Use Bronchoscope:
The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment.
The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.
UE Display:
The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices.
7. Comparison to the Predicate Device
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| K number | K251823 | K173727 | / |
| Manufacturer | Zhejiang UE Medical Corp. | Ambu Inc. | / |
| Model | UE BRONCHO Single-Use Bronchoscopes, model EBS-380C, EBS-500C, EBS-600CUE Display, model UE-M10S. | Ambu ® aScope™ 4 Broncho System:Ambu® aScope™ 4 Broncho Slim 3.8/1.2Ambu® aScope™ 4 Broncho Regular 5.0/2.2Ambu® aScope™ 4 Broncho Large 5.8/2.8Ambu® aView™ Monitor | / |
| Classification Name | Bronchoscope (flexible or rigid) and accessories | Bronchoscope (flexible or rigid) and accessories | / |
| Device trade name | UE BRONCHO Single-Use Bronchoscopes, model EBS-380C, EBS-500C, | Ambu® aScope™ 4 Broncho Slim 3.8/1.2; Ambu® | / |
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| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| EBS-600CUE Display, model UE-M10S. | aScope™ 4 Broncho Regular 5.0/2.2; Ambu® aScope™ 4 Broncho Large 5.8/2.8; Ambu® aView Monitor | ||
| Product Code | EOQ | EOQ | Same |
| Indication for use | The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment.The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.UE Display:The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices. | The aScope 4 Broncho endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.The aScope 4 Broncho system are for use in a hospital environment.The aScope 4 Broncho are single-use devices designed for use in adults. | Same |
| Population | Adults | Adults | Same |
| Anatomic sites | airways and tracheobronchial tree | airways and tracheobronchial tree | Same |
| Rx only | Yes | Yes | Same |
| Technology | The Flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. Anatomical | The Flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. | Same |
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| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the images showing on a monitor. | Anatomical images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the images showing on a monitor. | ||
| Performance | Complies with: ISO 8600 | Complies with: ISO 8600 | Same |
| Field of view (degree) | 90° | 85° | Similar |
| Direction of view (degree) | 0° | 0° | Same |
| Depth of view | 6-50 mm | 6-50 mm | Same |
| Working length (mm) | 600 mm | 600mm | Same |
| Deflection angle | 180° up, 180° down | Slim: 180° up, 180° downRegular: 180° up, 180° downLarge: 180° up, 160° down | Same |
| Insertion Tube Outer Diameter | EBS-380C: 3.8 mmEBS-500C: 5.0 mmEBS-600C: 5.8 mm | Slim: 3.8 mmRegular: 5.0 mmLarge: 5.8 mm | Same |
| Insertion Portion Maximum Diameter | EBS-380C: 4.4 mmEBS-500C: 5.5 mmEBS-600C: 6.5 mm | Slim: 4.3 mmRegular: 5.5 mmLarge: 6.3 mm | Equivalent |
| Minimum Working Channel Diameter | EBS-380C: 1.15 mmEBS-500C: 2.15 mmEBS-600C: 2.75 mm | Slim: 1.2 mmRegular: 2.0 mmLarge: 2.6 mm | Equivalent |
| Average Working Channel Diameter | EBS-380C: 1.2 mmEBS-500C: 2.2 mmEBS-600C: 2.8 mm | Slim: 1.2 mmRegular: 2.2 mmLarge: 2.8 mm | Same |
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| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Minimum ETT Inner Diameter Size | EBS-380C: 5.0 mmEBS-500C: 6.0 mmEBS-600C: 7.0 mm | Slim: 5.0 mmRegular: 6.0 mmLarge: 7.0 mm | Same |
| Minimum DLT Inner Diameter Size | EBS-380C: 35 FrEBS-500C: N/AEBS-600C: N/A | Slim: 35 FrRegular: 41 FrLarge: N/A | Similar |
| Light Source | LED | LED | Same |
| Sterilization | EO | EO | Same |
| Imaging Sensor | CMOS | CMOS | Same |
| Single-Use | Yes | Yes | Same |
| Image Display | Displays image on a reusable video monitor (UE Display) | Displays image on a reusable video monitor (aView™ Monitor) | Same |
| Maximum resolution | 1920*1200 | 800 x 480 | Different |
| Display Size | 10.1" | 8.5" | Similar |
| Display Type | 10.1" color TFT LCD | 8.5" color TFT LCD | Similar |
| Brightness control | Yes | Yes | Same |
| Contrast control | Yes | Yes | Same |
| Storage Capacity | 128 GB | 8 GB | Different |
| Display Operating Environment | 5 - 40°C≤85%860hPa～1060hPa | 10 - 40°C30 - 85%800 - 1090 hPa | Similar |
| Dimensions (W x H x D) | 257 mm x 195 mm x 36.2 mm | 241 mm x 175 mm x 33.5 mm | Similar |
| Weight | 1.50 kg | 1.50 kg | Same |
| Battery Type | Lithium battery | Lithium battery | Same |
8. Non-clinical Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the UE BRONCHO Single-Use Bronchoscopes was evaluated in
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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.
Sterilization and shelf life testing
The UE BRONCHO Single-Use Bronchoscopes are provided sterile, and its shelf-life is 3 years.
Sterilization Process has been validated accordance with ISO 11135:2014.
EO/ECH residual test was performed according to ISO 10993-7.
The shelf life is determined based on optical testing and product performance testing after accelerated aging test according to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Package validation was conducted according to ISO 11607-1 and ISO 11607-2.
Electrical safety and electromagnetic compatibility (EMC)
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.
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, "Content of Premarket Submissions for Device Software Functions".
Bench performance testing
The following bench tests were performed:
- Optical performance testing according to ISO 8600 series.
- Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), Noise and dynamic range, Frame rate compared with the predicate device.
9. Clinical study
Not applicable.
10. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed Bronchoscope system is substantially equivalent to the predicate device.
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§ 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.