(84 days)
Not Found
No
The summary describes a flexible endoscope and sample collection system with standard features like a camera, light source, and maneuverable tip. There is no mention of AI, ML, image processing for analysis, or any data processing beyond visualization. The performance studies are focused on physical and electrical safety, not algorithmic performance.
No.
This device is designed for endoscopic procedures, visualization, and fluid sample collection (diagnostic purposes), not for treating a disease or condition.
No
Explanation: The device is described as an endoscope with sample containers intended for visualization and collection of fluid samples. It facilitates diagnostic procedures by enabling sample collection, but it does not perform the diagnosis itself. Diagnosis would occur after laboratory analysis of the collected samples.
No
The device description explicitly details physical components such as a flexible endoscope, sample containers, camera, LED light source, and insertion cord, indicating it is a hardware device with software components for visualization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for endoscopic procedures and examination within the airways and tracheobronchial tree, providing visualization and enabling the collection of fluid samples. It is a tool for a medical procedure, not a device that performs a diagnostic test on a sample in vitro (outside the body).
- Device Description: The device is described as a flexible endoscope with sample containers. Its function is to facilitate the collection of samples during a procedure, not to analyze those samples.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis or testing of the collected fluid samples. The samples are collected by the device, but the diagnostic testing would be performed separately in a laboratory using other IVD devices.
While the device is used to obtain samples that may later be used for in vitro diagnostic testing, the device itself does not perform the diagnostic function.
N/A
Intended Use / Indications for Use
aScope 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration of fluid sample(s) from the bronchial or alveolar part of the lung.
It is designed for use in adults and intended for use in a hospital environment.
It is intended to provide visualization via Ambu Displaying Unit.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The Ambu® aScope™ 4 Broncho Sampler Set consists of:
• aScope 4 Regular/Large endoscope
• aScope BronchoSampler ™
Ambu® aScope™ 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. Both of the aScope 4 Broncho and BronchoSampler are already marketed separately.
Ambu® aScope™ 4 Broncho Sampler Set has the following physical and performance characteristics:
• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use
• Enables aspiration and sample collection in BAL and BW procedures
The differences between the endoscope sizes are as follows:
• Distal end outer diameter
• Insertion tube outer diameter
• Working channel inner diameter
• Angulation range
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree, bronchial or alveolar part of the lung
Indicated Patient Age Range
adults
Intended User / Care Setting
hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data - Bench:
The following data are described for the product line extension Ambu® aScope™ 4 Broncho Sampler Set in the premarket notification:
Declaration of Conformity with the product specific standards ISO 8600-1, ISO 8600-3 and ISO 8600-4
Aging performance test
Sterile Packaging Integrity
Electromagnetic Compatibility according to IEC 60601-1-2
Electrical Safety according to IEC 60601-1 and IEC 60601-2-18.
Performance test for Single-use receptacles according to EN 14254
Result: All tests were passed.
Performance Data - Clinical: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 17, 2021
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, Maryland 21045
Re: K210883
Trade/Device Name: aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: May 17, 2021 Received: May 18, 2021
Dear Sanjay Parikh:
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/cdrl/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.
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
1
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-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 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 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,
for Shu-Chen Peng 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
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Indications for Use
510(k) Number (if known) K210883
Device Name
Ambu® aScope™ 4 Broncho Regular Sampler Set 5.0/2.2 Ambu® aScope™ 4 Broncho Large Sampler Set 5.8/2.8
Indications for Use (Describe)
aScope 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration of fluid sample(s) from the bronchial or alveolar part of the lung.
It is designed for use in adults and intended for use in a hospital environment.
It is intended to provide visualization via Ambu Displaying Unit.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This Special 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summery has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
Tel.: +45 7225 2000
Fax.: +45 7225 2050 | | | |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------------------------------------------|-------------|
| Contact Person | Name: Gurpreet Kaur Rehal
Job Title: Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2116
Fax number: +45 7225 2050 | | | |
| Date Summary
Prepared | March, 23, 2021 | | | |
| 510(k) no. | K210883 | | | |
| Device Trade
Name | Ambu® aScope™ 4 Broncho Regular Sampler Set 5.0/2.2
Ambu® aScope™ 4 Broncho Large Sampler Set 5.8/2.8 | | | |
| Device Common
Name | Flexible Endoscope and Specimen Sampling System - Single Use | | | |
| Device
Classification | Bronchoscope (flexible or rigid) and accessories
Product Codes: EOQ
21 CFR 874.4680
Class II | | | |
| Legally
Marketed
devices to which
the device is
substantially
equivalent | Predicate
A: | Manufacturer | Trade Name | 510k number |
| | | Ambu A/S | Ambu® aScope™ 4
Broncho Regular and
Large | K173727 |
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| Description of the Device | The Ambu® aScope™ 4 Broncho Sampler Set consists of:
• aScope 4 Regular/Large endoscope
• aScope BronchoSampler ™
Ambu® aScope™ 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. Both of the aScope 4 Broncho and BronchoSampler are already marketed separately.
Ambu® aScope™ 4 Broncho Sampler Set has the following physical and performance characteristics:
• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use
• Enables aspiration and sample collection in BAL and BW procedures
The differences between the endoscope sizes are as follows:
• Distal end outer diameter
• Insertion tube outer diameter
• Working channel inner diameter
• Angulation range |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Ambu® aScope™ 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.
It is designed for use in adults and intended for use in a hospital environment.
It is intended to provide visualization via Ambu Displaying Unit. |
| Summary of the technological characteristics in comparison to the predicate devices | The endoscope of Ambu® aScope™ 4 Broncho Sampler Set is similar to the predicate device A in the following areas:
• They are all single-use devices delivered sterile.
• They are all flexible endoscopes with a maneuverable tip.
• They are all video endoscopes with a camera located in the distal tip to provide an image on a separate displaying unit.
• They all provide illumination from the distal tip.
• They all have suction functionality
• They all have the same insertion tube working length |
| | They all have equivalent inner and outer diameters in their
corresponding sizes.
The endoscope of Ambu® aScope™ 4 Broncho Sampler Set differs from
the predicate device A in the following areas:
Bronchosampler is added in Ambu® aScope™ 4 Broncho Sampler
Set which can be attached to the handle of the endoscope. |
| Performance
Data -Bench | The following data are described for the product line extension Ambu®
aScope™ 4 Broncho Sampler Set in the premarket notification: |
| | Declaration of Conformity with the product specific standards ISO
8600-1, ISO 8600-3 and ISO 8600-4Aging performance testSterile Packaging IntegrityElectromagnetic Compatibility according to IEC 60601-1-2Electrical Safety according to IEC 60601-1 and IEC 60601-2-18.Performance test for Single-use receptacles according to EN
14254 |
| | Result: All tests were passed. |
| Performance
Data - Clinical | Not applicable. |
| Conclusion | Based on the indication for use, technological characteristics,
performance data and comparison to predicate device it has been
concluded that the functionality and intended use of Ambu® aScope™ 4
Broncho Sampler Set is substantially equivalent to the predicate device.
It is concluded that Ambu® aScope™ 4 Broncho Sampler Set is as safe
and as effective and performs as well as the predicate device. |
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