(26 days)
Not Found
No
The summary describes a bronchoscope and sampling accessories, focusing on mechanical and visualization features. There is no mention of AI, ML, image processing for analysis, or performance metrics typically associated with AI/ML algorithms.
No.
The device is intended for visualization, examination, and fluid sample collection, which are diagnostic purposes, not therapeutic.
Yes
The device enables "aspiration and collection of fluid samples" from the airways and tracheobronchial tree through procedures like Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW). While it also provides visualization, the primary function of collecting samples for later analysis supports its role in diagnosis.
No
The device description explicitly lists multiple hardware components including an endoscope, sample containers, tubes, and adapters. There is no mention of software being the primary or sole component of the device.
Based on the provided information, the Ambu® aScope™ 5 Broncho Sampler Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for endoscopic procedures and examination within the airways and tracheobronchial tree, providing visualization, allowing passage of instruments, and enabling aspiration and collection of fluid samples. This describes a device used in vivo (within the body) for diagnostic and procedural purposes, not a device used in vitro (outside the body) to examine specimens.
- Device Description: The device is primarily an endoscope with accessories for collecting samples during the endoscopic procedure. The collected samples themselves might be used for in vitro diagnostic testing later, but the device itself is the tool for obtaining the sample from the patient.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological specimens in vitro. There are no reagents, test strips, analyzers, or software designed to interpret biological markers in a sample.
- Predicate Device: The predicate device (K230428) is also an endoscope, which is not an IVD.
While the device facilitates the collection of samples that may be used for in vitro diagnostic testing, the device itself is classified as a medical device used for an in vivo procedure.
N/A
Intended Use / Indications for Use
Ambu® aScope™ 5 Broncho Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.
Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.
Product codes (comma separated list FDA assigned to the subject device)
EOO
Device Description
The Ambu® aScope™ 5 Broncho Sampler Set consists of:
- Ambu® aScope™ 5 Broncho endoscope .
- Two Sample Containers (Ambu® aScope BronchoSampler™ 60 ടെടോ
- . Suction Connection Tube (SCT)
- . Bronchoscope Attachment Part (BAP)
- 2 Luer lock adapters (Introducers) .
Ambu® aScope™ 5 Broncho is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree (K230428).
The Ambu® aScope BronchoSampler™ 60 SC is a 510(k)-exempt device, also sold alone under the trade name Ambu® aScope BronchoSampler™ SC.
The combination of the Ambu® aScope BronchoSampler™ 60 SC, the Bronchoscope Attachment Part (BAP) and Suction Connection Tube (SCT) is collectively referred to as the BronchoSampler 60.
BronchoSampler 60 is a sterile, single-use medical component designed as an accessory to aScope™ 5 Broncho single-use endoscopes. It is used for fluid sampling in bronchoscopic procedures such as 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.
The Ambu® aScope BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure.
The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® aScope BronchoSampler™ 60 SC, where the aspirated sample is stored.
The Suction Connection Tube (SCT) facilitates connection to suction tubing.
The Ambu® aScope BronchoSampler™ 60 SC plus an additional Sample Container, BAP, SCT and two introducers will be packaged and sterilized together with Ambu® aScope™ 5 Broncho endoscope to form a self-contained set, the Ambu® aScope™ 5 Broncho Sampler Set.
Ambu® aScope™ 5 Broncho Sampler Set has the following physical and performance characteristics:
- Maneuverable Ambu® aScope™ 5 Broncho endoscope tip . controlled by the user
- Flexible Ambu® aScope™ 5 Broncho endoscope insertion . cord
- . Camera and LED light source at the distal tip of the Ambu® aScope™ 5 Broncho endoscope
- . Sterilized by Ethylene Oxide
- . For single use
- . Enables aspiration and sample collection in BAL and BW procedures
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing has been performed in accordance with ISO 14971 as Design Verification of those Design Input requirements that are specified as risk control measures for those risks arising from the addition of sampling functionality to the endoscope.
A summary of the activities carried out to verify the additional requirements and identified risks arising from the risk control measures are as follows:
• Transportation testing
• Packaging testing
• Suction Testing
• Connectivity testing
• Tests for basic function of BronchoSampler 60
• Biological evaluation
• Sterilization Validation
Result: All requirements are verified successfully.
Clinical Performance data: 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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 20, 2023
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046
Re: K232582
Trade/Device Name: Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: August 25, 2023 Received: August 25, 2023
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/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.
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
Indications for Use
510(k) Number (if known)
K232582
Device Name
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Indications for Use (Describe)
Ambu® aScope™ 5 Broncho Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.
Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.
| 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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See PRA Statement below.
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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) summary has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
Tel.: +45 7225 2000
Fax.: +45 7225 2050 | | | | | | | | |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| Contact Person | Name: Eva Lind Rasmussen
Job Title: Senior Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, 2750 Ballerup
Telephone number: Tel.: +45 7225 2000 | | | | | | | | |
| Date Summary Prepared | August 22, 2023 | | | | | | | | |
| Device Trade Name | Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | | | | | | | | |
| 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 Manufacturer Trade Name 510(k) number Ambu A/S Ambu A/S Ambu® aScope™ 5 Broncho 4.2/2.2 K230428 | | | | | | | | |
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| Description of | |
|---|---|
| the Device |
The Ambu® aScope™ 5 Broncho Sampler Set consists of:
- Ambu® aScope™ 5 Broncho endoscope .
- Two Sample Containers (Ambu® aScope BronchoSampler™ 60 ટેટો
- . Suction Connection Tube (SCT)
- . Bronchoscope Attachment Part (BAP)
- 2 Luer lock adapters (Introducers) .
Ambu® aScope™ 5 Broncho is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree (K230428).
The Ambu® aScope BronchoSampler™ 60 SC is a 510(k)-exempt device, also sold alone under the trade name Ambu® aScope BronchoSampler™ SC.
The combination of the Ambu® aScope BronchoSampler™ 60 SC, the Bronchoscope Attachment Part (BAP) and Suction Connection Tube (SCT) is collectively referred to as the BronchoSampler 60.
BronchoSampler 60 is a sterile, single-use medical component designed as an accessory to aScope™ 5 Broncho single-use endoscopes. It is used for fluid sampling in bronchoscopic procedures such as 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.
The Ambu® aScope BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure.
The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® aScope BronchoSampler™ 60 SC, where the aspirated sample is stored.
The Suction Connection Tube (SCT) facilitates connection to suction tubing.
The Ambu® aScope BronchoSampler™ 60 SC plus an additional Sample Container, BAP, SCT and two introducers will be packaged
5
and sterilized together with Ambu® aScope™ 5 Broncho endoscope to form a self-contained set, the Ambu® aScope™ 5 Broncho Sampler Set.
Ambu® aScope™ 5 Broncho Sampler Set has the following physical and performance characteristics:
- Maneuverable Ambu® aScope™ 5 Broncho endoscope tip . controlled by the user
- Flexible Ambu® aScope™ 5 Broncho endoscope insertion . cord
- . Camera and LED light source at the distal tip of the Ambu® aScope™ 5 Broncho endoscope
- . Sterilized by Ethylene Oxide
- . For single use
- . Enables aspiration and sample collection in BAL and BW procedures
| Indications for | Ambu® aScope™ 5 Broncho Sampler Set is intended for |
|---|---|
| Use | endoscopic procedures and examination within the airways and |
| tracheobronchial tree. |
Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit and to allow passing of endotherapy instruments via its working channel.
Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.
| Summary of the
technological
characteristics
in comparison to
the predicate
devices | The Ambu® aScope™ 5 Broncho endoscope in the Ambu®
aScope™ 5 Broncho Sampler Set is identical to the predicate
cleared under K230428.
Ambu® aScope™ 5 Broncho Sampler Set differs from the
predicate in the following areas:
The exempt device, Ambu® aScope BronchoSampler™ 60 SC,
BAP, SCT and two introducers are added to the Ambu® aScope™
5 Broncho endoscope.
Ambu® aScope BronchoSampler™ 60 SC, BAP, SCT and two
introducers are packaged and sterilized together with aScope™ 5
Broncho to form a self-contained set, the Ambu® aScope™ 5
Broncho Sampler Set. |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data - Bench | Bench testing has been performed in accordance with ISO 14971 as
Design Verification of those Design Input requirements that are
specified as risk control measures for those risks arising from the
addition of sampling functionality to the endoscope.
A summary of the activities carried out to verify the additional
requirements and identified risks arising from the risk control
measures are as follows:
• Transportation testing
• Packaging testing
• Suction Testing
• Connectivity testing
• Tests for basic function of BronchoSampler 60
• Biological evaluation
• Sterilization Validation
Result: All requirements are verified successfully. |
| Performance
Data - Clinical | Not applicable. |
| Conclusion | The Ambu® aScope™ 5 Broncho Sampler Set has the same
intended use and indications for use, and similar technological
characteristics and principles of operation as the predicate device.
The minor differences between the Ambu® aScope™ 5 Broncho
Sampler Set and its predicate device, namely the addition of the
510(k)-exempt device Ambu® aScope BronchoSampler™ 60 SC and
the BAP, SCT and introducers do not raise any new concerns
regarding safety or effectiveness.
It is concluded that Ambu® aScope™ 5 Broncho Sampler Set is
substantially equivalent to its predicate device. |
6