(27 days)
Ambu® aScope™ 5 Broncho HD Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD 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 HD Sampler Set enables aspiration and collection of fluid samples.
The Ambu® aScope™ 5 Broncho HD Sampler Set consists of:
Ambu® aScope™ 5 Broncho HD
Two Sample Containers (aScope BronchoSampler™ 60 SC)
Suction Connection Tube (SCT)
Bronchoscope Attachment Part (BAP)
2 Luer lock adapters (introducers)
Ambu® aScope™ 5 Broncho HD 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.
The Ambu® BronchoSampler™ 60 SC is a sterile, single-use medical device designed as an accessory to aScope 5 Broncho HD single- use endoscopes. It enables aspiration and collection of fluid samples.
The Ambu® BronchoSampler™ 60 SC will be sold alone as an add-on to aScope 5 Broncho HD and as a part in the Ambu® aScope™ 5 Broncho HD Sampler Set.
The Ambu® BronchoSampler™ 60 SC achieves its function by being inserted into the suction pathway between the endoscope and the vacuum source.
The Sample Container Ambu® 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 HD endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® BronchoSampler™ 60 SC, where the aspirated sample is stored.
The Suction Connection Tube (SCT) facilitates connection to suction tubing having end connectors of the male type, instead of the more typical female type.
The Ambu® BronchoSampler™ 60 SC plus an additional Sampler Container, BAP, SCT and two introducers will be packaged and sterilized together with a aScope 5 Broncho HD endoscope to form a self-contained set, the aScope 5 Broncho HD Sampler Set.
There will be two sets, corresponding to the two sizes of aScope 5 Broncho HD:
a. Ambu® aScope 5 Broncho HD 5.6/2.8 Sampler Set
b. Ambu® aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu® aScope™ 5 Broncho HD Sampler Set has the following physical and performance characteristics:
- Maneuverable Ambu® aScope 5 Broncho HD endoscope tip . controlled by the user
- Flexible Ambu® aScope 5 Broncho HD endoscope insertion . cord
- . Camera and LED light source at the distal tip of the Ambu® aScope 5 Broncho HD endoscope
- . Sterilized by Ethylene Oxide
- For single use
- Enables aspiration and sample collection ●
The following characteristic of the endoscope varies between sizes:
- Distal end outer diameter
- Insertion tube outer diameter
- Working channel inner diameter ●
- . Angulation range
This document describes the Ambu® aScope™ 5 Broncho HD Sampler Set, a new device that builds upon the previously cleared Ambu® aScope™ 5 Broncho HD endoscope by adding components for aspiration and collection of fluid samples. The clearance is based on proving substantial equivalence to the predicate device, Ambu® aScope™ 5 Broncho HD (K220606).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, as this is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device for an accessory, not a diagnostic AI device requiring such metrics.
Instead, the performance data provided focuses on verifying the safety and functionality of the added components and their integration with the existing endoscope. The acceptance is based on successful verification of design input requirements related to safety and functionality.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional & Safety | Result: All requirements are verified successfully. This general statement covers several specific tests related to the modifications. |
| Transportation | Performance tests related to transportation were conducted. |
| Packaging | Performance tests related to packaging were conducted. |
| Suction | Suction testing was performed to document properties of the modification. |
| Connectivity | Connectivity testing was performed. |
| Basic BronchoSampler Function | Tests for basic function of the BronchoSampler 60 were performed. |
| Biological Evaluation | Biological evaluation was performed in accordance with risk control measures. |
| Sterilization Validation | Sterilization validation was performed. |
| Overall Equivalence | 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. It is concluded that Ambu® aScope™ 5 Broncho Sampler Set is substantially equivalent to its predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not involve clinical data or patient samples in the traditional sense for evaluating diagnostic performance. The "test set" refers to the specific physical devices and components undergoing bench testing. The sample sizes for these bench tests are not explicitly quantified in the provided text (e.g., "Performance tests related to the modifications was performed"). The provenance information (country of origin, retrospective/prospective) is not applicable or provided given the nature of the bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this submission. The "ground truth" for these engineering and safety tests is established by documented design specifications and engineering standards, not by expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the focus here.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (endoscope with sampling accessory), not an AI-powered diagnostic tool. The document explicitly states "Performance Data - Clinical: Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical endoscope and sampling system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench testing is defined by the device's design input requirements, engineering specifications, and applicable medical device standards (e.g., ISO 14971 for risk management). Successful verification against these established requirements constitutes the "ground truth" for demonstrating the safety and performance of the device's modifications.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this type of medical device submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
January 12, 2023
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6721 Columbia Gateway Drive, suite 200 Columbia, Maryland 21046
Re: K223782
Trade/Device Name: Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: December 12, 2022 Received: December 16, 2022
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.
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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 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.
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
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Indications for Use
510(k) Number (if known) K223782
Device Name
Ambu® aScope™ 5 Broncho HD 5.6/2.8 Sampler Set Ambu® aScope™ 5 Broncho HD 5.0/2.2 Sampler Set
Indications for Use (Describe)
Ambu® aScope™ 5 Broncho HD Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD 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 HD 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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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/SBaltorpbakken 132750 BallerupDenmarkTel.: +45 7225 2000Fax.: +45 7225 2050 | |||
|---|---|---|---|---|
| Contact Person | Name: Kristian MoltvedJob Title: Associate Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, 2750 BallerupTelephone number: +45 7225 2116Fax number: +45 7225 2050 | |||
| Date SummaryPrepared | December 12, 2022 | |||
| Device TradeName | Ambu® aScope™ 5 Broncho HD 5.6/2.8 Sampler SetAmbu® aScope™ 5 Broncho HD 5.0/2.2 Sampler Set | |||
| Device CommonName | Flexible Endoscope and Specimen Sampling System - Single Use | |||
| DeviceClassification | Ambu® aScope™ 5 Broncho HD Sampler Set:Bronchoscope (flexible or rigid) and accessoriesProduct Codes: EOQ21 CFR 874.4680Class II | |||
| Legally Marketeddevices to whichthe device issubstantiallyequivalent | Predicate | ManufacturerAmbu A/S | Trade NameAmbu® aScope™5 Broncho HD | 510(k)numberK220606 |
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| Description ofthe Device | The Ambu® aScope™ 5 Broncho HD Sampler Set consists of:Ambu® aScope™ 5 Broncho HD Two Sample Containers (aScope BronchoSampler™ 60 SC) Suction Connection Tube (SCT) Bronchoscope Attachment Part (BAP) 2 Luer lock adapters (introducers) |
|---|---|
| Ambu® aScope™ 5 Broncho HD 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. | |
| The Ambu® BronchoSampler™ 60 SC is a sterile, single-use medical device designed as an accessory to aScope 5 Broncho HD single- use endoscopes. It enables aspiration and collection of fluid samples. | |
| The Ambu® BronchoSampler™ 60 SC will be sold alone as an add-on to aScope 5 Broncho HD and as a part in the Ambu® aScope™ 5 Broncho HD Sampler Set. | |
| The Ambu® BronchoSampler™ 60 SC achieves its function by being inserted into the suction pathway between the endoscope and the vacuum source. | |
| The Sample Container Ambu® 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 HD endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® BronchoSampler™ 60 SC, where the aspirated sample is stored. |
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The Suction Connection Tube (SCT) facilitates connection to suction tubing having end connectors of the male type, instead of the more typical female type.
The Ambu® BronchoSampler™ 60 SC plus an additional Sampler Container, BAP, SCT and two introducers will be packaged and sterilized together with a aScope 5 Broncho HD endoscope to form a self-contained set, the aScope 5 Broncho HD Sampler Set.
There will be two sets, corresponding to the two sizes of aScope 5 Broncho HD:
- a. Ambu® aScope 5 Broncho HD 5.6/2.8 Sampler Set
- b. Ambu® aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu® aScope™ 5 Broncho HD Sampler Set has the following physical and performance characteristics:
- Maneuverable Ambu® aScope 5 Broncho HD endoscope tip . controlled by the user
- Flexible Ambu® aScope 5 Broncho HD endoscope insertion . cord
- . Camera and LED light source at the distal tip of the Ambu® aScope 5 Broncho HD endoscope
- . Sterilized by Ethylene Oxide
- For single use
- Enables aspiration and sample collection ●
The following characteristic of the endoscope varies between sizes:
- Distal end outer diameter
- Insertion tube outer diameter
- Working channel inner diameter ●
- . Angulation range
{6}------------------------------------------------
| Indications forUse | Ambu® aScope™ 5 Broncho HD Sampler Set is intended forendoscopic procedures and examination within the airways andtracheobronchial tree.Ambu® aScope™ 5 Broncho HD Sampler Set is intended toprovide visualization via a compatible Ambu displaying unit and toallow passing of endotherapy instruments via its working channel.Ambu® aScope™ 5 Broncho HD Sampler Set enables aspirationand collection of fluid samples. |
|---|---|
| Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevice | The Ambu® aScope™ 5 Broncho HD endoscope in the Ambu®aScope™ 5 HD Broncho Sampler Set is identical to the predicate. |
| Ambu® aScope™ 5 Broncho HD Sampler Set differs from thepredicate in the following areas:Ambu® aScope™ BronchoSampler 60 SC, BAP, SCT andtwo introducers are added to the Ambu® aScope™ 5Broncho HD endoscope. Ambu® aScope™ BronchoSampler 60 SC, BAP, SCT andtwo introducers are packaged and sterilized together withaScope 5 Broncho HD endoscopes to form a self-containedset, the Ambu® aScope™ 5 Broncho HD Sampler Set. | |
| PerformanceData -Bench | Performance tests related to the modifications was performed todocument the following properties of the modification to Ambu®aScope™ 5 Broncho HD.In addition to the non-clinical performance testing documented forthe Ambu® aScope™ 5 Broncho HD (K220606), additional benchtesting has been performed in accordance with ISO 14971 asDesign Verification of those Design Input requirements that arespecified as risk control measures for those risks arising from theaddition of sampling functionality to the endoscope. A table of thisspecial 510(k) cross references these additional risks, documentedin the Product Risk Evaluation for the Ambu® aScope™ 5 BronchoSampler Set, with the risk control measures and the subsequentverification results. |
| A summary of the methods to verify the additional requirementsand identified risks arising from the risk control measures are asfollows:• Transportation testing• Packaging testing• Suction Testing• Connectivity testing• Tests for basic function of BronchoSampler 60• Biological evaluation• Sterilization ValidationResult: All requirements are verified successfully. | |
| PerformanceData - Clinical | Not applicable. |
| Conclusion | The Ambu® aScope™ 5 Broncho Sampler Set has the sameintended use and indications for use, and similar technologicalcharacteristics and principles of operation as the predicate device. |
| It is concluded that Ambu® aScope™ 5 Broncho Sampler Set issubstantial equivalent to its 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.