(20 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no description of training or test sets for AI/ML models.
No
The device is intended for examination and visualization (diagnostic purposes), not for treating conditions or diseases (therapeutic purposes).
Yes
The intended use states "endoscopic procedures within the airways and tracheobronchial tree," and the device description mentions it "facilitates examination of the airways and trachea," indicating a diagnostic purpose.
No
The device description explicitly states it is a "single-use bronchoscope" and describes physical components like "insertion tube stiffness," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "endoscopic procedures within the airways and tracheobronchial tree." This involves directly examining the inside of the body.
- Device Description: The description details a bronchoscope, which is a tool used for visualizing and accessing the respiratory tract.
- Anatomical Site: The anatomical site is the "airways and tracheobronchial tree," which are internal body structures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside of the body, which is the defining characteristic of an IVD. The device is used for direct visualization and potentially delivering accessories within the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This bronchoscope is a surgical/endoscopic device used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.
Product codes
EOQ
Device Description
The EXALT Model B Single-Use Bronchoscope is a sterile, single-use bronchoscope available in three sizes (Slim, Regular, and Large). The proposed device facilitates examination of the airways and trachea. delivery of accessories (Regular and Large sizes only), and delivery of live video when connected to an EXALT Monitor.
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
Performance testing was not required to establish a finding of substantial equivalence between the proposed device and the predicate device, since the device is unchanged, Performance testing was conducted on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish the insertion tube stiffness seen in commercial use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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July 28, 2022
Boston Scientific Corporation Carter Navarro Fellow, Regulatory Affairs 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K222014
Trade/Device Name: EXALT Model B Single-Use Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: July 7, 2022 Received: July 8, 2022
Dear Carter Navarro:
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 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
1
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, 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) K222014
Device Name EXALT Model B Single-Use Bronchoscope
Indications for Use (Describe)
The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.
| 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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Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way Marlborough, MA 01752 (508) 683-4000 www.bostonscientific.com
510(k) Summary for EXALT Model B Single-Use Bronchoscope (K222014)
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Carter Navarro Contact: Fellow, Regulatory Affairs Phone: (508) 382-0356 E-mail: carter.navarro@bsci.com
Date Prepared: July 7, 2022
2. Device
| Trade Name: | EXALT Model B Single-Use Bronchoscope (Slim); |
|---|---|
| EXALT Model B Single-Use Bronchoscope (Regular); | |
| EXALT Model B Single-Use Bronchoscope (Large); | |
| Common Name: | |
| Product Code: | EOQ |
| Device Class: | Class II |
| Device Panel: | Ear Nose & Throat |
| Classification Regulation: | 21 CFR 874.4680, Bronchoscope (flexible or rigid) and |
| accessories |
3. Predicate Device
| Trade Name: | EXALT Model B Single-Use Bronchoscope (Slim); |
|---|---|
| EXALT Model B Single-Use Bronchoscope (Regular); | |
| EXALT Model B Single-Use Bronchoscope (Large); | |
| Clearance Number: | K211030 |
| Common Name: | Bronchoscope (flexible or rigid) |
| Product Code: | EOQ |
| Device Class: | Class II |
| Device Panel: | Ear Nose & Throat |
| Classification Regulation: | 21 CFR 874.4680, Bronchoscope (flexible or rigid) and accessories |
4
4. Device Description
The EXALT Model B Single-Use Bronchoscope is a sterile, single-use bronchoscope available in three sizes (Slim, Regular, and Large). The proposed device facilitates examination of the airways and trachea. delivery of accessories (Regular and Large sizes only), and delivery of live video when connected to an EXALT Monitor.
5. Indications for Use
The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.
6. Technological Characteristics
The proposed EXALT Model B Single-Use Bronchoscope is identical to the predicate device.
7. Substantial Equivalence
The proposed EXALT Model B Single-Use Bronchoscope is identical to the predicate device. The purpose of this Special 510(k) was to revise the specifications for insertion tube stiffness for the Slim, Regular, and Large sizes of the proposed device. For all three sizes, the upper end of the two-sided specification was increased. The new specifications were set based on test results from new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to which the EXALT Model B Single-Use Bronchoscope was shown to be substantially equivalent in the original premarket notification (K211030).
8. Performance Data
Performance testing was not required to establish a finding of substantial equivalence between the proposed device and the predicate device, since the device is unchanged, Performance testing was conducted on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish the insertion tube stiffness seen in commercial use.
9. Conclusion
Boston Scientific has demonstrated that the proposed EXALT Model B Single-Use Bronchoscope is substantially equivalent to the currently marketed predicate device.