The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.

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.

AI/ML Overview

This document is an FDA 510(k) summary for the EXALT Model B Single-Use Bronchoscope. It states that the proposed device is identical to its predicate device (EXALT Model B Single-Use Bronchoscope, K211030). The purpose of the Special 510(k) was only to revise the specifications for insertion tube stiffness. Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of device performance or clinical effectiveness.

Instead, it focuses on demonstrating substantial equivalence to a predicate device, which largely means showing that the new device has the same technological characteristics and indications for use as the predicate.

Here's a breakdown of why the requested information cannot be fully provided based on the given document:

Acceptance Criteria and Reported Device Performance: This document states the device is identical to the predicate and only revised a specification for insertion tube stiffness. It does not provide performance metrics or acceptance criteria for clinical outcomes or device effectiveness.
Study That Proves the Device Meets Acceptance Criteria: No such study is described for the proposed device. The only "testing" mentioned was on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish insertion tube stiffness in commercial use, which informed the revised specifications for the EXALT Model B.
Absence of specific information regarding clinical trials or performance studies for the EXALT Model B: The document explicitly states, "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."

Therefore, it is not possible to fill in the requested table or answer the specific questions about clinical performance, test sets, ground truth, experts, or MRMC studies based solely on this 510(k) summary.

Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria	Reported Device Performance
NOTE: This document is a 510(k) Special Notification for a device that is identical to its predicate model (K211030) with only a change in insertion tube stiffness specifications. Therefore, it does not include acceptance criteria or reported performance data related to clinical effectiveness or new functional metrics for the device itself. The clearance is based on substantial equivalence.
Insertion Tube Stiffness	(Not explicitly stated for clinical performance, but the change in specification for the proposed device was based on test results from the original predicate device K173727)	New specifications for insertion tube stiffness were set based on test results from new, unopened samples of the Ambu aScope 4 Broncho (K173727). Specific numerical performance values are not provided in this summary.

Missing Information (Not available in the provided document):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical "test set" for performance evaluation of the EXALT Model B is described.
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): Not applicable, as no such test set or ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable; this is a bronchoscope, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance/testing:

The proposed EXALT Model B Single-Use Bronchoscope is identical to its predicate device (K211030).
The "special" nature of this 510(k) is to revise the specifications for insertion tube stiffness for the Slim, Regular, and Large sizes.
Performance testing was NOT required to establish substantial equivalence for the EXALT Model B because it is "unchanged" from the predicate, except for the stiffness specification.
"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." This testing informed the new specifications for the EXALT Model B.

In essence, this FDA letter and summary confirm that the EXALT Model B is substantially equivalent to a previously cleared device, and the specific change addressed (insertion tube stiffness specifications) was supported by testing performed on the original predicate device, not the EXALT Model B itself as a new performance study.

Summary

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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

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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

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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)
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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

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4. Device Description

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.

Regulation Number and Section

§ 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.