Intended Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is intended for use in minimally invasive ligament or fascia release.

Indications for Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is indicated for:

· Carpal tunnel release in the wrist
Cubital tunnel release in the elbow
· Trigger finger release in the hand

Device Description

MicroAire's SmartRelease Endoscopic Soft Tissue Release System is comprised of the following components: the SmartRelease Endoscope, the SmartRelease Handpiece, and the SmartRelease Standard and Onyx Blade Assemblies. The system includes a set of accessory Manual Surgical Instruments. The SmartRelease Handpiece, the SmartRelease Endoscope, and the Manual Surgical Instruments are reusable after cleaning and subsequent sterilization. The SmartRelease Blade Assemblies are gamma sterilized and intended for single-use only.

AI/ML Overview

The provided text is a 510(k) summary for the MicroAire® SmartRelease® Endoscopic Soft Tissue Release System. This document focuses on demonstrating that the subject device is substantially equivalent to a previously cleared predicate device (K181819). The key aspect of this submission is the addition of a new indication for use: "Trigger finger release in the hand."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to proving that this new indication does not introduce new questions of safety or effectiveness, given that the device itself is identical to the cleared predicate.

Here's the analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating safety and effectiveness for the new indication. Since the device itself is identical to the predicate, the performance data provided focuses on the usability and safety of the device for trigger finger release.

Acceptance Criteria (Implicit for New Indication)	Reported Device Performance (for Trigger Finger Release)
No usability risks	"The results confirm that the SmartRelease Endoscopic Soft Tissue Release System... presents no usability risks"
Can be safely and effectively used as intended for trigger finger release	"The results confirm that the SmartRelease Endoscopic Soft Tissue Release System... can be safely and effectively used as intended"
Meets the User Needs for trigger finger release	"The results confirm that the SmartRelease Endoscopic Soft Tissue Release System... meets the User Needs"

Note: The document explicitly states: "As the subject device is identical in construction, geometry, functionality, and Intended Use to its cleared predicate, previous testing provided in the cleared K181819 demonstrates that the SmartRelease Endoscopic Soft Tissue Release System is safe and effective for its Intended Use. Nothing has changed with the SmartRelease System to alter that conclusion." This indicates that the core mechanical and material performance criteria were already met by the predicate and are considered met by the subject device due to identity.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: A "User Validation" study was performed.
Sample Size: "Twenty users participated."
Data Provenance: The study involved "cadaver labs," implying a laboratory setting. The country of origin is not specified but is likely the US, given the FDA submission. The study is prospective in nature, as it was conducted specifically to evaluate the new indication.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not describe "ground truth experts" in the typical sense of diagnostic imaging (e.g., radiologists interpreting images). Instead, the user validation involved clinical use in cadavers. The "experts" in this context would be the "Twenty users" who participated, acting as the "intended user groups." Their qualifications are not explicitly stated, but they are described as "appropriate users for the subject device's new Indication for Use," implying they are surgeons or medical professionals who would perform trigger finger release procedures.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense of diagnostic assessment adjudication (e.g., 2+1, 3+1). The user validation study likely involved direct observation of performance and evaluation against pre-defined usability and safety criteria, rather than a consensus-based review of diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. This type of study is typically done for AI-driven diagnostic devices to compare human performance with and without AI assistance. The SmartRelease device is a surgical instrument, not a diagnostic AI. The user validation was to confirm that the device itself can be safely and effectively used for the new indication, not to assess improvement in human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way, the mechanical and material performance testing of the device can be considered "standalone" as it evaluates the device's inherent properties. The document states: "previous testing provided in the cleared K181819 demonstrates that the SmartRelease Endoscopic Soft Tissue Release System is safe and effective for its Intended Use." And "Nothing has changed with the SmartRelease System to alter that conclusion." This confirms that the device components and system function were tested independently of clinical use.

7. The Type of Ground Truth Used

For the user validation study, the "ground truth" was the demonstrated safe and effective use of the device in cadaveric models for trigger finger release, and meeting pre-defined user needs. This is assessed through observed performance and compliance with usability criteria, rather than a diagnostic "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This device is a mechanical surgical instrument, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable (as above).

Summary

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February, 2, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

MicroAire Surgical Instruments Glenn Gerstenfeld Vice President, QA/RA & Compliance Officer 3590 Grand Forks Blvd Charlottesville, Virginia 22911

Re: K223406

Trade/Device Name: SmartRelease® Endoscopic Soft Tissue Release System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, KCT, EMF Dated: November 4, 2022 Received: November 9, 2022

Dear Glenn Gerstenfeld:

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 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,

Sara S. Thompson -S

For

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223406

Device Name

SmartRelease® Endoscopic Soft Tissue Release System

Indications for Use (Describe)

The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is indicated for:

· Carpal tunnel release in the wrist
Cubital tunnel release in the elbow
· Trigger finger release in the hand

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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Section 5: 510(k) Summary

SmartRelease® Endoscopic Soft Tissue Release System

1. Submission Sponsor

MicroAire® Surgical Instruments, LLC

3590 Grand Forks Blvd.

Charlottesville, VA 22911

USA

Contact: Glenn Gerstenfeld

Title: VP, QA/RA and Compliance Officer

Phone: (434) 975-8344

Fax: (434) 975-4144

2. Date Prepared

November 4, 2022

3. Device Identification

Trade/Proprietary Name: SmartRelease Endoscopic Soft Tissue Release System Common/Usual Name: SmartRelease Classification Name: Arthroscope Regulation Number: 21 CFR 888.1100 Product Code: HRX, KCT, EMF Class: Class II Classification Panel: Orthopedic

4. Predicate Device(s)

The predicate device for this submission is MicroAire's SmartRelease® Endoscopic Soft Tissue Release System (K181819). This predicate has not been the subject of a design-related recall. No reference devices were used in this submission.

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5. Intended Use / Indication for Use Statement

Intended Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is intended for use in minimally invasive ligament or fascia release.

Indications for Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is indicated for:

Carpal tunnel release in the wrist
. Cubital tunnel release in the elbow
Trigger finger release in the hand

6. Device Description

Carpal Tunnel:

The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The carpal tunnel device attaches to any standard video camera and light source used in endoscopic/arthroscopy procedures. The surgeon introduces the Disposable Blade assembly into the carpal tunnel through an incision in the proximal wrist flexion crease. Viewing the deep side of the transverse carpal ligament (flexor retinaculum) through a window at the tip of the instrument, the surgeon elevates the blade to cut the ligament as the instrument is withdrawn.

Cubital Tunnel:

The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The cubital tunnel device attaches to any standard video camera and light source used in endoscopic procedures. The surgeon introduces the disposable blade assembly into the cubital tunnel through a 3-cm longitudinal incision between the medial epicondyle and olecranon. Viewing the roof of the cubital tunnel fascia through a window at the tip of the instrument, the surgeon elevates the blade to cut the instrument is withdrawn.

Trigger Finger:

The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The trigger finger device attaches to any standard video camera and light source used in endoscopic procedures. The surgeon introduces the

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disposable blade assembly into the finger through a 1-cm incision crease of the affected finger. Viewing the roof of the A1 Pulley through a window at the tip of the instruments, the surgeon elevates the blade to cut the pulley as the instrument is withdrawn.

7. Substantial Equivalence Discussion

Technological Characteristics

This submission is to add an Indication for Use to the SmartRelease Endoscopic Soft Tissue Release System and does not include any design changes to the product family. There have been no design changes between the originally cleared SmartRelease Endoscopic Soft Tissue Release System and the proposed product family. Thus, the two SmartRelease devices have technological characteristics as there have been no changes to the design, material, chemical composition, energy source, manufacturing, packaging, or sterilization of the device, as summarized in the table below.

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Performance Data

As the subject device is identical in construction, geometry, functionality, and Intended Use to its cleared predicate, previous testing provided in the cleared K181819 demonstrates that the SmartRelease

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Endoscopic Soft Tissue Release System is safe and effective for its Intended Use. Nothing has changed with the SmartRelease System to alter that conclusion.

Shelf life testing originally submitted in K181819 was based on product that had undergone accelerated aging conditioning. Since that submission was cleared, performance testing has been completed on product that has undergone real time aging to support the labeling shelf life. All products under consideration passed this testing.

A new User Validation was performed with appropriate users for the subject device's new Indication for Use to evaluate the user interfaces and to confirm that the intended user groups can appropriately use the device and demonstrate that the device is safe and effective for the new Indication for Use. Twenty users participated in cadaver labs with the subject device, walking through the procedure for trigger finger release on both fingers and thumbs on multiple hands each, for a total evaluation of 80 fingers and 40 thumbs. The results confirm that the SmartRelease Endoscopic Soft Tissue Release System 1) presents no usability risks, 2) can be safely and effectively used as intended, and 3) meets the User Needs.

Intended Use

The Intended Use is identical between the subject device and predicate. The addition of the "Trigger finger release in the hand" Indication for Use does not change the Intended Use nor raise any concerns regarding safety or effectiveness, as discussed above.

8. Statement of Substantial Equivalence

The subject device, SmartRelease Endoscopic Soft Tissue Release System, is the identical product as its predicate, cleared under K181819. It has the same technological characteristics, same performance testing and results, and the same Intended Use as its predicate. The added Indication for Use does not raise new or different questions of safety or effectiveness, as demonstrated in the User Validation. Therefore, the subject SmartRelease Endoscopic Soft Tissue Release System is substantially equivalent to the predicate device.

9. Referenced Standards

The SmartRelease Endoscopic Soft Tissue Release System also complies in whole or in part to the following consensus standards.

ISO 14971:2019, Medical devices – Application of risk management to medical devices
ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
. ISO 15223-1:2021, Medical devices – Symbol to be used with information to be supplied by the manufacturer - Part 1: General requirements
ISO 20417:2021, Medical devices – Information to be supplied by the manufacturer

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IEC 62366-1:2020, Medical devices – Part 1: Application of usability engineering to medical devices
. ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development validation and routine control of a sterilization process for medical devices
. ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
ISO 11607-1:2019, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials sterile barrier systems and packaging systems
. ISO 11607-2:2019, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming sealing and assembly processes
. ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2096-11, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ANSI AAMI ST77:2013/(R)2018, Containment devices for reusable medical device sterilization
ANSI AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in ● health care facilities

10. Conclusion

SmartRelease Endoscopic Soft Tissue Release System is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties. The SmartRelease Endoscopic Soft Tissue Release System is designed to comply with applicable federal safety and performance standards. The User Validation data support the new indication claim. There are no new safety and effectiveness issues.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

TechnologicalCharacteristic	SUBJECTSmartRelease Endoscopic SoftTissue Release System	PREDICATE510(K) K181819SmartRelease Endoscopic SoftTissue Release System	Comparison
Design
Mechanism ofAction	The blade assembly locks onto the front of the handpiece. The endoscope is inserted through the handpiece into the blade assembly. A light source and camera are attached to the endoscope. When the blade assembly is inserted into the surgical site, the endoscope provides a view of the distal end of the blade assembly and tissue to be resected. When the user pulls the trigger on the handpiece, it advances the shuttle into the proximal end of the blade assembly, pushing the actuator forward. This forward movement of the actuator raises the cutting blade along a track in the blade case. With the cutting blade fully raised, the user can slowly pull the assembly back out of the surgical site, allowing the cutting blade to	The blade assembly locks onto the front of the handpiece. The endoscope is inserted through the handpiece into the blade assembly. A light source and camera are attached to the endoscope. When the blade assembly is inserted into the surgical site, the endoscope provides a view of the distal end of the blade assembly and tissue to be resected. When the user pulls the trigger on the handpiece, it advances the shuttle into the proximal end of the blade assembly, pushing the actuator forward. This forward movement of the actuator raises the cutting blade along a track in the blade case. With the cutting blade fully raised, the user can slowly pull the assembly back out of the surgical site, allowing the cutting blade to	Identical topredicate device
TechnologicalCharacteristic	SUBJECTSmartRelease Endoscopic SoftTissue Release System	PREDICATE510(K) K181819SmartRelease Endoscopic SoftTissue Release System	Comparison
	resect the tissue of interest.When the trigger is released, theforce of the shuttle on theactuator is removed, and a springin the blade assembly returns theactuator and cutting blade to theiroriginal, retracted position.	resect the tissue of interest.When the trigger is released, theforce of the shuttle on theactuator is removed, and a springin the blade assembly returns theactuator and cutting blade to theiroriginal, retracted position.
Materials	• Handpiece – aluminum,stainless steel, Radel	• Handpiece – aluminum,stainless steel, Radel	Identical topredicate device
	• Blade Assemblies –polyetherimide,polyacrylamide, stainless steel	• Blade Assemblies –polyetherimide,polyacrylamide, stainless steel
	• Endoscope – stainless steel,titanium, PEEK, Sapphire glass,CASTIN lead-free solder	• Endoscope - stainless steel,titanium, PEEK, Sapphire glass,CASTIN lead-free solder
	• Sterilization Tray – stainlesssteel, silicone	• Sterilization Tray – stainlesssteel, silicone
	• Accessory Instruments -stainless steel	• Accessory Instruments -stainless steel
Single-Use /Reusable	• Blade Assemblies are singleuse, disposable devices	• Blade Assemblies are singleuse, disposable devices	Identical topredicate device
	• Handpiece, endoscope,sterilization tray, and accessoryinstruments are reusabledevices	• Handpiece, endoscope,sterilization tray, and accessoryinstruments are reusabledevices
Shelf Life	Blade Assemblies have 4 year shelflife	Blade Assemblies have 4 year shelflife	Identical topredicate device
Energy Output	None	None	Identical topredicate device
Battery Operated	No	No	Identical topredicate device
AC Powered	No	No	Identical topredicate device
TechnologicalCharacteristic	SUBJECTSmartRelease Endoscopic SoftTissue Release System	PREDICATE510(K) K181819SmartRelease Endoscopic SoftTissue Release System	Comparison
Complies with ISO10993-1	Yes, complies with ISO 10993-1:2018	Yes, complies with ISO 10993-1:2018	Identical topredicate device
Electrical SafetyTesting	N/A	N/A	Identical topredicate device
Manufacturing
Handpiece	Components machined bothinternally and by externalsuppliers. Anodized by externalsupplier. Assembled, labeled, andpackaged internally.	Components machined bothinternally and by externalsuppliers. Anodized by externalsupplier. Assembled, labeled, andpackaged internally.	Identical topredicate device
Endoscope	Manufactured, labeled, andpackaged complete by externalsupplier.	Manufactured, labeled, andpackaged complete by externalsupplier.	Identical topredicate device
Blade Assemblies	Components molded/manufactured by externalsuppliers. Assembled, packaged,and labeled internally. Sterilizedby external supplier.	Components molded/manufactured by externalsuppliers. Assembled, packaged,and labeled internally. Sterilizedby external supplier.	Identical topredicate device
Sterilization Tray	Manufactured, labeled, andpackaged complete by externalsupplier.	Manufactured, labeled, andpackaged complete by externalsupplier.	Identical topredicate device
AccessoryInstruments	Manufactured and labeledcomplete by external supplier.Packaged internally.	Manufactured and labeledcomplete by external supplier.Packaged internally.	Identical topredicate device
TechnologicalCharacteristic	SUBJECTSmartRelease Endoscopic SoftTissue Release System	PREDICATE510(K) K181819SmartRelease Endoscopic SoftTissue Release System	Comparison
Packaging
Reusable Devices	• Handpiece – placed in a Korrvuinsert (plastic film andcorrugated board), then placedin corrugated shipper box.• Endoscope – placed in acustom-fit foam insert, thenplaced in corrugated shipperbox.• Sterilization Tray – shrink-wrapped with plastic film, thenplaced in corrugated shipperbox.• Accessory Instruments – placedin poly bags, heat-sealed onboth ends.	• Handpiece – placed in a Korrvuinsert (plastic film andcorrugated board), then placedin corrugated shipper box.• Endoscope – placed in acustom-fit foam insert, thenplaced in corrugated shipperbox.• Sterilization Tray – shrink-wrapped with plastic film, thenplaced in corrugated shipperbox.• Accessory Instruments – placedin poly bags, heat-sealed onboth ends.	Identical topredicate device
Sterile Devices(blade assemblies)	Device placed in PETG Tray withTyvek lid, heat sealed on all foursides. Tray placed in SBS box(single- or 6-pack configuration).	Device placed in PETG Tray withTyvek lid, heat sealed on all foursides. Tray placed in SBS box(single- or 6-pack configuration).	Identical topredicate device
Sterilization
Sterilization	• Blade Assemblies are providedsterile via gamma radiation, 25-40kGy• Handpiece, endoscope, and allaccessories are provided non-sterile, to be cleaned andsterilized via steam autoclaveby user prior to each use	• Blade Assemblies are providedsterile via gamma radiation, 25-40kGy• Handpiece, endoscope, and allaccessories are provided non-sterile, to be cleaned andsterilized via steam autoclaveby user prior to each use	Identical topredicate device