SX-One MicroKnife

K192873 · Sonex Health, Inc. · LXH · Dec 20, 2019 · Orthopedic

Device Facts

• Record ID: K192873
• Device Name: SX-One MicroKnife
• Applicant: Sonex Health, Inc.
• Product Code: LXH · Orthopedic
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

Device Story

Mechanical surgical instrument; used for carpal tunnel release. Device features thin stainless-steel shaft, ambidextrous handpiece, and integrated balloons at distal tip. User activates lever on handle to inflate balloons, creating space within carpal tunnel; blade actuator then deploys cutting blade. Blade is manually moved proximally and distally along track to transect transverse carpal ligament (TCL). Used in clinical setting by surgeons. Output is physical transection of TCL; facilitates decompression of carpal tunnel. Benefits patient by providing minimally invasive surgical treatment for carpal tunnel syndrome.

Clinical Evidence

No clinical data was required. Bench testing included sterilization validation, biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), and accelerated aging shelf-life testing.

Technological Characteristics

Stainless-steel shaft; ambidextrous handpiece; integrated inflatable balloons at distal tip. Manual blade actuation. Sterile, single-use. Sterilization per ISO 11137-1:2018 and ISO 11137-2:2013. Shelf life per ASTM F1980-16.

Indications for Use

Indicated for patients requiring surgical treatment of carpal tunnel syndrome via transection of the transverse carpal ligament.

Regulatory Classification

Identification

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Predicate Devices

• Orthomet Anatomically Guided Carpal Tunnel Release (K943873)

Reference Devices

• LB Medical Inflatable Tissue Elevator/Expander System (K080158)

Submission Summary (Full Text)

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December 20, 2019

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Sonex Health, Inc. % Keri Ng Consultant Keri Ng Consulting 11 1st Ave SW Rochester, Minnesota 55902

Re: K192873

Trade/Device Name: SX-One MicroKnife Regulation Number: 21 CFR 888.4540 Regulation Name: Orthopedic Manual Surgical Instrument Regulatory Class: Class I, reserved Product Code: LXH Dated: October 7, 2019 Received: October 8, 2019

Dear Keri Ng:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192873

Device Name SX-One MicroKnife

Indications for Use (Describe)

The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

Type of Use (Select one or both, as applicable)

| <div></div> | Research Use (FDA 21 CFR 201.260 or 21 CFR 809.10(c)(2)(i)) |
|-------------|-------------------------------------------------------------|
| <div></div> | For Emergency Use Only (21 CFR 56.104(c)) |

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Number: K192873 Date Submitted: December 20, 2019

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K192873 Page 1 of 3

Sonex Health, Inc. SX-One MicroKnife®

Traditional 510(k)

| Sponsor/Submitter: | Sonex Health<br>11 1st Avenue SW, Suite 202<br>Rochester, MN 55902 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Aaron Keenan<br>Vice President, Operations<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | December 20, 2019 |
| Device Trade Name: | Sonex Health SX-One MicroKnife |
| Common Name: | Carpal Tunnel Release System |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 888.4540 |
| Classification Name: | Orthopedic Manual Surgical Instrument |
| Product Code: | LXH |
| Primary Predicate Device: | Orthomet Anatomically Guided Carpal Tunnel Release (K943873) |
| Reference Device: | LB Medical Inflatable Tissue Elevator/Expander System<br>(K080158) |
| Device Description: | The Sonex Health SX-One MicroKnife is a mechanical device that<br>uses a blade to manually transect the transverse carpal ligament.<br>The device is provided sterile and intended for single use. |
| Device Operation: | The SX-One MicroKnife® consists of a thin stainless-steel shaft<br>connected to a handpiece that is designed to be ambidextrous. A<br>lever on the handle is activated to unlock the blade actuator and<br>inflate the two balloons located on the lateral sides of the tip of the<br>device. The blade actuator is used to activate a cutting blade that<br>transects the TCL. The cutting blade is manually moved<br>proximally and distally along a track. The purpose of the blade is<br>to transect the transverse carpal ligament to treat carpal tunnel<br>syndrome. |
| Indications for Use: | The SX-One MicroKnife is a disposable device intended to create<br>space within the carpal tunnel and transect the transverse<br>carpal ligament (TCL) for the treatment of carpal tunnel syndrome |
| Technological<br>Characteristics: | The Sonex Health SX-One MicroKnife is designed with a blade<br>that can transect the transverse carpal ligament to treat carpal<br>tunnel syndrome. The subject device also utilizes balloons on the<br>distal tip, and when inflated, increase the width of the distal tip<br>creating space in the carpal tunnel to help move tissue away from<br>the distal tip to assist the user during TCL transection. |
| Performance Data: | The function of SX-One has been validated through:<br>Performance Testing Sterilization Validation: The sterilization of the subject<br>device was validated per ISO 11137-1:2018 (Sterilization<br>of medical devices -- Microbiological methods -- Part 1:<br>Determination of a population of microorganisms on<br>products) and ISO 11137-2: 2013 (Sterilization of health<br>care products -- Radiation -- Part 2: Establishing the<br>sterilization dose) Biocompatibility: Cytotoxicity, Sensitization, and<br>Irritation, and Acute Systemic Toxicity was performed. Shelf Life: The shelf life of the subject device was<br>substantiated by accelerated aging performance testing per<br>ASTM F1980-16 (Standard Guide for Accelerated Aging<br>of Sterile Barrier Systems for Medical Devices). |
| Clinical Data: | No clinical data was required. |
| Animal Data: | No animal performance data was required. |

SECTION 5: 510(K) SUMMARY

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# Sonex Health, Inc. SX-One MicroKnife®

K192873 Page 2 of 3

## Traditional 510(k)

| Predicate Device Comparison | | |
|-----------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------|
| Attribute | Subject Device<br>Sonex Health SX-One MicroKnife | Primary Predicate Device<br>Orthomet Anatomically Guided<br>Carpal Tunnel Release |
| 510(k) number | TBD | K943873 |
| Clearance Date | TBD | April 26, 1995 |
| Manufacturer | Sonex Health | Orthomet |
| Trade Name | SX-One MicroKnife | Anatomically Guided Carpal Tunnel Release |
| Common Name | Carpal Tunnel Release System | Same, Carpal Tunnel Release System |
| Class | Class I | Same, Class I |
| Product Code | LXH | Same, LXH |
| Classification Section | 888.4540 | Same, 888.4540 |

#### Predicate Device ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ :

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### Sonex Health, Inc. SX-One MicroKnife®

| Attribute | Subject Device<br>Sonex Health SX-One MicroKnife | Primary Predicate Device<br>Orthomet Anatomically Guided<br>Carpal Tunnel Release |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The SX-One MicroKnife is a<br>disposable device intended to create<br>space within the carpal tunnel and<br>transect the transverse carpal<br>ligament for the treatment of carpal<br>tunnel syndrome. | The Orthomet Anatomically Guided<br>Carpal Tunnel Release System is<br>intended for accessing and<br>surgically cutting the transverse<br>carpal ligament for the surgical<br>treatment of carpal tunnel<br>syndrome. |
| Intended Region | Wrist | Same, Wrist |
| Intended Use | To cut the transverse carpal<br>ligament | Same, To cut the transverse carpal<br>ligament |
| Technological<br>Characteristics | Uses a blade to manually cut the<br>transverse carpal ligament to treat<br>carpal tunnel syndrome | Same, Uses a blade to manually cut<br>the transverse carpal ligament to<br>treat carpal tunnel syndrome |
| Cuts the Transverse<br>Carpal Ligament? | Yes | Same, Yes |
| Clinical Benefit | To treat carpal tunnel syndrome | Same, To treat carpal tunnel<br>syndrome |
| Single Use? | Yes | Same, Yes |
| Provided Sterile? | Yes | Same, Yes |
| Number of<br>Components | Two.<br>MicroKnife and Syringe | Three.<br>Curved anatomic guide, nerve<br>probe, guide knife |
| Ambidextrous | Yes | No. Curved anatomic guide is<br>provided in both a right and left<br>hand configuration |
| Flexible Distal Tip? | Yes | Same, Yes |

Summary of Substantial Equivalence:

The Sonex Health SX-One MicroKnife is substantially equivalent to the predicate device as confirmed through relevant performance tests and attributes. There are no differences between the subject and predicate device affecting the safety and effectiveness of the SX-One MicroKnife.