(73 days)
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.
The Sonex Health SX-One MicroKnife is a mechanical device that uses a blade to manually transect the transverse carpal ligament. The device is provided sterile and intended for single use.
The SX-One MicroKnife® consists of a thin stainless-steel shaft connected to a handpiece that is designed to be ambidextrous. A lever on the handle is activated to unlock the blade actuator and inflate the two balloons located on the lateral sides of the tip of the device. The blade actuator is used to activate a cutting blade that transects the TCL. The cutting blade is manually moved proximally and distally along a track. The purpose of the blade is to transect the transverse carpal ligament to treat carpal tunnel syndrome.
This document describes the Sonex Health SX-One MicroKnife, a manual surgical instrument for carpal tunnel release. The information provided is primarily related to its regulatory clearance (510(k) submission) and does not contain details about acceptance criteria, clinical study results, or AI/software performance.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC studies, as the provided text explicitly states "No clinical data was required" and describes a mechanical device with no mention of AI or software.
The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance testing related to sterilization, biocompatibility, and shelf life for a mechanical surgical instrument.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Research Use (FDA 21 CFR 201.260 or 21 CFR 809.10(c)(2)(i)) | |
|---|---|
| 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 Health11 1st Avenue SW, Suite 202Rochester, MN 55902 |
|---|---|
| Contact Person: | Aaron KeenanVice President, OperationsPhone: (507) 219-1464Fax: (507) 201-8766 |
| 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(K080158) |
| Device Description: | The Sonex Health SX-One MicroKnife is a mechanical device thatuses a blade to manually transect the transverse carpal ligament.The device is provided sterile and intended for single use. |
| Device Operation: | The SX-One MicroKnife® consists of a thin stainless-steel shaftconnected to a handpiece that is designed to be ambidextrous. Alever on the handle is activated to unlock the blade actuator andinflate the two balloons located on the lateral sides of the tip of thedevice. The blade actuator is used to activate a cutting blade thattransects the TCL. The cutting blade is manually movedproximally and distally along a track. The purpose of the blade isto transect the transverse carpal ligament to treat carpal tunnelsyndrome. |
| Indications for Use: | The SX-One MicroKnife is a disposable device intended to createspace within the carpal tunnel and transect the transversecarpal ligament (TCL) for the treatment of carpal tunnel syndrome |
| TechnologicalCharacteristics: | The Sonex Health SX-One MicroKnife is designed with a bladethat can transect the transverse carpal ligament to treat carpaltunnel syndrome. The subject device also utilizes balloons on thedistal tip, and when inflated, increase the width of the distal tipcreating space in the carpal tunnel to help move tissue away fromthe distal tip to assist the user during TCL transection. |
| Performance Data: | The function of SX-One has been validated through:Performance Testing Sterilization Validation: The sterilization of the subjectdevice was validated per ISO 11137-1:2018 (Sterilizationof medical devices -- Microbiological methods -- Part 1:Determination of a population of microorganisms onproducts) and ISO 11137-2: 2013 (Sterilization of healthcare products -- Radiation -- Part 2: Establishing thesterilization dose) Biocompatibility: Cytotoxicity, Sensitization, andIrritation, and Acute Systemic Toxicity was performed. Shelf Life: The shelf life of the subject device wassubstantiated by accelerated aging performance testing perASTM F1980-16 (Standard Guide for Accelerated Agingof 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 DeviceSonex Health SX-One MicroKnife | Primary Predicate DeviceOrthomet Anatomically GuidedCarpal 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 DeviceSonex Health SX-One MicroKnife | Primary Predicate DeviceOrthomet Anatomically GuidedCarpal Tunnel Release |
|---|---|---|
| Indications for Use | The SX-One MicroKnife is adisposable device intended to createspace within the carpal tunnel andtransect the transverse carpalligament for the treatment of carpaltunnel syndrome. | The Orthomet Anatomically GuidedCarpal Tunnel Release System isintended for accessing andsurgically cutting the transversecarpal ligament for the surgicaltreatment of carpal tunnelsyndrome. |
| Intended Region | Wrist | Same, Wrist |
| Intended Use | To cut the transverse carpalligament | Same, To cut the transverse carpalligament |
| TechnologicalCharacteristics | Uses a blade to manually cut thetransverse carpal ligament to treatcarpal tunnel syndrome | Same, Uses a blade to manually cutthe transverse carpal ligament totreat carpal tunnel syndrome |
| Cuts the TransverseCarpal Ligament? | Yes | Same, Yes |
| Clinical Benefit | To treat carpal tunnel syndrome | Same, To treat carpal tunnelsyndrome |
| Single Use? | Yes | Same, Yes |
| Provided Sterile? | Yes | Same, Yes |
| Number ofComponents | Two.MicroKnife and Syringe | Three.Curved anatomic guide, nerveprobe, guide knife |
| Ambidextrous | Yes | No. Curved anatomic guide isprovided in both a right and lefthand 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.
§ 888.4540 Orthopedic manual surgical instrument.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.