(73 days)
No
The device description and performance studies focus on mechanical function and sterilization, with no mention of AI or ML.
Yes
The device is intended to treat a medical condition (carpal tunnel syndrome) by performing a medical procedure (transecting the transverse carpal ligament).
No
Explanation: The device description clearly states its purpose is to "manually transect the transverse carpal ligament" to treat carpal tunnel syndrome, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a mechanical device with a blade, shaft, handpiece, lever, and balloons, indicating it is a physical hardware device, not software only.
Based on the provided information, the SX-One MicroKnife is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SX-One MicroKnife Function: The SX-One MicroKnife is a surgical device used to physically cut the transverse carpal ligament within the body. It is a mechanical tool for a surgical procedure, not for analyzing biological samples.
The description clearly states its purpose is to "create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome." This is a direct intervention on the body, not an analysis of a sample taken from the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LXH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The function of SX-One has been validated through: Performance Testing Sterilization Validation: The sterilization of the subject device was validated per ISO 11137-1:2018 (Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products) and ISO 11137-2: 2013 (Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose) Biocompatibility: Cytotoxicity, Sensitization, and Irritation, and Acute Systemic Toxicity was performed. Shelf Life: The shelf life of the subject device was substantiated by accelerated aging performance testing per ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Orthomet Anatomically Guided Carpal Tunnel Release (K943873)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
LB Medical Inflatable Tissue Elevator/Expander System (K080158)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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,
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
11 1st Avenue SW, Suite 202
Rochester, MN 55902 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Aaron Keenan
Vice President, Operations
Phone: (507) 219-1464
Fax: (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 that
uses 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 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. |
| Indications for 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 |
| Technological
Characteristics: | The Sonex Health SX-One MicroKnife is designed with a blade
that can transect the transverse carpal ligament to treat carpal
tunnel syndrome. The subject device also utilizes balloons on the
distal tip, and when inflated, increase the width of the distal tip
creating space in the carpal tunnel to help move tissue away from
the 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 subject
device was validated per ISO 11137-1:2018 (Sterilization
of medical devices -- Microbiological methods -- Part 1:
Determination of a population of microorganisms on
products) and ISO 11137-2: 2013 (Sterilization of health
care products -- Radiation -- Part 2: Establishing the
sterilization dose) Biocompatibility: Cytotoxicity, Sensitization, and
Irritation, and Acute Systemic Toxicity was performed. Shelf Life: The shelf life of the subject device was
substantiated by accelerated aging performance testing per
ASTM F1980-16 (Standard Guide for Accelerated Aging
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 | |
| Sonex Health SX-One MicroKnife | Primary Predicate Device | |
| Orthomet Anatomically Guided | ||
| 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
Sonex Health SX-One MicroKnife | Primary Predicate Device
Orthomet Anatomically Guided
Carpal Tunnel Release |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The SX-One MicroKnife is a
disposable device intended to create
space within the carpal tunnel and
transect the transverse carpal
ligament for the treatment of carpal
tunnel syndrome. | The Orthomet Anatomically Guided
Carpal Tunnel Release System is
intended for accessing and
surgically cutting the transverse
carpal ligament for the surgical
treatment of carpal tunnel
syndrome. |
| Intended Region | Wrist | Same, Wrist |
| Intended Use | To cut the transverse carpal
ligament | Same, To cut the transverse carpal
ligament |
| Technological
Characteristics | Uses a blade to manually cut the
transverse carpal ligament to treat
carpal tunnel syndrome | Same, Uses a blade to manually cut
the transverse carpal ligament to
treat carpal tunnel syndrome |
| Cuts the Transverse
Carpal Ligament? | Yes | Same, Yes |
| Clinical Benefit | To treat carpal tunnel syndrome | Same, To treat carpal tunnel
syndrome |
| Single Use? | Yes | Same, Yes |
| Provided Sterile? | Yes | Same, Yes |
| Number of
Components | Two.
MicroKnife and Syringe | Three.
Curved anatomic guide, nerve
probe, guide knife |
| Ambidextrous | Yes | No. Curved anatomic guide is
provided in both a right and left
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.