Disc-FX System

• K Number: K162490
• Device Name: Disc-FX System
• Manufacturer: ELLIQUENCE LLC
• Date Cleared: 2017-01-06 ( 121 days)
• Product Code: GEI , HRX
• Regulation Number: 878.4400
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K052241 , K100353
• Predicate For: N/A

Intended Use

The Disc-FX System is intended for use in ablation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine.

Device Description

The Disc-FX® System is a single-use, disposable kit which is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine. This device originally received requlatory clearance under 510(k) number K052241 with indications for use limited to the lumbar spine. The design of the Disc-FX® System remains unchanged; the purpose of this 510(k) submission is solely to expand the existing indications of use to include both cervical and thoracic applications.

The Disc-FX® System consists of the following components:

1. Trigger Flex® Bipolar System
2. Triager Flex® Depth Stop
3. Surgical guidewires
4. Straight cannula
5. Beveled cannula
6. Tapered dilator
7. Trephine

AI/ML Overview

This document is a 510(k) premarket notification for the Disc-FX System, seeking to expand its indications for use from only the lumbar spine to include cervical and thoracic applications. The submission primarily relies on demonstrating substantial equivalence to a previously cleared version of the Disc-FX System (K052241) and the Arthrocare Coblator IQ™ Perc-D® Spinewand® (K100353).

The document does not contain acceptance criteria or detailed results of a study proving the device meets specific acceptance criteria in the typical format of a clinical performance study with sensitivity, specificity, or similar metrics. The information provided focuses on non-clinical testing to support substantial equivalence for the expanded indications.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/device performance study. The non-clinical testing sections broadly mention "various performance tests including mechanical testing and simulated use tests" and "Comparison of the thermal effect of the subject device on intervertebral tissue as compared to predicate." However, specific numerical acceptance criteria and reported numerical results against those criteria are not provided for these tests in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not applicable. This submission does not describe a clinical performance study with a test set of patient data to evaluate algorithmic performance. The submission uses non-clinical testing (mechanical, simulated use, thermal effect, electrical safety, biocompatibility).
• Data Provenance: Not applicable.

3. 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 clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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

No such study is mentioned or described in this document. The submission explicitly states: "Clinical testing was not included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is an electrosurgical system, not an AI algorithm. Its performance is evaluated through non-clinical functional tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the non-clinical tests, "ground truth" would relate to engineering specifications, material properties, safety standards, and physiological responses in simulated environments, rather than clinical ground truth diagnoses.

8. The sample size for the training set

Not applicable. The device is a medical instrument (electrosurgical system), not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2017

Elliquence, LLC. Mr. Paul Buhrke IV QA/RA Manager 2455 Grand Avenue Baldwin, New York 11510

Re: K162490

Trade/Device Name: Disc-FX System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HRX Dated: November 22, 2016 Received: November 25, 2016

Dear Mr. Buhrke:

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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162490

Device Name Disc-FX System

Indications for Use (Describe)

The Disc-FX System is intended for use in ablation of intervertebral disc material during discectorny procedures in the cervical, thoracic, and lumbar spine.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510 (k) Summary

(As required by 21 CFR 807.92(a))

Date Prepared

September 2, 2016

Submitter's Information (807.92(a)(1))

Company Name and Address:

Elliquence, LLC. 2455 Grand Avenue Baldwin, NY 11510 Phone: [phone] Fax: [phone] www.elliquence.com

Establishment Registration for Elliquence, LLC is 3007024186.

Contact Information:

Daniel Connell - Regulatory Affairs Associate Phone: [phone] Fax: [phone] Email: [e-mail]

Paul D. Buhrke IV- QA/RA Manager Phone: [phone] Fax: [phone] Email: [e-mail]

Device Information (807.92(a)(2))

Trade Name Disc-FX® System

Common/Usual Name Bipolar electrosurgical device and arthroscopic accessories

elliquence, LLC. 2455 Grand Avenue · Baldwin, New York 11510 [phone] · Fax: [phone] · www.elliquence.com

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K162490

Classification Name and Regulation Arthroscope & Accessories; 21 CFR 888.1100 Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400

Class FDA Classification: Class II FDA Product Code: GEI, HRX

Predicate Devices (807.92(a)(3))

• Disc-FX® System (K052241) ●
• Arthrocare® Coblator IQ™ Perc-D® Spinewand® (K100353) ●

Device Description (807.92(a)(4))

The Disc-FX® System is a single-use, disposable kit which is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine. This device originally received requlatory clearance under 510(k) number K052241 with indications for use limited to the lumbar spine. The design of the Disc-FX® System remains unchanged; the purpose of this 510(k) submission is solely to expand the existing indications of use to include both cervical and thoracic applications.

The Disc-FX® System consists of the following components:

• 1. Trigger Flex® Bipolar System
• 2. Triager Flex® Depth Stop
• 3. Surgical guidewires
• 4. Straight cannula
• 5. Beveled cannula
• 6. Tapered dilator
• 7. Trephine

Intended Use (807.92(a)(5))

The Disc-FX® System is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine.

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Image /page/5/Figure/0 description: The image shows a logo for a company called "Olliquence Innovative Medical Solutions". The logo is black and white and features a stylized image of a person's back. The text "K162490" is also present in the upper right corner of the image.

Substantial Equivalence Comparison (807.92(a)(6))

The Disc-FX® System is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the two chosen predicate devices:

• (1) Disc-FX® System (K052241)
• (2) Arthrocare® Coblator IQTM Perc-D® Spinewand® (K100353)

The following chart provides a side-by-side comparison of the Subject Device and the two predicate devices:

	Disc-FX® System(Subject Device)	Disc-FX® System (K052241)	ArthroCare® Coblator IQTMPerc-D® SpineWand®(K100353)
510(k)submitter/holder	elliquence, LLC	Original submitter: EllmanInternational Inc.Current holder: elliquence, LLC	ArthroCare Corp.
Intended use	The Disc-FX® System isintended for use in ablation andcoagulation of intervertebraldisc material during discectomyprocedures in the cervical,thoracic, and lumbar spine.	The Disc-FX® System isintended for use in ablation andcoagulation of intervertebraldisc material during discectomyprocedures in the lumbar spine.	The ArthroCare® Coblator IQTMPerc-D® SpineWand® isindicated for ablation,coagulation, anddecompression of disc materialto treat symptomatic patientswith contained herniated discs.
Target anatomy	Cervical, thoracic, and lumbarspine	Lumbar spine	Cervical, thoracic, and lumbarspine
Deviceclassification andcode(s)	Arthroscope: Class II, HRXElectrosurgical accessory:Class II, GEI	Arthroscope: Class II, HRXElectrosurgical accessory:Class II, GEI	Electrosurgical accessory:Class II, GEI
Regulation(s)	21 CFR 888.1100: Arthroscope& Accessories21 CFR 878.4000:Electrosurgical Cutting &Coagulation Device andAccessories	21 CFR 888.1100: Arthroscope& Accessories21 CFR 878.4000:Electrosurgical Cutting &Coagulation Device andAccessories	21 CFR 878.4000:Electrosurgical Cutting &Coagulation Device andAccessories
Principle ofoperation	Bipolar electrosurgery	Bipolar electrosurgery	Bipolar electrosurgery
Mechanics ofaction	Ablation & coagulation ofintervertebral disc material	Ablation & coagulation ofintervertebral disc material	Ablation & coagulation ofintervertebral disc material
Components	1. Trigger-Flex®2. Depth-stop3. Guidewires4. Cannula, straight5. Cannula, beveled6. Tapered dilator7. Trephine	1. Trigger-Flex®2. Depth-stop3. Guidewires4. Cannula, straight5. Cannula, beveled6. Tapered dilator7. Trephine	1. ArthroCare® CoblatorIQTM Perc-D®SpineWand® (variousmodels)2. (Used with separately-marketed/clearedneedles/cannulas)
	Disc-FX® System(Subject Device)	Disc-FX® System (K052241)	ArthroCare® Coblator IQ™Perc-D® SpineWand®(K100353)
Access cannula /instrumentationdiameter	3.3mm outer diameter (cannula)	3.3mm outer diameter (cannula)	Used with 17G cannula(~1.5mm outer diameter) or19G cannula (~1.1mm outerdiameter)(*Separate from 510(k)submission)
Electrode diameter	2.5mm	2.5mm	0.8mm or 1.0mm (varies bymodel)
Electrode shaftlength	240mm	240mm	76mm, 157mm, 208mm,219mm or 274mm (varies bymodel)
Manual controls	Yes; compression of Trigger-Flex® handle controls distal tipprotrusion	Yes; compression of Trigger-Flex® handle controls distal tipprotrusion	No
RF energy source	elliquence Surgi-Max®generators	elliquence Surgi-Max®generators	ArthroCare® Coblator IQ™Controller
Maximum poweroutput (Wattage)	120W	120W	400W
RF outputfrequency	1.7 MHz	1.7 MHz	100 kHz
Patient leakagecurrent	Type BF	Type BF	Type BF
Activation method	Footswitch	Footswitch	Footswitch
Internalmemory/circuitryfor generatorrecognition	None	None	None
Single-use only	Yes	Yes	Yes
Supplied sterile /sterilization method	Yes / Ethylene oxide	Yes / Ethylene oxide	Yes / Irradiation
Expiration dating	Yes	Yes	Yes
Packaging	Sterile blister tray, cardboardbox	Sterile blister tray, cardboardbox	Sterile blister tray, cardboardbox
Materialcomposition	Bipolar Probe (Trigger-Flex®):ABS, nylon 12, Loctite, PVC,SUS 304 stainless steel, nickel-plated stainless steel,polypropylene, silicon, andcopper	Bipolar Probe (Trigger-Flex®):ABS, nylon 12, Loctite, PVC,SUS 304 stainless steel, nickel-plated stainless steel,polypropylene, silicon, andcopper	Bipolar probe (Perc-D®SpineWand®): Stainless steel,polycarbonate
	Access components:ABS and SUS 304 stainlesssteel	Access components:ABS and SUS 304 stainlesssteel	Access components:Stainless steel, plastic
Patient-contactingmaterials	Stainless steel, nylon 12,Loctite	Stainless steel, nylon 12,Loctite	Stainless steel, polycarbonate
Temperature Probe	No	No	No
Cooling function	Saline attachment capability	Saline attachment capability	Saline attachment capability

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Non-Clinical Testing (807.92(b)(1))

Testing included to support substantial equivalence:

• Various performance tests including mechanical testing and simulated use tests ●
• Comparison of the thermal effect of the subject device on intervertebral tissue as ● compared to predicate
• Electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2
• Testing to support the shelf life determination and sterility of the product ●
• . Biocompatibility analysis

Clinical Testing (807.92(b)(2))

Clinical testing was not included in this submission.

Conclusion (807.92(b)(3))

Based upon a comparison of the intended uses, technological characteristics, and performance testing, we have concluded that the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.