Disc-FX System

K162490 · Elliquence, LLC · GEI · Jan 6, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162490
• Device Name: Disc-FX System
• Applicant: Elliquence, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Disc-FX System is a single-use, disposable kit for intervertebral disc ablation/coagulation during discectomy. System components include Trigger-Flex bipolar probe, depth stop, guidewires, straight/beveled cannulas, tapered dilator, and trephine. Operated by physicians in clinical settings; utilizes bipolar electrosurgery via connection to Surgi-Max generators. Physician uses manual handle compression to control distal tip protrusion; footswitch activates RF energy. Saline attachment provides cooling. Device enables minimally invasive disc material removal; intended to benefit patients by facilitating discectomy procedures across cervical, thoracic, and lumbar regions.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including mechanical performance, simulated use, thermal effect analysis on tissue, electrical safety/EMC testing, shelf-life/sterility validation, and biocompatibility analysis.

Technological Characteristics

Bipolar electrosurgical device. Materials: ABS, nylon 12, Loctite, PVC, SUS 304 stainless steel, nickel-plated stainless steel, polypropylene, silicon, copper. RF energy source: Surgi-Max generator (1.7 MHz, 120W max). Connectivity: Standalone. Sterilization: Ethylene oxide. Form factor: Single-use kit with 3.3mm cannula and 2.5mm electrode. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2.

Indications for Use

Indicated for ablation and coagulation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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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#### 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<br>(Subject Device) | Disc-FX® System (K052241) | ArthroCare® Coblator IQTM<br>Perc-D® SpineWand®<br>(K100353) |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>submitter/holder | elliquence, LLC | Original submitter: Ellman<br>International Inc.<br>Current holder: elliquence, LLC | ArthroCare Corp. |
| Intended use | The Disc-FX® System is<br>intended for use in ablation and<br>coagulation of intervertebral<br>disc material during discectomy<br>procedures in the cervical,<br>thoracic, and lumbar spine. | The Disc-FX® System is<br>intended for use in ablation and<br>coagulation of intervertebral<br>disc material during discectomy<br>procedures in the lumbar spine. | The ArthroCare® Coblator IQTM<br>Perc-D® SpineWand® is<br>indicated for ablation,<br>coagulation, and<br>decompression of disc material<br>to treat symptomatic patients<br>with contained herniated discs. |
| Target anatomy | Cervical, thoracic, and lumbar<br>spine | Lumbar spine | Cervical, thoracic, and lumbar<br>spine |
| Device<br>classification and<br>code(s) | Arthroscope: Class II, HRX<br>Electrosurgical accessory:<br>Class II, GEI | Arthroscope: Class II, HRX<br>Electrosurgical accessory:<br>Class II, GEI | Electrosurgical accessory:<br>Class II, GEI |
| Regulation(s) | 21 CFR 888.1100: Arthroscope<br>& Accessories<br>21 CFR 878.4000:<br>Electrosurgical Cutting &<br>Coagulation Device and<br>Accessories | 21 CFR 888.1100: Arthroscope<br>& Accessories<br>21 CFR 878.4000:<br>Electrosurgical Cutting &<br>Coagulation Device and<br>Accessories | 21 CFR 878.4000:<br>Electrosurgical Cutting &<br>Coagulation Device and<br>Accessories |
| Principle of<br>operation | Bipolar electrosurgery | Bipolar electrosurgery | Bipolar electrosurgery |
| Mechanics of<br>action | Ablation & coagulation of<br>intervertebral disc material | Ablation & coagulation of<br>intervertebral disc material | Ablation & coagulation of<br>intervertebral disc material |
| Components | 1. Trigger-Flex®<br>2. Depth-stop<br>3. Guidewires<br>4. Cannula, straight<br>5. Cannula, beveled<br>6. Tapered dilator<br>7. Trephine | 1. Trigger-Flex®<br>2. Depth-stop<br>3. Guidewires<br>4. Cannula, straight<br>5. Cannula, beveled<br>6. Tapered dilator<br>7. Trephine | 1. ArthroCare® Coblator<br>IQTM Perc-D®<br>SpineWand® (various<br>models)<br>2. (Used with separately-<br>marketed/cleared<br>needles/cannulas) |
| | Disc-FX® System<br>(Subject Device) | Disc-FX® System (K052241) | ArthroCare® Coblator IQ™<br>Perc-D® SpineWand®<br>(K100353) |
| Access cannula /<br>instrumentation<br>diameter | 3.3mm outer diameter (cannula) | 3.3mm outer diameter (cannula) | Used with 17G cannula<br>(~1.5mm outer diameter) or<br>19G cannula (~1.1mm outer<br>diameter)<br>(*Separate from 510(k)<br>submission) |
| Electrode diameter | 2.5mm | 2.5mm | 0.8mm or 1.0mm (varies by<br>model) |
| Electrode shaft<br>length | 240mm | 240mm | 76mm, 157mm, 208mm,<br>219mm or 274mm (varies by<br>model) |
| Manual controls | Yes; compression of Trigger-<br>Flex® handle controls distal tip<br>protrusion | Yes; compression of Trigger-<br>Flex® handle controls distal tip<br>protrusion | No |
| RF energy source | elliquence Surgi-Max®<br>generators | elliquence Surgi-Max®<br>generators | ArthroCare® Coblator IQ™<br>Controller |
| Maximum power<br>output (Wattage) | 120W | 120W | 400W |
| RF output<br>frequency | 1.7 MHz | 1.7 MHz | 100 kHz |
| Patient leakage<br>current | Type BF | Type BF | Type BF |
| Activation method | Footswitch | Footswitch | Footswitch |
| Internal<br>memory/circuitry<br>for generator<br>recognition | None | None | None |
| Single-use only | Yes | Yes | Yes |
| Supplied sterile /<br>sterilization method | Yes / Ethylene oxide | Yes / Ethylene oxide | Yes / Irradiation |
| Expiration dating | Yes | Yes | Yes |
| Packaging | Sterile blister tray, cardboard<br>box | Sterile blister tray, cardboard<br>box | Sterile blister tray, cardboard<br>box |
| Material<br>composition | Bipolar Probe (Trigger-Flex®):<br>ABS, nylon 12, Loctite, PVC,<br>SUS 304 stainless steel, nickel-<br>plated stainless steel,<br>polypropylene, silicon, and<br>copper | Bipolar Probe (Trigger-Flex®):<br>ABS, nylon 12, Loctite, PVC,<br>SUS 304 stainless steel, nickel-<br>plated stainless steel,<br>polypropylene, silicon, and<br>copper | Bipolar probe (Perc-D®<br>SpineWand®): Stainless steel,<br>polycarbonate |
| | Access components:<br>ABS and SUS 304 stainless<br>steel | Access components:<br>ABS and SUS 304 stainless<br>steel | Access components:<br>Stainless steel, plastic |
| Patient-contacting<br>materials | Stainless steel, nylon 12,<br>Loctite | Stainless steel, nylon 12,<br>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.