(121 days)
No
The summary describes a mechanical and electrical system for surgical procedures and explicitly states the design is unchanged from a previous clearance, with the submission focused solely on expanding indications for use. There is no mention of AI or ML components or functionality.
Yes
The device is intended for ablation and coagulation of intervertebral disc material during discectomy procedures, which aims to treat a medical condition.
No
The device is described as being used for "ablation and coagulation of intervertebral disc material during discectomy procedures," which indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (Trigger Flex® Bipolar System, cannulas, dilator, trephine, etc.) and the performance studies include mechanical testing, electrical safety testing, and biocompatibility analysis, all indicative of a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ablation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The components listed (cannulas, dilator, trephine, etc.) are surgical instruments used for accessing and manipulating tissue within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such testing on specimens.
The Disc-FX System is a surgical device used in vivo (within the living body) for a therapeutic purpose (ablation of disc material).
N/A
Intended Use / Indications for 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.
Product codes
GEI, HRX
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:
-
- Trigger Flex® Bipolar System
-
- Triager Flex® Depth Stop
-
- Surgical guidewires
-
- Straight cannula
-
- Beveled cannula
-
- Tapered dilator
-
- Trephine
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic, and lumbar spine.
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
Non-Clinical Testing:
- 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: Not included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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Image /page/3/Picture/1 description: The image is a logo of a person's back. The logo is white and is on a dark blue background. The person in the logo is facing away from the viewer and has their arms raised.
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: (516) 277-9000 Fax: (516) 277-9001 www.elliquence.com
Establishment Registration for Elliquence, LLC is 3007024186.
Contact Information:
Daniel Connell - Regulatory Affairs Associate Phone: (516) 277-9036 Fax: (516) 277-9011 Email: dconnell@elliquence.com
Paul D. Buhrke IV- QA/RA Manager Phone: (516) 277-9010 Fax: (516) 277-9011 Email: pbuhrke@elliquence.com
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 (516) 277.9000 · Fax: (516) 277.9001 · www.elliquence.com
4
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))
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:
-
- Trigger Flex® Bipolar System
-
- Triager Flex® Depth Stop
-
- Surgical guidewires
-
- Straight cannula
-
- Beveled cannula
-
- Tapered dilator
-
- 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:
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 IQTM
Perc-D® SpineWand®
(K100353) |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
submitter/holder | elliquence, LLC | Original submitter: Ellman
International Inc.
Current holder: elliquence, LLC | ArthroCare Corp. |
| 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. | The Disc-FX® System is
intended for use in ablation and
coagulation of intervertebral
disc material during discectomy
procedures in the lumbar spine. | The ArthroCare® Coblator IQTM
Perc-D® SpineWand® is
indicated for ablation,
coagulation, and
decompression of disc material
to treat symptomatic patients
with contained herniated discs. |
| Target anatomy | Cervical, thoracic, and lumbar
spine | Lumbar spine | Cervical, thoracic, and lumbar
spine |
| Device
classification and
code(s) | Arthroscope: Class II, HRX
Electrosurgical accessory:
Class II, GEI | Arthroscope: Class II, HRX
Electrosurgical accessory:
Class II, GEI | Electrosurgical accessory:
Class II, GEI |
| Regulation(s) | 21 CFR 888.1100: Arthroscope
& Accessories
21 CFR 878.4000:
Electrosurgical Cutting &
Coagulation Device and
Accessories | 21 CFR 888.1100: Arthroscope
& Accessories
21 CFR 878.4000:
Electrosurgical Cutting &
Coagulation Device and
Accessories | 21 CFR 878.4000:
Electrosurgical Cutting &
Coagulation Device and
Accessories |
| Principle of
operation | Bipolar electrosurgery | Bipolar electrosurgery | Bipolar electrosurgery |
| Mechanics of
action | Ablation & coagulation of
intervertebral disc material | Ablation & coagulation of
intervertebral disc material | Ablation & coagulation of
intervertebral disc material |
| Components | 1. Trigger-Flex®
2. Depth-stop
3. Guidewires
4. Cannula, straight
5. Cannula, beveled
6. Tapered dilator
7. Trephine | 1. Trigger-Flex®
2. Depth-stop
3. Guidewires
4. Cannula, straight
5. Cannula, beveled
6. Tapered dilator
7. Trephine | 1. ArthroCare® Coblator
IQTM Perc-D®
SpineWand® (various
models)
2. (Used with separately-
marketed/cleared
needles/cannulas) |
| | Disc-FX® System
(Subject Device) | Disc-FX® System (K052241) | ArthroCare® Coblator IQ™
Perc-D® SpineWand®
(K100353) |
| Access cannula /
instrumentation
diameter | 3.3mm outer diameter (cannula) | 3.3mm outer diameter (cannula) | Used with 17G cannula
(~1.5mm outer diameter) or
19G cannula (~1.1mm outer
diameter)
(*Separate from 510(k)
submission) |
| Electrode diameter | 2.5mm | 2.5mm | 0.8mm or 1.0mm (varies by
model) |
| Electrode shaft
length | 240mm | 240mm | 76mm, 157mm, 208mm,
219mm or 274mm (varies by
model) |
| Manual controls | Yes; compression of Trigger-
Flex® handle controls distal tip
protrusion | Yes; compression of Trigger-
Flex® handle controls distal tip
protrusion | No |
| RF energy source | elliquence Surgi-Max®
generators | elliquence Surgi-Max®
generators | ArthroCare® Coblator IQ™
Controller |
| Maximum power
output (Wattage) | 120W | 120W | 400W |
| RF output
frequency | 1.7 MHz | 1.7 MHz | 100 kHz |
| Patient leakage
current | Type BF | Type BF | Type BF |
| Activation method | Footswitch | Footswitch | Footswitch |
| Internal
memory/circuitry
for generator
recognition | 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, cardboard
box | Sterile blister tray, cardboard
box | Sterile blister tray, cardboard
box |
| Material
composition | Bipolar Probe (Trigger-Flex®):
ABS, nylon 12, Loctite, PVC,
SUS 304 stainless steel, nickel-
plated stainless steel,
polypropylene, silicon, and
copper | Bipolar Probe (Trigger-Flex®):
ABS, nylon 12, Loctite, PVC,
SUS 304 stainless steel, nickel-
plated stainless steel,
polypropylene, silicon, and
copper | Bipolar probe (Perc-D®
SpineWand®): Stainless steel,
polycarbonate |
| | Access components:
ABS and SUS 304 stainless
steel | Access components:
ABS and SUS 304 stainless
steel | Access components:
Stainless steel, plastic |
| Patient-contacting
materials | 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 |
6
7
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.