Endiscope, Endiscope Cervical

K180766 · Elliquence, LLC · HRX · Jun 11, 2018 · Orthopedic

Device Facts

• Record ID: K180766
• Device Name: Endiscope, Endiscope Cervical
• Applicant: Elliquence, LLC
• Product Code: HRX · Orthopedic
• Decision Date: Jun 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Indications for Use

Elliquence endoscopes are indicated for visualization of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.

Device Story

Endiscope and Endiscope Cervical are rigid, optical and fiber-optic based endoscopes designed for visualization during spinal endoscopic procedures and minimally invasive surgery. Devices feature working channels (2.2 mm to 4.3 mm) for insertion of microsurgical instrumentation; outer diameters range from 3.6 mm to 7.0 mm; working lengths from 95 mm to 208 mm. Devices are reusable and non-sterile upon delivery. Operated by surgeons in clinical settings; compatible with standard fiber optic light sources, video adapters, and cameras (e.g., Storz, Olympus, Wolf). Provides direct visualization of the intraoperative site to assist in procedures like endoscopic-assisted discectomy. Benefits include minimally invasive access to the spinal column.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including thermal safety (IEC 60601-2-18), electrical safety (IEC 60601-2-18), optical performance verification, sterilization validation (ANSI/AAMI ST81, TIR12, EN ISO 17665/17664), and biocompatibility (ISO 10993-1).

Technological Characteristics

Rigid optical/fiber-optic endoscope. Working channels: 2.2-4.3 mm. Outer diameters: 3.6-7.0 mm. Working lengths: 95-208 mm. Viewing angle: 80° +/- 5°. Direction of view: 0°/6° or 30°. Reusable. Compatible with standard external light sources/cameras. Biocompatibility per ISO 10993-1. Electrical/thermal safety per IEC 60601-2-18.

Indications for Use

Indicated for visualization of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery in patients undergoing spinal or minimally invasive surgical interventions.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Discoscopes, Cervical Endoscopes (K130778)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below. The logos are placed side-by-side.

June 11, 2018

Elliquence, LLC Paul Buhrke, IV Director, Global Sales & Operations 2455 Grand Avenue Baldwin, New York 11510

Re: K180766

Trade/Device Name: Endiscope, Endiscope Cervical Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: May 17, 2018 Received: June 6, 2018

Dear Paul Buhrke, IV:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Jennifer R. Stevenso 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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Expiration Date: 06/30/2020

See PRA Statement below.

Form Approved: OMB No. 0910-0120

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K180766

Device Name Endiscope, Endiscope Cervical

Indications for Use (Describe)

Elliquence endoscopes are indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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K180766

Image /page/3/Picture/1 description: The image is a sketch of a person from the back. The person is facing away from the viewer, and their head is slightly tilted to the side. The person's back is bare, and their shoulders are visible. The sketch is done in a simple style, with only a few lines used to create the image.

Image /page/3/Picture/2 description: The image shows the text "Page 1 of 3" at the top. Below that is the logo for "elliquence" in a stylized font. Underneath the word "elliquence" is the phrase "Less Is More" in a smaller font. The logo is in blue and has a curved line above and below the text.

# 510(k) Summary

(As required by 21 CFR 807.92(a))

Date Prepared

March 19, 2018

# 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: Peter Browne - Regulatory Affairs Associate Phone: [phone] Fax: [phone] Email: [e-mail]

Paul D. Buhrke IV - Director, Global Sales & Operations Phone: [phone] Fax: [phone] Email: pbuhrke(@elliquence.com

## Device Information (807.92(a)(2))

Trade Name Endiscope, Endiscope Cervical

Common/Usual Name Spinal Endoscope

Classification Name and Regulation Arthroscope; 21 CFR 888.1100

Class FDA Classification: Class II FDA Product Code: HRX

## Predicate Devices (807.92(a)(3))

| Predicate Device | 510(k) Number | 510(k) Holder |
|-------------------------------------|---------------|-------------------|
| Discoscopes, Cervical<br>Endoscopes | K130778 | RZ Medizintechnik |

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K180766

Image /page/4/Picture/1 description: The image is a simple line drawing of a person's back and shoulders. The person is facing away from the viewer, and their head is slightly turned to the side. The lines are clean and minimal, and the overall effect is one of simplicity and elegance. The drawing captures the basic form of the human body in a stylized way.

Image /page/4/Picture/2 description: The image shows the Elliquence logo with the tagline "Less Is More". The logo is in blue and features a stylized "e" followed by the rest of the company name. Above the logo, the text "Page 2 of 3" is visible, indicating this is part of a multi-page document.

## Device Description (807.92(a)(4))

The Endiscope is an optical and fiber optic based rigid endoscope available with working channels of 2.8 mm, 3.75 mm and 4.3 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the spinal column such as endoscopic assisted discectomy.

The Endiscope Cervical is an optical and fiber optic-based rigid endoscope available with a working channel of 2.2 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the cervical spine.

Elliquence endoscopes may be attached to standard fiber optic light sources, commonly available video adapters and cameras such as Storz, Olympus and Wolf.

The devices are reusable, delivered in non-sterile conditions and available in various designs:

- Outer Diameters from 3.6 mm to 7.0 mm
- Diameter of working channel from 2.2 mm to 4.3 mm ●
- Working length from 95 mm to 208 mm
- Direction of view: 0%6° (Endiscope Cervical), 30° (Endiscope) ●
- Viewing angle 80° +/- 5°

#### Intended Use (807.92(a)(5))

Elliquence endoscopes are indicated for visualization of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.

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

Elliquence endoscopes are substantially equivalent in both intended use and technological characteristics to the previously cleared Discoscopes, Cervical Endoscopes (K130778) by RZ Medizintechnik. An extensive comparison chart concerning key characteristics is provided in Section 12.

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

Testing in order to prove safety and effectivence endoscopes have been performed according to recognized consensus standards and results are conforming to the respective requirements.

#### o Thermal Safety

Temperature profile studies according to IEC 60601-2-18 have been conducted in order to provide evidence of sufficient thermal safety of the devices. Results show, that thermal hazards may be excluded if the devices are used according their indications.

#### o Electrical Safety

The devices subject to this submission have been tested according to the requirements of IEC 60601-2-18. Test setup covered interconnection test and capacitive coupled HF current. Results indicate electrical safety of the devices as required per respective standard.

#### o Optical Performance

Optical performance of our spinal endoscopes is continuously checked during final inspection of the devices. Every device is checked for optical performance before final release.

#### elliquence, LLC.

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

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Image /page/5/Picture/2 description: The image shows the logo for "elliquence" with the tagline "Less Is More" underneath. The logo is in blue and features a stylized "e" with a dot above it. Above the logo, the text "Page 3 of 3" is visible, indicating that this image is the last page of a document.

#### o Sterilization

Safety and efficiency of the specified sterilization cycle referenced within the instructions for use has been validated under consideration of the requirements set out in ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665 and EN ISO 17664.

#### 0 Biocompatibility

The devices have been subjected to biocompatibility testing to ISO 10993-1. Testing has been conducted with greatest challenge devices and provides evidence on acceptable levels of biocompatibility.

#### Clinical Testing (807.92(b)(2))

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

#### Conclusion (807.92(b)(3))

Based on available 510(k) information provided herein, Elliquence endoscopes are considered substantially equivalent to the predicate device in terms of indications for use, material, technology, design and performance specifications.

There are no differences between the devices which would raise new issues of safety or effectiveness.