(80 days)
Not Found
No
The device description focuses on optical and mechanical components, and there is no mention of AI, ML, or image processing capabilities. The performance studies are related to thermal, electrical, optical, sterilization, and biocompatibility safety, not algorithmic performance.
No
The device is described as an endoscope used for visualization and to facilitate surgical intervention, not to provide therapy itself.
No
Explanation: The "Intended Use" section states that the endoscopes are for "indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery," and the "Device Description" states they allow "insertion of microsurgical instrumentation to perform endoscopic intervention." This indicates the device is used for visualization during surgical intervention rather than diagnosing a condition.
No
The device description explicitly states it is an "optical and fiber optic based rigid endoscope" with physical components like working channels, outer diameters, and working lengths. It also mentions being reusable and delivered in non-sterile conditions, requiring sterilization validation. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery." This describes a device used during a surgical procedure to visualize the internal anatomy.
- Device Description: The description details an "optical and fiber optic based rigid endoscope" with working channels for inserting surgical instruments. This is a surgical tool for visualization and intervention within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes based on analyzing such samples.
The device is clearly a surgical endoscope used for visualization and facilitating surgical procedures within the spinal column. This falls under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Elliquence endoscopes are indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
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°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical and fiber optic based
Anatomical Site
Spinal column, cervical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Thermal Safety: Temperature profile studies according to IEC 60601-2-18 conducted to prove sufficient thermal safety. Results show thermal hazards may be excluded if devices are used according to indications.
- Electrical Safety: Devices tested according to IEC 60601-2-18, covering interconnection test and capacitive coupled HF current. Results indicate electrical safety as required.
- Optical Performance: Continuously checked during final inspection of devices; every device checked for optical performance before final release.
- Sterilization: Safety and efficiency of specified sterilization cycle validated under ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665, and EN ISO 17664.
- Biocompatibility: Subjected to biocompatibility testing to ISO 10993-1 with greatest challenge devices, providing evidence of acceptable levels of biocompatibility.
Clinical Testing: This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
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.
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.
Not Found
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
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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
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: (516) 277-9000 Fax: (516) 277-9001 www.elliquence.com
Establishment Registration for Elliquence, LLC is 3007024186.
Contact Information: Peter Browne - Regulatory Affairs Associate Phone: (516) 277-9036 Fax: (516) 277-9037 Email: pbrowne@elliquence.com
Paul D. Buhrke IV - Director, Global Sales & Operations Phone: (516) 277-9010 Fax: (516) 277-9011 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 | ||
| Endoscopes | K130778 | RZ Medizintechnik |
4
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 (516) 277.9000 · Fax: (516) 277.9001 · www.elliquence.com
5
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.