(54 days)
The Endius Endoscopic Access System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized. The Endius Endoscopic Access System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.
The Endoscopic Access System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used. These include, an endoscope, a light source, light guide, a camera control unit, and a camera head. The Endoscope may be used to visualize the operative site. When using the system for discectomy, nucleotomy, or non-instrumented posterolateral fusion procedures the retractor used with the system has a 16mm diameter tube portion and expands distally in the range of 25-35mm. When the system is used for the placement of pedicle screws a larger retractor may be used. The larger sized retractor has a 20mm diameter tube portion and expands distally in the range of 30-40mm. The camera head, scope, and light guide are supported by a circular mount, which allows manual 360-degree rotation of the scope. The mount is connected to a vacuum powered arm that may be used to manipulate the construct in any position.
This document is a 510(k) summary for the Endius Endoscopic Access System. It describes the device and its intended use, and claims substantial equivalence to a predicate device (Sofamor Danek Microendoscopic Discectomy System). However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent from the provided text.
The document primarily focuses on:
- Identifying the submitter and device.
- Classifying the device.
- Stating its indications for use.
- Claiming substantial equivalence to a predicate device, along with a table comparing features of the two systems.
- The FDA's letter of clearance (K002437).
There is no section dedicated to preclinical or clinical studies, performance data, or an analysis of how the device met specific acceptance criteria.
{0}------------------------------------------------
Section 7 - 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being 7.1 submitted in accordance with the requirement of SMDA 1990 and 21 CFR Statement 807.92
7.2 Endius, Inc. Submitter 23 West Bacon Street Plainville, MA. 02762 (USA)
7.3 Susan Finneran QA/RA Manager, Endius, Inc.) Company Contact 508-643-0983
7.4 Device Name/
Classification
Proprietary Name: Endius Endoscopic Access System Common Name: Endoscopic Spinal Access System Classification Name: Endoscope and Accessories
The devices in the Endoscopic Spinal Access System can be classified as class II, 876.1500 Endoscope and Accessories. The primary device in the system is the endoscope. The accessory equipment is needed to gain access for placement of the endoscope, to support the endoscope in position, or to work with the endoscope for the purpose of visualization.
{1}------------------------------------------------
7.5 Predicate Legally Marketed Devices
Sofamor Danek Microendoscopic Discectomy System (Sofamor Danek Memphis, Tennessee)
7.6 Device The Endoscopic Access System includes instruments used to access the spine Description by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used. These include, an endoscope, a light source, light guide, a camera control unit, and a camera head.
The Endoscope may be used to visualize the operative site. When using the system for discectomy, nucleotomy, or non-instrumented posterolateral fusion procedures the retractor used with the system has a 16mm diameter tube portion and expands distally in the range of 25-35mm.
When the system is used for the placement of pedicle screws a larger retractor may be used. The larger sized retractor has a 20mm diameter tube portion and expands distally in the range of 30-40mm.
The camera head, scope, and light guide are supported by a circular mount, which allows manual 360-degree rotation of the scope. The mount is connected to a vacuum powered arm that may be used to manipulate the construct in any position.
7.7 Indications for Use
The Endius Endoscopic Access System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized.
The Endius Endoscopic Access System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.
7.8 The Endius Endoscopic Spinal Access System is substantially equivalent to the Substantial Sofamore Danek USA Microendoscopic System (Memphis, TN) Equivalence A summary of the features of the two systems follows:
{2}------------------------------------------------
| Table of Substantial Equivalent Device Similarities | ||
|---|---|---|
| MED System | Endius Spinal Access | |
| ProductComponents | Guidewire/ Dilator Set Tubular Retractor Endoscope Light Source Camera and Control unit Flexible Arm Assembly | Guidewire and Dilator Set Flexposure Retractor Endoscope Light Source Camera and control unit Flexarm and Scope retractorMount |
| ProductLabeling | Non-sterile, ReusableFor all components with theexception of the scope | Non-sterile, Reusable for allcomponents except Flexposureretractor |
| Materials | Material composition isprimarily Stainless Steel andAnodized Aluminum | Material composition is primarilyStainless Steel and AnodizedAluminum |
| Indications | Posterior lateral visualization | Access to the spine for variousspinal repair procedures includingnucleotomy, discectomy, non-instrumented fusion procedures,and instrumented fusionprocedures when the TriFixPedicle screw system is used. |
| Intended use | The System is used to accessthe lumbar Spine | The system will be used to accessthe lumbar spine. |
Applicant. Susan Lee
:
Date 8/9/00
:
.
-
- 1
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 2 2000
Ms. Susan Finneran Quality Assurance, Regulatory Affairs Manager Endius, Inc. 23 West Bacon Street Plainville, Massachusetts 02762
Re: K002437
Trade Name: Endius Endoscopic Access System Regulatory Class: II Product Code: HRX Dated: August 8, 2000 Received: August 9, 2000
Dear Ms. Finneran:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls Connect Fee (110). provisions of ation, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major ( regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
Page 2 - Ms. Susan Finneran
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark N Melkerson
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number (if known):
Device Name: Endius Endoscopic Access System
Indications for Use: The Endius Endoscopic Access System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized. The Endius Endoscopic Access System is also intended to be used for posterior endoscopic The Eneral Entrober ppine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Posted July 1, 1998)
Mark N. Mulleken
(Optional Format 3-10-98)
(Division Sign-Off) Division of General Restorative Devices K002437 510(k) Number
§ 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.