Who is the manufacturer of MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM?

Endius, Inc. filed the 510(k) submission for MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM (K994425).

What is the FDA product code for MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM?

MicroEndoscopic Discectomy System (Sofamor Danek USA).

Who can help prepare an FDA 510(k) submission like MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM

K994425 · Endius, Inc. · HRX · Feb 16, 2000 · Orthopedic

Device Facts

Record ID	K994425
Device Name	MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
Applicant	Endius, Inc.
Product Code	HRX · Orthopedic
Decision Date	Feb 16, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2
Attributes	Therapeutic

Intended Use

the Endius Endoscopic Access System is intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy and non-instrumented posterolateral fusion procedures. Warning: The Endius Endoscopic Access System is not intended to be used for other types of fusion procedures such as posterior lumbar interbody fusions (non-instrumented or instrumented) or posterolateral fusions which employ instrumentation (pedicle screws/cages)

Device Story

Endoscopic Spinal Access System provides surgical access and visualization to lumbar spine. Components include guidewire/dilator set, Flexposure retractor, endoscope, light source, camera/control unit, and Flexarm/scope retractor mount. Used by surgeons in clinical/OR settings to facilitate minimally invasive spinal procedures; discectomy, nucleotomy, non-instrumented posterolateral fusion. System transforms physical access to spinal anatomy into visual output via endoscope/camera chain for surgeon guidance. Benefits include minimally invasive approach to spinal procedures. Device is non-sterile, reusable (except retractor).

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Materials: Stainless steel and anodized aluminum. Components: Guidewire/dilator set, Flexposure retractor, endoscope, light source, camera/control unit, Flexarm. Connectivity: Standalone. Energy: Light source/camera power. Reusable, non-sterile (except retractor).

Indications for Use

Indicated for posterior endoscopic access to the lumbar spine for patients requiring discectomy, nucleotomy, or non-instrumented posterolateral fusion. Contraindicated for posterior lumbar interbody fusions (instrumented or non-instrumented) and instrumented posterolateral fusions.

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

MicroEndoscopic Discectomy System (Sofamor Danek USA)

Related Devices

K991794 — ENDOSCOPIC SPINAL ACCESS SYSTEM · Endius, Inc. · Aug 13, 1999
K002437 — ENDIUS ENDOSCOPIC ACCESS SYSTEM · Endius, Inc. · Oct 2, 2000
K021748 — ENDIUS ATAVI SYSTEM · Endius, Inc. · Jun 26, 2002
K061345 — MODIFICATION TO ENDIUS ATAVI SYSTEM · Endius, Inc. · Jun 6, 2006
K022199 — ENDIUS ATAVI SYSTEM · Endius, Inc. · Oct 2, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ : の 2017年 10:00 lot 2 K994425 Section 7 - 510(k) Summary of Safety and Effectiveness 2 / 945 | 7.1 Statement | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92 | | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 7.2 Submitter | Endius, Inc. 23 West Bacon Street Plainville, MA. 02762 | | | 7.3 Company Contact | Susan Finneran QA/ RA Manager 508-643-0983 | | | 7.4 Device Name: | Proprietary Name: Endoscopic Spinal Access System Common Name: Endoscopic Spinal Access System Classification Name: Endoscope and Accessories | | | 7.5 Predicate Legally Marketed Devices | MicroEndoscopic Discectomy System Sofamor Danek USA Memphis, TN. 38132 | | | 7.6 Device Description | The Endoscopic Spinal Access System is a family of devices which are intended to be used to gain access and visualization to the spine in order to aid in various spinal procedures. | | | 7.7 Device Indications and Intended use | Indications for Use: the Endius Endoscopic Access System is intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy and non- instrumented posterolateral fusion procedures. | | | | Warning: The Endius Endoscopic Access System is not intended to be | | - . {1}------------------------------------------------ Ksi 94425 2082 used for other types of fusion procedures such as posterior lumbar interbody fusions (non-instrumented or instrumented) or posterolateral fusions which employ instrumentation. ## 7.8 Substantial Equivalence The Endius Endoscopic Spinal Access System is substantially equivalent to the Sofamore Danek USA Microendoscopic System (Memphis, TN) A summary of the features of the two systems follows: | Table of Substantial Equivalent Device Similarities | | | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | | MED System | Endius Spinal Access | | Product Components | • 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 retractor Mount | | Product Labeling | Non-sterile, Reusable For all components with the exception of the scope | Non-sterile, Reusable for all components except Flexposure retractor | | Materials | Material composition is primarily Stainless Steel and Anodized Aluminum | Material composition is primarily Stainless Steel and Anodized Aluminum | | Indications | Posterior lateral visualization | Various Spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusions. | | Intended use | The System is used to access the lumbar Spine | The system will be used to access the lumbar spine. | Applicant Susan Fun Date 12/28/99 {2}------------------------------------------------ Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other. Public Health Service FEB 16 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Susan Finneran Quality Assurance/Regulatory Affairs Manager Endius, Incorporated 23 West Bacon Street Plainville, Massachusetts 02762 Re: K994425 Trade Name: Endius Endoscopic Access System Regulatory Class: II Product Code: HRX Dated: December 29, 1999 Received: December 30, 1999 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 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. 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. 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. {3}------------------------------------------------ Page 2 – Ms. Susan Finneran 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, i.i.i.i.i.i. James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## 510(k) Number (if known): Device Name: Endius Endoscopic Access System Indications for Use: the Endius Endoscopic Access System is intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy and non-instrumented posterolateral fusion procedures. Warning: The Endius Endoscopic Access System is not intended to be used for other types of fusion procedures such as posterior lumbar interbody fusions (non-instrumented or instrumented) or posterolateral fusions which employ instrumentation (pedicle screws/cages) Ninel ignm Division Sign-Off Division of General Restorative Devices 510(k) Number . (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) Prescription Use (Per 21 CFR 801.109) (Optional Format 3-10-98)