(48 days)
Not Found
Not Found
No
The summary describes a system for physical access and visualization during spinal procedures, with no mention of AI/ML, image processing, or data-driven performance metrics.
No
The Endius Endoscopic Access System is an access and visualization tool for spinal procedures, not a device that directly treats a condition or provides therapy itself.
No
Explanation: The device is described as an "Endoscopic Access System" intended for "posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy and non-instrumented posterolateral fusion procedures." This describes a surgical tool for performing procedures, not for diagnosing conditions.
No
The device description clearly states it is a "family of devices" used to gain access and visualization, implying physical components for surgical procedures, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures". This describes a surgical tool used on the patient's body for a procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description reinforces this by stating it's used to "gain access and visualization to the spine". This is consistent with a surgical access system.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the Endius Endoscopic Access System is a surgical device, not an In Vitro Diagnostic device.
N/A
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 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)
Product codes (comma separated list FDA assigned to the subject device)
HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine
Indicated Patient Age Range
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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)
Not Found
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.
Not Found
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.
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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)