(79 days)
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 and nucleotomy.
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.
The provided text describes a medical device submission (510(k)) for the Endius Endoscopic Spinal Access System. This document is a premarket notification for a medical device seeking clearance based on substantial equivalence to a predicate device, not a study reporting on the device's performance against specific acceptance criteria.
As such, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth methods because it is not a clinical study report. It is a registration document for a medical device.
Therefore, I cannot provide the requested table and study details.
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AUG 1 3 1000
大991784 Section 7 - 510(k) Summary of Safety and Effectiveness
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| 7.1Statement | This summary of 510(k) safety and effectiveness information is being submittedin accordance with the requirements of SMDA 1990 and CFR 807.92 | |
|---|---|---|
| 7.2Submitter | Endius, Inc.23 West Bacon StreetPlainville, MA. 02762 | |
| 7.3CompanyContact | Susan FinneranQA/ RA Manager508-643-0983 | |
| 7.4Device Name: | Proprietary Name: Endoscopic Spinal Access SystemCommon Name: Endoscopic Spinal Access SystemClassification Name: Endoscope and Accessories | |
| 7.5PredicateLegallyMarketedDevices | MicroEndoscopic Discectomy SystemSofamor Danek USAMemphis, TN. 38132 | |
| 7.6DeviceDescription | The Endoscopic Spinal Access System is a family of devices which areintended to be used to gain access and visualization to the spine in order to aidin various spinal procedures. | |
| 7.7DeviceIndications andIntended use | Indications for Use: The Endius Endoscopic Access System is intended to beused for posterior endoscopic access to the lumbar spine for variousendoscopic spinal procedures such as discectomy and nucleotomy. |
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The Endius Endoscopic Spinal Access System is substantially equivalent to the 7.8 Sofamore Danek USA Microendoscopic System (Memphis, TN) Substantial Equivalence A summary of the features of the two systems follows:
| 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 retractor Mount |
| ProductLabeling | Non-sterile, ReusableFor 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 nucleotomy and discectomy |
| Intended use | The System is used to access the lumbar Spine | The system will be used to access the lumbar spine |
Applicant
Date 8/9/99
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of a bird or eagle in flight, with three distinct lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 13 1999
Ms. Susan Finneran Quality Assurance/Regulatory Affairs Manager Endius. Inc. 23 West Bacon Street Plainville, Massachusetts 02762
Re: K991794
Trade Name: Endius Endoscopic Access System Regulatory Class: II Product Code: HRX Dated: May 25,1999 Received: May 26, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
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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 vours.
Sincerely, years,
Colin McWhirter, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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11: 33:
510(k) Number (if known): K991794
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 and nucleotomy.
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Concurence of CDRH, Office of Device Evaulation (ODE) (Optional Format 3-10-98) (Posted July 1, 1998)
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of General Restorative Device
Prescription Use
X
(Per 21 CFR 801.109)
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§ 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.