(48 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, 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)
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 510(k) submission for the "Endius Endoscopic Spinal Access System." This document is a premarket notification for a medical device seeking clearance based on substantial equivalence to an existing device, not a study proving device performance against acceptance criteria in the way a clinical trial for an AI/ML device would.
Therefore, most of the requested information (items 1 through 9) related to a study proving device performance against acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission.
The 510(k) process focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This is primarily done through comparison of device descriptions, indications for use, technological characteristics, and material compositions.
Here's a breakdown of what can be extracted from the provided text, while also explicitly stating what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document is a 510(k) summary demonstrating substantial equivalence, not a clinical study with predefined acceptance criteria and performance metrics. The "performance" assessment here is conceptual, comparing the new device's features and safety/effectiveness profile to that of a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of a clinical performance study described in this document. The submission relies on a comparison table to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a surgical access system, not an AI/ML medical imaging device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to AI/ML algorithm performance, which is not relevant to this mechanical surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for performance evaluation is described. The "ground truth" for the 510(k) process is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No training set ground truth is discussed.
Information that is available from the provided text:
While the document doesn't fit the mold of an AI/ML device performance study, it does highlight the regulatory process for a physical medical device. Here's a summary of the relevant information provided:
- Device Name: Endius Endoscopic Spinal Access System
- Predicate Device: MicroEndoscopic Discectomy System (Sofamor Danek USA)
- Indications for Use: Posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy and non-instrumented posterolateral fusion procedures.
- Warnings/Limitations: Not intended 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).
- Substantial Equivalence Justification: The document provides a "Table of Substantial Equivalent Device Similarities" comparing:
- Product Components: Both have Guidewire/Dilator Set, Tubular Retractor (or similar), Endoscope, Light Source, Camera and Control unit, and Flexible Arm Assembly (or similar).
- Product Labeling: Both are primarily Non-sterile, Reusable (with minor variations for specific components).
- Materials: Both are primarily Stainless Steel and Anodized Aluminum.
- Indications/Intended Use: Both are for accessing the lumbar spine for visualization and various spinal procedures. The Endius system specifies discectomy, nucleotomy, and non-instrumented posterolateral fusions.
The FDA's decision letter (FEB 16 2000) confirms that the device was found substantially equivalent to the predicate device for the stated indications for use, thereby allowing it to be marketed. This regulatory approval is the "proof" in this context, demonstrating that the device meets the safety and effectiveness standards by being comparable to an already approved device.
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Section 7 - 510(k) Summary of Safety and Effectiveness 2 / 945
| 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, nucleotomy and non-instrumented posterolateral fusion procedures. | |
| Warning: The Endius Endoscopic Access System is not intended to be |
.
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Ksi 94425
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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 | |
| 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 Flexposureretractor |
| Materials | Material composition is primarily Stainless Steeland Anodized Aluminum | Material composition is primarilyStainless Steel and AnodizedAluminum |
| Indications | Posterior lateralvisualization | Various Spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateralfusions. |
| Intended use | The System is used toaccess the lumbar Spine | The system will be used to accessthe lumbar spine. |
Applicant Susan Fun
Date 12/28/99
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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.
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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
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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)
§ 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.