(70 days)
When used with a fiberoptic endoscope, the EBI VueCath™ Spinal Endoscopic System can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.
In addition, the system may be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.
The EBI VueCath™ Endoscopic Spinal System is an arthroscope consisting of several components and different accessories for viewing the lumbar and sacral spinal anatomy. This system includes a fiberscope, disposable catheter, and various accessories. The fiberscope is designed to connect to any compatible commercially available endoscopic video imaging system by using a camera coupler and light cord adapters.
This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the EBI VueCath™ Spinal Endoscopic System. It is a submission to the FDA (Food and Drug Administration) to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
The request asks for information related to acceptance criteria and a study proving the device meets these criteria. However, this 510(k) summary does not contain the level of detail typically found in a clinical study report for AI/software-as-a-medical-device (SaMD) products. This submission is for an endoscopic system, which is a physical medical device, not a diagnostic AI algorithm. Therefore, many of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "sample size for training set," are not applicable to this type of device and submission.
The "study" referenced in this document is primarily a comparison to predicate devices and bench testing to confirm functional requirements.
Here's the closest possible answer based on the provided text, acknowledging the limitations:
Acceptance Criteria and Device Performance Study
As this is a submission for a physical medical device (an endoscopic system), not an AI/SaMD product, the concept of "acceptance criteria" and "study" differs significantly from what might be expected for an AI algorithm. The primary "acceptance criteria" for this device, as implied by the 510(k) process, is substantial equivalence to existing legally marketed predicate devices, along with meeting its functional requirements through bench testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence | Substantially equivalent to Myelotec Myeloscope System |
| Functional Requirements | Bench testing demonstrates that the device meets its functional requirements |
| Materials | Medical grade polyurethane (catheter), polyimide (fiberscope outer jacket) |
| Intended Use | - Observing epidural anatomy, pathology and drug delivery- Illumination and visualization for diagnosis assistance |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a physical device, "test set" and "data provenance" as described typically refer to clinical data. This document relies on bench testing and comparison to predicates, not a clinical trial with a "test set" in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided and is not applicable to this type of device submission. Ground truth for diagnostic accuracy is not the focus here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable.
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
This information is not provided and is not applicable. This is a physical endoscopic system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This describes a physical endoscopic system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "bench testing" mentioned, the "ground truth" would be the engineering specifications and functional requirements of the device. For example, if a criterion is "light output intensity," the ground truth is the specified intensity in lumens, and the device is tested against that. For safety, this would involve material compatibility and sterility testing, where "ground truth" is established through industry standards and regulatory requirements for biocompatibility and sterilization.
8. The sample size for the training set
This information is not provided and is not applicable. This is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable.
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Kq90459
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI Spinal Endoscopic System is provided as required per Section 513(1)(3) of the Federal Food. Drug and Cosmetic Act.
| 1. Submitter: | Jon Caparotta |
|---|---|
| Electro-Biology, Inc. | |
| 100 Interpace Parkway | |
| Parsippany. NJ 07054 | |
| Contact Person: | Jonas Wilf |
| Telephone: | (973) 299-9022 X2208 |
Date prepared: February 11, 1999
| 2. Proprietary Name: | EBI VueCath™ Spinal Endoscopic System |
|---|---|
| Common Name: | Catheter |
| Classification Name: | Catheter, Conduction, Anesthesia (868.5120) |
-
- Predicate or legally marketed* devices that are substantially equivalent:
- . EBI Spinal Endoscopic System - Electro-Biology, Inc.
- . Myelotec Myeloscope System - Myelotec Inc.
- Description of the device: The EBI VueCath™ Endoscopic Spinal System is an arthroscope ব consisting of several components and different accessories for viewing the lumbar and sacral spinal anatomy. This system includes a fiberscope, disposable catheter, and various accessories. The fiberscope is designed to connect to any compatible commercially available endoscopic video imaging system by using a camera coupler and light cord adapters.
- న. Intended Use: When used with a fiberoptic endoscope, the EBI VueCath™ Spinal Endoscopic System can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.
In addition, the system may be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.
- Materials: The catheter is the patient contacting portion of the system. It is manufactured from 6. medical grade polyurethane. The outer jacket of the fiberscope is made out of polyimide.
-
- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI VueCath™ Spinal Endoscopic System and another spinal arthroscopes and endoscopes currently on the market. It is substantially equivalent to the virtually identical Myelotec Myeloscope System device in design, materials and intended use. * Also, bench testing demonstrates that the device meets its functional requirements.
* Any statements made in conjunction with this submission regarding a determination of substantial equivalence to to "legally marketed" products are intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and are not intended to be relevant to or interpreted as an admission or any other patent infringement litigation or any other context. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 1999
Mr. Jon Caparotta Manager, Regulatory Affairs Electro Biology, Inc. 100 Interpace Parkway Parsippany, New Jersey 07054
K990459 Re: Trade Name: EBI VueCath™ Spinal Endoscopic System Regulatory Class: II Product Code: HRX Dated: February 11, 1999 Received: February 12, 1999
Dear Mr. Caparotta:
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.
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Page 2 - Mr. Jon Caparotta
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,
fr 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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Statement of Indications for Use:
When used with a fiberoptic endoscope, the EBI VueCath™ Spinal Endoscopic System can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.
In addition, the system may be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.
Prescription Use
(Per 21 CFR 801.109)
bcottifo
visior 510(k) Num
§ 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.