(83 days)
The EBI VueCath™ Spinal Endoscopic System is intended to 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 adaptors.
The provided document is a 510(k) summary for the EBI VueCath™ Spinal Endoscopic System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, studies proving device performance against those criteria, sample sizes for testing, ground truth establishment, or human-in-the-loop studies.
Instead, the document primarily focuses on establishing substantial equivalence to existing legally marketed devices based on design, materials, and intended use, and mentions "bench testing demonstrates that the device meets its functional requirements" without providing specifics of that testing.
Therefore, much of the requested information cannot be extracted from this document. I will fill in the requested sections with "Not provided in the document" where the information is absent.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specifically stated (e.g., optical resolution, illumination intensity, catheter flexibility, insertion force) | "bench testing demonstrates that the device meets its functional requirements." (No specific quantitative performance metrics provided.) |
Study Information
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided in the document. The document only vaguely refers to "bench testing."
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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/Not provided. The document does not describe studies involving human interpretation or ground truth establishment by experts. The "bench testing" likely refers to engineering or materials testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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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
- No MRMC study was mentioned. This device is an arthroscope, not an AI-powered diagnostic tool, so such a study would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This device is a physical medical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The document refers to "bench testing" for functional requirements, not clinical ground truth.
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The sample size for the training set
- Not applicable/Not provided. No training set is mentioned as this is a physical device, not a machine learning model.
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How the ground truth for the training set was established
- Not applicable/Not provided.
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Kg827484
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 Food, Drug and Cosmetic Act.
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- Submitter: Jon Caparotta
Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054
- Submitter: Jon Caparotta
Contact Person: Jonas Wilf Telephone: (973) 299-9022 X2208
Date prepared: July 16, 1998
| 2. Proprietary Name: | EBI VueCath ™ Spinal Endoscopic System |
|---|---|
| Common Name: | Arthroscope |
| Classification Name: | Arthroscope and Accessories (888.1100) |
3. 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 4. 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 adaptors.
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- Intended Use: The EBI VueCath Spinal Endoscopic System is intended to 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 7. are no significant differences between the EBI VueCath™ Spinal Endoscopic System and another spinal arthroscope 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 any other product or to "legally marketed" products are intended only to relate 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 itigation or any other context. [Establishment Registration Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)}
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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of an eagle, with its wings forming three distinct, curved lines.
OCT 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jonas Wilf Regulatory Affairs Specialist Electro-Biology, Inc. 6 Upper Pond Rd. Parsippany, New Jersey 07054
Re: K982484 EBI VueCath™ Spinal Endoscopic System Trade Name: Regulatory Class: ı i Product Code: HRX Dated: July 16, 1998 Received: July 17, 1998
Dear Mr. Wilf:
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. ਉ 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 requlations.
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Page 2 - Mr. Jonas Wilf
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) 594-4659. 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,
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
The EBI VueCath™ Spinal Endoscopic System is intended to 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)
coole
06
1982484
§ 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.