(70 days)
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No
The document describes a standard endoscopic system with a fiberscope and accessories for visualization. There is no mention of AI, ML, image processing, or any data analysis beyond direct visualization.
No
The device is used for observing epidural anatomy, pathology, and assisting in the diagnosis of disease. It can also deliver drugs approved for epidural indications, but its primary function as described is diagnostic and observational, not directly therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "may be used by physicians for the illumination and visualization of tissues of the epidural space... for the purpose of assisting in the diagnosis of disease".
No
The device description explicitly lists hardware components such as a fiberscope, disposable catheter, and various accessories, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for observing anatomy, pathology, and delivering drugs. It also mentions assisting in the diagnosis of disease by visualizing tissues in vivo.
- Device Description: The device is described as an arthroscope used for viewing spinal anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is used for direct visualization and intervention within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lumbar and sacral spine, epidural space, sacral hiatus
Indicated Patient Age Range
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Intended User / Care Setting
physicians / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
bench testing demonstrates that the device meets its functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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.
0
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) |
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- 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.
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- 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.)]
1
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.
2
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
3
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