(25 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description and performance studies focus on mechanical functionality and drug delivery, not data analysis or algorithmic processing.
Yes
The device is used for "delivery of drugs approved for epidural indications," which is a therapeutic purpose, and also for "assisting in the diagnosis and treatment of disease."
Yes
The "Intended Use / Indications for Use" section states: "The System may also be used for the purpose of assisting in the diagnosis and treatment of disease utilizing a caudal approach via the sacral hiatus."
No
The device description explicitly states the system includes a "disposable catheter, and various accessories," indicating it is a hardware-based medical device with physical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The EBI® TargetCath™ Fluoro-Guided Steerable Catheter System is a device used within the body (in vivo) to deliver drugs or assist in diagnosis and treatment directly in the lumbar and sacral spine.
- Intended Use: The intended use clearly describes a procedure performed on a patient, not a test performed on a sample.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
When used with a fluoroscope, the EBI® TargetCath™ Fluoro-Guided Steerable Catheter System can be used in the lumbar and sacral spine for delivery of drugs approved for epidural indications. The System may also be used for the purpose of assisting in the diagnosis and treatment of disease utilizing a caudal approach via the sacral hiatus.
Product codes
BSO
Device Description
The EBI® TargetCath™ Fluoro-Guided Steerable Catheter System consists of several components and different accessories for delivery of approved epidural drugs. This system includes a disposable catheter, and various accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscope
Anatomical Site
lumbar and sacral spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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)
Not Found
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).
0
03239o
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI® TargetCath™ Fluoro-Guided Steerable Catheter System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.
| 1. Submitter: EBI, L.P. | Contact Person: Frederic Testa |
|---|---|
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | Tel: (973) 299-9300, x2208 |
July 30, 2003 Date prepared:
-
- Proprietary Name: EBI® TargetCath™ Fluoro-Guided Steerable Catheter System Common Name: Catheter Classification Name: Catheter, Conduction, Anesthesia (868.5120)
-
- Predicate or legally marketed* devices that are substantially equivalent:
EBI TargetCath™ Fuoro-Guided Steerable Catheter - EBI, L.P.
-
- Description of the device: The EBI® TargetCath™ Fluoro-Guided Steerable Catheter System consists of several components and different accessories for delivery of approved epidural drugs. This system includes a disposable catheter, and various accessories.
-
- Intended Use: When used with a fluoroscope, the EBI® TargetCath™ Fluoro-Guided Steerable Catheter can be used in the lumbar and sacral spine for observing epidural anatomy, pathology, and delivery of drugs approved for epidural indications.
- Materials: The catheter is the patient contacting portion of the system. It is manufactured 6. from medical grade polyurethane.
- Comparison of the technological characteristics of the device to predicate devices: There 7. are no significant differences between the EBI® TargetCath™ Fluoro-Guided Steerable Catheter System and other spinal systems currently on the market. It is substantially equivalent* to the predicate device(s) in design, materials and intended use. Also, mechanical testing demonstrates that the device meets its functional requirements.
- Any statement made in conjunction with this substantial equivalence to any other product is intended only to clare o whether the product can be lawfully market approval or reclassfication and is not interded to be interpreted as an admission or any other type of evidence in patent infringement litigation and Prenarket 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 features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
AUG 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Barry Sands Senior Director, Regulatory Affairs and Clinical Research EBI.L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K032390
Trade/Device Name: EBI® TargetCath™ Fluoro-Guided Steerable Catheter System Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: July 30, 2003 Received: August 4, 2003
Dear Mr. Sands:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Barry Sands
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Focelia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
Page / _of /
510(k) Number (if known): K032390
Device Name: EBI® TargetCath™ Fluoro-Guided Steerable Catheter System
Indications For Use:
When used with a fluoroscope, the EBI® TargetCath™ Fluoro-Guided Steerable Catheter System can be used in the lumbar and sacral spine for delivery of drugs approved for epidural indications. The System may also be used for the purpose of assisting in the diagnosis and treatment of disease utilizing a caudal approach via the sacral hiatus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
Division Sion-Off Division of General, Restorative and Neurological Devices
510(k) Number K032390