(77 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.
Yes
The device is used for the "delivery of drugs approved for epidural indications" and for "assisting in the diagnosis and treatment of disease," which are therapeutic applications.
Yes
Explanation: 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." The phrase "assisting in the diagnosis" clearly indicates a diagnostic function for the device.
No
The device description explicitly states that the system "consists of several components and different accessories for delivery of approved epidural drugs," including a "disposable catheter, and various accessories," indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of drugs and assisting in the diagnosis and treatment of disease in the body (lumbar and sacral spine). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is a catheter system used for direct intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is an interventional medical device used for procedures within the patient's body, not for testing samples outside the body.
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
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
DEC 1 3 2002
Ko23233
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(1)(3) of the Food, Drug and Cosmetic Act.
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- Submitter: EBI, L.P. Contact Person: Jon Caparotta Tel: (973) 299-9300, x3964 100 Interpace Parkway Parsippany, NJ 07054
9/26/2002 Date prepared:
- Submitter: EBI, L.P. Contact Person: Jon Caparotta Tel: (973) 299-9300, x3964 100 Interpace Parkway Parsippany, NJ 07054
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EBI® TargetCath™ Fluoro-Guided Steerable Catheter System 2. Proprietary Name: Common Name: Catheter Catheter, Conduction, Anesthesia (868.5120) Classification Name:
3. Predicate or legally marketed* devices that are substantially equivalent:
EBI VueCath™ Spinal Endoscopic System - EBI, L.P. Myelotec Video Guided Catheter - Myelotec, Inc. Myelotec Myeloscope System - Myelotec, Inc. Myelotec NaviCath™ Steerable Catheter - Myelotec, Inc. NaviCath™ Steerable Catheter - Clarus Medical, LLC NaviCath™ Steerable Catheter - Visionary™ BioMedical, Inc.
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- 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 న్ 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.
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- Comparison of the technological characteristics of the device to predicate devices: There 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 submintion of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringenent litigation and Prematiet Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)}
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, rendered in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 13 2002
EBI. L.P Jon Caparotta Manager, Regulatory Affairs 100 Interpace Parkway Parsippany, New Jersey 07054
. Re: K023233
Trade/Device Name: EBI® TargetCath™ Fluoro-Guided Steerable Catheter System Regulation Number: 868.5120 Regulation Name: Anesthesia conduction catheter Regulatory Class: Class II Product Code: BSO Dated: September 26, 2002 Received: September 27, 2002
Dear Mr. Caparotta:
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
2
Page 2 - Mr. Jon Caparotta
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.
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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours,
Miriam C. Provost
for Celia M. Witten, Ph.D., MD 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):
Device Name: EBI® TargetCath™ Fluoro-Guided Steerable Catheter System
023233
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
Orvision Sign-Off) Civision of General, Restorative and Neurological Devices
Number K623233