(25 days)
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.
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.
The provided 510(k) summary for the EBI® TargetCath™ Fluoro-Guided Steerable Catheter System is for a medical device, not an AI/ML-driven diagnostic or assistive technology. Therefore, many of the typical acceptance criteria and study components related to AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment for AI, and training/test set details) are not applicable to this submission.
This submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, intended use, and mechanical testing. The information provided does not contain details about acceptance criteria in the context of an AI/ML algorithm's diagnostic performance, nor does it describe a study designed to prove such performance.
Here's an analysis based on the information provided, highlighting why certain AI-specific questions cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "mechanical testing demonstrates that the device meets its functional requirements." However, it does not provide a table with specific acceptance criteria (e.g., tensile strength, steerability force, drug delivery rate consistency) or quantitative performance data to show the device meets those criteria. The comparison is made against a predicate device, focusing on substantial equivalence rather than novel performance claims requiring specific quantitative acceptance thresholds.
2. Sample size used for the test set and the data provenance:
- Not Applicable in the AI/ML context. For a mechanical device, a "test set" would refer to the number of devices subjected to mechanical or bench testing. The document does not specify the sample size for this mechanical testing.
- Data Provenance: Not applicable in the context of clinical data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the AI/ML context. The ground truth for this device would be established by engineering specifications and objective measurements from mechanical tests, not by expert interpretation of data relevant to an AI algorithm.
4. Adjudication method for the test set:
- Not Applicable in the AI/ML context. Adjudication methods like "2+1" are used for resolving disagreements among human readers in a diagnostic setting, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is specifically designed to evaluate the diagnostic performance of an AI system, often comparing it with human readers or human readers assisted by AI. This is not relevant for a steerable catheter system demonstrating substantial equivalence through mechanical testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no AI algorithm involved in this device.
7. The type of ground truth used:
- Mechanical Specifications/Engineering Standards: For a physical device like a catheter, the "ground truth" would be established by predefined engineering specifications, material properties, and functional requirements verified through physical and mechanical testing. The document states "mechanical testing demonstrates that the device meets its functional requirements," implying such a ground truth.
8. The sample size for the training set:
- Not Applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established:
- Not Applicable. There is no AI model or training set involved.
In summary, both the acceptance criteria and the study described in this 510(k) summary are for a conventional medical device (a catheter) and not for an AI/ML-powered system. Therefore, the questions posed, which are tailored for AI/ML device evaluations, are largely not applicable. The core of this submission is demonstrating "substantial equivalence" to a predicate device through comparison of design, materials, intended use, and general statement of meeting functional requirements via mechanical testing.
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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 ParkwayParsippany, NJ 07054 | Tel: (973) 299-9300, x2208 |
July 30, 2003 Date prepared:
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- Proprietary Name: EBI® TargetCath™ Fluoro-Guided Steerable Catheter 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 TargetCath™ Fuoro-Guided Steerable Catheter - EBI, L.P.
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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.
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- 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.)]
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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 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.
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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
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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
§ 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).