(767 days)
Not Found
Not Found
No
The summary describes a physical medical device (epidural catheter) and contains no mention of software, algorithms, AI, or ML.
No
The information provided only describes the device as a "Combined End Multilateral Holes (CEMLH) Epidural Catheter." While epidural catheters are often used in therapeutic procedures (like administering analgesia), the description itself does not state that the device is a therapeutic device, nor does it provide "Intended Use / Indications for Use" to clarify its purpose.
No
Explanation: A "Combined End Multilateral Holes (CEMLH) Epidural Catheter" is an invasive medical device used for drug delivery (e.g., anesthesia) or fluid aspiration, not for diagnosing conditions.
No
The device description explicitly states "Combined End Multilateral Holes (CEMLH) Epidural Catheter," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This crucial section for identifying an IVD is "Not Found". IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description "Combined End Multilateral Holes (CEMLH) Epidural Catheter" clearly indicates a device used within the body for delivering substances (likely anesthetic) into the epidural space. This is a therapeutic or procedural device, not a diagnostic one that analyzes samples.
- Lack of IVD-related information: The absence of mentions of image processing, AI/ML (often used in analyzing diagnostic data), input imaging modality, anatomical site (relevant for imaging or sample collection), patient age range (sometimes specified for diagnostic tests), intended user/care setting (often clinical labs for IVDs), and performance study details (common for validating diagnostic accuracy) further supports that this is not an IVD.
In summary, the description points to a medical device used for a procedure, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Not Found
Product codes
73 BSO
Device Description
Combined End Multilateral Holes (CEMLH) Epidural Catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 30 1997
Ms .. Rochelle Froloff CSEN Ltd. ...................... c/o Alexander Medical 9055 Northwest 13th Court Coral Springs, Florida 33071
Re: K951927 Combined End Multilateral Holes (CEMLH) Epidural Catheter Requlatory Class: II (two) Product Code: 73 BSO Dated: March 1, 1997 Received: March 3, 1997
Dear Ms. Froloff:
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 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, qood manufacturing practice, labelinq, 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 Good Manufacturing Practice for Medical Devices: General (GMF) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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.
1
Page 2 - Ms. Rochelle Froloff
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) 594-4646. 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,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health