(680 days)
The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of local anesthetic and/or analgesic solutions into the epidural or Caudal space for up to 72 hours.
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I am sorry. This document is a 510(k) clearance letter from the FDA to Te Me Na S.A.R.L. for their Model C20900-03 Polymedic Epidural Catheter. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The document does not contain information about any AI/ML device, clinical study, acceptance criteria for an AI/ML device, or device performance metrics. Therefore, I cannot provide the requested information based on this text.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2001
Mr. Joe Harms Te Me Na S.A.R.L. c/o Avid-Nit, Inc. 390 Scarlet Boulevard Oldsmar, FL 34677
Re:
K991259 Model C20900-03 Polymedic Epidural Catheter Regulatory Class: II (two) Product Code: 73 BSO Dated: November 22, 2000 Received: November 27, 2000
Dear Mr. Harms:
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 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). 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 requirements, 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
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Page 2 - Mr. Joe Harms
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.
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) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Hypt Rhodes
Image /page/1/Picture/6 description: The image shows a handwritten symbol that appears to be a combination of the letters 'f' and 'a'. The 'f' is written in a cursive style, with a curved top stroke extending to the left. The 'a' is connected to the 'f' and is also written in a cursive style. The symbol is written in black ink on a white background.
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K991259
Te me na SARL Polymedic Epidural Anesthesia Catheter Device Name:
Indications For Use:
The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of Iocal The Te me na Polymedic Epidural Anesuesia Catinece 15 michied of Caudal anesthesia for up to 72 hours.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyatt Claude
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K991259
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).