(175 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrical conductivity and nerve stimulation, not AI/ML processing.
Yes
The device is used for continuous nerve block anesthesia or analgesia, which are therapeutic techniques aimed at managing pain or facilitating medical procedures.
No.
The device's purpose is to facilitate continuous nerve block anesthesia or analgesia, not to diagnose a condition. It helps locate nerves for therapeutic intervention.
No
The device description explicitly states it is a "Stimulating Catheter System" and an "anesthesia conduction catheter that is electrically conductive," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for placing catheters next to nerves for continuous nerve block anesthesia or analgesia. This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is an electrically conductive catheter used for nerve stimulation to locate nerves. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Product codes
BSO, CAZ
Device Description
The Polyplex Stimulating Catheter System is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia.
The Polyplex Stimulating Catheter System is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerves and nerve plexuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY - #K060186 (as required by 807.92(c))
JUL 1 8 2006
| Submitter of 510(k): | TE ME NA SAS
16, Rue Des Entrepreneurs
Carriere Sur Seine, FRANCE 78420 |
|-------------------------|-------------------------------------------------------------------------------|
| | Phone: 011-331-30860530 |
| Contact Person: | Wilhelm Waskonig |
| Date of Summary: | January 3, 2006 |
| Trade/Proprietary Name: | Polyplex Stimulating Catheter System |
| Classification Name: | Catheter, Conduction, Anesthetic |
| Product Code: | BSO, CAZ |
Device Description:
The Polyplex Stimulating Catheter System is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia.
The Polyplex Stimulating Catheter System is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.
Predicate Device:
Te me na – Polymedic Epidural Anesthesia Catheter K991259 Arrow International - StimuCath Continuous Nerve Block Set K021567
Substantial Equivalence:
Te me na claims the proposed device system to be substantially equivalent to the devices previously cleared by FDA in K991259 and K021567. The modifications to the previously have been described in Section 5 of this submission. Te me na claims this equivylence he cause the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical, operational and biological specification as compared to the predicate devices.
1
The similarities and differences between the proposed and predicate devices have been identified and explained in the Comparison Matrix which has been included in Section 9 of this submission. These differences have no effect on safety and effectiveness.
Intended Use:
The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, represented by curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2006
Te Me Na Sas C/O Mr. Arthur Ward RMS Regulatory & Marketing Services, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K060186
Trade/Device Name: Polyplex Stimulating Catheter System Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: July 10, 2006 Received: July 13, 2006
Dear Mr. Ward:
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.
3
Page 2 - Mr. Ward
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.
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K060186
Device Name: POLYPLEX Stimulating Catheter System
Indications for Use:
The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aury Solomon
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on of Anesthesiology, General Hospital, tion Control, Dental Devices