(155 days)
Not Found
No
The device description and intended use focus on the physical characteristics of the needle and its use with existing nerve stimulators and ultrasound devices. There is no mention of AI or ML in the provided text, and the "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a nerve location needle, used to locate peripheral nerves. It does not provide any therapeutic intervention itself, but rather aids in a diagnostic or preparatory step for a procedure like regional anesthesia.
No
This device is used for locating peripheral nerves, which is a procedural aid, not a diagnostic function that identifies a disease or condition.
No
The device description explicitly states the device includes a stainless steel cannula and connections, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
- Temena Nerve Location Needles: The description clearly states the needles are used in regional anesthesia procedures for the location of peripheral nerves within the body, using a nerve stimulator and/or ultrasound. This is an in vivo procedure, meaning it's performed inside the body.
The device's function is to facilitate a medical procedure performed directly on the patient, not to analyze samples taken from the patient.
N/A
Intended Use / Indications for Use
The Temena Nerve Location Needles are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves with a nerve stimulator and/or with an ultrasound device.
Product codes
BSP
Device Description
The Temena Hybrid and USC Nerve Location Needles include a stainless steel cannula and connections for anesthetic administration and with the Hybrid Needle a connection for nerve stimulation. The needle is available in a range of lengths and 21 or 22 AWG. The USC (uncoated version) may be used for echo nerve location and the Hybrid (coated version) for both stimulator and echo location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
anesthesiologists or other trained professionals / regional anesthesia procedures
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
Substantial Equivalence: The Temena Hybrid needle is identical to the already cleared Te me na UPC Needle under K990100 with modifications to the coating and surface for use as either echo or stimulation nerve location. Testing has been performed under Design Controls to confirm these changes with acceptable results.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY - K080603 (as required by 807.92(c))
| Regulatory Correspondent | Regulatory and Marketing Services
962 Allegro Lane
Apollo Beach, FL 33572 | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter of 510(k): | TE ME NA
16, rue des Entrepreneurs
Z.I. des Amandiers
F-78420 CARRIERES-SUR-SEINE
FRANCE 78420
Phone: 011-331-30860530
Fax: | |
| Contact Person: | Wilhelm Waskönig | |
| Date of Summary: | July 23, 2008 | |
| Trade/Proprietary Name:
Uncoated (USC) | Temena Nerve Location Needles Coated (Hybrid) and | |
| Classification Name: | Anesthesia Conduction Needle | |
| Product Code: | BSP | |
Intended Use:
The Temena Nerve Location Needles are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves with a nerve stimulator and/or with an ultrasound device.
Device Description:
The Temena Hybrid and USC Nerve Location Needles include a stainless steel cannula and connections for anesthetic administration and with the Hybrid Needle a connection for nerve stimulation. The needle is available in a range of lengths and 21 or 22 AWG. The USC (uncoated version) may be used for echo nerve location and the Hybrid (coated version) for both stimulator and echo location.
Predicate Device:
Temena UPC Nerve Stimulator Needle -- K990100 Havel Echostim Facit Tip K063380
1
Substantial Equivalence:
The Temena Hybrid needle is identical to the already cleared Te me na UPC Needle under K990100 with modifications to the coating and surface for use as either echo or stimulation nerve location. Testing has been performed under Design Controls to confirm these changes with acceptable results. Therefore this Te me na hybrid needle is considered to be substantially equivalent.
2
| Characteristics | Hybrid and USC | Temena
K990100 | Havel K063380 |
|-----------------------------------|-------------------------|-----------------------------------|---------------|
| Nerve Location | Yes | Yes | Yes |
| Electro Stimulation | Yes | Yes | Yes |
| Echo Location | Yes | No | Yes |
| Sizes | 21-22 awg | 21-30 awg | 21 awg |
| Lengths | 35-150mm | 25-150mm | 40-150mm |
| Coating | Parylene
(Nanolyene) | Teflon | Nanoline |
| Uncoated Version | Yes | No | Yes |
| Packaging | Single Teflon
Sealed | Same | Same |
| Sterilization | ETO | ETO | ETO |
| Regional Anesthesia | Yes | Yes | Yes |
| Anesthetic
Administration Line | Yes | Yes | Yes |
| Needle Tip | Bevel | Pencil Point (UPA)
Bevel (UPC) | Bevel |
| Coating | Hybrid Yes, USC
No | Yes | Yes |
| Tip Roughness | Yes | No | Yes |
Te me na 510(k) Device Comparison Chart Hybrid and USC Needles
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol on the right, which is a symbol of medicine and health. To the left of the caduceus is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 2008
Te Me Na SAS C/O Mr. Arthur Ward Regulatory and Marketing Services RMS Regulatory & Marketing Services, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K080603
Trade/Device Name: Hybrid (Coated) and USC (Uncoated) Nerve Location Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: July 23, 2008 Received: July 28, 2008
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.
4
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Himmelsferd, mr foel/
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
Enclosure
5
Indications for Use
510(k) Number (if known): K080603
Device Name: Hybrid (Coated) and USC (Uncoated) Nerve Location Needle
Indications for Use:
The Temena Nerve Location Needles are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves with a nerve stimulator and/or with an ultrasound device.
Prescription Use (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)
Mr. Thad
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
080603 510(k) Number:
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