HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED

K080603 · Te ME NA Sas · BSP · Aug 5, 2008 · Anesthesiology

Device Facts

• Record ID: K080603
• Device Name: HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
• Applicant: Te ME NA Sas
• Product Code: BSP · Anesthesiology
• Decision Date: Aug 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Temena Nerve Location Needles (Hybrid and USC) are stainless steel cannulas used in regional anesthesia; operated by anesthesiologists or trained professionals in clinical settings. Hybrid needles feature a coating for nerve stimulation and echo location; USC (uncoated) needles are for echo location. Both include connections for anesthetic administration. Needles facilitate peripheral nerve location via nerve stimulator and/or ultrasound device. By providing precise needle placement, the device assists clinicians in delivering regional anesthesia, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel cannula; 21-22 AWG; 35-150mm lengths. Hybrid version uses Parylene (Nanolyene) coating for nerve stimulation and echo location; USC version is uncoated for echo location. Bevel tip design. Sterilized via ETO. Manual operation; no software or electronic components.

Indications for Use

Indicated for use in regional anesthesia procedures by anesthesiologists or trained professionals to locate peripheral nerves using nerve stimulation and/or ultrasound guidance.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• Temena UPC Nerve Stimulator Needle (K990100)
• Havel Echostim Facit Tip (K063380)

Submission Summary (Full Text)

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# 510(K) SUMMARY - K080603 (as required by 807.92(c))

| Regulatory Correspondent | Regulatory and Marketing Services<br>962 Allegro Lane<br>Apollo Beach, FL 33572 | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter of 510(k): | TE ME NA<br>16, rue des Entrepreneurs<br>Z.I. des Amandiers<br>F-78420 CARRIERES-SUR-SEINE<br>FRANCE 78420<br>Phone: [phone]<br>Fax: | |
| Contact Person: | Wilhelm Waskönig | |
| Date of Summary: | July 23, 2008 | |
| Trade/Proprietary Name:<br>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

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## 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.

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| Characteristics | Hybrid and USC | Temena<br>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<br>(Nanolyene) | Teflon | Nanoline |
| Uncoated Version | Yes | No | Yes |
| Packaging | Single Teflon<br>Sealed | Same | Same |
| Sterilization | ETO | ETO | ETO |
| Regional Anesthesia | Yes | Yes | Yes |
| Anesthetic<br>Administration Line | Yes | Yes | Yes |
| Needle Tip | Bevel | Pencil Point (UPA)<br>Bevel (UPC) | Bevel |
| Coating | Hybrid Yes, USC<br>No | Yes | Yes |
| Tip Roughness | Yes | No | Yes |

# Te me na 510(k) Device Comparison Chart Hybrid and USC Needles

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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.

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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 [phone]. 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 [phone] or [phone] 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

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### 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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