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.

AI/ML Overview

The provided text describes a 510(k) summary for the Temena Nerve Location Needles, which seeks substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis. Therefore, much of the requested information cannot be directly extracted as it pertains to a different type of regulatory submission or study design.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Temena UPC Nerve Stimulator Needle K990100 and Havel Echostim Facit Tip K063380) by comparing key characteristics. The "reported device performance" is implicitly that it functions similarly to the predicate devices and the modifications (coating, surface for echo location) were confirmed with "acceptable results" under Design Controls. The table provided is a comparison chart of characteristics rather than an acceptance criteria table with performance metrics.

Characteristic	Temena Hybrid and USC (New Device)	Temena K990100 (Predicate 1)	Havel K0633380 (Predicate 2)
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 Admin. 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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions that "Testing has been performed under Design Controls to confirm these changes with acceptable results." However, it does not specify the sample size for any test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). This information is typically found in detailed validation reports, which are not part of this 510(k) summary. Given the nature of a 510(k) for a Class II device like a needle, the "testing" likely refers to bench testing (e.g., electrical conductivity, mechanical strength, biocompatibility, coating adhesion, visualization properties for ultrasound) rather than a clinical study with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the summary. For a device like this, the "ground truth" for performance would likely be established through objective measurements in laboratory or simulation settings, not typically by expert consensus on clinical data in the way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Given the type of device and the "substantial equivalence" pathway, a formal adjudication process for a test set, as seen in clinical trials for diagnostic devices, is not describednor is it expected for this type of submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or reported. This device is a medical instrument (needle) for nerve location, not an AI diagnostic tool. Therefore, the concept of "human readers improve with AI" does not apply.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical device (needle), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of "ground truth" used. However, for a nerve location needle, the "ground truth" for its performance would likely be based on:

Physical and electrical properties: Bench testing for electrical impedance, mechanical strength, coating integrity, and ultrasonic visibility.
Biocompatibility: In vitro and/or in vivo testing (not described here but standard for implanted devices).
Functionality: Demonstration that the needle can deliver current for nerve stimulation and/or is visible under ultrasound as intended.

These would be measured against engineering specifications and industry standards rather than human-derived ground truths like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI model.

Summary

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

Regulatory Correspondent	Regulatory and Marketing Services962 Allegro LaneApollo Beach, FL 33572
Submitter of 510(k):	TE ME NA16, rue des EntrepreneursZ.I. des AmandiersF-78420 CARRIERES-SUR-SEINEFRANCE 78420Phone: 011-331-30860530Fax:
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:

Device Description:

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	TemenaK990100	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 TeflonSealed	Same	Same
Sterilization	ETO	ETO	ETO
Regional Anesthesia	Yes	Yes	Yes
AnestheticAdministration Line	Yes	Yes	Yes
Needle Tip	Bevel	Pencil Point (UPA)Bevel (UPC)	Bevel
Coating	Hybrid Yes, USCNo	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 (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

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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:

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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Regulation Number and Section

§ 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).