(28 days)
No
The device description explicitly states that the needles are passive devices and do not contain electrical hardware components or software. There is no mention of AI or ML in the document.
No.
The device is intended for recording, monitoring, and stimulation/recording of biopotential signals, not for treating a disease or condition.
Yes
Explanation: The device description explicitly states that the "TECA™ ELITE Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user." Biopotential signals, such as electromyograph (EMG) and nerve potential signals, are gathered to provide information for diagnosis.
No
The device description explicitly states that the device "do[es] not contain electrical hardware components or software." It is a physical needle intended to sense or stimulate biopotential signals.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals" by insertion into the patient's muscle. This involves direct interaction with the patient's body to measure electrical activity.
- Device Description: The device is described as a needle inserted into the patient's muscle to "sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response." It's a passive device that connects to an EMG machine to display this information.
- Nature of IVDs: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro). They are used to diagnose diseases or other conditions.
This device operates in vivo (within the living body) to directly measure electrical signals, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
TECATM ELITE Disposable Concentric Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
Product codes (comma separated list FDA assigned to the subject device)
IKT
Device Description
CareFusion 209, Inc. TECATM ELITE Disposable Concentric Needles (TECATM ELITE Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM ELITE Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user.
TECATM ELITE Needles consist of a stainless steel tube with a conductive core. A polyesterimide isolative coating resides between the core and the stainless steel tube. The exterior surface of the needle is dipped in a low-friction lubricant. TECATM ELITE Needles are passive devices, and do not contain electrical hardware components or software.
The following device modifications were made to the TECATM ELITE Needles: Modification of the core material; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the packaging materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A comparison of the TECA™ ELITE Needles core material was made Biocompatibility with the core material from the following devices: K991522, FHC Micro Targeting Electrode; and . K033173, FHC Micro Targeting Electrode. . Biocompatibility verification was performed on direct patient contact materials comprising the TECA™ ELITE Needles that were affected by the device modifications in accordance with and the applicable portions of the following Standards:
- ISO 10993-1: 2009, Biological evaluation of medical devices -. Part 1: Evaluation and testing within a risk management process.
Additionally, a comparison of the low friction lubricant characteristics used on the exterior surface of the TECA™ ELITE Needles was made to the low friction lubricant characteristics used on the following device: - KII1131, TECA™ elite Disposable Monopolar Needles. .
Verification results and device material comparisons indicated that the TECA™ ELITE Needles comply with their predetermined specifications, and with the applicable portions of the Standard.
Performance testing was performed on device characteristics of the Performance Testing TECA™ ELITE Needles that were affected by the device modifications - Bench in accordance with internal requirements and the applicable portions of the following Standards:
- ASTM F88 07, Standard Test Method for Seal Strength of Flexible . Barrier Materials
- ASTM F 1929 04, Standard Test Method for Detecting Seal Leaks . in Porous Medical Packaging by Dye Penetration
- ISO 7864: 1993, Sterile hypodermic needles for single use .
Performance testing related to internal requirements consisted of:
- . Verification of lubricant performance;
- . Validation of insertion force; and
- Validation of recording characteristics including noise and . impedance testing.
Verification and validation results indicated that the TECA™ ELITE Needles comply with their predetermined specification and with the applicable Standard.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the TECA™ ELITE Needles. The results of these activities demonstrate that the TECA™ ELITE Needles are safe and effective when used in accordance with the intended use and labeling. Therefore, the TECA™ ELITE Needles are considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).
0
Special 510(k) Premarket Notification CareFusion 209, Inc. TECA™ ELITE Disposable Concentric Needles 510(k) Summary
AUG 1 2 2011
| Submission Date: | 10 July 2011 | ||
|---|---|---|---|
| Submitter: | CareFusion 209, Inc. | ||
| 1850 Deming Way | |||
| Middleton, WI 53562 | |||
| Submitter Contact: | Mr. Glen Hermanson | ||
| Regulatory Affairs Manager - Manufacturing | |||
| CareFusion 209, Inc. | |||
| 1850 Deming Way | |||
| Middleton, WI 53562 | |||
| +1 (608) 829 8608 | |||
| +1 (608) 829 8737 (fax) | |||
| Glen.Hermanson@CareFusion.com | |||
| Manufacturing Site: | CareFusion Manufacturing Ireland 241, Ltd. | ||
| IDA Business Park | |||
| Gort, Co. Galway | |||
| Ireland | |||
| Trade Name: | TECA™ ELITE Disposable Concentric Needles | ||
| Classification | |||
| Name: | Diagnostic electromyograph needle electrode | ||
| Classification | |||
| Regulation: | 21 CFR §890.1385 | ||
| Product Code: | IKT | ||
| Substantially | |||
| Equivalent Devices: | New Care Fusion | ||
| Model | 510(k) | ||
| Number | Predicate | ||
| Manufacturer / Model | |||
| TECA™ ELITE | |||
| Disposable Concentric | |||
| Needles | K961013 | Medelec, Limited (now owned | |
| by CareFusion) / Disposable | |||
| Needle Electrode |
i
1
Special 510(k) Premarket Notification CareFusion 209, Inc. TECA™ ELITE Disposable Concentric Needles 510(k) Summary
| Device Description: | CareFusion 209, Inc. TECATM ELITE Disposable Concentric Needles
(TECATM ELITE Needles) are disposable, single use, sterile products
intended to sense subcutaneous bioelectrical activity, or to stimulate
nerve or muscular response by insertion into the patients muscle(s)
through the skin where the recording area can differentiate between
individual motor units. TECATM ELITE Needles are connected to an
electromyographic (EMG) device through a cable. The EMG device
detects and displays the biopotential information to the user.
TECATM ELITE Needles consist of a stainless steel tube with a
conductive core. A polyesterimide isolative coating resides between the
core and the stainless steel tube. The exterior surface of the needle is
dipped in a low-friction lubricant. TECATM ELITE Needles are passive
devices, and do not contain electrical hardware components or software.
The following device modifications were made to the TECATM ELITE
Needles:
Modification of the core material; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the packaging materials. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | TECATM ELITE Disposable Concentric Needles are intended for use
with recording, monitoring and stimulation/recording equipment for the
stimulation/recording of biopotential signals including electromyograph
(EMG) and nerve potential signals. |
| Technology
Comparison: | TECATM ELITE Needles employ the same technological characteristics
as the predicate device. |
2
Special 510(k) Premarket Notification CareFusion 209, Inc. TECA™ ELITE Disposable Concentric Needles 510(k) Summary
Summary of Performance Testing:
ﺔ ﺗﻢ
A comparison of the TECA™ ELITE Needles core material was made Biocompatibility with the core material from the following devices: K991522, FHC Micro Targeting Electrode; and . K033173, FHC Micro Targeting Electrode. . Biocompatibility verification was performed on direct patient contact materials comprising the TECA™ ELITE Needles that were affected by the device modifications in accordance with and the applicable portions of the following Standards:
-
ISO 10993-1: 2009, Biological evaluation of medical devices -. Part 1: Evaluation and testing within a risk management process.
Additionally, a comparison of the low friction lubricant characteristics used on the exterior surface of the TECA™ ELITE Needles was made to the low friction lubricant characteristics used on the following device: -
KII1131, TECA™ elite Disposable Monopolar Needles. .
Verification results and device material comparisons indicated that the TECA™ ELITE Needles comply with their predetermined specifications, and with the applicable portions of the Standard.
3
Special 510(k) Premarket Notification CareFusion 209, Inc. TECA™ ELITE Disposable Concentric Needles 510(k) Summarv
Performance testing was performed on device characteristics of the Performance Testing TECA™ ELITE Needles that were affected by the device modifications - Bench in accordance with internal requirements and the applicable portions of the following Standards:
- ASTM F88 07, Standard Test Method for Seal Strength of Flexible . Barrier Materials
- ASTM F 1929 04, Standard Test Method for Detecting Seal Leaks . in Porous Medical Packaging by Dye Penetration
- ISO 7864: 1993, Sterile hypodermic needles for single use .
Performance testing related to internal requirements consisted of:
- . Verification of lubricant performance;
- . Validation of insertion force; and
- Validation of recording characteristics including noise and . impedance testing.
Verification and validation results indicated that the TECA™ ELITE Needles comply with their predetermined specification and with the applicable Standard.
Conclusion
Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the TECA™ ELITE Needles. The results of these activities demonstrate that the TECA™ ELITE Needles are safe and effective when used in accordance with the intended use and labeling.
Therefore, the TECA™ ELITE Needles are considered substantially equivalent to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CareFusion 209 Inc. % Mr. Glen Hermanson Regulatory Affairs Manager - Manufacturing 1850 Deming Way Middleton, WI 53562
AUG 1 2 2011
Re: K112034
Trade/Device Name: TECA™ ELITE Disposable Concentric Needles Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: Class II Product Code: IKT Dated: 10 July 2011 Received: 15 July 2011
Dear Mr. Hermanson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical
5
Page 2 - Mr. Glen Hermanson
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Melvina B. Eydelman, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
K | 12034
TECATM ELITE Disposable Concentric Needles
TECA™ ELITE Disposable Concentric Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
John Grimes
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112034