(57 days)
TECA™ elite Disposable Monopolar 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.
CareFusion TECAT™ elite Disposable Monopolar 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. TECAT™ elite Needles are stainless steel, platinum alloy, and/or gold plated stainless steel, and coated with a polytetrafluoroethylene (PTFE) insulator. A low-friction lubricant is applied to the exterior surface of the needle. TECAT™ elite Needles are passive devices, and do not contain electrical hardware components or software. The following device modifications were made to the TECAT™ elite Needles: Reformulation of the PTFE exterior needle coating; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the needle tip geometry.
The provided text describes the 510(k) Premarket Notification for CareFusion's TECA™ elite Disposable Monopolar Needles. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing the performance of a novel AI/ML device against specific acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, sample sizes, expert ground truthing, MRMC studies, or training sets is not applicable here.
However, I can extract information related to the device's characteristics and the testing performed to show its compliance.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on verifying that the modified TECA™ elite Needles comply with predetermined specifications and applicable standards, specifically referencing ISO 10993-1 for biocompatibility and ISO 7864 for performance. The "acceptance criteria" here are implied by these standards and the internal requirements, and the "reported device performance" is a general statement of compliance.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet biological evaluation requirements. | "Biocompatibility verification was performed on direct patient contact materials... in accordance with... ISO 10993-1: 2009... Verification results and device material comparisons indicated that the TECAT™ elite Needles comply with their predetermined specifications, and with the applicable portions of the Standard." |
| Performance - Coating: Coating performance | "Verification of coating performance... indicated that the TECAT™ elite Needles comply with their predetermined specification and with the applicable Standard." |
| Performance - Tip Geometry: Tip geometry | "Verification of tip geometry... indicated that the TECAT™ elite Needles comply with their predetermined specification and with the applicable Standard." |
| Performance - Insertion Force: Validated insertion force | "Validation of insertion force... indicated that the TECAT™ elite Needles comply with their predetermined specification and with the applicable Standard." |
| Performance - Recording Characteristics: Noise and impedance testing | "Validation of recording characteristics including noise and impedance testing... indicated that the TECAT™ elite Needles comply with their predetermined specification and with the applicable Standard." |
| Overall Safety and Effectiveness | "Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications... The results... demonstrate that the TECA™ elite Needles are safe and effective when used in accordance with the intended use and labeling." |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the study described is a device modification verification, not a clinical study with a specific test set of patient data. The testing involved bench performance and biocompatibility assessments of the physical device and its materials.
3. Number of Experts Used to Establish the Ground Truth and Qualifications of Those Experts
This information is not provided and is not applicable to the type of device verification described. Ground truth for clinical outcomes or diagnostic accuracy by experts is not relevant here.
4. Adjudication Method for the Test Set
Not applicable. The testing described involves bench tests and biocompatibility assessments, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a passive, disposable electromyograph needle, not an AI-powered diagnostic tool that would typically undergo such a study to evaluate human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is not an AI/ML algorithm. It's a physical medical device.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" was established by compliance with the ISO 10993-1 standard and comparison of direct patient contact materials. For performance testing, the "ground truth" was established by compliance with internal requirements and the ISO 7864 standard for sterile hypodermic needles.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
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k 111131
JUN 1 7 2011
Special 510(k) Premarket Notification CareFusion 209, Inc. TECA™ ëlitë Disposable Monopolar Needles 510(k) Summary
| Submission Date: | 18 April 2011 | ||
|---|---|---|---|
| Submitter: | CareFusion 209, Inc.1850 Deming WayMiddleton, WI 53562 | ||
| Submitter Contact: | Mr. Glen HermansonRegulatory Affairs Manager - ManufacturingCareFusion 209, Inc.1850 Deming WayMiddleton, WI 53562+1 (608) 829 8608+1 (608) 829 8737 (fax)Glen.Hermanson@CareFusion.com | ||
| Manufacturing Site: | CareFusion Manufacturing Ireland 241, Ltd.IDA Business ParkGort, Co. GalwayIreland | ||
| Trade Name: | TECA™ elite Disposable Monopolar Needles | ||
| ClassificationName: | Diagnostic electromyograph needle electrode | ||
| ClassificationRegulation: | 21 CFR §890.1385; 21 CFR §882.1350 | ||
| Product Code: | IKT; GXZ | ||
| SubstantiallyEquivalent Devices: | New CareFusionModel | 510(k)Number | PredicateManufacturer / Model |
| TECA™ eliteDisposable MonopolarNeedles | K011818 | Nicolet Biomedical, Inc.(nowowned by CareFusion) / SterileEMG Electrodes |
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Special 510(k) Premarket Notification CareFusion 209, Inc. TECA™ elite Disposable Monopolar Needles 510(k) Summary .
| Device Description: | CareFusion TECAT™ elite Disposable Monopolar 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.TECAT™ elite Needles are stainless steel, platinum alloy, and/or gold plated stainless steel, and coated with a polytetrafluoroethylene (PTFE) insulator. A low-friction lubricant is applied to the exterior surface of the needle. TECAT™ elite Needles are passive devices, and do not contain electrical hardware components or software.The following device modifications were made to the TECAT™ elite Needles: Reformulation of the PTFE exterior needle coating; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the needle tip geometry. |
|---|---|
| Intended Use: | TECAT™ elite Disposable Monopolar 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: | TECAT™ elite Needles employ the same technological characteristics as the predicate device. |
| Biocompatibility | Low friction lubricant used on the exterior surface of the TECAT™ eliteNeedles is qualified by predicate use of an equivalent low frictionlubricant used on the following devices:K092973, Bionen s.a.s Disposable Concentric Needle Electrode;Disposable Monopolar/Subdermal Needle Electrode; andDisposable Monopolar Needle Electrode K093109, Novo Nordisk Inc. NovaTwist® needle. |
| Biocompatibility verification was performed on direct patient contactmaterials comprising the TECAT™ elite Needles that were affected bythe device modifications in accordance with and the applicable portionsof the following Standards:ISO 10993-1: 2009, Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process. | |
| Verification results and device material comparisons indicated that theTECAT™ elite Needles comply with their predetermined specifications,and with the applicable portions of the Standard. | |
| Performance Testing- Bench | Performance testing was performed on device characteristics of theTECAT™ elite Needles that were affected by the device modifications inaccordance with internal requirements and the applicable portions ofthe following Standard:ISO 7864: 1993, Sterile hypodermic needles for single use |
| Performance testing related to internal requirements consisted of:Verification of coating performance; Verification of tip geometry; Validation of insertion force; and Validation of recording characteristics including noise andimpedance testing. | |
| Verification and validation results indicated that the TECAT™ eliteNeedles comply with their predetermined specification and with the |
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Image /page/2/Picture/0 description: The image shows a series of dots and dashes, which could represent Morse code or some other form of encoded information. The dots and dashes are arranged in a horizontal line across the image. Below the line of dots and dashes, there is a number 219. The dots and dashes are spaced evenly apart.
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Special 510(k) Premarket Notification CareFusion 209, Inc. TECA™ elite Disposable Monopolar Needles 510(k) Summary
Summary of Performance Testing:
applicable Standard.
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Special 510(k) Premarket Notification CareFusion 209, Inc. TECATM elite Disposable Monopolar Needles 510(k) Summary
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.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 7 2011
CareFusion 209, Inc. c/o Glen Hermanson Regulatory Affairs Manager 1850 Deming Way Middleton, WI 53562
Re: K111131
Trade/Device Name: TECA ™ Elite Disposable Monopolar Needles Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic electromyograph needle electrode Regulatory Class: Class II Product Code: IKT: GXZ Dated: May 25, 2011 Received: May 26, 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
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Page 2 – Mr. Hermanson
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/CDRH0ffices/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,
Debra Falls
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
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Indications for Use
510(k) Number (if known):
K | | | | 3 |
Device Name:
Indications for Use:
TECA™ elite Disposable Monopolar Needles
TECA™ elite Disposable Monopolar 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.
and the comments of the comments of the comments of
Prescription Use (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)
ALEx BAILEY
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_KULLI 3 K
Page 1 of 1
§ 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).