(43 days)
Not Found
No
The summary describes a physical electrode device for recording biopotential signals and does not mention any software or algorithms that would incorporate AI or ML. The performance studies focus on physical and electrical properties and sterilization.
No.
The device is described as being used for recording biopotential signals (e.g., EMG, EEG, nerve potential signals), which indicates a diagnostic or monitoring function rather than a therapeutic one.
Yes
The device's intended use is to record biopotential signals (EMG, EEG, nerve potential signals), which are used for diagnostic purposes to assess the health and function of muscles and nerves.
No
The device description clearly states it is a sterile, single-use, invasive needle electrode, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for recording, monitoring, and stimulation of biopotential signals (EMG, EEG, nerve potentials). This involves interacting directly with the patient's body to measure electrical activity.
- Device Description: The device is described as being placed subcutaneously or in contact with nerve or muscle tissue. This is an invasive procedure performed on the patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
This device is clearly designed for in vivo use (within the living body) to measure physiological signals, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG), and Nerve potential signals. The electrodes are sterile and for single patient use.
Product codes (comma separated list FDA assigned to the subject device)
GXZ
Device Description
Guardian Needle™ Electrodes are a sterile, single-use device. The electrodes are applied during the study of biopotentials such as electromyography (EMG), electroencephalography (EEG), nerve conduction and stimulation/response. The electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The needle is housed inside a sheath until application and secured to the patient during use with adhesive tape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Subdermal muscle or nerve tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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)
No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2).
Benchtop performance testing passed predetermined acceptance criteria, demonstrating Guardian Needle™ Electrodes are equivalent to the predicate device in functionality, safety, and effectiveness.
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.
Not Found
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
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 27, 2020
Rhythmlink International, LLC Gabriel Orsinger Vice President of Engineering and R&D 1140 First Street South Columbia, South Carolina 29209
Re: K200984
Trade/Device Name: Guardian Needle Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: April 9, 2020 Received: April 14, 2020
Dear Gabriel Orsinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Guardian Needle™ Electrode
Indications for Use (Describe)
Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG), and Nerve potential signals. The electrodes are sterile and for single patient use.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- |
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Guardian Needle™ Electrode Rhythmlink International, LLC
3
510(k) Summary – K200984
| 807.92(a)(1)
Submitter
Information | Rhythmlink International, LLC
1140 First Street South
Columbia, SC 29209
Phone: 803-252-1222
FDA Registration #: 1067162 | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official
Correspondent | Gabriel Orsinger, PhD
Vice President of Engineering and R&D
Email: gorsinger@rhythmlink.com
Phone: 803-365-9664 | |
| Summary Date | May 27, 2020 | |
| 807.92(a)(2)
Device
Identification | Device Trade Name:
Classification Name:
Product Code:
Classification:
Classification Panel: | Guardian Needle™ Electrode
Needle Electrode
GXZ
21 CFR 882.1350 Class II
Neurology |
| 807.92(a)(3)
Predicate Device | Device Trade Name:
Classification Name:
510(k) Number:
Product Code:
Classification:
Classification Panel:
Manufacturer: | Subdermal Needle Electrodes
Needle Electrode
K022914
GXZ
21 CFR 882.1350 Class II
Neurology
Rhythmlink International, LLC
1140 First Street South
Columbia, SC 29209 |
| 807.92(a)(4)
Device Description | Guardian Needle™ Electrodes are a sterile, single-use device. The
electrodes are applied during the study of biopotentials such as
electromyography (EMG), electroencephalography (EEG), nerve conduction
and stimulation/response. The electrodes are invasive as they are placed
subcutaneously or in contact with nerve or muscle tissue. The needle is
housed inside a sheath until application and secured to the patient during use
with adhesive tape. | |
| 807.92(a)(5)
Intended Use | Rhythmlink International Guardian Needle™ Electrodes are intended
for use with recording, monitoring and stimulation equipment for the
purpose of recording of biopotential signals. Examples include:
Electromyography (EMG), Electroencephalography (EEG) and Nerve
potential signals. The electrodes are sterile and for single patient use
only | |
| 807.92(a)(6)
Technological
Characteristics | The technological characteristics of Guardian Needle™ Electrodes are
identical to the predicate device (K022914), with the addition of a needle
sheath and adhesive tape, both of which have been assessed to not change the
fundamental scientific technology, intended use, performance, or safety and
effectiveness of the predicate device (reference Substantial Equivalence of | |
4
| Technological Characteristics table, below). The test methods were identical
| to those used to assess the predicate device. |
|---|
| 807.92(b)(1) |
| Summary of Non- |
| Clinical Tests |
| Guardian Needle™ Electrodes are substantially equivalent in technology, |
| safety, and effectiveness as the predicate device (K022914), as demonstrated |
| by the test results. |
| The Guardian Needle™ Electrode was assessed by applying the TIR 28:2009 |
| Guidance, from which it was determined that the subject device does not |
| challenge the Submitter's Master Challenge Device and can thus fall under |
| the previously validated EtO sterilization cycle. Reevaluation of the EtO |
| residuals was performed to confirm low levels of EtO and Ethylene |
| Chlorohydrin (ECH) after a 24-hour aeration time below the maximum limits |
| described in ANSI/AAMI/ISO 10993-7:2008/(R) 2012. |
| The biocompatibility evaluation was conducted within the risk management |
| framework and in compliance with ISO 10993 standards. This |
| biocompatibility evaluation establishes the biological safety for the Guardian |
| Needle™ Electrode with intact skin contact for a limited (≤24 hours) |
| duration |
| Functional performance equivalency was determined by electrical and |
| adhesive benchtop testing, as follows: |
| Electrical Continuity Adhesion Testing |
| Benchtop performance testing passed predetermined acceptance criteria, |
| demonstrating Guardian Needle™ Electrodes are equivalent to the predicate |
| device in functionality, safety, and effectiveness. |
| 807.92(b)(2) |
| Clinical Tests |
| No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2). |
| 807.92(b)(3) |
| Clinical Summary |
| No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3). |
5
Substantial Equivalence Table
| Characteristic | Subject Device:
Guardian Needle™
Electrodes | Predicate Device:
Subdermal Needle
Electrodes | Substantial
Equivalence
(SE)1 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K200984 | K022914 Subdermal Needle
Electrodes | |
| Manufacturer | Rhythmlink International,
LLC | Rhythmlink International,
LLC | SE |
| Device Class | Class II | Class II | SE |
| Product Code | GXZ | GXZ | SE |
| Regulatory
Name | Subdermal Needle | Subdermal Needle | SE |
| Device Type | Subdermal Needle Electrodes | Subdermal Needle Electrodes | SE |
| Regulation # | 21 CFR 882.1350 | 21 CFR 882.1350 | SE |
| Intended Use | Rhythmlink International
Subdermal Needle Electrodes
are intended for use with
recording, monitoring and
stimulation equipment for the
purpose of recording of
biopotential signals.
Examples include:
Electromyography (EMG),
Electroencephalography
(EEG), and Nerve potential
signals. The electrodes are
sterile and for single patient
use. | Rhythmlink International
Subdermal Needle Electrodes
are intended for use with
recording, monitoring and
stimulation equipment for the
purpose of recording of
biopotential signals.
Examples include:
Electromyography (EMG),
Electroencephalography
(EEG), and Nerve potential
signals. The electrodes are
sterile and for single patient
use. | SE |
| Anatomical
Site(s) | Subdermal muscle or nerve
tissue | Subdermal muscle or nerve
tissue | SE |
| Environment
usage | Hospital | Hospital | SE |
| Electrode
Material | Medical Grade 304VM
(vacuum melt) Stainless Steel | Medical Grade 304VM
(vacuum melt) Stainless Steel | SE |
| Electrode
Length | 7mm to 22 mm | 7mm to 22 mm | SE |
| Electrode
Diameter | 0.4mm | 0.4mm | SE |
| Leadwire
Material | PVC-coated Electrical Wire | PVC-coated Electrical Wire | SE |
| Leadwire
Length | 1.0m to 3.0m | 1.0m to 3.0m | SE |
| Connector | 1.5mm DIN 42 802 pin touch
proof connector | 1.5mm DIN 42 802 pin touch
proof connector | SE |
| Characteristic | Subject Device:
Guardian Needle™
Electrodes | Predicate Device:
Subdermal Needle
Electrodes | Substantial
Equivalence |
| 510(k)
Number | K200984 | K022914 Subdermal Needle
Electrodes | (SE)1 |
| Use of
Adhesive Tape | YES | NO | SE; Material
change has
been validated
by testing and
does not
adversely
impact safety
Or
effectiveness |
| Needle Cover | Thermoplastic polyester
elastomer sheath | PVC tube | SE; Material
and
dimensional
change has
been validated
by testing and
does not
adversely
impact safety
Or
effectiveness |
| Operation of
Applying the
Device | Applied subcutaneously to the
skin | Applied subcutaneously to the
skin | SE |
| Prescription
Use | YES - Inserted by a licensed
physician or practitioner | YES - Inserted by a licensed
physician or practitioner | SE |
| Targeted
Procedures | IONM, EMG, EP, EEG | IONM, EMG, EP, EEG | SE |
| Compatibility
with other
devices | Neurophysiology Monitors
with a 1.5mm DIN 42 802 pin
touch proof connector | Neurophysiology Monitors
with a 1.5mm DIN 42 802 pin
touch proof connector | SE |
| Packaging | 24 electrodes sealed in a
Tyvek pouch and placed
inside a sealed, labeled box | 24 electrodes sealed in a
Tyvek pouch and placed
inside a sealed, labeled box | SE |
| Sterilization
Method | Supplied EtO Sterile | Supplied EtO Sterile | SE |
| Single Patient
Use | YES - disposable | YES - disposable | SE |
| Electrical
Safety | Connectors comply with IEC
60601-1 (1988) sub clause
56.3(c) per CFR 898.12 | Connectors comply with IEC
60601-1 (1988) sub clause
56.3(c) per CFR 898.12 | SE |
| Characteristic | Subject Device:
Guardian Needle™
Electrodes | Predicate Device:
Subdermal Needle
Electrodes | Substantial
Equivalence
(SE)1 |
| 510(k)
Number | K200984 | K022914 Subdermal Needle
Electrodes | |
| Mechanical
Safety | Leadwires are soldered to
electrode using Tin/Silver
solder and covered with heat
shrink | Leadwires are soldered to
electrode using Tin/Silver
solder and covered with heat
shrink | SE |
| Duration of
use | ≤24 hours | ≤24 hours | SE |
| Standards | • IEC 60601-1-1: 1988/a1:
1991/A2 :1995 § 56.3(c)
per CFR 898.12
• DIN 42802
• ISO 14971
• ISO 15223-1 | • IEC 60601-1-1: 1988/a1:
1991/A2 : 1995 § 56.3(c)
per CFR 898.12
• DIN 42802
• ISO 14971
• ISO 15223-1 | SE |
| Biocompatible | Yes | Yes | SE |
6
7
¹Only differences are indicated in this column.