(238 days)
Not Found
No
The summary describes a physical medical device (needle electrodes) and its intended use for recording biopotential signals. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on the physical and electrical properties of the electrode itself.
No.
The device is intended for recording and monitoring biopotential signals (EEG, EMG, nerve potential) and for stimulation/recording with specific equipment, which are diagnostic rather than therapeutic purposes.
Yes
The device is intended for recording biopotential signals (EEG, EMG, nerve potentials) and for stimulation/recording with equipment for EMG and nerve potential signals, which are diagnostic procedures to identify and characterize neurological conditions.
No
The device description clearly details physical components like needles, lead wires, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for recording and stimulating biopotential signals (EEG, EMG, nerve potentials) from the body. This is a direct interaction with the patient's physiological signals.
- Device Description: The device is a needle electrode designed to be applied to subdermal tissue. This is a physical interface with the patient.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes.
This device is used in vivo (within the body) to acquire physiological signals directly from the patient. Therefore, it falls under the category of a medical device used for physiological monitoring and stimulation, not an IVD.
N/A
Intended Use / Indications for Use
Needle Electrodes for neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
Product codes
GXZ, IKT
Device Description
Disposable Subdermal Needle Electrodes, Corkscrew are single-patient use electrodes, delivered Ethylene Oxide (EtO) sterilized. They include a needle at one end which is connected to a lead wire with a 1.5 mm female safety DIN 42802 connector. The needle, which is fabricated using stainless steel, is formed into a corkscrew shape, with a regular bevel tip. The connecting lead wire, which may be supplied in different lengths and colors is terminated with a DIN 42802 connector to enable connection to recording or monitoring / stimulation equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
To be applied to subdermal tissue
Indicated Patient Age Range
All patients identified by the healthcare professional to benefit from the diagnostic procedures as listed in the indications for use.
Intended User / Care Setting
These devices are used by healthcare professionals specifically trained and certified in electrophysiology techniques, in healthcare facility/hospital environment.
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
Non-clinical Testing
- Performance Testing (Visual, dimensional, electrical, and mechanical aspects):
- Method: Internal test methods were applied. Visual checks: including fixation of protection cap to hub, visibility of bare wires, visual damage. Dimensional checks. Electrical testing: including impedance measurements. Mechanical testing: including torsion and pull force measurements.
- Results/Comment: The product passed the tests and meets the set requirements. The testing did not raise new or different questions of safety and effectiveness.
- Shelf life (Accelerated aging):
- Method: Aging was performed according to ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. Label assessment method was based on ISO 20417:2021 (Ed. 1) Medical devices – Information to be supplied by the manufacturer. Pouch integrity testing was performed according to ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
- Results/Comment: The product passed the 3-years accelerated shelf-life validation and meets the set requirements. The testing did not raise new or different questions of safety and effectiveness.
- Transit testing:
- Method: Electrical and mechanical assessment were performed according to internal test method. Label assessment method was based on ISO 20417:2021 (Ed. 1) Medical devices – Information to be supplied by the manufacturer. Pouch integrity testing was performed according to ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. Transit simulation was performed according to ISTA 3A (2018) Packaged-Products For Parcel Delivery System Shipment 70 Kg (150 Lb) Or Less.
- Results/Comment: The product passed the tests and meets the set requirements. The testing did not raise new or different questions of safety and effectiveness.
- Electrical, Mechanical and Thermal Safety:
- Method: IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Ed. 3.2) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; section 8.5.2.3.
- Results/Comment: The product meets the applicable requirements of section 8.5.2.3. The testing did not raise new or different questions of safety and effectiveness.
- Biocompatibility (including Chemical characterization, cytotoxicity, intracutaneous reactivity, acute systemic toxicity, sensitization and pyrogenicity):
- Method: A biological evaluation plan was written. Chemical characterization, cytotoxicity, intracutaneous reactivity, acute systemic toxicity, sensitization and pyrogenicity were tested in accordance with ISO 10993 series by an independent laboratory.
- Results/Comment: The product is evaluated to be biocompatible. The testing did not raise new or different questions of safety and effectiveness.
- Sterilization:
- Method: ISO 11135:2014+AMD1:2018 (Ed. 2) – Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices.
- Results/Comment: The changes to the product do not have any impact on the latest sterilization validation. The changes to the product did not raise new or different questions of safety and effectiveness regarding sterilization.
- Pyrogenicity:
- Method: A LAL test of the product was performed after sterilization by the sterilization provider.
- Results/Comment: The product conformed to the requirements of the test. The changes to the product did not raise new or different questions of safety and effectiveness.
- Usability:
- Method: IEC 62366-1:2015+AMD1:2020 (Ed. 1.1) – Medical devices - Part 1: Application of usability engineering to medical devices.
- Results/Comment: The UOUP assessment of the DSNE, Corkscrew determined the usability of the DSNE, Corkscrew to be acceptable. The user interface of unknown provenance (UOUP) principle was applied. The user interface for both the predicate device and the subject device are equivalent. The changes to the product did not raise new or different questions of safety and effectiveness regarding usability.
Clinical testing
There is no clinical testing required to support this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 11, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Technomed Europe Sanne Habets Team Lead Regulatory Affairs Amerikalaan 71 Maastricht-Airport, 6199 AE Netherlands
Re: K241045
Trade/Device Name: Disposable Subdermal Needle Electrode, Corkscrew Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ, IKT Dated: November 14, 2024 Received: November 14, 2024
Dear Sanne Habets:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Image /page/2/Picture/3 description: The image contains the text "Patrick Antkowiak -S". To the left of the text is a faded blue logo that appears to be "FDA". The text is black and the background is white. The text is aligned to the left.
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
3
Indications for Use
510(k) Number (if known) K241045
Device Name
Disposable Subdermal Needle Electrode, Corkscrew
Indications for Use (Describe)
Needle Electrodes for neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
| 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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4
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K240145 Traditional 510(k) Summary Technomed Europe's Disposable Subdermal Needle Electrode, Corkscrew
Prepared according to the requirements outlined in 21 CFR 807.92
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Technomed Europe Amerikalaan 71, 6199 AE, Maastricht-Airport The Netherlands Phone: Facsimile: Contact Person: E-mail:
+31 (0) 43 408 6868 N/A Sanne Habets, Team Lead Regulatory Affairs regulatory@technomed.nl
Date Prepared: December 10, 2024
Trade Name of Device
Disposable Subdermal Needle Electrode, Corkscrew
Common or Usual Name
Disposable Subdermal Corkscrew Needle Electrode
Classification
21 C.F.R. § 882.1350, Needle Electrode, Class II, product code GXZ and IKT
Predicate Devices
K130136 Disposable Monopolar Needle Electrode and Disposable Subdermal Needle Electrode, 21 C.F.R. § 882.1350, GXZ and IKT.
Device Description
Disposable Subdermal Needle Electrodes, Corkscrew are single-patient use electrodes, delivered Ethylene Oxide (EtO) sterilized. They include a needle at one end which is connected to a lead wire with a 1.5 mm female safety DIN 42802 connector. The needle, which is fabricated using stainless steel, is formed into a corkscrew shape, with a regular bevel tip. The connecting lead wire, which may be supplied in different lengths and colors is terminated with a DIN 42802 connector to enable connection to recording or monitoring / stimulation equipment.
5
These devices are used by healthcare professionals specifically trained and certified in electrophysiology techniques, in healthcare facility/hospital environment. These professionals can use the devices on patients for use with recording / monitoring equipment for the recording of biopotential signals including electroencephalography (EEG). electromyography (EMG) and nerve potential signals.
The technological characteristics are described in further detail below.
Indications for Use
Needle Electrodes for neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
Technological Characteristics
The DSNE, Corkscrew's technological characteristics remain almost identical to that cleared within K130136.
The proposed modification to the DNSE, Corkscrew is to change the soldering connection between lead wire and needle to a crimped connection, which is qlued to the hub. Also, the internal shape of the hub has been optimized to fit the new connection. As demonstrated within this 510(k) premarket notification, this change does not raise new or different questions of safety and effectiveness, and is supported by non-clinical testing of the product.
The positioning, functioning and use of the product remains unchanged.
All other aspects of the device compared to the currently marketed version remain unchanged and are identical. For further information on substantial equivalence, see Table 1.
| Predicate
Disposable
Subdermal
Needle
Electrode,
Corkscrew
(covered by
K130136) | New Disposable Subdermal
Needle Electrode,
Corkscrew | Discussion of
potential
differences | |
|------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------|----|
| Device Name | Disposable Subdermal Needle Electrode,
Corkscrew | Identical | |
| 510(k) number | K130136 | K241045 | NA |
| 510(k) clearance date | 19th of July,
2013 | Unknown yet | NA |
| Product code | GXZ and IKT | Identical | |
| Intended use / | Needle Electrodes for Neurological purposes are | Identical | |
Table 1: Substantial Equivalence Summary
6
| Indications for use (as
submitted to FDA during
510(k) submission; and
as listed in the IFU) | intended for use with recording, monitoring
equipment for the recording of biopotential
signals including electroencephalograph (EEG),
electromyograph (EMG) and nerve potential
signals, and are intended for
stimulation/recording with stimulation/recording
equipment for electromyograph (EMG) and
nerve potential signals. | | | | | | |
|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Regulation name | Needle Electrode | Identical | | | | | |
| Regulation number | 21 CFR 882.1350 | Identical | | | | | |
| Target population | All patients | All patients identified
by the healthcare
professional to benefit
from the diagnostic
procedures as listed in
the indications for use. | Specified in more
detail. | | | | |
| Where used | Hospital | Identical | | | | | |
| Human factors | Predicate and subject device are visually
identical, no change in user interface.
Compatibility and connections | Identical | | | | | |
| Connector | DIN 42802 | Identical | | | | | |
| Compatibility | This device is equipped with DIN 42802
connectors and is compatible with any
intraoperative neuromonitoring equipment that is
equipped with DIN 42802 connections. | Identical | | | | | |
| | Dimensions | | | | | | |
| Hub diameter | 10 mm | Identical | | | | | |
| Hub length | 13 mm | Identical | | | | | |
| Needle shape | Spiral (Corkscrew) | Identical | | | | | |
| Needle surface area | 49 mm² | Identical | | | | | |
| Needle length (Height of
needle windings coming
out of the hub) | 2.5-4.0 mm | Identical | | | | | |
| Needle diameter | 0.6 mm | Identical | | | | | |
| Tip geometry / angle
(defining sharpness) | 25° ± 5°
(equalling range:
20°-30°) | 24°+2°-4° (equalling range:
20°-26°) | The tip geometry
range of the subject
device falls within
the range of the
predicate device,
and therefore is
equivalent. | | | | |
| Lead wire lengths | 1.20-2.5 m | Identical | | | | | |
| | Materials | | | | | | |
| Needle to lead wire
connection | | Solder | | Brass crimp bushing | | Modification, as
described in current
submission. Non-
clinical testing did
not raise new or
different questions
relating to safety | |
| Lead wire lengths | 1.20-2.5 m | | | Identical | | | |
| Materials | | | | | | | |
| Needle to lead wire connection | Solder | Brass crimp bushing | | Modification, as described in current submission. Non-clinical testing did not raise new or different questions relating to safety and effectiveness. | | | |
| Hub to needle-lead wire | N/A | Glue (Loctite 454) | | Modification, as | | | |
7
| connection | described in current submission. Non-clinical testing did not raise new or different questions relating to safety and effectiveness. | ||
|---|---|---|---|
| Needle | AISI 304 | Identical | |
| Hub | PVC | Identical | |
| Lead wire | Multiple colours PVC insulated tin-plated copper strands | Identical | |
| DIN 42802 connector | PVC over-moulded tin-plated brass | Identical | |
| Protection cap | Polypropylene (PP) | Identical | |
| Electrical insulation | Electrical insulation is present on all surfaces that are not intended to provide electrical contact with the patient. | Identical | |
| Electrical behaviour | |||
| Impedance | 22N | >25N | Tightened specification. |
| Tensile strength needle to hub | Not specified | >25N | Added specification |
| Maximum retraction force protection cap versus hub (if applicable) | Not applicable | Max. 10N | Addition of protection cap and specification of force. This did not raise new or different questions relating to safety and effectiveness. |
| Torsion force Needle to hub | Not specified | > 15.5 Ncm | Added specification |
| Other information | |||
| Lead wire type | Single / Twisted | Identical | |
| Hub material colour | Blue | Identical | |
| Single use | Yes | Identical | |
| Provided to the user sterile | Yes | Identical | |
| Sterilization method | Ethylene oxide | Identical | |
| Sterility assurance level | 10-6 | Identical | |
| Shelf life | 3 years | Identical | |
| Sterile barrier / container (transparent - film) | Biaxially oriented polyethylene film | Identical | |
| Sterile barrier / container (paper) | Gas Paper | Identical | |
| Pouch size | 175x75 mm | ||
| 200x100 mm | Identical | ||
| Number of items per box | 12 pairs or 24 single pieces | Identical | |
| Anatomical site | To be applied to subdermal tissue | Identical | |
| Energy used and/or delivered | No energy used, no energy delivered, only conduction of electrical signals | Identical | |
| Biocompatible | Yes | Yes, tested in accordance with current ISO 10993 series | Non-clinical testing did not raise new or different questions relating to safety and effectiveness. |
8
Non-clinical Testing
Non-clinical testing was conducted to validate the performance and safety of the subject device, to ensure that the device performs as intended and meets the design specifications.
Mechanical, dimensional, electrical, and visual aspects of the device were tested according to internal test method.
Regarding accelerated aging, aging was performed according to ASTM F1980-21. Mechanical, dimensional, electrical, and visual assessment were performed according to internal test method. Label assessment was performed according to ISO 20417 (Ed. 1). Pouch integrity testing was performed according to ASTM F1929-15.
A transit simulation was performed according to ISTA 3A (2018 edition). Electrical and mechanical assessment of the products was done according to internal test methods.
Biocompatibility testing was performed by an external laboratory according to the ISO 10993 series. This included chemical characterization, cytotoxicity, intracutaneous reactivity, acute systemic toxicity, sensitization and pyrogenicity testing.
Regarding Electrical, Mechanical and Thermal Safety testing, compliance with the applicable section of IEC 60601-1 (Ed. 3.2) was tested.
Sterilization validation (ISO 11135:2014 (Ed. 2))) was leveraged from the predicate device as the changes to the product do not affect the sterilization, nor result in the need for choosing a different worst-case product in sterilization. The reason is that device and packaging materials, device dimensions and device shape are substantially equivalent to the predicate.
Regarding usability (IEC 62366-1:2015 (Ed. 1.1)), the User Interface of Unknown Provenance principle was applied in accordance with Annex C of IEC 62366-1 as the User Interface has been commercialized prior to the release of the standard and no modifications to the User Interface or its parts have been made.
A summary of the non-clinical testing performed on the subject device, Disposable Subdermal Needle Electrodes, Corkscrew is provided in Table 2.
Table 2: Summary of Non-Clinical Testing
| Test | Method | Results / Comment | ||
|---|---|---|---|---|
| Performance Testing | ||||
| (Visual, dimensional, | ||||
| electrical, and mechanical | ||||
| aspects) | Internal test methods were applied. | |||
| Visual checks: including fixation of protection cap to hub, visibility of bare wires, visual damage. Dimensional checks Electrical testing: including impedance measurements. Mechanical testing: including torsion and pull force measurements. | The product passed the tests and meets | |||
| the set requirements. | ||||
| The testing did not raise new or different | ||||
| questions of safety and effectiveness. | ||||
| Shelf life (Accelerated | ||||
| aging) | Aging was performed according to ASTM | |||
| F1980-21 Standard Guide for Accelerated | ||||
| Aging of Sterile Barrier Systems and | ||||
| Medical Devices. | ||||
| FDA recognition number: 14-575 | ||||
| Mechanical, dimensional, electrical, and | ||||
| visual assessment was performed | ||||
| according to internal test method. | ||||
| Label assessment method was based on | ||||
| ISO 20417:2021 (Ed. 1) Medical devices – | ||||
| Information to be supplied by the | ||||
| manufacturer. | ||||
| FDA recognition number: 5-135 | ||||
| Pouch integrity testing was performed | ||||
| according to ASTM F1929-15 Standard | ||||
| Test Method for Detecting Seal Leaks in | ||||
| Porous Medical Packaging by Dye | ||||
| Penetration. | ||||
| FDA recognition number: 14-484 | The product passed the 3-years | |||
| accelerated shelf-life validation and | ||||
| meets the set requirements. | ||||
| The testing did not raise new or different | ||||
| questions of safety and effectiveness. | ||||
| Transit testing | Electrical and mechanical assessment | |||
| were performed according to internal test | ||||
| method. | ||||
| Label assessment method was based on | ||||
| ISO 20417:2021 (Ed. 1) Medical devices – | ||||
| Information to be supplied by the | ||||
| manufacturer. | ||||
| FDA recognition number: 5-135 | ||||
| Pouch integrity testing was performed | ||||
| according to ASTM F1929-15 Standard | ||||
| Test Method for Detecting Seal Leaks in | ||||
| Porous Medical Packaging by Dye | ||||
| Penetration. | ||||
| FDA recognition number: 14-484 | ||||
| Transit simulation was performed | ||||
| according to ISTA 3A (2018) Packaged- | ||||
| Products For Parcel Delivery System | ||||
| Shipment 70 Kg (150 Lb) Or Less. | ||||
| FDA recognition number: 5-126 | The product passed the tests and meets | |||
| the set requirements. | ||||
| The testing did not raise new or different | ||||
| questions of safety and effectiveness. | ||||
| IEC 60601-1:2005+AMD1:2012 | ||||
| +AMD2:2020 (Ed. 3.2) - Medical electrical | ||||
| equipment - Part 1: General requirements | ||||
| for basic safety and essential performance; | ||||
| section 8.5.2.3. | ||||
| FDA recognition number: 19-49 | The product meets the applicable | |||
| requirements of section 8.5.2.3. | ||||
| Electrical, Mechanical and | ||||
| Thermal Safety | The testing did not raise new or different | |||
| questions of safety and effectiveness. | ||||
| A biological evaluation plan was written. | ||||
| Chemical characterization, cytotoxicity, | ||||
| intracutaneous reactivity, acute systemic | ||||
| toxicity, sensitization and pyrogenicity were | ||||
| tested in accordance with the below listed | ||||
| standards by an independent laboratory. | ||||
| Based on the data, a biological risk | ||||
| assessment was written. | ||||
| ISO 10993-1:2018 (Ed. 5) - | ||||
| Biological evaluation of medical | ||||
| devices - Part 1: Evaluation and | ||||
| testing within a risk management | ||||
| process. | ||||
| FDA recognition number: 2-258 ISO 10993-7:2008 (Ed. 2) - | ||||
| Biological evaluation of medical | ||||
| devices - Part 7: Ethylene oxide | ||||
| sterilization residuals. | ||||
| FDA recognition number: 2-275 ISO 10993-18:2020 (Ed. 2) - | ||||
| Biological evaluation of medical | ||||
| devices - Part 18: Chemical | ||||
| characterization of medical device | ||||
| materials within a risk | ||||
| management process | ||||
| FDA recognition number: 2-276 ISO 10993-5:2009 (Ed. 3) - | ||||
| Biological evaluation of medical | ||||
| devices - Part 5: Tests for in vitro | ||||
| cytotoxicity | ||||
| FDA recognition number: 2-245 ISO 10993-10:2021 (Ed. 4) - | ||||
| Biological evaluation of medical | ||||
| devices - Part 10: Tests for skin | ||||
| sensitization | ||||
| FDA recognition number: 2-296 ISO 10993-23:2021 (Ed. 1) - | ||||
| Biological evaluation of medical | ||||
| devices - Part 23: Tests for | ||||
| irritation | ||||
| FDA recognition number: 2-291 ISO 10993-11:2017 (Ed. 3) - | ||||
| Biological evaluation of medical | ||||
| devices - | ||||
| Part 11: Tests for systemic toxicity | ||||
| FDA recognition number: 2-255 ISO 10993-6:2016 (Ed. 3) - | ||||
| Biological evaluation of medical | ||||
| devices - Part 6: Tests for local | ||||
| effects after implantation | ||||
| Biocompatibility (including | ||||
| Chemical characterization, | ||||
| cytotoxicity, intracutaneous | ||||
| reactivity, acute systemic | ||||
| toxicity, sensitization and | ||||
| pyrogenicity) | The product is evaluated to be | |||
| biocompatible. | ||||
| The testing did not raise new or different | ||||
| questions of safety and effectiveness. | ||||
| FDA recognition number: 2-247 | ||||
| • ISO 10993-3:2014 (Ed. 3) - | ||||
| Biological evaluation of medical | ||||
| devices - Part 3: Tests for | ||||
| genotoxicity, carcinogenicity, and | ||||
| reproductive toxicity | ||||
| FDA recognition number: 2-228 | ||||
| ISO 11135:2014+AMD1:2018 (Ed. 2) – | ||||
| Sterilization of health-care products – | ||||
| Sterilization | Ethylene oxide – Requirements for the | |||
| development, validation, and routine | ||||
| control of a sterilization process for medical | ||||
| devices. | ||||
| FDA recognition number: 14-529 | The changes to the product do not have | |||
| any impact on the latest sterilization | ||||
| validation. | ||||
| The sterilization revalidation as executed in | ||||
| 2022 is still valid for the device that is | ||||
| subject of this submission as the predicate | ||||
| device was already part of the product | ||||
| portfolio that was validated in 2022; and | ||||
| the changes to the product do not affect | ||||
| the sterilization validation, nor result in the | ||||
| need for choosing a different worst-case | ||||
| product in sterilization revalidation. The | ||||
| reason is that device and packaging | ||||
| materials, device dimensions and device | ||||
| shape are substantially equivalent to the | ||||
| predicate. | The changes to the product did not raise | |||
| new or different questions of safety and | ||||
| effectiveness regarding sterilization. | ||||
| Pyrogenicity | A LAL test of the product was performed | |||
| after sterilization by the sterilization | ||||
| provider. | The product conformed to the | |||
| requirements of the test. | ||||
| The changes to the product did not raise | ||||
| new or different questions of safety and | ||||
| effectiveness. | ||||
| Usability | IEC 62366-1:2015+AMD1:2020 (Ed. 1.1) – | |||
| Medical devices - Part 1: Application of | ||||
| usability engineering to medical devices. | ||||
| FDA recognition number: 5-129 | The UOUP assessment of the DSNE, | |||
| Corkscrew determined the usability of | ||||
| the DSNE, Corkscrew to be acceptable. | ||||
| The user interface of unknown provenance | ||||
| (UOUP) principle was applied. The user | ||||
| interface for both the predicate device and | ||||
| the subject device are equivalent. | The changes to the product did not raise | |||
| new or different questions of safety and | ||||
| effectiveness regarding usability. | ||||
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Clinical testing
There is no clinical testing required to support this submission.
Substantial Equivalence
The device and its predicate are equivalent in most aspects, such as product classification, connections, sizes, majority of the materials used, sterilization characteristics, packaging materials, and safety characteristics. The difference is the internal joining method of the needle to the lead wire. The predicate device utilizes a soldering connection, whereas the
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proposed subject device utilizes a brass crimped connection, which is glued to the hub. Also, the internal shape of the hub has been optimized to fit the new connection.
The change does not raise new or different questions of safety and effectiveness and is supported by non-clinical testing of the product.
Thus, in summary, the DSNE, Corkscrew as cleared under K130136 and as part of the current submission are considered equivalent and do not raise new or different questions of safety and effectiveness.
All other aspects of the device compared to the predicate device remain unchanged and are identical. For further information on substantial equivalence, see Table 1.
Conclusion
In summary, the intended use, and indications for use for the DNSE, Corkscrew and its predicate devices are identical.
Non-clinical testing performed on the DSNE, Corkscrew has demonstrated that the minor modifications to Disposable Subdermal Needle Electrode, Corkscrew do not raise new or different questions regarding safety and effectiveness.
Although the internal joining method of needle to lead wire and the internal shape of the hub change, the overall operating principles of the device remain the same.
Thus, the information and data provided in this 510(k) premarket notification submission support a finding of substantial equivalence for the DNSE, Corkscrew.
A tabular comparison of device characteristics can be found in Table 1.