(218 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of leadwires for transmitting ECG signals, with no mention of AI or ML for signal processing or analysis.
No
The device transmits ECG signals for monitoring and diagnostic purposes; it does not administer any treatment or therapy to the patient.
No
Explanation: The device is a patient leadwire that transmits ECG signals for monitoring and diagnostic purposes, but it does not perform the diagnostic evaluation itself. It serves as a connector to an ECG or EKG monitoring device, which is responsible for the diagnostic evaluation.
No
The device description explicitly states it is comprised of "multiple patient leadwires" and mentions "electrical & mechanical safety" testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect electrodes on a patient to an ECG/EKG monitor for general monitoring and diagnostic evaluation. This involves measuring electrical signals from the patient's body.
- Device Description: The device transmits ECG signals from the patient.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device works in vivo (within the body) by connecting to the patient directly.
The device is a medical device used for physiological monitoring, specifically electrocardiography, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
9Line patient leadwires are intended to be used to connect electrodes placed at appropriate sites on ECG or EKG monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. The device is intended for single-patient use.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
9Line is comprised of multiple patient leadwires that connect electrodes affixed to the patient's body either to an external trunk cable or directly into an electrocardiogram (ECG) monitor. Each leadwire connects to a separate patient electrode. Leadwires and electrode placement are color-coded in accordance with Association for the Advancement of Medical Instrumentation (AAMI) recommendations.
The device transmits ECG signals from the patient for both diagnostic and monitoring purposes.
9Line is for prescription-use only. The product is sold non-sterile for single-patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper body
Indicated Patient Age Range
Adults
Intended User / Care Setting
healthcare professional / Health care facility
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)
Non-Clinical Testing:
- Biocompatibility, ISO 10993-5:2009 and ISO 10993-10:2010... Device is non-cytotoxic, non-sensitizing, and non-irritating.
- Electrical & Mechanical Safety, IEC 60601-1 (Part 8.5.2.3) and ANSI/AAMI EC 53:2013... Device meets electrical and mechanical safety standards.
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
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 27, 2022
Energetic Designs, Inc. % John Gillespy President FDA 510k Consultants, LLC 1100 Del Lago Circle #104 Palm Beach Gardens, Florida 33410
Re: K211941
Trade/Device Name: 9Line Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: December 22, 2021 Received: December 27, 2021
Dear John Gillespy:
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 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).
Sincerely,
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211941
Device Name 9Line
Indications for Use (Describe)
9Line patient leadwires are intended to be used to connect electrodes placed at appropriate sites on ECG or EKG monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. The device is intended 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 1. 510(k) Submitter: | Energetic Designs, Inc.
1100 Del Lago Cir, Palm Beach Gardens, FL
33410 Phone: 386-243-4332
Email: john@fda510kconsultants.com |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Company Contact: | John F. Gillespy, MBA |
| 3. Date of Submission: | June 17, 2021 |
| 4. 510(k) Preparer: | John F. Gillespy, MBA
FDA 510k Consultants, LLC
Palm Beach Gardens, FL 33410
Phone: 386-243-4332
Email: john@fda510kconsultants.com |
| 5. Device Classification: | Trade name: 9Line
Common name: ECG Disposable Lead Wires
Device: Cable, Transducer & Electrode, Patient,
(Including Connector)
Class: II
Regulation #: 870.2900
Product Code: DSA |
| 6. Predicate: | Applicant: APK Technology Co.
Device: ECG Disposable Lead Wires
510(k) Number: K170536 |
7. Indications For Use
9Line patient leadwires are intended to be used to connect electrodes placed at appropriate sites on the patient to an ECG or EKG monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. The device is intended for single-patient use.
8. Device Description
9Line is comprised of multiple patient leadwires that connect electrodes affixed to the patient's body either to an external trunk cable or directly into an electrocardiogram (ECG) monitor. Each
Image /page/3/Picture/7 description: In the image, a coiled white cable with multiple colored clips is displayed. The clips are brown, red, white, green, and black. The clips are attached to the end of the cable. The cable is coiled in a circular shape.
leadwire connects to a separate patient electrode (see photo of product at right). Leadwires and electrode placement are color-coded in accordance with Association for the Advancement of Medical Instrumentation (AAMI) recommendations.
The device transmits ECG signals from the patient for both diagnostic and monitoring purposes.
4
9Line is for prescription-use only. The product is sold non-sterile for single-patient use.
9. Device Models
9Line models are shown below:
| PART NUMBER | DESCRIPTION (SNAP TERMINATION) |
|---|---|
| 3SS-030 | 30" 3 Lead Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 3SS-050 | 50" 3 Lead Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 5SS-030 | 30" 5 Lead Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 5SS-050 | 50" 5 Lead Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 5VSS-030 | 30" 5 V Leads Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 5VSS-050 | 50" 5 V Leads Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| NK-3SS-030 | 30" 3 Lead Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| NK-3SS-050 | 50" 3 Lead Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| NK-6SS-030 | 30" 6 Lead Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| NK-6SS-050 | 50" 6 Lead Snap Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable |
| PART NUMBER | DESCRIPTION (PINCH TERMINATION) |
|---|---|
| 3PS-030 | 30" 3 Lead Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 3PS-050 | 50" 3 Lead Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 5PS-030 | 30" 5 Lead Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 5PS-050 | 50" 5 Lead Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 5VPS-030 | 30" 5 V Leads Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| 5VPS-050 | 50" 5 V Leads Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| NK-3PS-030 | 30" 3 Lead Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| NK-3PS-050 | 50" 3 Lead Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| NK-6PS-030 | 30" 6 Lead Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable | |
| NK-6PS-050 | 50" 6 Lead Pinch Single Patient Use AAMI |
| w/Shielded Systems Bonded Cable |
5
11. Comparison To Predicate Device
The following table compares 9Line with the predicate device:
Comparison Table
| Characteristics | Device | Predicate | Comparison |
|---|---|---|---|
| Name | 9Line | ECG Disposable Lead | |
| Wires | NA | ||
| Applicant | Energetic Designs Inc | APK Technology Co | NA |
| 510k Number | Applied For | K170536 | NA |
| Device Photo | Image: 9Line device photo | Image: ECG Disposable Lead Wires device photo | NA |
| Classification | II | II | Same |
| Regulation Number | 870.2900 | 870.2900 | Same |
| Product Code | DSA | DSA | Same |
| Intended Use | Connect patient | ||
| electrodes with ECG for | |||
| monitoring or | |||
| diagnostic evaluation. | Connect patient | ||
| electrodes with ECG for | |||
| monitoring or | |||
| diagnostic evaluation. | Same | ||
| Indications For Use | 9Line patient leadwires | ||
| are intended to be used | |||
| to connect electrodes | |||
| placed at appropriate | |||
| sites on the patient to | |||
| an ECG or EKG | |||
| monitoring device for | |||
| general monitoring | |||
| and/or diagnostic | |||
| evaluation by a health | |||
| care professional. The | |||
| device is intended for | |||
| single-patient use. | The ECG Disposable | ||
| Lead Wires are | |||
| intended to be used | |||
| with ECG. The lead wire | |||
| is used to connect | |||
| electrodes placed at | |||
| appropriate sites on the | |||
| patient to ECG for | |||
| general monitoring | |||
| and/or diagnostic | |||
| evaluation by health | |||
| care professional. | Same | ||
| Target Population | Adults | Adults | Same |
| Anatomical Site | Upper body | Upper body | Same |
| Where Used | Health care facility | Health care facility | Same |
| Reuse | Single patient only | Single patient only | Same |
| Rx/OTC/Both | Rx | Rx | Same |
6
| System Description | ECG lead wires with
terminal connectors | ECG lead wires with
terminal connectors | Same |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------|
| Design Concept | Lead wires transmit ECG
signals from patient to
trunk cable or
monitoring device | Lead wires transmit ECG
signals from patient to
trunk cable or
monitoring device | Same |
| Lengths | 30", 50" | 50" (per brochure) | Minor difference |
| Lead Sets | 3, 5, 6, 10 (by
combining two sets of
5 leads: one limb lead
set and one set of
vleads) | 3, 5, 6, 10 (brochure) | Same |
| Termination | Snap, Pinch | Snap, Pinch | Same |
| Multiple Models
Based on Features | Yes | Yes | Same |
| Peelable Ribbon | Yes | Yes | Same |
| Material
Composition | Medical-grade PVC
jacket | PVC | Same |
| Powered | No | No | Same |
| Components | | | |
| Shielded Lead Wires | Yes | Yes | Same |
| Patient Termination
Connector | Yes (Snap & Pinch) | Yes (Snap & Pinch) | Same |
| Trunk/Monitor
Connector | Yes | Yes | Same |
| Trunk Cable | No | No | Same |
| Accessories | None | None | Same |
| S&E Testing | | | |
| Biocompatibility | ISO 10993-5:2009
ISO 10993-10:2010 | ISO 10993-5:2009
ISO 10993-10:2010 | Same |
| Electrical Safety | IEC 60601-1:2005
MOD (Part 8.5.2.3) | IEC 60601-1:2005
MOD (Part 8.5.2.3) | Same |
| Mechanical Safety | ANSI/AAMI EC 53:
2013 | ANSI/AAMI EC 53:
2013 | Same |
Physical Characteristics
The subject device is comparable to the predicate in terms of design, function, materials, and performance. None of the differences raised different issues of safety and effectiveness.
Non-Clinical Testing
9Line passed the following non-clinical tests, all of which were performed to current FDArecognized standards:
- . Biocompatibility, ISO 10993-5:2009 and ISO 10993-10:2010... Device is non-cytotoxic, non-sensitizing, and non-irritating.
- Electrical & Mechanical Safety, IEC 60601-1 (Part 8.5.2.3) and ANSI/AAMI EC 53:2013... 510k Summary – Page 4
7
Device meets electrical and mechanical safety standards.
Substantial Equivalence
9Line patient leadwires successfully followed the pathway to Substantial Equivalence in the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" (2014). The steps are summarized below:
- The predicate device is legally marketed and was found substantially equivalent through 510(k) premarket submission.
- The subject and predicate devices have the same intended use (and indications for use).
- Technological differences between the subject and predicate were evaluated; none of the differences raised different issues of safety and effectiveness.
- . The following methods for evaluation of the effects of different characteristics on safety and effectiveness were deemed acceptable—testing for biocompatibility, electrical safety, and mechanical performance. Evaluation methods were conducted to FDArecognized standards where applicable.
- . Data from these tests demonstrated equivalence and support the indications for use.
In summary, all necessary testing has been performed and the results support the conclusion that 9Line patient leadwires is substantially equivalent to the legally marketed predicate, based on both (a) comparison of intended use, materials, technology, and design and (b) testing to FDA-recognized standards, and the device thus does not raise any concerns of safety or effectiveness.
Based on the information contained within this submission, the applicant concludes that 9Line is substantially equivalent to the identified predicate device.