9Line

K211941 · Energetic Designs, Inc. · DSA · Jan 27, 2022 · Cardiovascular

Device Facts

• Record ID: K211941
• Device Name: 9Line
• Applicant: Energetic Designs, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Jan 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

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.

Device Story

9Line consists of multiple patient leadwires with snap or pinch terminations; connects patient-affixed electrodes to external trunk cables or directly to ECG/EKG monitors. Transmits ECG signals from patient to monitor for diagnostic/monitoring purposes. Used in healthcare facilities by healthcare professionals. Color-coded per AAMI recommendations. Single-patient use; non-sterile. Benefits include reliable signal transmission for cardiac monitoring.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010) confirming non-cytotoxic, non-sensitizing, and non-irritating properties; electrical safety (IEC 60601-1:2005); and mechanical safety (ANSI/AAMI EC 53:2013).

Technological Characteristics

Medical-grade PVC jacket; shielded lead wires; snap or pinch terminations; 3, 5, 6, or 10 lead configurations; 30" or 50" lengths. Standards: ISO 10993-5:2009, ISO 10993-10:2010 (biocompatibility), IEC 60601-1:2005 (electrical safety), ANSI/AAMI EC 53:2013 (mechanical safety). Passive device; no power source.

Indications for Use

Indicated for adult patients requiring ECG or EKG monitoring or diagnostic evaluation in a healthcare facility. Intended for single-patient use.

Regulatory Classification

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.

Predicate Devices

• ECG Disposable Lead Wires (K170536)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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) | |
|------------------------------------------------------------------------------------|--|
| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |

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## 510(k) Summary

| 1. 510(k) Submitter: | Energetic Designs, Inc.<br>1100 Del Lago Cir, Palm Beach Gardens, FL<br>33410 Phone: [phone]<br>Email: [e-mail] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Company Contact: | John F. Gillespy, MBA |
| 3. Date of Submission: | June 17, 2021 |
| 4. 510(k) Preparer: | John F. Gillespy, MBA<br>FDA 510k Consultants, LLC<br>Palm Beach Gardens, FL 33410<br>Phone: [phone]<br>Email: [e-mail] |
| 5. Device Classification: | Trade name: 9Line<br>Common name: ECG Disposable Lead Wires<br>Device: Cable, Transducer & Electrode, Patient,<br>(Including Connector)<br>Class: II<br>Regulation #: 870.2900<br>Product Code: DSA |
| 6. Predicate: | Applicant: APK Technology Co.<br>Device: ECG Disposable Lead Wires<br>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.

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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<br>w/Shielded Systems Bonded Cable |
| 3SS-050 | 50" 3 Lead Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 5SS-030 | 30" 5 Lead Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 5SS-050 | 50" 5 Lead Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 5VSS-030 | 30" 5 V Leads Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 5VSS-050 | 50" 5 V Leads Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| NK-3SS-030 | 30" 3 Lead Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| NK-3SS-050 | 50" 3 Lead Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| NK-6SS-030 | 30" 6 Lead Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| NK-6SS-050 | 50" 6 Lead Snap Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |

| PART NUMBER | DESCRIPTION (PINCH TERMINATION) |
|-------------|--------------------------------------------------------------------------------|
| 3PS-030 | 30" 3 Lead Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 3PS-050 | 50" 3 Lead Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 5PS-030 | 30" 5 Lead Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 5PS-050 | 50" 5 Lead Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 5VPS-030 | 30" 5 V Leads Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| 5VPS-050 | 50" 5 V Leads Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| NK-3PS-030 | 30" 3 Lead Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| NK-3PS-050 | 50" 3 Lead Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| NK-6PS-030 | 30" 6 Lead Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |
| NK-6PS-050 | 50" 6 Lead Pinch Single Patient Use AAMI<br>w/Shielded Systems Bonded Cable |

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## 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<br>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<br>electrodes with ECG for<br>monitoring or<br>diagnostic evaluation. | Connect patient<br>electrodes with ECG for<br>monitoring or<br>diagnostic evaluation. | Same |
| Indications For Use | 9Line patient leadwires<br>are intended to be used<br>to connect electrodes<br>placed at appropriate<br>sites on the patient to<br>an ECG or EKG<br>monitoring device for<br>general monitoring<br>and/or diagnostic<br>evaluation by a health<br>care professional. The<br>device is intended for<br>single-patient use. | The ECG Disposable<br>Lead Wires are<br>intended to be used<br>with ECG. The lead wire<br>is used to connect<br>electrodes placed at<br>appropriate sites on the<br>patient to ECG for<br>general monitoring<br>and/or diagnostic<br>evaluation by health<br>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 |

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| System Description | ECG lead wires with<br>terminal connectors | ECG lead wires with<br>terminal connectors | Same |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------|
| Design Concept | Lead wires transmit ECG<br>signals from patient to<br>trunk cable or<br>monitoring device | Lead wires transmit ECG<br>signals from patient to<br>trunk cable or<br>monitoring device | Same |
| Lengths | 30", 50" | 50" (per brochure) | Minor difference |
| Lead Sets | 3, 5, 6, 10 (by<br>combining two sets of<br>5 leads: one limb lead<br>set and one set of<br>vleads) | 3, 5, 6, 10 (brochure) | Same |
| Termination | Snap, Pinch | Snap, Pinch | Same |
| Multiple Models<br>Based on Features | Yes | Yes | Same |
| Peelable Ribbon | Yes | Yes | Same |
| Material<br>Composition | Medical-grade PVC<br>jacket | PVC | Same |
| Powered | No | No | Same |
| Components | | | |
| Shielded Lead Wires | Yes | Yes | Same |
| Patient Termination<br>Connector | Yes (Snap & Pinch) | Yes (Snap & Pinch) | Same |
| Trunk/Monitor<br>Connector | Yes | Yes | Same |
| Trunk Cable | No | No | Same |
| Accessories | None | None | Same |
| S&E Testing | | | |
| Biocompatibility | ISO 10993-5:2009<br>ISO 10993-10:2010 | ISO 10993-5:2009<br>ISO 10993-10:2010 | Same |
| Electrical Safety | IEC 60601-1:2005<br>MOD (Part 8.5.2.3) | IEC 60601-1:2005<br>MOD (Part 8.5.2.3) | Same |
| Mechanical Safety | ANSI/AAMI EC 53:<br>2013 | ANSI/AAMI EC 53:<br>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

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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.