(218 days)
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.
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.
This document is a 510(k) Premarket Notification for a medical device called "9Line," which consists of patient leadwires for ECG/EKG monitoring. The purpose of this notification is to establish that the 9Line device is substantially equivalent to a previously cleared predicate device (APK Technology Co.'s ECG Disposable Lead Wires, K170536).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a Class II device (patient transducer and electrode cable), the "acceptance criteria" are primarily established by demonstrating equivalence to a predicate device and adherence to recognized electrical, mechanical, and biocompatibility standards. Performance is reported in terms of compliance with these standards.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate: Connect patient electrodes with ECG for monitoring or diagnostic evaluation. | Same: 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 healthcare professional. |
| Indications For Use | Same as predicate. | Same: As detailed in the "Indications For Use" section, both devices have identical indications. |
| Technological Characteristics | Similar design concept, materials, and features as predicate, with no new issues of safety or effectiveness. | Comparable: ECG lead wires with terminal connectors, transmit ECG signals, medical-grade PVC jacket, peelable ribbon, shielded lead wires. Minor differences in available lengths (30", 50" for 9Line vs. 50" for predicate) and lead sets (3, 5, 6, 10 for both). No new issues of safety or effectiveness raised. |
| Biocompatibility | Compliance with ISO 10993-5:2009 and ISO 10993-10:2010. | Passed: Device is non-cytotoxic, non-sensitizing, and non-irritating, meeting ISO 10993-5:2009 and ISO 10993-10:2010. |
| Electrical Safety | Compliance with IEC 60601-1:2005 MOD (Part 8.5.2.3). | Passed: Device meets electrical safety standards outlined in IEC 60601-1:2005 MOD (Part 8.5.2.3). |
| Mechanical Safety | Compliance with ANSI/AAMI EC 53:2013. | Passed: Device meets mechanical safety standards outlined in ANSI/AAMI EC 53:2013. |
2. Sample size used for the test set and the data provenance:
For this type of device (patient leadwires), the "test set" does not refer to a clinical study with a patient population in the way an AI/ML algorithm might. Instead, the testing is non-clinical and focuses on material properties, electrical, and mechanical performance. The "sample size" would refer to the number of leadwire units tested for each specific non-clinical test (biocompatibility, electrical safety, mechanical safety).
- Sample Size for Non-Clinical Testing: The document does not explicitly state the exact number of units tested for each non-clinical test (biocompatibility, electrical safety, mechanical safety). These numbers are typically found in detailed test reports referenced by the submission, but not usually in the summary document provided here.
- Data Provenance: The tests were conducted to FDA-recognized standards (ISO 10993-5:2009, ISO 10993-10:2010, IEC 60601-1:2005, ANSI/AAMI EC 53:2013). This implies that the testing was performed in a controlled laboratory environment, likely by accredited testing facilities specializing in medical device testing. The results are therefore prospective in nature, generated specifically for this submission. The country of origin of the data is not specified, but adhering to international standards suggests widely recognized testing practices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable in the typical sense for this device. The "ground truth" for patient leadwires is their compliance with established engineering and safety standards, rather than expert interpretation of medical images or clinical outcomes. The "experts" involved are the engineers and scientists who developed and executed the non-clinical tests, and the regulatory reviewers at the FDA who assess the compliance of the device with these standards and guidelines. Their qualifications would be expertise in biocompatibility, electrical engineering, mechanical engineering, and medical device regulation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This concept of adjudication (e.g., 2+1 reader scheme) is typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnosis or evaluation, often in the context of imaging or pathology. For non-clinical testing of a device like leadwires, there is no such adjudication method. The outcomes are objective measurements against predefined thresholds specified by the recognized standards. If there is a dispute in test results, it would typically be resolved through repeat testing or verification by a different accredited lab, not through expert adjudication in the medical sense.
**5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where the performance of human clinicians is assessed with and without AI assistance to measure the AI's incremental benefit. The 9Line device is a passive component (ECG leadwires) and does not involve AI or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not done. As explained above, the 9Line device is not an algorithm or an AI system. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the 9Line device is based on objective engineering and scientific standards:
- Biocompatibility: Established by in-vitro and in-vivo tests according to ISO 10993 standards, demonstrating the material's safety for contact with the body.
- Electrical Safety: Established by measurements against thresholds defined in IEC 60601-1, ensuring the device does not pose electrical hazards.
- Mechanical Safety: Established by physical tests against specifications in ANSI/AAMI EC 53, ensuring mechanical integrity and performance.
These are not forms of expert consensus, pathology, or outcomes data in a clinical sense, but rather compliance with universally recognized standards for medical device safety and performance.
8. The sample size for the training set:
Not applicable. The 9Line device is a physical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth establishment for it.
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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 (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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| 1. 510(k) Submitter: | Energetic Designs, Inc.1100 Del Lago Cir, Palm Beach Gardens, FL33410 Phone: 386-243-4332Email: john@fda510kconsultants.com |
|---|---|
| 2. Company Contact: | John F. Gillespy, MBA |
| 3. Date of Submission: | June 17, 2021 |
| 4. 510(k) Preparer: | John F. Gillespy, MBAFDA 510k Consultants, LLCPalm Beach Gardens, FL 33410Phone: 386-243-4332Email: john@fda510kconsultants.com |
| 5. Device Classification: | Trade name: 9LineCommon name: ECG Disposable Lead WiresDevice: Cable, Transducer & Electrode, Patient,(Including Connector)Class: IIRegulation #: 870.2900Product Code: DSA |
| 6. Predicate: | Applicant: APK Technology Co.Device: ECG Disposable Lead Wires510(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 AAMIw/Shielded Systems Bonded Cable |
| 3SS-050 | 50" 3 Lead Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 5SS-030 | 30" 5 Lead Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 5SS-050 | 50" 5 Lead Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 5VSS-030 | 30" 5 V Leads Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 5VSS-050 | 50" 5 V Leads Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| NK-3SS-030 | 30" 3 Lead Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| NK-3SS-050 | 50" 3 Lead Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| NK-6SS-030 | 30" 6 Lead Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| NK-6SS-050 | 50" 6 Lead Snap Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| PART NUMBER | DESCRIPTION (PINCH TERMINATION) |
|---|---|
| 3PS-030 | 30" 3 Lead Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 3PS-050 | 50" 3 Lead Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 5PS-030 | 30" 5 Lead Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 5PS-050 | 50" 5 Lead Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 5VPS-030 | 30" 5 V Leads Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| 5VPS-050 | 50" 5 V Leads Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| NK-3PS-030 | 30" 3 Lead Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| NK-3PS-050 | 50" 3 Lead Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| NK-6PS-030 | 30" 6 Lead Pinch Single Patient Use AAMIw/Shielded Systems Bonded Cable |
| NK-6PS-050 | 50" 6 Lead Pinch Single Patient Use AAMIw/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 LeadWires | 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 patientelectrodes with ECG formonitoring ordiagnostic evaluation. | Connect patientelectrodes with ECG formonitoring ordiagnostic evaluation. | Same |
| Indications For Use | 9Line patient leadwiresare intended to be usedto connect electrodesplaced at appropriatesites on the patient toan ECG or EKGmonitoring device forgeneral monitoringand/or diagnosticevaluation by a healthcare professional. Thedevice is intended forsingle-patient use. | The ECG DisposableLead Wires areintended to be usedwith ECG. The lead wireis used to connectelectrodes placed atappropriate sites on thepatient to ECG forgeneral monitoringand/or diagnosticevaluation by healthcare 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 withterminal connectors | ECG lead wires withterminal connectors | Same |
|---|---|---|---|
| Design Concept | Lead wires transmit ECGsignals from patient totrunk cable ormonitoring device | Lead wires transmit ECGsignals from patient totrunk cable ormonitoring device | Same |
| Lengths | 30", 50" | 50" (per brochure) | Minor difference |
| Lead Sets | 3, 5, 6, 10 (bycombining two sets of5 leads: one limb leadset and one set ofvleads) | 3, 5, 6, 10 (brochure) | Same |
| Termination | Snap, Pinch | Snap, Pinch | Same |
| Multiple ModelsBased on Features | Yes | Yes | Same |
| Peelable Ribbon | Yes | Yes | Same |
| MaterialComposition | Medical-grade PVCjacket | PVC | Same |
| Powered | No | No | Same |
| Components | |||
| Shielded Lead Wires | Yes | Yes | Same |
| Patient TerminationConnector | Yes (Snap & Pinch) | Yes (Snap & Pinch) | Same |
| Trunk/MonitorConnector | Yes | Yes | Same |
| Trunk Cable | No | No | Same |
| Accessories | None | None | Same |
| S&E Testing | |||
| Biocompatibility | ISO 10993-5:2009ISO 10993-10:2010 | ISO 10993-5:2009ISO 10993-10:2010 | Same |
| Electrical Safety | IEC 60601-1:2005MOD (Part 8.5.2.3) | IEC 60601-1:2005MOD (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
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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.
§ 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).