(187 days)
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No
The description focuses on standard electrical measurement and simulation functions, with no mention of AI or ML terms or capabilities.
No.
The device is an analyzer used to test other medical devices (defibrillators and pacemakers) to ensure they are performing within specifications, rather than directly providing therapy to a patient.
No
Explanation: This device is a test and measurement tool used to analyze the performance of medical equipment (defibrillators and pacemakers). It does not diagnose medical conditions in patients.
No
The device description explicitly states it is a "portable battery-powered device" and a "waveform analyzer," indicating it is a physical hardware device that measures electrical signals. The performance studies also include electrical safety and EMC testing, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to analyze the performance of medical devices (defibrillators and pacemakers) by measuring their energy output and other electrical characteristics. It is used for testing and verifying the functionality of medical equipment, not for analyzing biological samples from a patient to diagnose or monitor a medical condition.
- Device Description: The description reinforces that it's a "waveform analyzer" used by "trained service technicians" to verify the performance of defibrillators and pacemakers. It simulates ECG and arrhythmia waveforms for testing the monitor function of defibrillators, which is a test of the device itself, not a diagnostic test on a patient.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples (blood, urine, tissue, etc.) from a patient. IVDs are specifically designed to perform tests on such samples.
- Target User: The intended user is a "trained service technician," not a healthcare professional using the device for patient diagnosis or monitoring.
In summary, the Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is a medical device testing and calibration tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
Product codes (comma separated list FDA assigned to the subject device)
DRL
Device Description
Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
The portable battery-powered device is intended for use by trained service technicians. Delta 3300 is a waveform analyzer that determines the characteristics of an electrical discharge signal produced by a defibrillator and transcutaneous pacemaker.
It provides a basis for verifying the energy output of a defibrillator, including energy, peak current, and peak voltage. The device incorporates a simulation function of ECG and arrhythmia waveforms for verifying the performance of defibrillator monitors.
Delta 3300 also verifies transcutaneous pacemaker parameters such as pulse rate, width, amplitude, and energy as well as refractory and sensitivity measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained service technicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Delta 3300 passed the following non-clinical bench tests: (Animal /Clinical testing was not performed).
- Electrical Safety IEC 61010-1:2010 (Third Edition)... Safety requirements for . electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- EMC EN 61000-3-2 ... Electromagnetic Compatibility (EMC) Part 3-2 Limits -. Limits for harmonic current emissions
- . EMC - EN 61000-3-3... Electromagnetic Compatibility (EMC) Part 3 Limits -Section 3: Limitation of voltage fluctuations and flicker in public low voltage supply systems. For harmonic current emissions.
- IEC 61508 - Embedded software verification and validation.
In summary, all necessary testing has been performed and the results support the conclusion that Delta 3300 is substantially equivalent to the legally marketed predicate, DA-2006, based on intended use, materials, technology, and design, and the device thus does not raise any concerns of safety or effectiveness. This finding of substantial equivalence warrants clearance of Delta 3300 for marketing activities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 870.5325 Defibrillator tester.
(a)
Identification. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Netech Corporation % Mukesh Kumar CEO Brij Strategic Consultations, LLC 20271 Goldenrod Lane, Suite 2020 Germantown, Maryland 20876
Re: K190437
Trade/Device Name: Delta 3300 Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator Tester Regulatory Class: Class II Product Code: DRL Dated: July 29, 2019 Received: July 30, 2019
Dear Mukesh Kumar:
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 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
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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.
Nicole Goodsell Acting Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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) K190437
Device Name Delta 3300
Indications for Use (Describe)
Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
| 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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Section 5 – 510(k) Summary
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- 510(k) Submitter: Netech Corp. 110 Toledo St. Farmingdale, NY 11735 Phone: 631-531-0100 Email: md@netech.org
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- Company Contact: Mohan Das, President
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- Date of 510 (k) Summary Preparation: August 27, 2019
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- 510(k) Preparer: Mohan Das, Ph.D Netech Corp. 110 Toledo St. Farmingdale, NY 11735 Phone: 631-531-0100 Email: md@netech.org
| 5. Device Classification: | Trade name:
Common name:
Device:
Regulation:
Class:
Product Code: | Delta 3300
Defibrillator/Pacemaker Analyzer
Tester, Defibrillator
870.5325
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DRL |
|-----------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 6. Predicate: | Applicant:
Device:
510(k) Number: | BC Group International, Inc (St Charles, MO)
DA-2006
K110192 |
-
- Device Description... Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
The portable battery-powered device is intended for use by trained service technicians. Delta 3300 is a waveform analyzer that determines the characteristics of an electrical discharge signal produced by a defibrillator and transcutaneous pacemaker.
- Device Description... Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
It provides a basis for verifying the energy output of a defibrillator, including energy, peak current, and peak voltage. The device incorporates a simulation function of ECG and arrhythmia waveforms for verifying the performance of defibrillator monitors.
Delta 3300 also verifies transcutaneous pacemaker parameters such as pulse rate, width, amplitude, and energy as well as refractory and sensitivity measurement.
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-
- Indications For Use... Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
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- Comparison To Predicate... As shown in Table 5, Delta 3300 and the predicate share the
same:
- Indications for use
- Classification and product code
- Description - Defibrillator tester
- . Technology – Precision testing instrument
- . Intended User – Trained service technician
| Characteristics | Device | Predicate | Comparison |
|---|---|---|---|
| 510k Number | Applied For | K160761 | NA |
| Common Name | Defibrillator tester | Defibrillator tester | Same |
| Trade Name | Delta 3300 | ||
| (Netech Corp) | DA-2006 | ||
| (BC Group) | NA | ||
| Regulation Number | 21 CFR 870.5325 | 21 CFR 870.5325 | Same |
| Product Code | DRL | DRL | Same |
| Indications For Use | Precision instrument | ||
| for ensuring that | |||
| defibrillators and | |||
| defibrillators with | |||
| transcutaneous | |||
| pacemakers comply | |||
| with performance | |||
| specifications. | Used to determine that | ||
| defibrillators and | |||
| transcutaneous | |||
| pacemakers are | |||
| performing within their | |||
| performance | |||
| specifications. | Same | ||
| Maximum Voltage | 5000V | 5000V | Same |
| Maximum | |||
| Continuous Power | 10W, 10 defib pulses at | ||
| 360J every 5 min | 12W, 10 defib pulses at | ||
| 360J every 5 min | Power dissipation factor | ||
| increased by 2 W. | |||
| Inductance | 10, 100 | 0.1 J (Low Range) | |
| 1 J (High Range) | 0.01 resolution 10 -99.9 | ||
| ---------------------------------- | ----------------------------------------------------------------------------------- | --------------------------------------- | --------------------------------------------------------------- |
| Elec Spec: | |||
| Load Settings | 50 Ω, +/- 1% | 50 Ω, +/- 1% | Same |
| Elec Spec: | |||
| Accuracy (50) Ω | Auto Ranging | ||
| +/- 1% of reading for 100 Joules | +/- 2% of reading | ||
| +/- 2 Joules | +/- 1% of reading for 100 Joules | ||
| Physical: | |||
| Dimensions | 260mm X 160mm X | ||
| 640mm | 248.9mm X 205.7mm X | ||
| 120.7mm | Smaller foot print | ||
| Weight | 1.5 Kg | 2.37 Kg | Lighter |
| Operating Temp | 15 to 40 °C | 15 to 40 °C | Same |
| Storage Temp | -20 to +60 °C | -20 to +60 °C | Same |
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- Performance Testing... Delta 3300 passed the following non-clinical bench tests: (Animal /Clinical testing was not performed).
- Electrical Safety IEC 61010-1:2010 (Third Edition)... Safety requirements for . electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- EMC EN 61000-3-2 ... Electromagnetic Compatibility (EMC) Part 3-2 Limits -. Limits for harmonic current emissions
- . EMC - EN 61000-3-3... Electromagnetic Compatibility (EMC) Part 3 Limits -Section 3: Limitation of voltage fluctuations and flicker in public low voltage supply systems. For harmonic current emissions.
- IEC 61508 - Embedded software verification and validation.
-
- Substantial Equivalence... Delta 3300 successfully followed the pathway to Substantial Equivalence in the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" (July 2014). The steps are summarized below:
- The predicate is legally marketed because it was found substantially equivalent through the 510(k) process.
- The subject and predicate devices have the same intended use (and indications).
- . Technological differences between the subject and primary predicate were evaluated. It was found that the technological differences doesn't introduce any new and/or different concerns relating to its safety or effectiveness.
- The following methods for evaluation of the effects of different characteristics ● on safety and effectiveness were deemed acceptable-electrical safety, electromagnetic compatibility, and non-clinical performance testing.
- Data from these tests demonstrated equivalence and support the indications for use.
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In summary, all necessary testing has been performed and the results support the conclusion that Delta 3300 is substantially equivalent to the legally marketed predicate, DA-2006, based on intended use, materials, technology, and design, and the device thus does not raise any concerns of safety or effectiveness. This finding of substantial equivalence warrants clearance of Delta 3300 for marketing activities.