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.

AI/ML Overview

This document is a 510(k) premarket notification for the Delta 3300 Defibrillator/Pacemaker Analyzer. The information provided focuses on demonstrating substantial equivalence to a predicate device, the BC Group International, Inc. DA-2006.

Here's an analysis based on your requested criteria:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" for the Delta 3300's performance in the typical sense of a diagnostic device (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates performance by comparing its technical specifications and test results to those of the predicate device, aiming to show it is equivalent or better. The acceptance criteria are implicitly met by demonstrating that the Delta 3300's performance specifications are comparable to or improved over the predicate, and that it passed relevant safety and EMC standards.

Characteristic	Acceptance Criteria (Predicate DA-2006)	Reported Device Performance (Delta 3300)	Comparison
Maximum Voltage	5000V	5000V	Same
Maximum Continuous Power	12W, 10 defib pulses at 360J every 5 min	10W, 10 defib pulses at 360J every 5 min	Power dissipation factor increased by 2W (Predicate is higher)
Inductance	<10 µh	<3 µh @ 50 Ohm	Lower inductance factor by 7µh (Delta 3300 is better)
Sampling Time	100 µs	20 µs	80 µs faster sampling rate (Delta 3300 is better)
Sampling Window	100 ms	60 ms	40 ms sampling window for improved resolution (Delta 3300 is better, but the predicate has a larger window which could be viewed differently depending on context)
Display Resolution	0.1 J (Low Range); 1 J (High Range)	Auto Ranging: 0.01 < 9.9J; 0.1 > 10, < 99.9; 1 > 100	0.01 resolution <9.9J; 0.1 resolution >10 -99.9 (Delta 3300 offers higher resolution in lower ranges)
Elec Spec: Load Settings	50 Ω, +/- 1%	50 Ω, +/- 1%	Same
Elec Spec: Accuracy (50 Ω)	+/- 2% of reading; +/- 2 Joules	Auto Ranging: +/- 1% of reading for < 99.99 Joules; +/- 2% for >100 Joules	+/- 1% of reading for <99.99 Joules; +/- 2% for >100 Joules (Delta 3300 offers better accuracy in lower ranges)
Operating Temp	15 to 40 °C	15 to 40 °C	Same
Storage Temp	-20 to +60 °C	-20 to +60 °C	Same
Electrical Safety	Met IEC 61010-1:2010	Passed IEC 61010-1:2010 (Third Edition)	Compliance with safety standard
EMC	Met EN 61000-3-2; EN 61000-3-3	Passed EN 61000-3-2; EN 61000-3-3	Compliance with EMC standards
Software Verification	Implied by predicate clearance	Passed IEC 61508 - Embedded software verification and validation	Compliance with software standard

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This device is a defibrillator/pacemaker analyzer, a test and measurement instrument, not a diagnostic device that processes patient data. Therefore, the concept of a "test set" with patient data or provenance does not apply. The performance evaluation was based on non-clinical bench tests. The document does not specify a "sample size" in terms of number of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As a test and measurement device, ground truth is established by the known physical properties and outputs of the equipment being tested (e.g., a defibrillator's energy output), calibrated standards, and compliance with engineering standards. There is no mention of human expert consensus for establishing ground truth as there would be for an AI-powered diagnostic tool.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human readers or interpretation of results that would require an adjudication method.

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

Not applicable. This device is a standalone analyzer, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The "performance testing" described involved non-clinical bench tests of the device itself (electrical safety, EMC, embedded software verification). The device operates as a standalone instrument for measuring parameters of other medical devices (defibrillators and transcutaneous pacemakers) without human-in-the-loop interpretation of its internal functioning. Its performance is evaluated against engineering specifications and standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance testing of the Delta 3300 is based on:

Engineering specifications and standards: e.g., the specified voltage/current/energy output of a defibrillator for measurement, the requirements of IEC 61010-1 for electrical safety, EN 61000 series for EMC, and IEC 61508 for software.
Known, calibrated inputs/simulations: The device measures electrical signals; these signals would be generated by calibrated sources or actual medical devices with known performance characteristics to verify the analyzer's accuracy.

8. The sample size for the training set

Not applicable. This is a hardware device with embedded software, not a machine learning model that requires a training set in the AI sense. The embedded software was verified and validated according to IEC 61508, which involves testing against requirements, but not a "training set" of data.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of this device. The phrase "ground truth" for embedded software might refer to the functional requirements and intended behavior established during the design and development phases, against which the software's performance is tested.

Summary

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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)

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

1. 510(k) Submitter: Netech Corp. 110 Toledo St. Farmingdale, NY 11735 Phone: 631-531-0100 Email: md@netech.org
1. Company Contact: Mohan Das, President
1. Date of 510 (k) Summary Preparation: August 27, 2019
1. 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 3300Defibrillator/Pacemaker AnalyzerTester, Defibrillator870.53252DRL
6. Predicate:	Applicant:Device:510(k) Number:	BC Group International, Inc (St Charles, MO)DA-2006K110192

1. 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.

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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1. 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.
1. 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 instrumentfor ensuring thatdefibrillators anddefibrillators withtranscutaneouspacemakers complywith performancespecifications.	Used to determine thatdefibrillators andtranscutaneouspacemakers areperforming within theirperformancespecifications.	Same
Maximum Voltage	5000V	5000V	Same
MaximumContinuous Power	10W, 10 defib pulses at360J every 5 min	12W, 10 defib pulses at360J every 5 min	Power dissipation factorincreased by 2 W.
Inductance	<3 uh @ 50 Ohm	<10 uh	Lower inductance factorby 7uh.
Tech Spec:Sampling Time	20 us	100 us	80 us faster samplingrate.
Tech Spec:Sampling Window	60 ms	100 ms	40 ms samplingwindow for improvedresolution

Table 5 – Comparison Table

Physical Characteristics

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Tech Spec: DisplayResolution	Auto Ranging0.01 < 9.9J0.1 > 10, < 99.91 > 100	0.1 J (Low Range)1 J (High Range)	0.01 resolution <9.9J0.1 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 <99.99 Joules+/- 2% for >100 Joules	+/- 2% of reading+/- 2 Joules	+/- 1% of reading for <99.99 Joules+/- 2% for >100 Joules
Physical:Dimensions	260mm X 160mm X640mm	248.9mm X 205.7mm X120.7mm	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

1. 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.
1. 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.

Regulation Number and Section

§ 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).