GENESIS DM MODEL: 6053000A1 by HONEYWELL HOMMED, LLC

The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the Honeywell HomMed Genesis DM Monitor, focusing on acceptance criteria and study details.

Based on the provided document, there is no explicit mention of specific numerical acceptance criteria or a comparative study (like MRMC) for the device's performance in measuring vital signs. The document primarily focuses on regulatory compliance and the intended use of the device.

Here's what can be extracted and inferred:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Regulatory Compliance (General)	Compliance with applicable standards, guidelines, and regulations.	"Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards."
Software Validation	Compliance with FDA reviewer's guides and performance within specifications and functional requirements for software.	"The software validation results demonstrated that the Genesis DM Monitor was in compliance with the guidelines and standards referenced in the FDA reviewer's guides, and that it performed within its specifications and functional requirements for software."
Intended Use Fulfillment	Ability to retrospectively monitor vital signs (noninvasive blood pressure, pulse rate, weight), transmit data, and extend capabilities with optional products.	The device is designed to fulfill these functions, and the regulatory approval implies it met the necessary requirements for this design and intended use. (No direct performance metrics are given, but compliance with standards suggests it meets expected operational capabilities.)

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a sample size for any test set or the provenance of data used for performance testing. The 'performance data' section refers to general compliance testing (EMC, electrical, mechanical durability, safety, temperature/humidity) and software validation. These are typically engineering tests rather than clinical performance studies with patient data.
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):
This information is not provided in the document. Given the nature of the tests described (EMC, electrical, mechanical, software validation), "experts" in the sense of medical professionals establishing a ground truth for diagnostic accuracy would not be applicable here. The ground truth for these engineering tests would be established by the specifications and standards themselves.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable to the types of engineering and software validation tests described. Adjudication methods are typically used in clinical studies where expert consensus is needed for ground truth.
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 MRMC comparative effectiveness study was done or reported. The device described is a vital signs monitor, not an AI-assisted diagnostic tool for human readers. It's intended to collect and display vital signs retrospectively.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document mentions "software validation results demonstrated that the Genesis DM Monitor was in compliance... and that it performed within its specifications and functional requirements for software." This implies a standalone software validation was performed to ensure its functionality and adherence to specifications. However, this is distinct from a clinical performance study measuring diagnostic accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mentioned tests:
- EMC, electrical, mechanical durability, safety, temperature/humidity testing: The "ground truth" would be the specific technical standards and regulatory requirements (e.g., IEC standards, UL standards, etc.) that the device was tested against.
- Software validation: The "ground truth" would be the pre-defined software specifications and functional requirements themselves, alongside relevant FDA guidelines for medical device software.
The sample size for the training set:
Not applicable. The Honeywell HomMed Genesis DM Monitor is a vital signs monitoring device, not a machine learning or AI algorithm that requires a "training set" in the conventional sense of data-driven model development. The performance data refers to engineering and software validation tests.
How the ground truth for the training set was established:
Not applicable for the same reasons as point 7. No training set for an AI model is mentioned or implied.

Summary of what the document does provide:

The document details the regulatory submission for the Honeywell HomMed Genesis DM Monitor. It states that the device primarily passed various engineering and software validation tests to demonstrate compliance with applicable standards and its own specifications. These tests ensure the device is safe, functions as intended, and meets regulatory requirements for its class. The device's intended use is retrospective monitoring of vital signs, not real-time or emergency monitoring, and it does not appear to involve AI or diagnostic interpretation that would require clinical performance studies with expert consensus or MRMC studies.

Summary

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10/242 510(k) Summary for Honeywell HomMed Genesis DM Monitor

Submitter:		Honeywell HomMed, LLC
Address:		3400 Intertech Drive, Suite 200JUN 1 1 2010Brookfield, Wisconsin 53045
Corporate Contact:		Emily Vande Hei, Regulatory Manager and Quality ChampionHoneywell HomMed, LLC
Telephone:		Ph: (262) 783-5440Fax: (262) 783-5441
Establishment Registration #:		3004183721
Submission Contact:		Emily Vande Hei, Regulatory Manager and Quality ChampionHoneywell HomMed, LLC3400 Intertech Drive, Suite 200Brookfield, Wisconsin 53045Ph: (262) 252-6082Fax: (262) 252-6119
Trade Name:	Genesis DM Monitor
Predicate Device:	HomMed Genesis OTC, K061087Omron Automatic Blood Pressure Monitor Model:HEM-780N3, K061822
Common Name:		Patient Vital Signs Monitor
Classification Name:
	270.2910	DRG	Radiofrequency Physiological Signal	II
		2019 10	Transmitter and Receiveredical device product codes also supported by Genesis DM by meansof separate medical devices
	870.1130	DXN	Noninvasive Blood Pressure MeasurementSystem	II
	880.2700	FRI	Patient Weight Scale	I
	870.2700	DQA	Oximeter	II
	862.1345	NBW	Glucose Test System	II
	868.1860	BZH	Meter, Peak Flow, Spirometry	II ·
	880.2910	FLL	Thermometer, Electronic, Clinical	II
	864.7750870-2340	GIS	Test, Time, Prothrombin	II
	890.5060	DPSNXB	ElectrocardiographMedication Reminder	II
				T

Intended Use:

The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional

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commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.

Performance Data:

Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards. The software validation results demonstrated that the Genesis DM Monitor was in compliance with the guidelines and standards referenced in the FDA reviewer's guides, and that it performed within its specifications and functional requirements for software.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA regarding medical device software.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Honeywell HomMed c/o Ms. Emily Vande Hei Regulatory Manager and Quality Champion 3400 Intertech Drive, Suite 200 Brookfield, WI 53045

JUN 1 1 2010

Re: K101242

Trade/Device Name: Genesis DM, Model 6053000A1 Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: II (two) Product Code: DRG Dated: June 1, 2010 Received: June 3, 2010

Dear Ms. Vande Hei:

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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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.

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Page 2 – Ms. Emily Vande Hei

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

as Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

101242

Device Name: Honeywell HomMed Genesis DM

Indications For Use:

Prescription Use

(Part 21 CFR 801 Subpart D)

The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis, purc "weight" bala non" opilorial from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Million is not intended for emergency use or realtime monitoring.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

W. Watsd

Over-The-Counter Use _

(21 CFR 807 Subpart C)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).