(394 days)
Not Found
No
The summary explicitly states that the device "does not analyze patient information and does not offer medical advice to the patient. It collects, stores, and transmits patient information to the health professional." This indicates a lack of AI/ML capabilities for data analysis or interpretation.
No.
The device is described as a monitoring and data transfer system, not one that provides therapy or treatment.
Yes
Explanation: The device is described as taking vital signs (pulse, blood pressure, temperature, blood oxygen saturation, and ECG) and transmitting this patient information to a nurse or physician for review. While it doesn't analyze the data itself, the collection of physiological measurements for monitoring a patient's health status is a diagnostic function.
No
The device description explicitly states that the system consists of two parts: a programmable device called the HANC™ unit and a Remote Nursing Interface. The HANC™ unit is described as a physical device that monitors and transmits health information, takes vital signs, and incorporates other features like recording stethoscope sounds and capturing video images. This indicates the presence of hardware components beyond just software.
Based on the provided information, the HANC™ Network is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- HANC™ Network Function: The HANC™ Network primarily focuses on monitoring physiological parameters directly from the patient (pulse, blood pressure, temperature, blood oxygen saturation, ECG) and managing patient interactions (reminders, coaching, data input). It collects, stores, and transmits this data.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens. The measurements taken are direct physiological readings.
Therefore, the HANC™ Network falls under the category of devices that monitor and manage patient health through direct interaction and physiological measurement, rather than analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The HANC™ Network is intended to be used as a clinical tool to provide a method of monitoring a patient's health status at home and a method for transferring the data to a nurse for review. The HANC™ Network is indicated for use for patients that require medical observation and monitoring while at home, who have medication or therapy compliance issues, and who need training reinforcement. The HANC™ Network is not a patient emergency response system. It does not analyze patient information and does not offer medical advice to the patient. It collects, stores, and transmits patient information to the health professional.
Product codes
74DXN
Device Description
The HANC™ Network is a patient-support system designed to enhance the quality and lower the cost of healthcare services. The system consists of two parts: (1) a programmable device called the Home Assisted Nursing Care ("HANC"M") unit that monitors and transmits health information from a remote site such as a patient's home; and (2) a Remote Nursing Interface that receives, stores, and prints data for nurse or physician review.
The HANC™ unit is a speech and/or touch screen-activated device designed to monitor and assist patients in their homes. It coaches the patient in a conversational manner and manages patient schedules, takes vital signs, and has the ability to communicate over phone lines with an off-site Remote Nursing Interface that provides monitoring of the patient. The HANC™ unit may be used to perform measurements of pulse, blood pressure, temperature, blood oxygen saturation, and electrocardiogram (ECG). In addition, the HANC™ unit incorporates other features such as recording stethoscope sounds, capturing a video image, reminding patients to take medications, coaching screens, inputing data manually, and calling the nurse.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home (patient), Nurse or Physician (review)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
HealthTech Services has performed vital sign testing, and electrical, mechanical and environmental testing. The vital sign testing was designed to validate the design of the HANCTM unit and to demonstrate that the HANC™ unit is able to accurately and reliably measure vital sign parameters. It also was designed to ensure that integration of the previously cleared stand-alone components into the HANC™ unit will not affect the performance or operation of those components. The electrical, mechanical, and environmental testing performed was designed to demonstrate the safety and effectiveness of the performance characteristics of the product.
In all instances the HANC™ unit performed as expected and passed the test performed. The vital sign tests have shown that integration of the vital sign components into the HANC™ unit does not in any way affect their performance characteristics. In addition, the electrical, mechanical and environmental testing has shown that the HANC™ unit is both safe and effective in the home environment.
Key Metrics
Not Found
Predicate Device(s)
K864318, K945947, K921388/B, K875015, K874378
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Confidential
Attachment 7
JUL 25 1996
ATTACHMENT 7
510 (k) SUMMARY
This Attachment contains the HealthTech Services Corporation summary of the HANCTM Network 510(k) Submission
© 1995, HealthTech Services Corporation. All rights reserved.
1
510(k) SUMMARY THE HANC™ NETWORK
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
HealthTech Services Corporation
85 Revere Drive, Suite A Northbrook, Illinois 60062 Telephone: (708) 205-2530 Facsimile: (708) 205-1970
Michael J. Glynn, President & CEO Contact Person:
Date Prepared: June 24, 1995
Name of Device and Name/Address of Sponsor
The HANCTM Network
HealthTech Services Corporation 85 Revere Drive, Suite A Northbrook, Illinois 60062
Home Assisted Nursing Care (HANCTM) Common or Usual Name:
Classification Name: FDA has not specifically classified the device, however based on communications with the Agency, HealthTech Services Corporation was advised to make the HANC™ Network an accessory to a Semi-Automatic Indirect Blood Pressure Monitor. Semi-Automatic Indirect Blood Pressure Monitors along with their accessories, are classified under 21 C.F.R. § 870.1130 as Class II devices. The product code for such devices is 74DXN.
© 1995, HealthTech Services Corporation. All rights reserved.
HealthTech Services Corporation 85 Revere Drive, Suite A · Northbrook, IL 60062 708.205.2530 • 708.205.1970 fax
2
Predicate Devices:
Overall Predicate
The Buddy System 510(k) #: K864318
Vital Sign Component Predicates
| Blood Pressure | Nellcor Symphony™ N-3100 BP Monitor | K945947 |
|---|---|---|
| ECG | BCI 9100 Multigas Monitor | K921388/B |
| ECG electrodes | NDM Tracets 3000 | K875015 |
| Temperature | BCI 9100 Multigas Monitor | K921388/B |
| Temperature Probe | Criticon Dinamap™ 8100T Vital Signs Monitor | K874378 |
| Pulse Oximetry | BCI 9100 Multigas Monitor | K921388/B |
| Electronic Stethoscope | Andries Tek Electronic Stethoscope | Pre-1976 |
| Device |
Intended Use
The HANC™ Network is intended to be used as a clinical tool to provide a method of monitoring a patient's health status at home and a method for transferring the data to a nurse for review. The HANC™ Network is indicated for use for patients that require medical observation and monitoring while at home, who have medication or therapy compliance issues, and who need training reinforcement. The HANC™ Network is not a patient emergency response system. It does not analyze patient information and does not offer medical advice to the patient. It collects, stores, and transmits patient information to the health professional.
Technological Characteristics and Substantial Equivalence
The HANC™ Network is a patient-support system designed to enhance the quality and lower the cost of healthcare services. The system consists of two parts: (1) a programmable device called the Home Assisted Nursing Care ("HANC"M") unit that monitors and transmits health information from a remote site such as a patient's home; and (2) a Remote Nursing Interface that receives, stores, and prints data for nurse or physician review.
The HANC™ unit is a speech and/or touch screen-activated device designed to monitor and assist patients in their homes. It coaches the patient in a conversational manner and manages patient schedules, takes vital signs, and has the ability to communicate over phone lines with an off-site Remote Nursing Interface that provides monitoring of the patient. The HANC™ unit may be used to perform
© 1995, HealthTech Services Corporation. All rights reserved.
3
HealthTech
measurements of pulse, blood pressure, temperature, blood oxygen saturation, and electrocardiogram (ECG). In addition, the HANC™ unit incorporates other features such as recording stethoscope sounds, capturing a video image, reminding patients to take medications, coaching screens, inputing data manually, and calling the nurse.
The HANC™ Network is substantially equivalent to the Buddy System, referenced above. The HANC™ Network and its predicate both have the same general intended use, similar principles of operation, and similar technological characteristic. Both are intended to assist patients in managing their health at home and to provide a method for the clinician to gather medical data remotely. Both home devices utilize previously cleared Original Equipment Manufacturer (OEM) components to measure blood pressure, ECG, temperature and both products contain additional features such as medication reminders, coaching screens, and symptom reporting.
Likewise, in addition to the HANC™ Network's overall substantial equivalence to the Buddy System, each vital sign component of the HANC™ unit also is substantially equivalent to the pertinent cleared device in stand-alone form. The individual vital sign components of the HANC™ unit are OEM components that are each currently used in other previously cleared medical devices. Thus, each of the vital sign components integrated into the HANC™ unit is substantially equivalent to its stand-alone FDA-cleared counterpart.
The differences between the HANC™ Network and its predicate device are very minor. For example, the HANC™ Network incorporates additional features such as an electronic stethoscope, a pulse oximeter, and a camera, as well as newer and more advanced electronics. Therefore, HealthTech Services believes that the minor differences between the HANC™ Network and its predicate device do not substantially change either the performance of the HANC™ unit as compared to the Buddy unit, or the safety, efficacy, or intended use of the HANC™ Network as compared to the Buddy System.
Performance Data
HealthTech Services has performed vital sign testing, and electrical, mechanical and environmental testing. The vital sign testing was designed to validate the design of the HANCTM unit and to demonstrate that the HANC™ unit is able to accurately and reliably measure vital sign parameters. It also was designed to ensure that integration of the previously cleared stand-alone components into the HANC™ unit will not affect the performance or operation of those components. The electrical, mechanical, and environmental testing performed was designed to demonstrate the safety and effectiveness of the performance characteristics of the product.
In all instances the HANC™ unit performed as expected and passed the test performed. The vital sign tests have shown that integration of the vital sign components into the HANC™ unit does not in any way affect their performance characteristics. In addition, the electrical, mechanical and environmental testing has shown that the HANC™ unit is both safe and effective in the home environment.
© 1995, HealthTech Services Corporation. All rights reserved.