K Number
K062304
Device Name
DLM112 DAYLINK MONITOR
Manufacturer
Date Cleared
2006-09-29

(52 days)

Product Code
Regulation Number
870.2910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Daylink 112 Monitor ("DLM112") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM112 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line. The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.
Device Description
The DLM112 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The DLM112, with its build-in modem, transmits data using the public switched telephone network. The DLM112 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons The DLM112 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
More Information

Not Found

No
The description explicitly states the device "does not measure, interpret or make any decisions on the vital data that it conveys" and focuses on its function as a communication tool for transmitting data using standard digital communication technologies. There is no mention of AI or ML in the document.

No
The device is described as an "accessory device that is intended to be a communication tool" for transmitting historical patient information. It explicitly states that it "does not measure, interpret or make any decisions on the vital data that it conveys," indicating it does not provide any therapeutic effect.

No

The device description explicitly states, "The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys." Its purpose is to collect and transmit selected medical information, acting as a communication tool rather than performing diagnostic functions.

No

The device description explicitly states it is a "telemedicine device" with a "build-in modem" and a "screen" with "four large buttons," indicating it is a physical hardware device, not solely software.

Based on the provided information, the Daylink 112 Monitor (DLM112) is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The primary intended use of the DLM112 is to act as a communication tool to transmit historical patient information (like weight, blood pressure, blood glucose) from external devices to healthcare providers. It does not perform any tests on biological samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions.
  • Device Description: The description clearly states that the DLM112 "does not measure, interpret or make any decisions on the vital data that it conveys." It is a data transmission device, not a device that analyzes biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
    • Reagents or assays
    • Analysis of biological samples
    • Measurement of analytes in biological samples
    • Diagnostic, monitoring, or screening purposes based on sample analysis

The DLM112 falls under the category of a telemedicine or remote patient monitoring device, which facilitates the communication of patient data but does not perform the diagnostic testing itself. The external devices it connects to (which measure weight, blood pressure, blood glucose) might be considered medical devices, but the DLM112 itself is a communication gateway.

N/A

Intended Use / Indications for Use

The Daylink 112 Monitor ("DLM112") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM112 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.

Product codes

DRG

Device Description

The DLM112 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The DLM112, with its build-in modem, transmits data using the public switched telephone network.

The DLM112 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons

The DLM112 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home users and healthcare providers.

The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The DLM112 device has been tested to meet the requirements of the following standards and requlations used as acceptance criteria:

IEC 60601-1, IEC 60601-1-2, FCC part 15 and FCC Part 68.

Risk management is performed according to ISO14971:2000.

Based on the fact that the performance comparison of the predicate device and the submission device show that the differences are minor and causes no harm to the user, and the fact that the intended use and indication for use is the same, it was early in the project decided to focus on verification and internal validation instead of large scale validation in form of clinical investigation.

Verification and validation testing activities is conducted to establish performance and reliability characteristics of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K041816, K023749, K042273

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

K062304-
pi/5

Image /page/0/Picture/1 description: The image shows the logo for RTX Healthcare. The logo consists of the letters "RTX" in a bold, sans-serif font, with a stylized arrow pointing to the right. Below the letters is the word "Healthcare" in a smaller, sans-serif font. The logo is black and white.

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirement of 21 CFR 807.92

SEP 2 9 2006

| Submitter: | Bjarne Flou
Managing Director
RTX Healthcare
Stroemmen 6
DK-9400 Noerresundby
Denmark
Tel: +45 96322300
Fax: +45 96322310
Email: bf@rtx.dk |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Niels Ole Andersen
Engineering Manager
Email: noa@rtx.dk |
| Date of summary: | 07/07/2006 |
| Common Name: | Physiological Transmitter and Receiver |

DLM112 Daylink Monitor Trade name:

Classification name:21 CFR 870.2910 Physiological Signal Transmitter And Receiver. Classification no: DRG

Predicate Device:

510(k) number:K041816
Device name:RTX3320 Wireless Telehealth Gateway
Applicant:RTX Healthcare
510(k) number:K023749
Device name:M3810A Philips Telemonitoring System with M3812B TeleStation
Applicant:Philips Medical Systems.
510(k) number:K042273
Device name:Health Buddy with Device Connectivity.
Applicant:Health Hero Network

Submission Device Description:

The DLM112 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The DLM112, with its build-in modem, transmits data using the public switched telephone network.

The DLM112 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons

The DLM112 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

1

Intended use and indications for use:

The Daylink 112 Monitor ("DLM112") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM112 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.

| Item | Submission
device | Predicate
device
K041816
(RTX
Healthcare) | Predicate
device
K023749
(Philips) | Predicate
device
K042273
(Health Hero) | |
|------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended use /
Indication for use | See section 2 | See section 6 | See section 7 | See section 8 |
| 2 | Intended users | Home users and
healthcare
providers. | Home users and
healthcare
providers. | Home users and
healthcare
providers. | Home users and
healthcare
providers. |
| 3 | Site of use | Typically for use
in patient's
home, placed on
a normal table. | Typically for use
in patient's
home, placed on
a normal table. | Typically for use
in patient's
home, placed on
a normal table. | Typically for use
in patient's
home, placed on
a normal table. |
| 4 | System
description | Telemedicine
device that is
working as
hub/gateway
sending
measured data
from compatible
patient monitors
to a compatible
data server. | Telemedicine
device that is
working as
hub/gateway
sending
measured data
from compatible
patient monitors
to a compatible
data server. | Telemedicine
system
consisting of a
device that is
working as
hub/gateway
sending data
measured by
the system
patient monitors
to a system data
server. | Telemedicine
system
consisting of a
device that is
working as
hub/gateway
sending data
measured by
the system
patient monitors
to a system data
server. |
| 5 | Connection to
patient monitors | Wireless
connection
between the
patient monitors
and the
hub/gateway. | Wireless and
cable
connection
between the
patient monitors
and the
hub/gateway. | Wireless and
cable
connection
between the
patient monitors
and the
hub/gateway. | Cable
connection
between the
patient monitors
and the
hub/gateway. |
| 6 | Transmission | Residential
telephone line | Residential
telephone line | Residential
telephone line | Residential
telephone line |
| 7 | Patient
Interactions | Display and
push buttons for
collection of | No patient
interaction. | Display and
push buttons for
collection of | Display and
push buttons for
collection of |
| | | patient typed
data | | patient typed
data | patient typed
data |
| 8 | Measurements
taken | Blood pressure,
weight, ECG,
Blood glucose
and other
measurements
provided from
compatible
monitor devices. | Blood pressure,
weight, ECG,
Blood glucose
and other
measurements
provided from
compatible
monitor devices. | Blood pressure,
weight, ECG
and Blood
glucose | Blood pressure,
weight, Blood
glucose, Peak
Flow and others. |
| 9a | Contra indications
and warnings | The device is
not for
emergency
calls, and may
not be used to
send any real-
time alarms or
time-critical
data. | The device is
not for
emergency
calls, and may
not be used to
send any real-
time alarms or
time-critical
data. | The device does
not send any
real time alarms. | The device does
not send any
real time alarms. |
| 9b | Contra indications
and warnings | All patient
medical
diagnosis and
treatment are to
be performed
under the
supervision and
oversight of an
appropriate
healthcare
professional. | Clinical
judgment and
experience are
required to
check and
interpret the
measurements
that are taken,
collected, and
delivered by
systems using a
RTX3320
device. | Clinical
judgment and
experience are
required to
check and
interpret the
information
delivered. | All patient
medical
diagnosis and
treatment are to
be performed
under the
supervision and
oversight of an
appropriate
healthcare
professional. |
| 9c | Contra indications
and warnings | The device is
not for use in
systems which
substitute for
medical care. | The device is
not for use in
systems which
substitute for
medical care. | The device is
not intended as
a substitute for
medical care. | The device is
not to be used
as a substitute
for a
professional
healthcare
judgment. |
| 9d | Contra indications
and warnings | The device is
not for use in
systems set up
for patients who
need direct
medical
supervision or
who might need
emergency
intervention. | The device is
not for use in
systems set up
for patients who
need direct
medical
supervision or
who might need
emergency
intervention. | The device is
not for use in
systems set up
for patients who
need direct
medical
supervision | -No statement- |
| 10 | Wireless link
between patient
monitors and the
gateway | Short range
radio system
using Bluetooth
technology. | Short range
radio system
using Bluetooth
technology. | Short range
proprietary radio
system. | No wireless
connectivity |
| 11 | Device
specifications | See section 5 | See section 17 | Proprietary
information | Proprietary
information |

Substantial Equivalence Comparison table:

2

3

Discussion on differences:

Item 1: The intended use / Indications for use for the predicate devices and the submission device are generally the same. The exact use are for all devices limited to be within the same intended use and with respect to the contra indications and warnings which are also generally the same for all three devices.

Item 2: The user of the predicate devices and the submission device is the same. The requirements to the user and skills that the users need to have are the same.

Item 3: Both the predicate devices and the submission device are for use in patient's home, The requirement specifications and the used performance standards for the submission device are defined based on using the device in a home environment.

Item 4: The predicate devices K023749 (Philips) and K042273 (Health Hero) are systems consisting of patient monitor devices, a hub/gateway device and a system server software. The Submission device and the Predicate device K041816 (RTX Healthcare) are a hub/gateway devices with a specified generic protocol interface to a list of compatible patient monitors, and with a specified generic protocol interface to any compatible system server. The protocols for the Submission device and the Predicate device K041816 (RTX Healthcare) are validated against existing compatible patient monitors and servers, and in the labeling it is stated that only compatible patient monitors and servers must be used with the hub/gateway.

Item 5: Two of the predicate devices and the submission device uses wireless communication between the patient monitors and the hub/gateway device. The third predicate device use cable connection which is also available on the submission device. Item 6: Both the predicate devices and the submission device use a residential telephone line for data communication.

Item 7: The predicate devices K023749 (Philips) and K042273 (Health Hero) are fitted with a display and a few push buttons for patient interaction. The purpose is to interact with the patient to collect additional information. The submission device is also fitted with a display and a few push buttons, and with the same purpose as on the predicate devices.

Item 8: For the predicate devices K023749 (Philips) and K042273 (Health Hero) the measurements taken are defined by the patient monitors that are a part of the system. For the submission device and the predicate device K041816 (RTX Healthcare), the

measurements taken are defined by the compatible patient monitors. Because of the similar intended use and indication for use for both the predicate devices and the submission device, the type of measurements will be the same.

Ifem 9a: Neither the predicate or submission devices may be used to send real time alarms.

Ifem 9b: Both the predicate and submission devices defines that all patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Item 9c: Both the predicate and submission devices defines that it is not intended as a substitute for medical care or healthcare judgment.

Item 9d: Two of the predicate devices and the submission device state that it is not for use in systems set up for patients who need direct medical supervision.

Item 10: Two of the predicate devices use wireless connectivity like the submission device. One of the predicate devices and the submission device use the Bluetooth wireless technology that are known within medical devices, like the A&D Blood Pressure Meter

4

(FDA- K043217 ). The general radio signal safety requirements and FCC Part 15 rules are regulatory requirements that are equal for all devices containing radio transmitter. Item 11: Detailed environmental specifications are available for one of the predicate devices, but not for the two others since that is proprietary information not available for RTX Healthcare. This is evaluated not to add any additional risks to the patient since both the predicate devices and the submission device, according to the intended use, are designed for use by patients at home. The environmental specifications for the submission device are defined according to IEC/UL 60601-1 and specifications available for other medical devices for home use.

Performance data:

The DLM112 device has been tested to meet the requirements of the following standards and requlations used as acceptance criteria:

IEC 60601-1, IEC 60601-1-2, FCC part 15 and FCC Part 68.

Risk management is performed according to ISO14971:2000.

Based on the fact that the performance comparison of the predicate device and the submission device show that the differences are minor and causes no harm to the user, and the fact that the intended use and indication for use is the same, it was early in the project decided to focus on verification and internal validation instead of large scale validation in form of clinical investigation.

Verification and validation testing activities is conducted to establish performance and reliability characteristics of the device.

Conclusion

The DLM112 is substantially equivalent to the predicate devices cleared by FDA.

5

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2007 8 8 2006

RTX Healthcare c o Ms. Elizabeth A. Rosenfeld Administrative Coordinator KEMA Quality B.V. 4377 County Line Road Chalfont. PA 18914

Re: K062304

Trade Name: DLM112 Daylink Monitor Regulation Number: 21 CFR 870.2910 Regulation Name: Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: September 14, 2006 Received: September 18, 2006

Dear Ms. Rosenfeld:

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, listing 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 such 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.

6

Page 2 - Ms. Elizabeth A. Rosenfeld

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address.

Sincerely yours,

Bfmtmtmorfr

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

Enclosure

7

3. Indications for use statement

Indication for Use Statement

510(k) Number (if known):

Device name: DLM112 Daylink Monitor

The Daylink 112 Monitor ("DLM112") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM112 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummunon

(Division Sign-Off) Division of Cardiovascular Deyices 510(k) Number