Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard digital thermometer with predictive and standard modes, focusing on basic electronic functions and accuracy metrics. There is no mention of AI, ML, or related concepts.

Therapeutic

No
The device is used for measurement and monitoring of body temperature, which is diagnostic, not therapeutic.

Diagnostic

Yes
The device is a digital thermometer, which is used to measure human body temperature. Measuring body temperature is a diagnostic activity, as it provides information about a patient's physiological state that can be used to identify fever or other conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-held, non-sterile, reusable clinical thermometer," which is a physical hardware device. The performance studies also describe physical characteristics and functions of the unit.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

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. This testing is done outside of the body (in vitro).
Digital Thermometer Function: A digital thermometer measures body temperature directly from the body (in vivo) through contact with the skin or mucous membranes (oral, rectal, under the arm). It does not analyze samples taken from the body.

The description clearly states the device is used for "intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm." This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Digital Thermometer Model V901US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is intended for the adult and pediatric population.

The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).

Product codes (comma separated list FDA assigned to the subject device)

FLL

Device Description

The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human body

Indicated Patient Age Range

adult and pediatric population

Intended User / Care Setting

Not Found

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 submission includes verification and validation activities for minor changes from the predicate device, such as speed of temperature determination, battery type, display graphics, audible beep intensity, and power down time. These changes were verified and validated, and based on the provided tables, the device passed all verification tests, demonstrating that the changes do not raise new issues of safety and effectiveness.

Key verifications include:

Battery change: Unit operates as expected in factory and operating modes.
Backlight change: No backlight present as intended.
Indication icons for low/high temperature ("Lo", "Hi"): Displayed correctly.
Measurement time: Average measurement time is less than 10 seconds.
Beep count: 10 beeps after measurement completion.
Fever alert point: Activated correctly above 37.8°C/100.0°F.
Power down time: Unit automatically turns off in 10 ± 1 minutes when no action is taken.
Factory mode: Accessible only with password input, with accuracy verified against specified ranges in water-bath mode.

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

Not Found

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.

K082266

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Summary

0

Digital Clinical Thermometer Model V901US

KII2116

510(K) SUMMARY

OCT 4 2011

AS REQUIRED BY SECTION 21 CFR 807.92(c)

Amperor Electronics (SZ) Co., Ltd. Digital Clinical Thermometer Model V901US

1. SUBMITTED BY, CONTACT PERSON AND DATE OF THIS SUMMARY:

A. Company Name: Amperor Electronics (SZ) Co., Ltd.

Address: 8, Sarpotau Building, Ku-Su Village, Shi-Shian Town, Baoan County,

Shenzhen, Guang dong P.R. China

B. Contact Person

Amperor Electronics : Steel Chen, Director, Safety and Regulatory Kaz USA, Inc: Raj Kasbekar, Global Vice-President, Regulatory Affairs

C. Date of Preparation of this Summary: September 12, 2011

2. DEVICE NAME:

Table 1: Device Names

	Device
Proprietary Name	V901US
Common/Usual Name	Digital Clinical Thermometer
Classification Name	Clinical electronic thermometer

3. DEVICE CLASSIFICATION:

Digital Clinical Thermometer V901US (21CFR 880.2910, Product Code FLL) has been classified under section 510 of the Act as Class II (Clinical Electronic Thermometer).

2

1

4. INTENDED USE / INDICATIONS FOR USE:

The Digital Thermometer Model V901US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is intended for the adult and pediatric population.

The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).

5. SUBSTANIAL EQUIVALENCE:

The digital thermometer model V901US is substantially equivalent to the predicate device V9XX (K082266) made by Amperor electronics (SZ) Co., Ltd., for the following reasons:

1. It has the same intended use/indication for use as the predicate.
1. It has the same operating principle and technological characteristics as the predicate.
1. The digital thermometer model V901US has some minor changes from the predicate device that include speed of temperature determination and display, change in battery type, display graphics, audible beep intensity and power down time. These changes have been verified and validated ( as part of performance testing) and are included as part of this submission. A summary of these verification and validation activities is attached. These changes raise no new issues of safety and effectiveness.

The changes (minor) to the new device include:

1. The speed of temperature determination and display has increased.
1. Change in battery type from CR1225(3V) to LR41(1.5V).
1. The power down time has been changed from 90s to 10min.
1. The intensity of the three color backlight is reduced.
1. The indication icon for less than 32C has been changed from "L" to"Lo".
1. The indication icon for more than 42.9C has been changed from "H" to"Hi".

2

1. "Valid complete" beeps have been changed from 5 Beeps to 10 Beeps.
1. Fever alert point has been changed from 38.3C to 37.8C.
1. Changed the appearance of housing.

3

Digital Clinical Thermometer Model V901US

Design Control Activities Summary
Device Modification	Change in Risk	Verification
Activity	Acceptance
Criteria	Results of
Verification

Device Related Changes
Changes to device hardware, software or sensors.
		Changes to device hardware.
Battery change from
type:CR1225(unrechargeable)3V
to
type:LR41(unrechargeable)1.5V	No change in risk
profile	The verification
activity for the
change in battery
includes
confirmation that
the unit can go
into the operating
mode and factory
mode and carry
out its normal
functions. Start
the unit and hold
the start button
for 3 seconds. The
unit should enter
the factory mode.
Take a few
readings in this
mode. Shut the
unit off and start
it again. This will
put the unit in the
operating mode.
Take a few
readings in this
mode.	The Unit should
go into the
factory mode and
operating mode
and function as
expected.	PASS. Traceable to
V901US Design
Verification Tests
1 thru 28.
Backlight change from three
color: green,orange and red to
do not have backlight.	No change in risk
profile	Start the unit.
Ensure that the
unit does not have
backlight in
normal and
elevated
temperature	Verify by
observation that
unit does not
have backlight.	PASS. Traceable to
V901US Design
Verification Test

```
    |
```

| The indication icon for less than
32°C has been
changed from "L" to"Lo" | No change in risk
profile | For the normal
operating mode,
the software shall
signal the user
with no language-
specific words
other than Err, HI
and Lo. These
messages are
widely
understood and
have precedent
for successful
acceptance in
other
internationally
distributed
products. | Verify by
observation that
the "Lo" indicator
comes up for
temperature
below 32.0°C or
90°F | PASS. Traceable to
V901US Design
Verification Test
12. |
| The indication icon for more
than 42.9°C has been changed
from "H" to"Hi" | No change in risk
profile | For the normal
operating mode,
the software shall
signal the user
with no language-
specific words
other than Err, HI
and Lo.These
messages are
widely
understood and
have precedent
for successful
acceptance in
other
internationally
distributed
products. | Verify by
observation that
the "Hi" indicator
comes up for
temperature
above 42.9°C or
109.9°F | PASS. Traceable to
V901US Design
Verification Test
12. |
| Changes to device software. | | | | |
| Measurement time change from
8 seconds to 10 seconds. | No change in risk
profile | Start the unit.
Take a reading
using a simulated
waterbath. Record
the time required
to take a reading.
The average time
shall be less than
10 seconds. | The average
measurement
time shall be less
than 10 seconds. | PASS. Traceable to
V901US Design
Verification Test 1. |
| The amount of beeps after a
measurement is complete has
changed from 5 beeps to 10
beeps. | No change in risk
profile | Start the unit.
Take a reading
using a simulated
water-bath. Verify
that the number
of beeps to
indicate end of a
measurement is
10. | Verify by
observation that
the number of
beeps after a
measurement is
complete is 10. | Pass. Traceable to
V901US Design
Verification Tests
2 and 26. |
| The Fever alert point has been
changed from 38.3°C/100.9 to
37.8°C/100.0. | No change in risk
profile | Start the unit. Set
the water bath
temperature to
above 100 deg F.
Take a reading in
the water-bath.
Verify that the
fever alert beeps
sound. | Verify by
observation that
the number of
beeps for fever is
activated. | PASS. Traceable to
V901US Design
Verification Test
26. |
| The power down time has been
changed from 90s to 10min. | No change in risk
profile | Start the unit.
Keep it in the on
state for over 10
minutes.
Software control
unit should turns
itself off
automatically if
there is no action
taken for 10
minutes (± 1
minute). | Verify that Auto
power turns the
unit off in 10 ± 1
minutes when no
action is taken. | Pass. Traceable to
V901US Design
Verification Test 3. |
| A separate Factory mode was
added that can be triggered
only by inputting a password. | In the older
version, the
factory mode was
triggered without
any user input.
This was changed
such that a user
has to
intentionally put
in a password to
enable the factory
mode. This was
done to reduce
the risk related to
any inaccurate
measurements
during normal
clinical use. This | 1. After starting
the unit, press and
hold the ON
switch (power
key) for more
than 3 seconds.
The signal "- - -"
will appear. Then
key in a right one
digit password, by
pressing the same
ON switch, which
will put the unit
into the factory
mode.
2. Verify accuracy
of the product in a
water bath. | 1. Verify that the
unit goes into the
factory mode.
2.The product
should have the
following
accuracy in water-
bath mode:
±0.2 °F 98.0°F-
102.0°F

±0.3°F 96.4°F-
97.9°F,
102.1°F-106.0°F

±0.5 °F 106°F | PASS. Traceable to
V901US Design
Verification Tests
1 thru 28. |
| profile of the
thermometer by
eliminating any
inaccurate
temperature
measurements. | | | | |

4

Digital Clinical Thermometer Model V901US

б

5

Digital Clinical Thermometer Model V901US

"

ﻪ

6

Digital Clinical Thermometer Model V901US

.

Changes to device sensors.
NONE
Manufacturing Process Changes
NONE
Vendor Changes
NONE
Material Changes in Outer Casing of Device
There was no change to any patient contacting material. The probe cover is the only part that comes in contact with the patient or end user. Biocompatibility Testing for the probe cover was addressed in 510(K) K082266 of predicate device.
Labeling Changes

Changes done may have been to clarify or further elaborate existing language only. Legal entity and format only.

7

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Amperor Electronics (SZ) Company, Limited % Mr. Raj Kasbekar Regulatory Affairs Kaz Incorporated 250 Turnpike Road Southborough, Massachusetts 01772

OCT - 4 2011

Re: K112116

Trade/Device Name: Digital Clinical Thermometer Model V901US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 13, 2011 Received: September 14, 2011

Dear Mr. Kasbekar:

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. 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.

8

Page 2 - Mr. Kasbekar

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); 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.

Susan Quon

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

9

Digital Clinical Thermometer Model V901US

Intended Use/Indications for Use Statement

510(k) Number (if known): K | 1 2 \ 1 2 \ 1 2 \ (b

Digital Clinical Thermometer Model V901US Device Name:

Intended Use/Indications For Use:

The Digital Thermometer Model V901US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. This thermometer is intended for the adult and pediatric population.

The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive or Instant mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature ), or standard mode (actual determination of temperature).

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use _ _ _ _ _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ald C. Ch 9/30/4

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112116

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Date: 2010-10-14 Revision: 1.1