(218 days)
Not Found
No
The device description and performance studies focus on standard infrared temperature measurement and clinical validation against a predicate device, with no mention of AI or ML algorithms for data processing or interpretation.
No.
A therapeutic device is used for treatment or therapy. This device is an infrared thermometer used for measurement and monitoring, not for treatment.
Yes
The device is an infrared thermometer used for "intermittent measurement and monitoring of forehead temperature of human body," which is a diagnostic function to identify fever.
No
The device description clearly outlines physical hardware features such as buttons, display, and battery indication, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The infrared thermometer described measures the temperature of the human body externally, specifically on the forehead. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for "intermittent measurement and monitoring of forehead temperature of human body," which is a direct measurement of a physiological parameter, not an analysis of a sample.
Therefore, based on the provided information, the infrared thermometer Model XW-60 is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The infrared thermometer, Model XW-60 is intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of one month old and above age in the home.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The device is intended for the intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of all ages in the home. It has the following features:
- . Three button operation;
- Optional mode for Fahrenheit and Celsius; .
- Short measurement response time;
- . There are 20 measurement data can be memorized and stored;
- . Two color backlight display;
- Low and high temperature warning beeps;
- Automatic shutdown feature to save energy;
- . Low battery indication;
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
one month old and above age
Intended User / Care Setting
people / home
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)
Clinical study was conducted in according to ASTM E1965-98(Reapproved 2016). This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are one month to one year old, 50 subjects are one year to five years old, and 50 subjects are > 5 years old. The clinical test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability, met the acceptance criteria of the clinical study protocol.
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2021
Shenzhen Xunwei Industrial Co., Ltd. % Yoyo Chen Consultant Shenzhen Joyantech Consulting Co.,Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen. 518000 China
Re: K201579
Trade/Device Name: Infrared Thermometer, Model XW-60 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 10, 2020 Received: December 18, 2020
Dear Yoyo Chen:
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
1
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 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 medical devices and radiation-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,
CAPT Alan Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K201579
Device Name Infrared Thermometer, Model XW-60
Indications for Use (Describe)
The infrared thermometer, Model XW-60 is intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of one month old and above age in the home.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| Submission Date | June 3, 2020 |
|---|---|
| Manufacturer information | Shenzhen Xunwei Industrial Co., Ltd. |
| Address: | |
| First floor to fourth, Upper Small Industrial Zone, Jinhua Road, | |
| Block 75, Xixiang Street, Baoan District, Shenzhen City, | |
| Guangdong, 518102, China. | |
| Contact person: Liu Shengcai | |
| TEL: +86-755-86191210 | |
| E-Mail: richard@szxunwei.com | |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | |
| Province, China. | |
| Contact person: Ms. Yoyo Chen | |
| E-Mail: yoyo@cefda.com; field@cefda.com | |
| Establishment registration number | N/A |
2. Device Information
| Type of 510(k) | Traditional |
|---|---|
| Submission: | |
| Device Name: | Infrared Thermometer |
| Model: | XW-60 |
| Classification Name: | Thermometer, Electronic, Clinical |
| Review Panel: | General Hospital |
| Device Class: | 2 |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
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3. Predicate Device
| Manufacturer | Microlife Intellectual Property GmbH |
|---|---|
| Device name | Microlife Non-Contact Infrared Forehead Thermometer |
| Model | FR1DG1 (NC200) |
| 510(K) Number: | K191829 |
| Product Code | FLL |
4. Device Description
The device is intended for the intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of all ages in the home. It has the following features:
- . Three button operation;
- Optional mode for Fahrenheit and Celsius; .
- Short measurement response time;
- . There are 20 measurement data can be memorized and stored;
- . Two color backlight display;
- Low and high temperature warning beeps;
- Automatic shutdown feature to save energy; ●
- . Low battery indication;
5. Intended Use/Indication for Use
The infrared thermometer, Model XW-60 is intended for the intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of one month old and above age in the home.
6. Comparison with predicate device
The subject device infrared thermometer, Model XW-60 is substantially equivalent to the predicate device (K191829). This conclusion is based upon comparison on intended use, technological characteristics and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.
| Items | Subject Device
(XW-60) | Predicate Device
(K191829) | Comparison |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product code | FLL | FLL | Same |
| Regulation
number | 880.2910 | 880.2910 | Same |
| Device class | 2 | 2 | Same |
| Intended use | The infrared thermometer, Model XW-60 is intended for
the intermittent measurement | The Microlife Non-Contact
Infrared Forehead
Thermometer, Model | Different
(Note 1) |
| Items | Subject Device
(XW-60) | Predicate Device
(K191829) | Comparison |
| | and monitoring of forehead
temperature of human body.
The device is indicated for use
by people of one month old and
above age in the home. | FR1DG1 (NC200) is
intended for the intermittent
measurement and
monitoring of human body
temperature.
The device is indicated for
use by people of all ages in
the home. | |
| Prescription or
OTC | OTC | OTC | Same |
| Prescription or
OTC | OTC | OTC | Same |
| Thermometer
type | Infrared thermometer
Non-contact | Infrared thermometer
Non-contact | Same |
| Device
Measurement
Technology | Infrared | Infrared | Same |
| Measurement
location | Forehead | Forehead | Same |
| Measurement
Range | Body mode:
$32.0°C 43.0°C (89.6°F 55°C (-13°F~131°F);109.4°F);$ | Body mode: $34.0°C - 43.0 °C (93.2-109.4 °F);$ | Different55°C)
(Note 2) |
| Measurement
accuracy | $±0.2°C :35.0°C 42.0°C$104°F) ;
$± 0.3°C: 32.0°C 34.9°C,$43.0°C$
$42.1°C
$±0.4°F:95.0°F 107.6°F$40°C
$±0.5°F:89.6°F 94.8°F,$40°C)
$107.8°F 109.4°F$ | $±0.2 °C: 35.0 ~ 42.0 °C$104°F
$±0.3 °C: 34°C ~ 34.9°C,$
$42.1°C 43°C,$5cm | Appropriate within 5 cm | Similar |
$±0.4 °F: 95.0 ~ 107.6 °F,$
$±0.5 °F: 93.2 94.8 °F,$109.4 °F$ | Different
$107.8
(Note 2) |
| Temperature
Measurement
distance | 3cm
| Display Type | LCD Display | LCD Display | Same |
| Display
resolution | $0.1°C (0.1°F)$ | $0.1°C (0.1°F)$ | Same |
| Power supply | d.c.3.0V (2pcs AAA batteries) | d.c.3.0V (2pcs AAA batteries) | Same |
| Measurement | 1second | 3 second | Different |
| Items | Subject Device
(XW-60) | Predicate Device
(K191829) | Comparison |
| time
Measurement
data memories | 20 sets memories | 30 sets memories | Different
(Note 4) |
| Beeper setting | Yes | Yes | Same |
| Date and time
setting | No | Yes | Different
(Note 5) |
| Backlight | Green and orange backlight
according to the measured
temperature; | Green and red backlight
according to the measured
temperature; | Similar |
| Auto-off time | Approx. 1 minute after last
measurement has been taken | Approx. 1 minute after last
measurement has been
taken | Same |
| Operation
Condition | Temperature: 50°F
(10°C
Relative Humidity: 15%95%106kPa | Ambient Temperature:
Atmospheric Pressure:
70kPa
15°C
(59°F
Relative humidity:
15%95%RH | Different131°F
(Note 6) |
| Storage and
transportation
condition | Temperature: -4°F
(-20°C
Relative Humidity: 15%95%106kPa | Ambient Temperature: -
Atmospheric Pressure:
70kPa
25°C
Relative humidity:
15%~95%RH | Different
(Note 6) |
| Protection
against electric
shock | Internally power supply, Type BF | Internally power supply, Type BF | Same |
| IP Class | IP22 | IP22 | Same |
| Mode of
operation | Continuous | Continuous | Same |
| Error | Display Err when system has
malfunction | Display Er0 or Er6 when
system has malfunction | Different
(Note 7) |
| High
temperature
alarm | 3 short beeps and LCD display
" H ", while equal to or higher
than 37.5°C | 10 short beeps and a red
LCD backlight alerts that
the temperature equal to or
higher than 37.5°C | Different
(Note 8) |
| Auto
measurement | No | The device can take a
measurement automatically
when the device detects the
distance is appropriate
within
5 cm | Different
(Note 9) |
| Items | Subject Device
(XW-60) | Predicate Device
(K191829) | Comparison |
| Sensor type | HMSK1C1F5.5 | TPS336 | Different
(Note 10) |
| Housing
material | ABS/AG15A1-H | ABS/PA 707 | Different
(Note 11) |
| Patient-contact
button material | ABS/AG15A1-H | PMMA | Different
(Note 11) |
| IC (Integrated
Circuitry) | HY11P54 | HY11P14 | Different
(Note 12) |
| Signal
processing | 24 bit analog-to digital
converter | 24 bit analog-to digital
converter | Same |
| Algorithms | FR Algorithm | PH15.0Algorithm | Different
(Note 12) |
| Physical
Dimensions | 1403840mm | 156.74347 mm | Different
(Note 13) |
| Weight | 70g (Battery excluded) | 68.5 g (Battery excluded) | Similar |
| Expected
Service Life | 5 year | 5 year | Same |
| Safety &
Performance | IEC 60601-1:2005+AMD 1:
2012;
IEC 60601-1-2:2014;
IEC 60601-1-11:2015;
ISO 80601-2-56: 2017;
ASTM E1965-98. | IEC 60601-1:2005+AMD 1:
2012;
IEC 60601-1-2:2014;
IEC 60601-1-11:2015;
ISO 80601-2-56: 2017;
ASTM E1965-98. | Same |
| Biocompatibility | Cytotoxicity, ISO 10993-5
Skin Irritation, ISO 10993-10
Skin Sensitization,
ISO 10993-10 | Cytotoxicity, ISO 10993-5
Skin Irritation, ISO 10993-
10
Skin Sensitization,
ISO 10993-10 | Same |
| Clinical Study
Support | Yes | Yes | Same |
5
6
7
(1). Note 1: Indication for use
The subject device is intended to be measuring for the people of one month and above age in the home. This is different from the predicate device. However, we believe this different this does not raise a safety and effectiveness issue. A clinical study was carried out on the subject device for the intended population.
(2). Note 2: Measurement Range and Accuracy
Compared with the predicate device, the subject device has a wide measurement range and different measurement accuracy. They both meet the standard requirement of ASTM E1965-98 reapproved 2016 and ISO 80601-2-56:2018. Therefore, we believe this different will not raise any new safety and effectiveness issues.
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(3). Note 3: Measurement time
The measurement time of subject device is much quick than predicate device, but the accuracy of measurement has been validated during performance testing in according to the standard requirement of ASTM E1965-98 reapproved 2016 and ISO 80601-2-56:2018. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.
(4). Note 4: Measurement data memories
The functional purpose of measurement data memories is intended to record previous readings. The difference does not raise new questions of safety and effectiveness. This function has been verified during software verification.
(5). Note 5: Date and time setting
Although there is no date and time setting functions for the subject device, both of subject devices and predicate device meet the basic safety requirement of IEC 60601-1:2015, ASTM E1965-98 reapproved 2016, and ISO 80601-2-56:2018. The difference does not raise any new questions of safety and effectiveness.
(6). Note 6: Operation Condition, Storage and transportation condition Both of subject devices and predicate device are meet the basic safety requirement of IEC 60601-1:2015, ASTM E1965-98 reapproved 2016, ISO 80601-2-56:2018, IEC60601-1-11. The difference does not raise any new questions of safety and effectiveness.
(7). Note 7: Error
Both subject device and the predicate device have self-test function. The principle of self-test is the same. Devices can perform a self-test every time when it is switched on to verify the specified accuracy of any measurement. When an error is detected, it will display an error message. Subject device will display icon "Err" and the predicate device will display icon "Er0" and "Er6". Although the icons are different, the intended functions are the same.The icon has been defined in the user manual. The differences do not raise new questions of safety and effectiveness.
(8). Note 8: High temperature alarm
Both subject device and the predicate device have high temperature alarm function, when the reading temperature equal to or higher than 37.5℃, in the meantime the device will keep beeping. Even though the beeping time is different, the purposes are the same. It does not affect device's safety and effectiveness.
(9). Note 9: Auto measurement
This purpose of auto measurement of predicate device is to test the body temperature. However, for the subject device, the user can read the body temperature by aiming the probe
9
at the center of the forehead with any distance of no more than 3~ 5cm and pressing the "Start "button. The purpose of body temperature measurement can be achieved for subject device and predicate device. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.
(10). Note 10: Sensor type and IC
Although the sensor type and IC of subject devices are different with predicate device, but these devices are all tested to conform with same safety and performance standard IEC 60601-1:2015, ASTM E1965-98 reapproved 2016, and ISO 80601-2-56:2018. Otherwise, a clinical study was carried out on the subject device for febrile human subjects. It demonstrates the subject device is reliable under clinical use.
Note 11: Housing material, patient-contact button material (11).
Although the housing material and patient-contact button material for subject device and predicate devices are different, but they are all compliance with the biocompatibility standards ISO 10993-5 and ISO 10993-10. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.
(12). Note12: Algorithms
Although the algorithms for subject device and predicate devices are different, but they are all complied with performance standards ISO 80601-2-56: 2017 and ASTM E1965-98. In addition, a clinical study is carried out to validate the clinical accuracy of subject devices. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.
(13). Note13: Physical Dimensions
The difference is caused because of their different appearance, but the difference does not raise any new safety and effectiveness questions. This has been tested and confirmed according to IEC 60601-1-2 EMC, IEC60601-1, and ISO 80601-2-56 standards. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.
7. Non-Clinical Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
The subject device has passed safety testing in according to following standards.
-
- AAMI/IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
- IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for
10
basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
7.2. Biocompatibility Test
The subject device has passed biocompatibility tests in according to following standards.
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1) cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
7.3. Performance Test-Bench
The subject device has passed performance testing in according to following standard.
-
- ISO 80601-2-56:2017+AMD2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers 2) for Intermittent Determination of Patient Temperature
8. Clinical Study
Clinical study was conducted in according to ASTM E1965-98(Reapproved 2016). This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are one month to one year old, 50 subjects are one year to five years old, and 50 subjects are > 5 years old. The clinical test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability, met the acceptance criteria of the clinical study protocol.
9. Conclusion
Infrared Thermometer (Model XW-60) is substantially equivalent to The the predicate device (K191829). This conclusion is based upon comparison on intended use, technological characteristics and applicable standards. Any differences in the technological characteristics do not raise new questions of safety or effectiveness.