Predicate Devices

Reference Devices

There are no Reference Devices listed in the provided text.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard non-dispersive infrared gas analysis method with automated calibration and pressure compensation. There is no mention of AI, ML, or any learning algorithms in the description, performance studies, or key metrics.

Therapeutic

No

The device is designed for monitoring carbon dioxide and respiration rate, not for providing therapy or treatment.

Diagnostic

Yes

The device monitors carbon dioxide levels (EtCO2) and respiration rate, which are physiological parameters used to assess a patient's condition and help diagnose respiratory issues or assess the effectiveness of care during anesthesia, recovery, or in intensive care.

SaMD (Software as a Medical Device)

No

The device description clearly details hardware components such as a non-dispersive infrared gas analyzer, infrared sensor, three-way valve, and atmospheric absolute pressure sensors. The operation is based on physical principles of light absorption and pressure measurement, not solely software processing of data from external sources.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
Device Function: The CO2 Sidestream Module directly measures the concentration of carbon dioxide in the breathing gases of a patient. This is an in vivo measurement (within the living body), not an in vitro measurement (outside the living body using a specimen).
Intended Use: The intended use is for monitoring during anesthesia/recovery, in the ICU, and in respiratory care. This is direct patient monitoring, not laboratory testing of a specimen.

The device analyzes gases exhaled by the patient, which is a direct measurement from the body, not a test performed on a sample taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CO2 Sidestream Module is designed to provide carbon dioxide monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients.

Product codes

CCK

Device Description

The CO2 Sidestream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control.

The operation of the CO2 Sidestream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the Module's memory. As the sample gas passes through a three-way valve, with the change of temperature and time, the valve leading to the pure air will close for 3-4 seconds to adjust the zero point.

The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate for the calculation for the concentrations of carbon dioxide, which improves the design accuracy.

The Module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). Respiration rate is calculated by measuring the time interval between detected breaths.

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

adult patients.

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)

Non-Clinical Study:
Safety and EMC

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and -A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005. MODI
IEC 60601-1-2: 2014 Medical devices part 1-2: General requirements for basic safety and essential performance – Collateral standards: electromagnetic compatibility - Test and requirements

Performance Data:

ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment Part 2-55: -Particular requirements for the basic safety and essential performance of respiratory gas monitors

Test: EtCO2, Test Method: See test report, Test Result: Range: 0-150mmHg Accuracy: 0 - 40 mmHg: ± 2 mm Hg; 41- 70 mmHg: ± 5% of reading; 71 - 100 mmHg: ± 8% of reading; 101 -150 mmHg: ± 10% of reading, Test Report No.: JJX-FDA-A/0-06-04

Test: Inspired Dioxide Carbon (InsCO2), Test Method: See test report, Test Result: Not Provided, Test Report No.: JJX-FDA-A/0-06-06

Test: Respiration Rate, Test Method: See test report, Test Result: Range: 3bpm~150bpm Accuracy: ± 1% of reading or ± 1 breaths/min whichever is greater, Test Report No.: JJX-FDA-A/0-06-07

Biocompatibility

ISO 10993-5: 2009 Biological evaluation of medical devices Part 5 Tests for In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical Devices Part 10: Tests for - Irritation and Delayed-Type Hypersensitivity
ISO 10993-11: 2017 Biological evaluation of medical Devices – Part 11: Tests for systemic toxicity
ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

Device: Capno-S, Capno-S+, Category and Contact: Surface Device →Skin, Duration: A — Limited≤( 24h), Test Conducted: In Vitro Cytotoxicity (ISO10993-5) Irritation (ISO10993-10) Delayed-Type Hypersensitivity (ISO10993-10)

Device: Accessories (nasal tubes for adult and infant, filters, L- and T-Connectors, sampling line, etc.), Category and Contact: external communicating devices →Tissue contact (contacting the patient's inhaled and exhaled gases), Duration: A — Limited≤( 24h), Test Conducted: In Vitro Cytotoxicity (ISO10993-5) Irritation (ISO10993-10) Delayed-Type Hypersensitivity (ISO10993-10) Acute systemic toxicity(ISO10993-11) Material mediated pyrogenicity ISO10993-11)

Clinical Study:

No clinical studies were performed.

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

EtCO2 Accuracy: 0~~40 mmHg ±2 mmHg, 41~~70 mmHg ±5% of reading, 71~~100 mmHg ±8% of reading, 101~~150mmHg±10% of reading
Respiration Rate accuracy: ±1% of reading or ±1 breaths/min whichever is greater

Predicate Device(s)

K170820, K053174

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for 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.

Beijing Kingst Commercial & Trade Co.,Ltd. % Charlie Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K192488

Trade/Device Name: CO2 Sidestream Module, Capno-S, Capno-S+ Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: September 3, 2019 Received: September 11, 2019

Dear Charlie Mack:

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 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

1

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,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K192488

Device Name

CO2 Sidestream Module, Capno-S, Capno-S+

Indications for Use (Describe)

The CO2 Sidestream Module is designed to provide carbon dioxide monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows a logo with the word "lingst" in a stylized font. The word is in blue and is slanted upwards from left to right. Below the word "lingst" are three Chinese characters, also in blue. The logo appears to be for a company or organization.

Beijing Kingst Commercial & Trade Co., Ltd.

510(k) Summary (21 CFR §807.92)

Submitter Information:

Submitter Name:	Beijing Kingst Commercial & Trade Co., Ltd.
Address:	6th Floor of No.2-7, Beibinhe Road, Xibianmen, Xicheng
	Dist, Beijing, P.R.C. 100053
Telephone:	+86-10-68158013
Fax:	+86-10-68156857
Contact Person:	Mr. Judong Gao
	General Manager
Email:	charliemack@irc-us.com

Date of Preparation:	May 21, 2020

4

Subject Devices:

Trade/proprietary name: CO2 Sidestream Module Model Capno-S, Capno-S+ Common Name: CO2 Sidestream Module Regulation Number: 21CFR868.1400 Regulatory Class: Class II Classification Code: CCK

Predicate Device:

Trade Name:	Capnograph and Oximeter
510(k) Reference:	K170820
Common Name:	CO2 Sidestream Module and Oximeter
Regulation Number:	21CFR868.1400
Regulatory Class:	Class II
Manufacturer:	CMI Health Inc.
Trade Name:	LoFlo C5 CO2 sensor
510(k) Reference:	K053174
510(k) Reference:	R053174
Common Name:	CO2 Sidestream Module
Regulation Number:	21CFR868.1400
Regulatory Class:	Class II
Manufacturer:	Respironics Novametrix, LLC

Purpose of Submission

This is a new traditional 510(K) submission of CO2 Sidestream Module.

Device Description

The CO2 Sidestream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control.

The operation of the CO2 Sidestream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2

5

concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the Module's memory. As the sample gas passes through a three-way valve, with the change of temperature and time, the valve leading to the pure air will close for 3-4 seconds to adjust the zero point.

The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate for the calculation for the concentrations of carbon dioxide, which improves the design accuracy.

The Module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). Respiration rate is calculated by measuring the time interval between detected breaths.

Indication for use

The CO2 Sidestream Module is designed to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery, in the intensive care unit (ICU), and in Respiratory care.

The CO2 Sidestream Module is used for adult patients.

Comparison with the predicate device:

Beijing Kingst Commercial & Trade Co., Ltd. believes that the CO2 Sidestream Module is substantially equivalent to the CMI Health Inc. Capnograph and Oximeter (K170820) and the Respironics Novametrix LoFlo C5 CO2 sensor (K053174). The submitted Beijing Kingst Commercial & Trade Co., Ltd. CO2 Sidestream Module, Models Capno-S, and Capno-S+ were components within the predicate CMI Health's Capnograph and Oximeter for that device's FDA clearance. The subject device is also compared to the Respironics Novametrix LoFlo C5 sensor. Beijing Kingst Commercial & Trade Co., Ltd. is submitting the subject device for individual clearance, so that the manufacturer may market the Module separately. The submitted device will be installed in a host monitor, where the host monitor manufacturer will determine fit, form, and function.

6

The differences noted between the submitted CO2 Sidestream Module and the predicate Capnograph and Oximeter and Respironics Novametrix LoFlo C5 are based on the use. The Capnograph and Oximeter is a complete device that measures CO2 gas and also measures oxygen saturation. The Beijing Kingst Commercial & Trade Co., Ltd. CO2 Sidestream Module only measures CO2 gas. The display, any alarms, power supply, and physical configuration differences are due to the use in the end product. The subject device is manufactured to be a component of a complete device and not intended to be a stand-alone device and relies on a host device to display information or graphics. Please refer to the following pages for specific difference details.

7

| Element of

comparison	Capno-S	Capno-S+	Conclusion
Appearance	Image: Capno-S device	Image: Capno-S+ device	different
Indications for
Use	The CO2Sidestream Module is designed for
monitoring vital physiological signs of the patient.
It's intended to be used for non-invasive
continuous monitoring of EtCO2, InsCO2, and
Respiration Rate. The Module is indicated for
inpatients from newborn (neonate) to adult in a
hospital environment. It is intended to be used only
under the regular supervision of clinical personnel.	The CO2Sidestream Module is designed for
monitoring vital physiological signs of the patient.
It's intended to be used for non-invasive continuous
monitoring of EtCO2, InsCO2, and Respiration Rate.
The Module is indicated for inpatients from newborn
(neonate) to adult in a hospital environment. It is
intended to be used only under the regular
supervision of clinical personnel.	same
Intended
patient type	intubated patients and non-intubated patients	intubated patients and non-intubated patients	same
Operation
principles	Non-dispersive infrared gas analysis, multi-channel
infrared detector, no moving parts	Non-dispersive infrared (NDIR) single beam optics,
dual-wavelength, no moving parts	same
Units	mmHg, kPa or Vol%	mmHg, kPa or Vol%	same
EtCO2
Measurement
Range	0-150 mmHg
0-19.7%
0-20 kPa	0-150 mmHg
0-19.7%
0-20 kPa	same
EtCO2
Accuracy
(at 760
mmHg,
ambient
temperature
of 25°C)	0~40 mmHg ±2 mmHg
41~70 mmHg ±5% of reading
71~100 mmHg ±8% of reading
101~150mmHg±10% of reading	0~40 mmHg ±2 mmHg
41~70 mmHg ±5% of reading
71~100 mmHg ±8% of reading
101~150mmHg±10% of reading	same
Respiration
Rate
measure
range	3 - 150 breaths/minute (RPM)	3 - 150 breaths/minute (RPM)	same
Respiration
Rate
accuracy	±1% of reading or ±1 breaths/min whichever is
greater	±1% of reading or ±1 breaths/min whichever is
greater	same

Comparison Table of Capno-S and Capno-S+

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Comparison to Predicate Devices

Element of comparison	Subject Device	Predicate Device	Reference Device	Discussion
Company	Beijing Kingst Commercial & Trade	Respironics Novametrix, LLC	CMI Health Inc.	N/A
	Co., Ltd.
FDA510(K) Number	N/A	K053174	K170820	N/A
Device Name	CO2 Sidestream Module	LoFlo C5 CO2 sensor	Capnograph and Oximeter	N/A
Model Number	Capno-S, Capno-S+	LoFlo C5	Capno-H	N/A
CO2 Module	CapnoCore	LoFlo C5 CO2 sensor	CapnoCore	N/A
Indications for Use	The CO2 Sidestream Module is
designed to provide carbon dioxide
monitoring to a host monitoring
system during anesthesia/recovery
in the intensive care unit (ICU) and in
Respiratory care.
The CO2 Sidestream Module is used
for adult patients.	The intended use of the LoFlo C5 CO2
sensor is to provide carbon dioxide
monitoring to a host monitoring system
during anesthesia/recovery in the
intensive care unit (ICU) and
Emergency Medicine/Transport or
Respiratory care.	The Capnograph and Oximeter are
designed for monitoring the vital
physiological signs of the patient. It is
used for non-invasive continuous
monitoring of oxygen saturation (SpO2),
Pulse Rate, EtCO2, InsCO2, and
Respiration Rate.
The Capnograph and Oximeter are
adaptable to adult usage in a hospital
environment. It is intended to be used
only under regular supervision of
clinical personnel	Identical to the predicate device.

The indications for the use of the subject
device are the same as the predicate
device, LoFlo C5 CO2 sensor, and add
the limit to the adult patient population
only.

The subject CO2 Sidestream Module is
the same as the CO2 sidestream module
used in the Reference Device, and they
are the same manufacturer -Beijing
Kingst.

9

10

Safety and Performance Data:

To establish substantial equivalence to the identified predicate devices, tests were completed as defined below to the subject devices, CO2 Sidestream Module. The results of the testing demonstrate that the device complies with the requirements of the applicable standard, and the device is substantially equivalent to the predicate device.

Non-Clinical Study:

Safety and EMC

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and -A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005. MODI
IEC 60601-1-2: 2014 Medical devices part 1-2: General requirements for basic safety and essential performance – Collateral standards: electromagnetic compatibility - Test and requirements

Performance Data:

ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment Part 2-55: -Particular requirements for the basic safety and essential performance of respiratory gas monitors

Test	Test Method	Test Result	Test Report No.
EtCO2	See test report	Range: 0-150mmHg
Accuracy:
0 - 40 mmHg: $\pm$ 2 mm Hg;
41- 70 mmHg: $\pm$ 5% of reading; 71 -
100 mmHg: $\pm$ 8% of reading; 101
-150 mmHg: $\pm$ 10% of reading	JJX-FDA-A/0-06-04
Inspired Dioxide Carbon
(InsCO2)	See test report		JJX-FDA-A/0-06-06
Respiration Rate	See test report	Range: 3bpm~150bpm
Accuracy: $\pm$ 1% of reading or $\pm$ 1
breaths/min whichever is greater	JJX-FDA-A/0-06-07

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Biocompatibility

ISO 10993-5: 2009 Biological evaluation of medical devices Part 5 Tests for In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical Devices Part 10: Tests for - Irritation and Delayed-Type Hypersensitivity
ISO 10993-11: 2017 Biological evaluation of medical Devices – Part 11: Tests for systemic toxicity
ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

Device	Category and Contact	Duration
Capno-S, Capno-S+	Surface Device →Skin	A — Limited≤( 24
h)	In Vitro Cytotoxicity (ISO10993-5)
Irritation (ISO10993-10)
Delayed-Type Hypersensitivity (ISO10993-10)
Accessories
(nasal tubes for
adult and infant,
filters, L- and
T-Connectors,
sampling line,
etc.)	external
communicating
devices →Tissue
contact
(contacting
the
patient's
inhaled
and exhaled gases)	A — Limited≤( 24
h)	In Vitro Cytotoxicity (ISO10993-5)
Irritation (ISO10993-10)
Delayed-Type Hypersensitivity (ISO10993-10)
Acute systemic toxicity(ISO10993-11) Material
mediated pyrogenicity ISO10993-11)

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Test	Test Method	Result
In Vitro
Cytotoxicity Test	ISO10993-5 MTT method
extracts MEM with 10%
FBS Extract	Viability%: 87.9%
No toxicity.	SDWH-M201602887-1
Skin Sensitization
Test	ISO10993-10
Guinea Pig
Maximization Test
0.9% Sodium Chloride
Injection Extract	Skin sensitization rate:
0% No evidence of
sensitization.	SDWH-M201602887-2	skin
Skin Sensitization
Test	ISO10993-10
Guinea Pig
Maximization Test
Sesame Oil Extract	Skin sensitization rate:
0% No evidence
of sensitization.	SDWH-M201602887-3	skin
Skin Irritation Test	ISO10993-10
0.9% Sodium Chloride
Injection Extract	Primary irritation index:
0 Negligible.	SDWH-M201602887-4
Skin Irritation Test	ISO10993-10
Sesame Oil Extract	Primary irritation index:
0 Negligible.	SDWH-M201602887-5
Test for emissions
of particulate	ISO18562-2	Particulate Matter:
$3.2 \times 10^{-3}$ µg/m3(Particle size
≤2.5 μm)
$3.2 \times 10^{-3}$ µg/m3(Particle size
≤10 μm)
Qualified	SDWH-M201901183-2(E)
Tests for emissions
of volatile
organic
compounds (VOCs)	ISO18562-3	Each VOC