The TOPWIDE surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.

Device Description

The Topwide surgical face mask is with white color outer laver and white inner layer. Subject device is a Flat Pleated type mask, utilizing ear-loop way for wearing, and it has a nose piece design for fitting the facemask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner laver (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask has Level II fluid resistance under ASTM F2100. The mask is a single use, provided non sterile. This product contains no components made with natural rubber latex.

AI/ML Overview

The provided document is a 510(k) summary for a Topwide Surgical Face Mask (K210102). It details the device's characteristics and its equivalence to a predicate device, based on non-clinical performance testing.

It is crucial to understand that this document describes a surgical face mask, not an AI-powered medical device or software. Therefore, the questions related to AI-specific elements like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "number of experts used to establish ground truth," "adjudication method," and "training set details" are not applicable to this type of device and the information provided.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical performance testing of the mask against established ASTM and ISO standards for medical face masks.

Here's the breakdown of the acceptance criteria and performance based on the provided document:

1. Table of acceptance criteria and the reported device performance

Test Methodology, Standard	Purpose	Acceptance Criteria	Reported Device Performance (Results)
ASTM F1862	Resistance to penetration by synthetic blood	120 mm Hg	120 mm Hg (32 out of 32 pass)
ASTM F2299	Particulate filtration efficiency (PFE)	$\ge$ 98%	$\ge$ 99.78% (>99% for predicate)
ASTM F2101	Bacterial filtration efficiency (BFE)	$\ge$ 98%	$\ge$ 98% (Same as predicate: >99%)
16 CFR 1610	Flammability	Class 1	Class 1
ASTM F2100	Differential Pressure (Delta-P) (Breathability)	< 6.0 mm H2O/cm$^2$	2.94 mm H2O/cm$^2$ (<28.8 Pa/cm$^2$)
ISO 10993-5, ISO 10993-10	Biocompatibility (Cytotoxicity, Irritation, Sensitization)	Not cytotoxic, irritating, or sensitizing under the conditions of the studies	PASSED

Note: The document sometimes lists the predicate device's performance for comparison and sometimes the subject device's. I have focused on the subject device's reported performance where available and clearly distinguishable from the predicate's, and noted similarities where appropriate.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document mentions that performance data was "provided from 3 nonconsecutive lots." For Fluid resistance (ASTM F1862), it explicitly states "32 out of 32 pass." This implies a sample size of 32 units tested for this specific criterion, drawn from the 3 nonconsecutive lots. The exact sample sizes for other tests are not individually specified but would typically involve multiple units from those 3 lots to demonstrate consistency.
Data Provenance: The manufacturer is "Topwide (Hubei) Medical Products Manufacturer" located in Xiantao, Hubei, China. The data would therefore be laboratory test results conducted presumably in China, either by the manufacturer or a contracted testing facility. The data is retrospective in the sense that it was collected as part of the product development and validation before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a medical device (surgical face mask) that undergoes physical and chemical performance testing, not diagnostic or image-based AI software requiring expert human interpretation for ground truth. The "ground truth" here is the result of standardized test methods, not expert consensus on medical images.

4. Adjudication method for the test set

Not Applicable. As explained above, this is directly measured physical and chemical performance, not a subjective assessment requiring adjudication among multiple human readers. The results are quantitative and objective measurements from laboratory tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This study is for a physical medical device (surgical face mask), not an AI-powered diagnostic tool. There are no human readers or AI assistance involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or software. It is a physical product.

7. The type of ground truth used

The ground truth used for this product is based on objective measurements obtained from standardized laboratory testing methods against established national and international standards (ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR 1610, ASTM F2100, ISO 10993-5, ISO 10993-10). These standards define the specific parameters and methodologies for assessing performance attributes like fluid resistance, filtration efficiency, breathability, flammability, and biocompatibility.

8. The sample size for the training set

Not Applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The product's design and manufacturing processes are refined through engineering and material science, not data training.

9. How the ground truth for the training set was established

Not Applicable. There is no training set for this type of device. The "ground truth" for ensuring the product's quality and performance is established by adhering to manufacturing specifications and testing against the performance standards mentioned in point 7.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 17, 2021

Topwide Medical Products Manufacturer % Jimmy Wu Associate Lee and Xiao 2600 Mission Street, Suite 206 San Marino, California 91108

Re: K210102

Trade/Device Name: Topwide Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: General Hospital Regulatory Class: Class II Product Code: FXX Dated: October 30, 2021 Received: November 3, 2021

Dear Jimmy Wu:

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

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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,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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)

K210102

Device Name TOPWIDE SURGICAL FACE MASK

Indications for Use (Describe)

The TOPWIDE surgical face mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the posure to blood and body fluids. This device is non-sterile and for single use only.

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 K210102

1. Type of 510(k) submission:	Traditional	Submitted on:	12/13/2021
2. Device Type:	Mask, Surgical
3. 510(k) Submitter/Owner:
Name:	Topwide (Hubei) Medical Products Manufacturer
Address:	19 Xianhong Road, Xin Li Ren KouXiantao, Hubei 433012CHINA
Phone:	86-728-2714000	Fax:	86-728-2712999
Contact:	Jimmy Wu	Email:	JWU@LEEXIAO.COM
4. Device:
Common Name:	Surgical Face Mask
Trade Name:	Topwide Surgical Face Mask

CFR Section: Product Classification: Classification Panel: Product Code:

21 CFR 878.4040 Class II General Hospital FXX

1. Basis for the Submission: New Device
Predicate Device: Single-Use Surgical Mask with Ear Loop (K201691) 6.

7. Indication For Use:

The TOPWIDE surqical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.

8. Device Description:

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sterile.

This product contains no components made with natural rubber latex.

	Subject Device - Topwide	Predicate Device - Single-Use
	Surgical Face Mask	Surgical Mask with Ear Loop
Device	(K210102)	(K201691)	Comparison
	The TOPWIDE surgical face mask	The Single-Use Surgical Mask
	is intended to be worn to	with Ear Loop is intended to be
	protect both patient and	worn to protect both the
	healthcare personnel from	patient and healthcare
	transfer of microorganisms,	personnel from the transfer of
	body fluids and particulate	microorganisms, body fluids,
	material. The TOPWIDE surgical	and particulate material. The
Intended Use	intended for use in infection	Single-Use Surgical Mask with	Same
	control practices to reduce the	Ear Loop intended for use in
	potential exposure to blood and	infection control practices to
	body fluids. This device is non-	reduce the potential exposure
	sterile and for single use only.	to blood and body fluids. This is
		a single-use, disposable
		device(s), provided non-sterile.
		Model: M and L, blue color, and
		Level
		2 barrier level as ASTM F2100.
Design feature
	Spun-bond polypropylene
Outer layer		Spun-bond polypropylene
	Melt blown
Middle layer	polypropylene	Melt blown non-woven fabric	SAME
	Spun-bond polypropylene
Inner layer		Spun-bond polypropylene
	Wire, malleable nosepiece,
	plastic-	Wire, malleable aluminum	DIFFERENT
Nose piece	coated steel	nosepiece
	Polyester and spandex
Ear Loops	materials	Polyester	SAME

			DIFFERENT
Color	White outer layer	Blue
Mask style	Flat pleated, Ear-	Flat pleated, Ear-Loop	SAME
	LoopLength: 17.5 cm ± 0.5 cm, Width:
Size	9.5 cm ±	Large: Length - 18 cm ± 1 cm, Width	DIFFERENT
	0.5 cm	9 cm± 1 cm
Single Use	ત્વની દિવેલા તાલુકામાં આવેલું એક ગામ છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગના અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને	Yes
OTC Use	yes	Yes	SAME
Sterile	Non-Sterile	Non-Sterile

9. Technological Characteristic Comparison

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Performance
ASTM F2100Level	II	II	SAME
Fluid resistance(ASTM F1862)	32 out of 32 pass at16Kpa (120 mmHg)	31 out of 32 pass at 120 mmHg
ParticulateFiltration (ASTMF2299)	$\ge$ 99.78%	> 99%	SIMILAR
Bacterial Filtration(ASTM F2101)	$\ge$ 98%	> 99%
DifferentialPressure (Delta-P)(ASTM F2100)	<28.8 pa/cm2(2.94 mmH2O/cm2)	< 5.0 mmH2O/cm2
BiocompatibilityISO10993	Irritation (ISO 10993-10),Sensitization (ISO 10993-10),Cytotoxicity (ISO 10993-5)	Irritation (ISO 10993-10),Sensitization (ISO 10993-10),Cytotoxicity (ISO 10993-5)	SAME
Flammability	Class 1	Class 1

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10. Summary of Non-Clinical Test

Following performance data has been provided from 3 nonconsecutive lots to
demonstrate that the subject device meet the acceptance criteria the standard.

Test Methodology,Standard	Purpose	Acceptance Criteria	Results
ASTM F1862	Resistance to penetrationby synthetic blood	120 mm Hg	120 mm Hg
ASTM F2299	Particulate filtrationefficiency	≥ 98%	>99%
ASTM F2101	Bacterial filtration	≥ 98%	≥ 98%
16 CFR 1610	Flammability	Class 1	Class 1
ASTM F2100	Differential Pressure(Delta-P)	< 6.0 mm H2O/cm2	2.94mmH2O/cm2
ISO 10993-5, ISO 10993-10	Biocompatibility	Not cytotoxic, irritatingor sensitizing under theconditions of thestudies	PASSED

Conclusion 11.

The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.