Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.

Device Description

The Durio Surgical Face Mask is a non-sterile, single use, flat-pleated style surgical mask with ear loops and nose piece. The Durio Surgical Face Mask is available in three or four ply models. In all cases, the inner and outer layers of the Durio Surgical Face Mask are made of non-woven spunbond polypropylene (PP). The outer layer repels fluid and droplets. The middle layer is made of non-woven melt blown PP fabric for filtration by mechanical blocking and electrostatic attraction. For the four-ply model, there is an additional middle layer made of non-woven spunbound PP. The ear loops are made of polyester covered spandex yarn. The elastic ear loops pull inward from welding on the outer layer to reduce gaps as the side between the face and mask. The nose strip is made of zinc electro galvanized steel wire allowing adjustability and to let it stand fixed for better fit. The Durio Surgical Face Mask is provided in blue. The device is not made from any natural rubber latex.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device (Durio Surgical Face Mask). It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document is NOT about an AI/ML medical device where the "device performance" refers to the output of an algorithm against a ground truth. Instead, the "device performance" here refers to the performance of the physical surgical face mask according to established ASTM (American Society for Testing and Materials) standards.

Therefore, many of the requested elements of your prompt (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth for AI, training set ground truth establishment) do not apply to this document as it does not describe an AI medical device.

However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria for this physical medical device.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance (Physical Surgical Face Mask)

The acceptance criteria for the Durio Surgical Face Mask are defined by specific ASTM standards and a CFR regulation, demonstrating its barrier performance and safety. The "study" proving these criteria involved various bench performance tests as opposed to a study on an AI/ML algorithm.

1. A table of acceptance criteria and the reported device performance

Test Parameter / Acceptance Criteria Standard	Required Level (for specific models)	Reported Device Performance (Durio Surgical Face Mask)
Bacterial Filtration Efficiency (BFE) (per ASTM F2101-19)	Level 2 (3-Ply Model)	Passed
	Level 3 (4-Ply Model)	Passed
Sub-micron Particulate Efficiency (PFE) (per ASTM F2100-19)	Level 2 (3-Ply Model)	Passed
	Level 3 (4-Ply Model)	Passed
Resistance to Penetration by Synthetic Blood (per ASTM F1862/F1862M-17)	Level 2 (3-Ply Model)	Passed
	Level 3 (4-Ply Model)	Passed
Differential Pressure (per ASTM F2100-19)	Not explicitly stated in levels, but indicates breathable performance.	Passed
Flame Spread (per 16 CFR 1610)	Class 1	Class 1 (Passed)
Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization per ISO 10993-5 and ISO 10993-10)	Biocompatible	Biocompatible (Passed per ISO 10993 Series Testing)
Shipping Performance (per ASTM D4169-16)	N/A (Standard for packaging integrity)	Passed

Note on ASTM F2100 Levels: The document states that the 3-ply model meets Level 2, and the 4-ply model meets Level 3 of ASTM F2100. This standard defines performance requirements for medical face masks by classifying masks at Level 1, 2, or 3 based on their barrier properties (BFE, PFE, fluid resistance, differential pressure). By stating "Level 2 (3-Ply) and Level 3 (4-Ply)", it implicitly means the masks met the criteria for these specific levels for BFE, PFE, and synthetic blood penetration.

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

Sample Size: The document does not specify the exact sample size for each bench performance test. It broadly states that "Durio Surgical Face Masks passed the testing in accordance with internal requirements and standards." Regulatory submissions for physical devices typically rely on accredited lab testing according to the relevant standard. These standards often dictate minimum sample sizes for testing (e.g., a certain number of masks for BFE or PFE testing).
Data Provenance: The tests were conducted by an "applicant's internal" process ("Durio completed various bench performance tests... passed the testing in accordance with internal requirements and standards") likely in Malaysia (given the sponsor's location in Johor Bahru, Malaysia). The nature of these tests for a physical device is inherently "prospective" as new masks are manufactured and tested.

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 physical non-AI device. "Ground truth" for these performance tests is established by the specified ASTM and ISO standards' methodologies, not by human expert consensus or labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. This relates to human expert review and consensus for data labeling, which is not relevant for a physical device's bench testing.

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 is specific to AI/ML device evaluations.

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

Not Applicable. This is specific to AI/ML device evaluations.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Defined by Standardized Test Methods: The "ground truth" for the device's performance is determined by adherence to standardized, quantitative testing methods defined in documents like ASTM F2101, ASTM F2100, ASTM F1862/F1862M, 16 CFR 1610, and ISO 10993. For example:
- BFE: Percentage of bacteria filtered.
- PFE: Percentage of sub-micron particles filtered.
- Synthetic Blood Penetration: Pass/fail based on blood penetration.
- Biocompatibility: Absence of toxic, irritating, or sensitizing responses in preclinical models.

8. The sample size for the training set:

Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not Applicable. This is a physical device, not an AI/ML model.

In summary, the document demonstrates the substantial equivalence of the Durio Surgical Face Mask to a predicate device based on standardized, non-clinical bench testing for its physical and barrier properties, addressing safety and effectiveness without involving AI/ML components or associated data science methodologies.

Summary

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July 17, 2023

Durio PPE SDN BHD % Ms. Sarah Fitzgerald Senior Consultant, Regulatory and Quality Affairs Emergo Global Consulting, LLC 2500 Bee Caves Rd., Bldg. 1, Ste. 300 Austin, Texas 78746

Re: K230395

Trade/Device Name: Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 12, 2023 Received: June 12, 2023

Dear Ms. Fitzgerald:

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.

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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) 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 mediation-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.

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K230395

Device Name Durio Surgical Face Mask

Indications for Use (Describe)

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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K230395: 510(k) Summary

Durio Surgical Face Masks:

Model 501 (3-ply, blue) and Model 545 (4-ply,blue)

1. Submission Sponsor

Durio PPE SDN BHD 16, Jalan Temenggong Johor Bahru, Johor 81100 Malaysia Contact: Xavier Kong Title: Deputy General Manager

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Sarah Marie Fitzgerald Title: Senior Consultant, Regulatory and Quality Affairs

3. Date Prepared

June 16, 2023

4. Device Identification

Trade/Proprietary Name:	Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
Common/Usual Name:	Surgical Mask
Classification Name:	Surgical apparel
Regulation Number:	21 CFR 878.4040
Product Code:	FXX
Class:	II
Classification Panel:	General Hospital

5. Legally Marketed Predicate and Reference Device(s)

Device name:	Surgical Mask
510(k) number:	K212344
Type:	Predicate

K230395 510k Summary Page 1 of 4

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Manufacturer:	Xiantao Dingcheng Non-Woven Product Co., Ltd.
Device name:	CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
510(k) number:	K203078
Type:	Reference
Manufacturer:	Guangdong Kaidi Garments Co., Ltd.

6. Indication for Use Statement

7. Device Description

The Durio Surgical Face Mask is a non-sterile, single use, flat-pleated style surgical mask with ear loops and nose piece.

The Durio Surgical Face Mask is available in three or four ply models. In all cases, the inner and outer layers of the Durio Surgical Face Mask are made of non-woven spunbond polypropylene (PP). The outer layer repels fluid and droplets. The middle layer is made of non-woven melt blown PP fabric for filtration by mechanical blocking and electrostatic attraction. For the four-ply model, there is an additional middle layer made of non-woven spunbound PP. The ear loops are made of polyester covered spandex yarn. The elastic ear loops pull inward from welding on the outer layer to reduce gaps as the side between the face and mask. The nose strip is made of zinc electro galvanized steel wire allowing adjustability and to let it stand fixed for better fit.

The Durio Surgical Face Mask is provided in blue. The device is not made from any natural rubber latex.

8. Substantial Equivalence Discussion

The following table compares the Durio Surgical Face Mask to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

Attribute	Subject Durio Surgical FaceMask	Predicate Surgical Mask(K212344)	Comparison
Product Code	FXX	FXX	Same
Regulation	21 CFR 878.4040	21 CFR 878.4040	Same
Indications for Use	Surgical Mask is intended to beworn to protect both the patientand healthcare personnel fromtransfer of microorganisms,	Surgical Mask is intended to beworn to protect both the patientand healthcare personnel fromtransfer of microorganisms,	Same
Attribute	Subject Durio Surgical FaceMask	Predicate Surgical Mask(K212344)	Comparison
	body fluids and particulatematerial. It is intended for usein infection control practices toreduce the potential exposureto blood and body fluids. This isa single use, disposabledevice(s), provided non sterile.	body fluids, and particulatematerial. It is intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. This isa single use, disposabledevice(s), provided non sterile.
Mechanism ofAction	Physical barrier	Physical barrier	Same
Single-Use	Yes	Yes	Same
Sterility	Non-sterile	Non-sterile	Same
Composite	Flat Pleated, 3 or 4 Layers	Flat Pleated, 3 Layers	Equivalent*Same as referenceK203078
Materials: Outer	Spunbond Polypropylene (SBPP)	Spunbond Polypropylene (SBPP)	Same
Materials:Middle	Melt Blown Polypropylene(MBPP)	Melt Blown Polypropylene(MBPP)	Same
Materials: 4thLayer	None or MBPP	None	Equivalent*Same as referenceK203078
Materials:Inner	Hydrophilic SpunbondPolypropylene (HPP)	Spunbond Polypropylene (SBPP)	Equivalent*
Materials:Nose-Piece	Galvanized steel wire, flexible	Galvanized iron wire, flexible	Equivalent*
Materials:Earloop	Polyester and Spandex	Polyester and Spandex	Same
Dimensions	175mm x 95mm	175mm x 95mm	Same
Color	Blue	Blue	Same
OTC Use	Yes	Yes	Same
ASTM F2100Level	Level 2 (3-Ply)Level 3 (4-Ply)	Level 3	Equivalent**
Biocompatibility	Biocompatible per ISO 10993Series Testing	Biocompatible per ISO 10993Series Testing	Same

Table 5A - Comparison of Characteristics

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The devices have minor differences in materials. The differences do not raise new or different questions related to the safety or effectiveness of the device, and performance and biocompatibility evaluation and testing addresses these differences; therefore the devices are substantially equivalent.

** Testing was conducted within alignment with the labeled protection level; therefore the devices are substantially equivalent.

9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of the Durio Surgical Face Mask and to show substantial equivalence to the predicate device, Durio completed various bench performance tests. No animal or clinical testing was required. Results confirm that the design inputs and performance specification of the device are met. Durio Surgical Face Masks passed the testing in accordance with internal requirements

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and standards as shown below, supporting its safety, effectiveness, and substantial equivalence to the predicate device.

Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization) per ISO 10993-5 and ISO 10993-10
Bacterial Filtration Efficiency (BFE) per ASTM F2101-19
Sub-micron Particulate Efficiency (PFE) per ASTM F2100-19
Resistance to Penetration by Synthetic Blood per ASTM F1862/F1862M-17 ●
Differential Pressure per ASTM F2100-19
Flame Spread per 16 CFR 1610 (Class 1)
Shipping Performance per ASTM D4169-16 ●

10. Clinical Performance Data

No animal or clinical testing was required.

11. Statement of Substantial Equivalence

The Durio Surgical Face Mask has the same indications for use as the Surgical Mask (K212344). Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, the Durio Surgical Face Mask has been determined to be substantially equivalent to predicate Surgical Mask (K212344).

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.