(32 days)
The disposable surgical face masks are intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
The Kangbeier Surgical Mask (Model: KBR-1001) is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
The document describes the non-clinical testing performed on the Kangbeier Surgical Mask (Model: KBR-1001) to support its 510(k) submission and demonstrate substantial equivalence to a predicate device. This device is a surgical mask, not an AI-based or image analysis device, therefore, many of the requested items related to AI/MRMC studies, ground truth establishment, and data provenance are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a clear table (Table 2) outlining the acceptance criteria and the results for several non-clinical performance tests.
| Item | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Level 3 Fluid Resistance Performance ASTM F1862 | Resistance to Fluid | 29 Out of 32 pass at 160 mmHg | Pass LOT #1: 30/32 passed, @ 160 mmHg LOT #2: 30/32 passed, @ 160 mmHg LOT #3: 31/32 passed, @ 160 mmHg (Overall: 30-31 Out of 32 pass at 160 mmHg) |
| Particulate Filtration Efficiency ASTM F2299 | Particulate Filtration Efficiency | ≥ 98% | Pass LOT #1: AVE Filtration Efficiency ≥ 98% LOT #2: AVE Filtration Efficiency ≥ 98% LOT #3: AVE Filtration Efficiency ≥ 98% (Overall: 98.62-99.34%) |
| Bacterial Filtration Efficiency ASTM F2101 | Bacterial Filtration Efficiency | ≥ 98% | Pass LOT #1: AVE Filtration Efficiency ≥ 98% LOT #2: AVE Filtration Efficiency ≥ 98% LOT #3: AVE Filtration Efficiency ≥ 98% (Overall: 99.5 - 99.1%) |
| Differential Pressure ASTM F2100 | Differential Pressure | < 6.0 mmH2O/cm2 | Pass LOT #1: AVE Differential Pressure 5.0 LOT #2: AVE Differential Pressure 5.0 LOT #3: AVE Differential Pressure 5.0 (Overall: 3.92 - 4.78 mmH2O/cm2) |
| Class 1 Flammability 16 CFR 1610 | Flammability | < 3.5 second burn time | Pass LOT #1: Did not ignite LOT #2: Did not ignite LOT #3: Did not ignite (Overall: Class 1, Did Not Ignite (DNI)) |
Additionally, Biocompatibility testing was performed (Table 3):
| Item | Purpose / Method | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Cytotoxicity - ISO 10993-5 | Cytotoxic potential (MEM Extraction Test) | If viability is reduced to <70% of the reagent control extract, a cytotoxic potential exists. | Pass Under the conditions of the study the device is non-cytotoxic. |
| Skin Sensitization - ISO 10993-10 | Sensitizing potential (Magnusson-Kligman Sensitization / Guinea Pig Maximization Test (GPMT)) | Magnusson and Kligman grades of less than 1. | Pass Under the conditions of the study the device is non-sensitizing. |
| Skin Irritation - ISO 10993-10 | Potential for irritation (Intracutaneous Injection Test) | Erythema and Eschar Formation Value (total possible =4), No erythema = 0, Very slight erythema (barely perceptible) =1, Well defined erythema=2, Moderate erythema = 3, Severe erythema (beet redness) to eschar Formation (preventing grading of erythema) =4. Total possible erythema score = 4. Edema Formation Value, No edema = 0, Very slight edema (barely perceptible) = 1. (Note: The provided text is truncated for edema acceptance criteria, but the result is clear). | Pass Under the conditions of the study the device is non-irritating. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: For performance testing (Table 2), the sample sizes are indicated for each test:
- Fluid Resistance: 3 lots tested, with 32 samples per lot (total 96 samples).
- Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability: The document indicates results for 3 lots for each, but does not explicitly state the number of samples per lot for these tests. However, standard ASTM methods like F2101 and F2299 specify minimum sample sizes for reliable results. For flammability, it states "Did Not Ignite" for each lot.
- Biocompatibility Testing (Table 3): Standard biological tests (Cytotoxicity, Sensitization, Irritation) were performed according to ISO 10993. The specific sample sizes (e.g., number of cells, guinea pigs) are not detailed within this summary, but these are standardized animal/in-vitro models.
- Data Provenance: The tests are non-clinical (benchtop and biocompatibility) performed on the manufactured device. There is no mention of country of origin of the testing data itself, but the manufacturer is Xinxiang Kangbeier Medical Technology Co., Ltd. from China. These are laboratory tests, not retrospective or prospective patient data studies.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
N/A. This is a physical device being tested against recognized performance standards (ASTM, ISO, CFR). "Ground truth" in the context of expert consensus (e.g., for image analysis) is not applicable here. The performance criteria are defined by the standards themselves, and the results are quantitatively measured by testing laboratories.
4. Adjudication Method for the Test Set
N/A. As this is a physical device undergoing standardized benchtop and biocompatibility testing, there is no human adjudication process involved in interpreting results in the way there would be for an AI algorithm's output. The criteria are objective measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This document does not pertain to an AI algorithm or an imaging device, thus, an MRMC study is not relevant or performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A. No algorithm is involved. This is a medical device (surgical mask) that is physically tested.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by international and national standards (ASTM F1862, ASTM F2299, ASTM F2101, ASTM F2100, 16 CFR 1610 for performance, and ISO 10993 for biocompatibility) and regulatory guidance from the FDA. These standards define the acceptable range or threshold for specific physical and biological properties. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it's understood for diagnostic AI/imaging devices.
8. The Sample Size for the Training Set
N/A. This is a medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. No training set is applicable for this type of device submission.
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January 16, 2022
Xinxiang Kangbeier Medical Technology Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K213920
Trade/Device Name: Kangbeier Surgical Mask (Model: KBR-1001) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 14, 2021 Received: December 15, 2021
Dear Prithul Bom:
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.
For 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213920
Device Name Kangbeier Surgical Mask (Model: KBR-1001)
Indications for Use (Describe)
The disposable surgical face masks are intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
| 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 K213920
This summary of 510(k) is submitted in accordance with the requirements of 21 CFR §807.92:
l. SUBMITTER
Xinxiang Kangbeier Medical Technology Co., Ltd. East Mancun Industrial District, Changyuan, Henan 48105 China Tel: +86-13341254319 Fax: N/A
| Contact Person: | Shaoju Tian |
|---|---|
| Date Prepared: | December 8, 2021 |
II. SUBJECT DEVICE
| Device Trade Name: | Kangbeier Surgical Mask (Model: KBR-1001) |
|---|---|
| Classification Name: | Surgical Mask |
| Regulation: | 21 CFR §878.4040 |
| Regulatory Class: | Class II |
| Device Panel: | General Hospital |
| Product Classification Code: | FXX |
lll. PREDICATE DEVICE
| Predicate Manufacturer: | DemeTECH Corporation |
|---|---|
| Predicate Trade Name: | DemeMASK |
| Predicate 510(k): | K201479 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Kangbeier Surgical Mask (Model: KBR-1001) is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
V. INDICATIONS FOR USE
The disposable surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in Table 1 below.
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| Device | Subject Device -Kangbeier Surgical Mask(Model: KBR-1001) | Predicate Device -DemeMASK (K201479) | Result |
|---|---|---|---|
| Manufacturer | Xinxiang KangbeierMedical Technology Co.,Ltd. | DemeTECH Corporation | N/A |
| 510K Number | TBD | K201479 | N/A |
| Product Common Name | SURGICAL FACE MASK | SURGICAL FACE MASK | Identical |
| Trade Name | Kangbeier Surgical Mask(Model: KBR-1001) | DemeMASK Surgical Mask | N/A |
| Product Code | FXX | FXX | Identical |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Identical |
| Intended Use | The disposable surgical facemasks are intended to be wornto protect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial.These face masks are intendedfor use in infection controlpractices to reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable deviceprovided non-sterile. | The Disposable Surgical Face Masksare intended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material.These face masks are intended foruse in infection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable deviceprovided non- sterile. | Identical |
| Model | 3 Ply, Ear Loops, Flat-PleatedStyle | 3 Ply, Ear Loops or Tie-On | No tie-onoption forsubject device |
Table 1 is continued on page 2
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| Materials | |||
|---|---|---|---|
| Outer FacingLayer | Spun-Bond Polypropylene | Spun-Bond Polypropylene | Similar |
| Middle Layer | Melt-Blown Polypropylene | Melt-Blown Polypropylene Filter | Similar |
| Inner Facing Layer | Spun-Bond Polypropylene | Spun-Bond Polypropylene | Similar |
| Nose Piece | Galvanized wire coated withpolyethylene | Single Galvanized Wire, CoatedBy PE | Similar |
| Ear Loops | Nylon & polyurethane | Not made with natural rubber latex | Similar |
| Color | Blue | White | Subject deviceincludes bluecolorant |
| Dimension (Width) | $9.2 cm \pm 0.2 cm$ | $9.5 cm \pm 1.0 cm$ | More narrowtolerance for subjectdevice |
| Dimension(Length) | $17.8 cm \pm 0.2 cm$ | $17.5 cm \pm 1.0 cm$ | More narrowtolerance for subjectdevice |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100 Level | Level 3 | Level 3 | Same |
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VII. NON-CLINICAL DATA
The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2 along with the acceptance criteria.
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Level 3 FluidResistancePerformance ASTMF1862 | Resistance to Fluid | 29 Out of 32 pass at 160mmHg | Pass30-31 Out of 32 pass at 160 mmHgLOT #1, 30/32 passed, @ 160 mmHgLOT #2 30/32 passed, @ 160 mmHgLOT #3 31/32 passed, @ 160 mmHg |
| Particulate FiltrationEfficiency ASTMF2299 | Particulate FiltrationEfficiency | ≥ 98% | Pass98.62-99.34%LOT #1 AVE Filtration Efficiency ≥ 98%LOT #2 AVE Filtration Efficiency ≥ 98%LOT #3 AVE Filtration Efficiency ≥ 98% |
| Bacterial FiltrationEfficiency ASTMF2101 | Bacterial Filtration Efficiency | ≥ 98% | Pass99.5 - 99.1%LOT #1 AVE Filtration Efficiency ≥ 98%LOT #2 AVE Filtration Efficiency ≥ 98%LOT #3 AVE Filtration Efficiency ≥ 98% |
| Differential PressureASTM F2100 | Differential Pressure | < 6.0 mmH20/cm2 | Pass3.92 - 4.78 mmH20/cm2LOT #1 AVE Differential Pressure 5.0LOT #2 AVE Differential Pressure 5.0LOT #3 AVE Differential Pressure 5.0 |
| Class 1 Flammability16 CFR 1610 | Flammability | < 3.5 second burn time | PassClass 1, Did Not Ignite (DNI)LOT #1 Did not igniteLOT #2 Did not igniteLOT #3 Did not ignite |
| Table 2 - Benchtop Performance Testing | ||
|---|---|---|
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BIOCOMPATIBILITY TESTING
Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.
| Result | |||
|---|---|---|---|
| Standards | Purpose / Method | AcceptanceCriteria | |
| Cytotoxicity -ISO 10993-5 | Purpose: CytotoxicpotentialMethod: Evaluation oftest Articles by theMEM Extraction Test | If viability is reduced to<70% of the reagentcontrol extract, acytotoxic potentialexists. | PassUnder the conditions of the study the device isnon- cytotoxic |
| Skin Sensitization- ISO 10993-10 | Purpose: SensitizingpotentialMethod: Magnusson-Kligman Sensitization /Guinea PigMaximization Test(GPMT) | Magnusson and Kligmangrades of less than 1 | PassUnder the conditions of the study the device isnon- sensitizing |
| Skin Irritation -ISO 10993-10 | Purpose: Potential forirritationMethod: IntracutaneousInjection Test | Erythema and EscharFormation Value (totalpossible =4)No erythema = 0Very slight erythema(barely perceptible) =1Well definederythema=2Moderate erythema = 3Severe erythema (beetredness) to escharFormation (preventinggrading of erythema) =4Total possible erythemascore = 4Edema Formation ValueNo edema = 0Very slight edema(barely perceptible) = 1 | PassUnder the conditions of the study the device isnon- irritating |
Table 3 - Biocompatibility Testing
VIII. CONCLUSIONS
The conclusions drawn from the nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device(K201479), manufactured by DemeTECH Corporation.
§ 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.