(72 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Surgical Mask 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, provided non-sterile.
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the layers of the face mask is to allow the user to fit the face mask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model 0868F is Carbon black (CAS No.1333-86-4), and for the model 0866F is Pigment Blue 15 (CAS No.147-14-8). The model 0866F will be provided in blue and labeled in Level 3, the model 0868F will be provided in black and labeled in Level 1.
The provided document is a 510(k) Premarket Notification for a Surgical Mask. It details the device's technical specifications, intended use, and a comparison to predicate devices, along with performance and biocompatibility testing. The document does not describe an AI/ML-driven medical device, but rather a traditional medical device (a surgical mask).
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) for an AI/ML device is not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices through physical and performance testing, rather than through a clinical study involving AI/ML performance metrics.
Here's a breakdown of the information that is available related to the device's performance, as per the tables in the document, interpreted as "acceptance criteria" and "reported performance" for a surgical mask:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML)
The document presents performance data for two models of the surgical mask (0868F and 0866F), which align with different performance levels (Level 1 and Level 3, respectively, based on ASTM F2100 standards).
| Test Item | Acceptance Criteria (Level 1 for 0868F) | Reported Performance (0868F) | Acceptance Criteria (Level 3 for 0866F) | Reported Performance (0866F) |
|---|---|---|---|---|
| Performance Testing | ||||
| Fluid Resistance (ASTM F1862) | Pass at 80 mmHg | Pass at 80 mmHg | Pass at 160 mmHg | Pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE, ASTM F2299) | ≥ 95% (at 0.1 µm) | Pass (≥ 95%) | ≥ 98% (at 0.1 µm) | Pass (≥ 98%) |
| Bacterial Filtration Efficiency (BFE, ASTM F2101) | ≥ 95% | Pass (≥ 95%) | ≥ 98% | Pass (≥ 98%) |
| Differential Pressure (ΔP, EN 14683 / ASTM F2100) | < 5.0 mm H2O/cm² | Pass (< 5.0 mm H2O/cm²) | < 6.0 mm H2O/cm² | Pass (< 6.0 mm H2O/cm²) |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 | Class 1 | Class 1 |
| Biocompatibility Testing | ||||
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Pass | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Non-irritating | Pass | Non-irritating | Pass |
| Sensitization (ISO 10993-10) | Non-sensitizing | Pass | Non-sensitizing | Pass |
Points 2-9 (Specific to AI/ML Device Study Design) are Not Applicable:
Since this document describes a surgical mask and not an AI/ML device, the following points are not addressed:
- 2. Sample sized used for the test set and the data provenance: Not applicable. Performance is evaluated on physical samples of the mask, not a data test set.
- 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for a surgical mask is based on standardized physical and chemical tests, not expert interpretation of AI outputs.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for evaluating changes in human diagnostic performance with AI assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a surgical mask's performance is established by the standardized test methods themselves (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE).
- 8. The sample size for the training set: Not applicable. There is no AI model to train.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance for a traditional medical device (surgical mask) based on established performance standards and biocompatibility, rather than a clinical study of an AI/ML device.
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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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
July 6, 2022
Jiangxi SanHao Medical Instruments Co., Ltd % Ms. Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China
Re: K221173
Trade/Device Name: Surgical Mask (Model: 0868F, 0866F) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 14, 2022 Received: April 25, 2022
Dear Ms. Lee:
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, 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) K221173
Device Name Surgical Mask (Model: 0868F, 0866F)
Indications for Use (Describe)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Surgical Mask 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, 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: Jiangxi SanHao Medical Instruments Co.,Ltd Address: Chengxi Industrial Park, Jishui County, Ji'an City, Jiangxi Province. China Post Code: 331699 Contact name: Wangfenfang (General Manager) Tel: +86 0796-3256750 Phone: +86-151 7966 0192 E-mail: 1218060588@qq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@share-info.com
Date of the summary prepared: July 1, 2022
2. Subject Device Information
Common Name: Surgical Mask Classification Name: Mask, Surgical Trade Name: Surgical Mask Model Name: 0868F, 0866F Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: Class II
3. Predicate Device Information
Predicate Device 1 (Primary predicate device): Sponsor: Jiangmen Ningrui Medical Supplies Co., Ltd. Trade Name: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
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Classification Name: Mask, Surgical 510(k) Number: K212293 Review Panel: General Hospital Product Code: FXX Requlation Number: 21 CFR 878.4040 Requlation Class: II
Predicate Device 2 (Additional predicate device):
Sponsor: Shandong Shengquan New Materials Co., Ltd. Trade Name: Surgical mask Classification Name: Mask, Surgical 510(k) Number: K211552 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
4. Device Description
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the layers of the face mask is to allow the user to fit the face mask around their nose, which is made of polyethylene coated iron wire.
The mask will be provided in black and blue color, the colorant for the model 0868F is Carbon black (CAS No.1333-86-4), and for the model 0866F is Pigment Blue 15 (CAS No.147-14-8). The model 0866F will be provided in blue and labeled in Level 3, the model 0868F will be provided in black and labeled in Level 1.
5. Intended Use / Indications for Use
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Surgical Mask 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, provided non-sterile.
Comparison to predicate device and conclusion 6.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
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| Elements ofComparison | Subject Device | Predicate Device 1 (Primarypredicate device) | PredicateDevice 2(Additionalpredicatedevice) | Remark |
|---|---|---|---|---|
| Company | Jiangxi SanHaoMedicalInstruments Co.,Ltd | Jiangmen Ningrui MedicalSupplies Co., Ltd. | ShandongShengquanNew MaterialsCo., Ltd. | -- |
| 510 (k) | K221173 | K212293 | K211552 | -- |
| Trade Name | Surgical Mask | Surgical Mask | Surgical mask | -- |
| Model | 0868F, 0866F | WK1701-02A, WK1701-03A,WK1701-04A | SMDP20608 | -- |
| ClassificationName | Mask, Surgical | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Class II | Same |
| ProductCode | FXX | FXX | FXX | Same |
| Intended use | The Surgical Maskis intended to beworn to protectboth the patientand healthcarepersonnel fromtransfer ofmicroorganisms,body fluids, andparticulate material.The Surgical Maskis intended for usein infection controlpractices to reducethe potentialexposure to bloodand body fluids.This is a single- | The Surgical Mask is intendedto be worn to protect both thepatient and healthcarepersonnel from the transfer ofmicroorganisms, body fluids,and particulate material. TheSurgical Mask is intended foruse in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle-use, disposabledevice(s), provided non-sterile. | The surgicalmasks areintended to beworn to protectboth the patientand healthcarepersonnel fromtransfer ofmicroorganisms,body fluids andparticulatematerial. Thesesurgical masksare intended foruse in infectioncontrol practicesto reduce thepotential | Same |
| Elements ofComparison | Subject Device | Predicate Device 1 (Primarypredicate device) | PredicateDevice 2(Referencepredicatedevice) | Remark |
| use, disposabledevice, providednon-sterile. | exposure toblood and bodyfluids. This is asingle use,disposabledevice, andprovided non-sterile. | |||
| Materials | ||||
| Outer facinglayer | Polypropylenespunbond | Polypropylene spunbondfabric | PolypropyleneSpunbond | Same |
| Middle filterlayer | Melt blownpolypropylene | Polypropylene spunbondfabric | Melt blownpolypropylenefilter | Same |
| Inner facinglayer | Polypropylenespunbond | Polypropylene spunbondfabric | PolypropyleneSpunbond | Same |
| Nose piece | Polyethylenecoated iron wire | Polypropylene coatedgalvanized iron wire | Malleablepolyethylene | SimilarNote 1 |
| Ear loops | Spandex | Nylon, spandex | Spandex,Polyester | SimilarNote 1 |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | Same |
| Color | Blue (0866F),Black (0868F) | Bule | Black and White | SimilarNote 1 |
| Dimensions | 175mm x 95mm(±5mm)Ear loop: 175mmNose piece: 80 ±2mm | Length: 17.5 cm ±5mmWidth: 9.5 cm±3mm | Length:17.5cm±0.88cmWidth:9.5cm±0.48cm | SameNote 1 |
| OTC use | Yes | Yes | Yes | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single-use | Yes | Yes | Yes | Same |
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| Elements ofComparison | Subject Device | Predicate Device 1 (Primarypredicate device) | Predicate Device 2(Reference predicatedevice) | Remark | |||
|---|---|---|---|---|---|---|---|
| PerformanceTesting | Level 1(0868F) | Level 3(0866F) | Level 1 | Level 2 | Level 3 | Level 3 | Same |
| FluidResistancePerformance(ASTMF1862) | Pass at80 mmHg | Pass at160 mmHg | Pass at80 mm Hg | Pass at120 mm Hg | Pass at160 mm Hg | Passed at 29out of 32 passat 160 mmHg | Same |
| ParticulateFiltrationEfficiency(ASTMF1215) | Pass at$\ge$ 95% | Pass at$\ge$ 98% | Pass at$\ge$ 99% | Pass at $\ge$99% | Pass at$\ge$ 99% | $\ge$ 98% | SimilarNote 2 |
| BacterialFiltrationEfficiency(ASTMF2101) | Pass at$\ge$ 95% | Pass at$\ge$ 98% | Pass at$\ge$ 99% | Pass at $\ge$99% | Pass at$\ge$ 99% | $\ge$ 98% | SimilarNote 2 |
| DifferentialPressure(ASTMF2100) | Pass at$<$ 5.0 mmH2O/cm² | Pass at$<$ 6.0 mmH2O/cm² | Pass at$<$ 3.4 mmH2O /cm² | Pass at <3.5 mmH2O /cm² | Pass at$<$ 3.4 mmH2O /cm² | $<$ 6.0 mmH2O/cm² | SimilarNote 2 |
| Flammability | Class 1 | Class 1 | Class 1 | Same | |||
| Biocompatibility | |||||||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Conform to ISO10993-5:2009 | Same | |||
| Irritation | Non-irritating | Non-irritating | Conform to ISO10993-10:2010 | Same | |||
| Sensitization | Non-sensitizing | Non-sensitizing | Conform to ISO10993- | Same |
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| Elements ofComparison | Subject Device | Predicate Device 1 (Primarypredicate device) | PredicateDevice 2(Referencepredicatedevice) | Remark |
|---|---|---|---|---|
| 10:2010 |
Comparison in Detail(s):
Note 1:
Although the Materials of "Nose piece", "Ear loops", "Color" and "Dimensions" of subject device are a little different from the predicate devices, they all met the requirements of biocompatibility standards ISO 10993-5 and ISO 10993-10. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
Note 2:
Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of the subject device are a little different from predicate devices, they all met the requirements of performance standard ASTM F2100. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
7. Summary of Non-Clinical Performance Testing
Performance Testing Summary
| Test item | Test method | Pass criteria | Test results/Verdict | |
|---|---|---|---|---|
| For Level 1 | For Level 3 | |||
| Bacterialfiltrationefficiency | ASTM F2101-19 Standard TestMethod for Evaluating the BacterialFiltration Efficiency (BFE) of MedicalFace Mask Materials, Using aBiological Aerosol of Staphylococcusaureus according to ASTM F2100:2019 | ≥ 95% | ≥ 98% | Pass |
| Differentialpressure | EN 14683: 2019, Annex C Medicalface masks - Requirements and test | <5.0 mmH2O/cm² | <6.0 mmH2O/cm² | Pass |
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| (Delta-P) | methods according to ASTM F2100:2019 | |||
|---|---|---|---|---|
| Sub-micronparticulatefiltrationefficiency at 0.1µm ofPolystyreneLatex Spheres | ASTM F2299 Standard Test Methodfor Determining the Initial Efficiency ofMaterials Used in Medical Face Masksto Penetration by Particulates UsingLatex Spheres according to ASTMF2100: 2019 | ≥ 95% | ≥ 98% | Pass |
| Resistance topenetration bysynthetic blood,minimumpressure in mmHg for passresult | ASTM F1862/F1862M-17Standard Test Method for Resistance ofMedical Face Masks to Penetration bySynthetic Blood (Horizontal Projection ofFixed Volume at a Known Velocity)according to ASTM F2100:2019 | Passat 80 mmHg | Passat 160 mmHg | Pass |
| Flame spread | 16 CFR Part 1610 Standard for theFlammability of Clothing according toASTM F2100:2019 | Class 1 | Class 1 | Pass |
Biocompatibility Testing Summary
According to ISO 10993-1: 2018, the nature of body contact for the subject device is direct surface contact with skin and indirect contact with the respiratory tract, and the duration of the contact is A-Limited (<24 h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
| Title of the test | Purpose of the test | Reference forTest method | Acceptancecriteria | Testresults |
|---|---|---|---|---|
| ------------------- | --------------------- | ------------------------------ | ------------------------ | ----------------- |
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| In vitroCytotoxicity Test | Under the researchconditions,determine whetherthe target deviceextract is cytotoxic. | ISO 10993-5:2009Biological evaluationof medical devices-Part 5: Tests for invitro cytotoxicity | Under theconditions of thestudy, the subjectdevice extract wasdetermined to benon-cytotoxic. | Pass |
|---|---|---|---|---|
| SkinSensitizationTest | Under the researchconditions,determine whetherthe non-polar andpolar extracts ofthe target deviceare sensitive. | ISO 10993-10:2010Biological evaluationof medical devices-Part 10: Tests forirritation and skinsensitization | Under theconditions of thestudy, the subjectdevice non-polarand polar extractswere determined tobe non-sensitizing. | Pass |
| Skin IrritationTest | Under the researchconditions,determine whetherthe non-polar andpolar extracts ofthe target deviceare irritating. | ISO 10993-10:2010Biological evaluationof medical devices-Part 10: Tests forirritation and skinsensitization | Under theconditions of thestudy, the subjectdevice non-polarand polar extractswere determined tobe non-irritating. | Pass |
8. Summary of Clinical Performance Test
No clinical study is included in this submission.
9. Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K212293 and K211552.
§ 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.