(99 days)
The Disposable Surgical Face Mask is 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 a single use, disposable device(s), provided non-sterile.
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On (model: JB-DM04) or Ear Loops (model: JB-DM03) way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model JB-DM04 of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model JB-DM03 of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and spandex.
The nose chip contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and iron.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) Summary for a Disposable Surgical Face Mask, which is a medical device. The information requested pertains to the acceptance criteria and study proving a digital health or AI/ML-driven device's performance. This document does not describe such a device. Instead, it outlines the non-clinical performance testing for a physical medical device (a face mask).
Therefore, I cannot extract the information required by your prompt, such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, or how ground truth was established for training, because these concepts are not applicable to the evaluation of a physical surgical face mask as presented in this document.
The document focuses on:
- Acceptance Criteria for the Face Mask: These are based on established standards for surgical masks, such as ASTM F2100 performance levels (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) and ISO 10993 for biocompatibility.
- Study Proving Device Meets Criteria: This involves non-clinical laboratory tests performed directly on the mask material or a sample of masks.
Here's an analysis of what is present in the document, framed against your request:
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Acceptance Criteria (level 2 & 3) | Proposed Device 1 (model: JB-DM04) Reported Performance | Proposed Device 2 (model: JB-DM03) Reported Performance | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3; 29 out of 32 pass at 120 mmHg for Level 2 | 32 out of 32 pass at 160 mmHg | 32 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.9% | 99.9% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | >99.9% | >99.9% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH2O/cm² | 2.21 mmH2O/cm² | 2.53 mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 | PASS |
Biocompatibility Testing:
| Item | Acceptance Criteria | Reported Performance (Proposed Device) | Result |
|---|---|---|---|
| Cytotoxicity | No potential cytotoxicity | Under the conditions of the study, the subject device extract did not show potential toxicity to L929 cells. | PASS |
| Irritation | Non-Irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample sized used for the test set and the data provenance:
* Sample Size (Test Set): For Fluid Resistance, 32 masks were tested. For other tests like PFE, BFE, Differential Pressure, Flammability, and Biocompatibility, specific sample sizes are not explicitly stated but are implicit in the methodology of these lab tests (e.g., usually multiple samples are tested).
* Data Provenance: The tests were non-clinical, laboratory-based. The location where the tests were performed is not explicitly stated, but the manufacturer is Anhui Jiabao Protective Equipments Co., Ltd in China. The submission correspondent is in Shanghai, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth for a physical medical device like a face mask is established by validated laboratory test methods and established standards (e.g., ASTM, ISO), not by human expert consensus or adjudication in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable. This is for a physical device, evaluated by objective lab tests, not human interpretation/adjudication.
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 for a physical device, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is for a physical device, not an algorithm.
7. The type of ground truth used:
* Established by Objective Laboratory Test Standards: The "ground truth" for the performance claims of this medical device is the adherence to the specified performance criteria as measured by internationally recognized and validated laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 series).
8. The sample size for the training set:
* Not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
* Not applicable as this is not an AI/ML device requiring a training set.
In summary, the provided document describes the safety and performance evaluation of a physical medical device (surgical face mask) through non-clinical laboratory testing against established industry standards, rather than the evaluation of a digital health or AI/ML-driven device.
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April 6, 2021
Anhui Jiabao Protective Equipments Co., Ltd % Mandy Wu Consultant Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K203801
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 28, 2020 Received: December 28, 2020
Dear Mandy Wu:
We have reviewed vour 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/cdrl/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 -S
For Ryan Ortega, PhD Acting 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) K203801
Device Name Disposable Surgical Face Mask
Indications for Use (Describe)
The Disposable Surgical Face Mask is 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 a single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) | X |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------- |
| | 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
for K203801
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312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China,
237000
510(K) Summary
K203801
Summary prepared date:2021-03-05
A. Applicant:
Name: Anhui Jiabao Protective Equipments Co., Ltd Address: 312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China, 237000 Contact Person: Mark Zhang Tel: +86 564-3963993, +86 180 7272 9283 Fax: +86 564-3963997 Mail: mark.zhang@jjabaofs.com
Submission Correspondent: Primary contact: Ms. Mandy Wu Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: min.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Disposable Surgical Face Mask Common Name: Surgical Face Mask Model(s):JB-DM03 (Ear Loops), JB-DM04 (Tie on)
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K153496 Disposable Surgical Face Mask K200923 Single-use Surgical Mask
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312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China,
237000
D. Indications for use of the device:
The Disposable Surgical Face Mask is 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 a single use, disposable device(s), provided non-sterile.
E. Device Description:
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On (model: JB-DM04) or Ear Loops (model: JB-DM03) way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model JB-DM04 of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model JB-DM03 of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and spandex.
The nose chip contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and iron.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
F. Technological Characteristics Comparison with predicate device
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | Anhui Jiabao ProtectiveEquipments Co., Ltd | BYD PrecisionManufacturer Co. Ltd | - |
| 510K number | K203801 | K200923 | - |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same |
| Indications for use | The Disposable SurgicalFace Mask is intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended for usein infection controlpractices to reduce thepotential exposure toblood and body fluids.This a single use, | The Single-use SurgicalMasks (Model: FE2311)are intended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids. | Similar |
Table 1 General Comparison
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312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China,
| disposable device(s),provided non-sterile. | This is a single use,disposable device(s),provided non-sterile. | Comparison | ||
|---|---|---|---|---|
| Ear loop modeland tie-on model | JB-DM03(Ear Loops, FlatPleated, 3 layers)JB-DM04(Tie-On, FlatPleated, 3 layers), | Ear Loops, Flat Pleated, 3layers | Analysis | |
| Material | Outer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middlelayer | Melt blownpolypropylene filter | Melt blown polypropylenefilter | Same | |
| Inner | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose clip | PE and iron | Malleable aluminum wire | Analysis | |
| Tie-one | Spun-bond polypropylene | / | Analysis | |
| Ear loops | Nylon and spandex | Polyester | Analysis | |
| Color | Blue | Blue | Same | |
| Dimension | 17.5 cm +/- 0.5 cm | 17.5 cm +/- 0.4 cm | Analysis | |
| Dimension | 9.5 cm +/- 0.5 cm | 9.5 cm +/- 0.4 cm | Analysis | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 level | Level 2 and 3 | Level 3 | Analysis | |
| Biocompatibility | ISO10993 | ISO10993 | Same |
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device meets the acceptance criteria with 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 ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of > Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
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- 312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu'an City, Anhui Province, China,
237000
- A ASTM F2299, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
16 CFR 1610, Standard for the Flammability of clothing textiles;
| Test Methodology | Proposed device1 (model: JB-DM04) | Proposed device2 (model: JB-DM03) | Acceptance Criteria (level 2&3) | Result |
|---|---|---|---|---|
| Fluid ResistancePerformance ASTM F1862 | 32 out of 32 pass at 160 mmHg | 32 out of 32 pass at 120 mmHg | 29 out of 32 pass at 160 mmHg for level 329 out of 32 pass at 120 mmHg for level 2 | PASS |
| ParticulateFiltrationEfficiencyASTM F2299 | 99.9% | 99.9% | ≥ 98% | PASS |
| BacterialFiltrationEfficiencyASTM F2101 | >99.9% | >99.9% | ≥ 98% | PASS |
| Differential Pressure(Delta P) EN 14683Annex C | 2.21mmH2O/cm² | 2.53mmH2O/cm² | <6.0mmH2O/cm² | PASS |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Class 1 | PASS |
Table 2 - Performance Testing
Table 3 Biocompatibility Comparison
| Item | Proposed device | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditions of the study, the subject device extractdid not show potential toxicity to L929 cells. | Nopotentialcytotoxicity | PASS |
| Irritation | Under the conditions of the study, the device is non-irritating. | Non-Irritating | PASS |
| Sensitization | Under the conditions of the study, the device is non-sensitizing | Non-Sensitizing | PASS |
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312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China, 237000
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K200923 BYD Precision Manufacturer Co. Ltd. Single-use Surgical Mask.
§ 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.