(90 days)
The Hygenix is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms. body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.
The Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PC coated Aluminium wire. The model ear loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of Polyester and Spandex. The dimensions of the Mask are: length- 175 ± 5 mm and width- 95 ± 5 mm. These masks are single-use, disposable devices, provided non-sterile.
Here's an analysis of the Hygenix device based on the provided FDA 510(k) summary, specifically focusing on its acceptance criteria and the study that proves it meets those criteria.
Acceptance Criteria and Device Performance for Hygenix (K232797)
The Hygenix device is a 3-ply disposable mask, and its performance is evaluated against established standards for surgical masks. The study proving its compliance is a non-clinical performance and biocompatibility testing regime.
1. Table of Acceptance Criteria and Reported Device Performance
| SI No. | Purpose | Reference Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1. | Fluid resistance | ASTM F1862/F1862M-17 | Pass at 160 mmHg | Pass at 160 mmHg |
| 2. | Particulate Filtration Efficiency (PFE) | ASTM F2299/F2299M-03(2017) | ≥ 98% | > 98% (Pass) |
| 3. | Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 | ≥ 98% | > 98% (Pass) |
| 4. | Differential pressure (ΔP) | EN 14683 (Annex C): 2019 | < 6.0 mm H₂O/cm² | < 6.0 mm H₂O/cm² (Pass) |
| 5. | Flammability | 16 CFR 1610 | Class 1 | Class 1 (Pass) |
| 6. | In-vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass |
| 7. | Skin Irritation | ISO 10993-10:2010 | Non-irritating | Pass |
| 8. | Skin Sensitization | ISO 10993-10:2010 | Non-sensitizing | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each individual performance test (fluid resistance, PFE, BFE, etc.) or biocompatibility test. However, these are standard laboratory tests conducted on samples of the device materials and/or finished products as per the referenced ASTM, EN, and ISO standards.
The data provenance is from non-clinical laboratory testing. The country of origin of the data is not explicitly stated, but the manufacturer is Shenzhen Hygenix Industrial Co., Ltd, located in China. Therefore, it is highly probable the testing was conducted in laboratories associated with the manufacturer or in accredited testing facilities, potentially in China or other regions adhering to these international standards. This data is prospective in the sense that it evaluates the manufactured device against pre-defined criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of testing (performance and biocompatibility for a surgical mask) does not involve experts establishing a "ground truth" in the way a clinical study with medical image interpretation would. The "ground truth" for these tests is defined by the objective, quantitative measurements obtained through standardized laboratory protocols as outlined in the referenced ASTM, EN, and ISO standards. The results are compared against the numerical acceptance criteria specified in those standards. The expertise lies in the certified laboratory technicians and scientists performing the tests and interpreting the results within the framework of these internationally recognized standards.
4. Adjudication method for the test set
There is no formal "adjudication method" in the sense of multiple expert reviewers. The tests are designed to produce objective, measurable results. The "adjudication" is inherent in the adherence to the detailed methodologies prescribed by the relevant standards (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE). A test result either objectively meets or fails the specified numerical acceptance criterion.
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 device is a surgical mask, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (surgical mask), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating the Hygenix mask's performance and biocompatibility is based on:
- Objective, quantitative measurements obtained from standardized laboratory tests (e.g., filtration percentages, differential pressure values, flammability class).
- Established biological endpoints for biocompatibility (e.g., absence of cytotoxicity, irritation, or sensitization), as defined by ISO standards and assessed through specific in-vitro and in-vivo (e.g., skin patch) testing.
These are not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on the empirical results of validated scientific and engineering tests.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." The evaluation methodology is based on physical and chemical testing, not machine learning.
9. How the ground truth for the training set was established
Not applicable. As stated in point 8, there is no training set for this type of device.
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December 11, 2023
Shenzhen Hygenix Industrial Co., Ltd % Jerry Doane US Agent FDAbasics 5815 SW 11th Court Rd Ocala, Florida 34473
Re: K232797
Trade/Device Name: Hygenix Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 21, 2023 Received: September 12, 2023
Dear Jerry Doane:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director
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DHT4B: Division of Infection Control and Plastic and Reconstructive 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) K232797
Device Name Hygenix
Indications for Use (Describe)
The Hygenix is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms. body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☐ Registration (Part 41 CFR 229 Subpart B) | ☑ One-Time Correction (49 CFR 229 Subpart C) |
|---|---|
| -------------------------------------------- | ---------------------------------------------- |
| | 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 (K232797)
[AS REQUIRED BY 21CFR807.92]
I. APPLICANT INFORMATION
| Submitter's Name | Shenzhen Hygenix Industrial Co., Ltd |
|---|---|
| Submitter's Address | 3rd Floor, Building A3, Fang Xing Technology Park,Longgang District, Shenzhen, China, 518100 |
| Name of Contact Person | Jia Du |
| Designation | General Manager |
| Division Name of Contact Person | Quality Management |
| Contact Number | +86-755-89788050 |
| Contact E-mail | Eva.du@adurochina.com |
| Date of Summary Prepared | 07/Nov/2023 |
II. DEVICE DETAILS
| Device Trade Name | Hygenix |
|---|---|
| Device Common Name | 3 Ply Disposable Mask |
| Model(s) | Ear Loop |
| Device Classification name | Mask, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |
III. PREDICATE DEVICE DETAILS
| Device Trade Name | Disposable Medical Face Mask (ear loop) |
|---|---|
| Device Manufacturer Name | Xiantao Topmed Nonwoven Protective Products Co., Ltd. |
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| Model(s) | Ear Loop |
|---|---|
| 510(k) Number | K221196 |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |
DEVICE DESCRIPTION IV.
The Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PC coated Aluminium wire.
The model ear loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of Polyester and Spandex.
The dimensions of the Mask are: length- 175 ± 5 mm and width- 95 ± 5 mm. These masks are single-use, disposable devices, provided non-sterile.
V. INDICATIONS FOR USE
The Hygenix is intended to be worn to protect both the patient and health care 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 device is disposable, non-sterile and for single use only.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE
| SI. No | Features compared | Proposed Device | Predicate Device | Result |
|---|---|---|---|---|
| General Information | ||||
| 1. | 510(k) Number | K232797 | K221196 | - |
| 2. | Manufacturer | Shenzhen Hygenix IndustrialCo., Ltd | Xiantao Topmed NonwovenProtective Products Co., Ltd. | - |
| 3. | Common Name | 3 Ply Disposable Mask | Disposable Medical Face Mask(ear loop) | Same |
| SI.No | Featurescompared | Proposed Device | Predicate Device | Result |
| 4. | Classification Name | Mask, Surgical | Mask, Surgical | Same |
| 5. | Classification andRegulation number | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Same |
| 6. | Product Code | FXX | FXX | Same |
| 7. | Indications For Use | The Hygenix is intended to beworn to protect both the patientand health care personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masks areintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This device isdisposable, non-sterile and forsingle use only. | The Disposable Medical FaceMasks are intended to be wornto protect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masks areintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device(s), providednon-sterile. | Same |
| 8. | Model specifications | 3 ply flat-pleated masks withear loops | Ear loop, Flat pleated,3 layers | Same |
| Materials | ||||
| 9. | Outer layer | Spun bond Polypropylene(SBPP) | Spun bond Polypropylene | Same |
| 10. | Filter layer | Melt Blown Polypropylene(MBPP) | Melt Blown Polypropylene | Same |
| 11. | Inner layer | Spun bond Polypropylene(SBPP) | Spun bond Polypropylene | Same |
| 12. | Nose wire | PC coated Aluminium wire | Galvanized iron wire coated byPE | Similar |
| 13. | Ear loop | Polyester and Spandex | Polyester + Spandex | Same |
| 14. | Mask color | Blue | Blue | Same |
| 15. | Dimensions | Length- 175 ± 5 mmWidth- 95 ± 5 mm | Length- 175 ± 5 mmWidth- 95 ± 5 mm | Same |
| SI.No | Featurescompared | Proposed Device | Predicate Device | Result |
| 16. | OTC Use | Yes | Yes | Same |
| 17. | Sterility | Non-sterile | Non-sterile | Same |
| 18 | Reusability | Single use | Single use | Same |
| 19 | ASTM F2100 Level | Level 3 | Level 3 | Same |
| Non-Clinical Testing | ||||
| 20. | Fluid resistance | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| 21. | Flammability | Class 1 | Class 1 | Same |
| 22. | Particulate FiltrationEfficiency (PFE) | ≥ 98% | ≥ 98% | Same |
| 23. | Bacterial FiltrationEfficiency (BFE) | ≥ 98% | ≥ 98% | Same |
| 24. | Differential pressure( $Δ$ Ρ) | < 6.0 mm H2O/cm² | < 6.0 mm H2O/cm² | Same |
| 25. | BiocompatibilityTesting | Non-cytotoxicNon-irritatingNon-sensitizing | Non-cytotoxicNon-irritatingNon-sensitizing | Same |
Table 1: General Comparison
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VII. SUMMARY OF NON-CLINICAL TESTING
Performance Tests
Hygenix is subjected to the following performance tests according to the requirements provided in the guidance Surgical Masks - Premarket Notification [510(k)] Submissions.
- . Fluid resistance
- . Bacterial filtration efficiency
- . Particulate filtration efficiency
- . Differential pressure
- . Flammability
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
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ASTM F2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
ASTM F2299 / F2299M - 03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
EN 14683 (Annex C): 2019 Medical Face Masks - Requirements And Test Methods
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
16 CFR 1610 Standard for the Flammability of clothing textiles
Biocompatibility
The materials used in the Hygenix is biocompatible based on the biocompatibility tests mentioned in the guidance Surgical Masks - Premarket Notification [510(k)] Submissions:
- . In-vitro Cytotoxicity
- . Skin irritation
- . Skin Sensitization
These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Table 2: Test Summary
| SI.No | Purpose | Reference Standard | Acceptancecriteria | Result |
|---|---|---|---|---|
| 1. | Fluid resistance | ASTM F1862/ F1862M-17 | Pass at 160 mmHg | Pass at 160 mmHg |
| 2. | Particulate FiltrationEfficiency (PFE) | ASTM F2299 / F2299M -03(2017) | ≥ 98% | >98%Pass |
| 3. | Bacterial FiltrationEfficiency (BFE) | ASTM F2101-19 | ≥ 98% | > 98%Pass |
| 4. | Differential pressure (ΔP) | EN 14683 (Annex C):2019 | < 6.0 mm H₂O/cm² | < 6.0 mm H₂O/cm²Pass |
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| SI.No | Purpose | Reference Standard | Acceptancecriteria | Result |
|---|---|---|---|---|
| 5. | Flammability | 16 CFR 1610 | Class 1 | Class 1Pass |
| 6. | In-vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass |
| 7. | Skin Irritation | ISO 10993-10:2010 | Non-irritating | Pass |
| 8. | Skin Sensitization | ISO 10993-10:2010 | Non-sensitizing | Pass |
VIII. Clinical Test Data
No clinical study is included in this submission.
CONCLUSION IX.
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.