(59 days)
Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Savewo ClassicMASKs 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(s) and provided non-sterile.
Savewo ClassicMASK is a 3-layered mask. The outer layer is made of spunbond polypropylene with white color, the inner layer is made of hydrophilic polypropylene/polyethylene non-woven fabric, and the middle layer with filtration function is made of melt-blown polypropylene. The mask contains ear loops to secure the mask over the users' mouth and face and the metal nose strip over the top edge which secures the mask to stay firmly in place. Savewo ClassicMASK is single use, disposable, non-sterile and ASTM Level 3 certified.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Savewo ClassicMASK:
Description of the Acceptance Criteria and Study
The Savewo ClassicMASK is a 3-layered surgical mask intended to protect both patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The device underwent non-clinical testing to demonstrate its performance against established standards, specifically the ASTM F2100-19 standard for Level 3 surgical masks, and to ensure biocompatibility and flammability compliance. The study aims to prove substantial equivalence to a predicate device (Single-use Surgical Mask, K200923) by meeting the outlined acceptance criteria for various performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Method/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5:2009 - Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity | Non-Cytotoxic | Pass (Non-Cytotoxic) |
| Sensitization | ISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization | Non-sensitizing | Pass (Non-sensitizing) |
| Irritation | ISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization | Non-irritating | Pass (Non-irritating) |
| Performance Tests | |||
| Bacterial filtration efficiency (BFE) (%) | 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 | Passed at ≥98% | Lot 1: ≥99.9%, Lot 2: ≥99.9%, Lot 3: ≥99.9% |
| Particulate filtration efficiency (PFE) (%) | ASTM F2299/F2299M-03 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | Pass at ≥98% | Lot 1: ≥99.6%, Lot 2: ≥99.7%, Lot 3: ≥99.7% |
| Differential pressure (mmH2O/cm²) | MIL-M-36945C, Military Specifications: Surgical Mask, disposable | Passed at <6 mmH2O/cm² | Lot 1: <4.11 mmH2O/cm², Lot 2: <4.19 mmH2O/cm², Lot 3: <4.08 mmH2O/cm² |
| Resistance to penetration by synthetic blood (mmHg) | 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) | Passed at 160mm Hg | Lot 1: 32 out of 32 Pass, Lot 2: 31 out of 32 Pass, Lot 3: 31 out of 32 Pass |
| Flammability | 16 CFR Part 1610 - Standard for the Flammability of Clothing Textiles | Class 1 | Lot 1: Class 1, Lot 2: Class 1, Lot 3: Class 1 |
| Other Tests | |||
| Accelerated aging test | ASTM F1980-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | (Implied conformance) | (Not explicitly detailed, but stated as conforming) |
| Transportation test | ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems | (Implied conformance) | (Not explicitly detailed, but stated as conforming) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests (BFE, PFE, Differential Pressure, Synthetic Blood Resistance, Flammability): 3 non-consecutive lots were tested for each performance characteristic. For each lot, a sample size of 32 units was used.
- Data Provenance: The document does not explicitly state the country of origin of the data. The data appears to be from prospective testing conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" for surgical masks is established by objective, standardized laboratory test methods (e.g., ASTM, ISO standards) that measure physical and biological barrier properties, not by expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective assessment or interpretation by multiple readers (e.g., medical image analysis), not for objective laboratory performance tests of physical devices. The results are obtained directly from established test procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, where the AI's effect on human reader performance is being evaluated. The Savewo ClassicMASK is a physical barrier device, and its performance is evaluated through laboratory tests, not human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical product (a surgical mask), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance reported is the inherent performance of the device as measured by various laboratory tests.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests of the Savewo ClassicMASK is based on established industry standards and regulatory requirements. For example:
- Biocompatibility: ISO 10993 series standards.
- Bacterial Filtration Efficiency (BFE): ASTM F2101-19.
- Particulate Filtration Efficiency (PFE): ASTM F2299/F2299M-03.
- Differential Pressure: MIL-M-36945C.
- Resistance to Synthetic Blood Penetration: ASTM F1862/F1862M-17.
- Flammability: 16 CFR Part 1610.
These standards define the methodologies and the acceptable performance thresholds.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The tested masks were production samples, not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this physical 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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 2, 2022
Savewo Limited % Ivy Lai Regulatory Manager Long Jing Technology Ltd. 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong 0000 China
Re: K221957
Trade/Device Name: Savewo ClassicMASK Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 1, 2022 Received: July 5, 2022
Dear Ivy Lai:
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 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.
for 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) K221957
Device Name Savewo ClassicMASK
Indications for Use (Describe)
Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Savewo ClassicMASKs 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(s) and 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) Submission
510(k) Summary
1 Date Prepared
06/30/2022
2 Submitter's Information
Name of Sponsor: Savewo Limited Address: 1/F & 2/F, 266-270 Texaco Road, Tsuen Wan, Hong Kong Contact Name: Melanie Choi Telephone No.: +852 5503 2370 E-mail: melanie@savewo.com
3 Trade Name, Common Name, Classification
Trade/Device Name: Savewo ClassicMASK Common Name: Surgical face mask Classification Name: Surgical apparel Review Panel: General and Plastic Surgery Product Code: FXX Device Classification: 2
- Identification of Predicate Device(s) 4 Predicate Device: Single-use Surgical Mask (K200923)
5 Description of the Device
Savewo ClassicMASK is a 3-layered mask. The outer layer is made of spunbond polypropylene with white color, the inner layer is made of hydrophilic polypropylene/polyethylene non-woven fabric, and the middle layer with filtration function is made of melt-blown polypropylene. The
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mask contains ear loops to secure the mask over the users' mouth and face and the metal nose strip over the top edge which secures the mask to stay firmly in place. Savewo ClassicMASK is single use, disposable, non-sterile and ASTM Level 3 certified.
6 Indication
Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Savewo ClassicMASKs 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(s) and provided non-sterile.
7 Comparison to the Predicate Device
Savewo ClassicMASK, the subject of this application, is compared with the predicate Device, Single-use Surgical Mask (K200923), in terms of indication, mechanism, design features, structure/material, and performance. The subject device and predicate devices claim Level 3 in accordance with ASTM F2100-19 standard.
The results are shown below in the Technological Characteristics Comparison Table:
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Manufacturer | Savewo Limited | BYD PrecisionManufacturer Co.Ltd. | |
| Trade Name | Savewo ClassicMASK | Single-use Surgical Mask | |
| 510(k) number | N/A | K200923 | -- |
| Device Class | 2 | 2 | Same |
| Product Code | FXX | FXX | Same |
| Device classificationName | Surgical apparel | Surgical apparel | Same |
| Regulation number | 878.4040 | 878.4040 | Same |
| Intended Use/Indications for Use | Savewo ClassicMASKs areintended to be worn toprotect both patient and | The Single-use SurgicalMasks (Model: FE2311)are intended to be worn | Same |
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510(k) Submission
| healthcare personnel fromtransfer ofmicroorganisms, bodyfluids, and particulatematerial.Savewo ClassicMASKs areintended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids.This is a single use,disposable device(s) andprovided non-sterile. | to protect boththepatient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids andparticulatematerial.These face masks areintended for use ininfection controlpractices to reducethepotential exposureto blood and bodyfluids.This is a single use,disposable device(s),provided non-sterile. | ||||||
|---|---|---|---|---|---|---|---|
| Materials | |||||||
| Outer cover web | Spunbond Polypropylene | Spunbond polypropylene | Same | ||||
| Middle web | Melt-Blown Polypropylene | Melt-blownpolypropylene filter | Same | ||||
| Inner cover web | 50% polypropylene + 50%polyethylene Hydrophilicnon-woven fabric | Spunbond polypropylene | Different*¹ | ||||
| Nose wire | 75% polypropylene + 25%iron nose-strip | Metal Core Plastic | Different*1 | ||||
| Ear loop | 80% polyamide + 20%spandex ear-loop | Polyester | Different*1 | ||||
| Design Features | |||||||
| Colors | White | Blue | Different*2 | ||||
| Style | Flat-pleated | Flat Pleated | Same | ||||
| Multiple layers | 3 layers | 3 layers | Same | ||||
| Single use | Yes | Yes | Same | ||||
| Dimensions | 175x95 mm | 175x95 mm | Same | ||||
| Sterility | |||||||
| Sterile | Non-Sterile | Non-Sterile | Same | ||||
| Biocompatibility | |||||||
| Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | Same | ||||
| Sensitization/irritation | Non-sensitizing, Non-irritating | Non-sensitizing, Non-irritating | Same | ||||
| Product barrier specification ASTM F2100 - Meets ASTM Level 3 | |||||||
| Bacterial filtrationefficiency (BFE) (%)ASTM F2101 | Passed at ≥98% | Passed at ≥98% | Same | ||||
| Particulate filtrationefficiency (PFE) (%)ASTM F2299 | Pass at ≥98% @ 0.1micron | Pass at ≥98% @ 0.1micron | Same | ||||
| Differential pressure(mmH2O/cm²)MIL-M36954C | Passed at <6 mmH2O/cm² | Passed at <6 mmH2O/cm² | Same | ||||
| Resistance topenetration bysynthetic blood(mmHg) | Passed at 160mm Hg | Passed at 160mm Hg | Same |
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Savewo Limited Savewo ClassicMASK
510(k) Submission
| ASTM F1862 | |||
|---|---|---|---|
| FlammabilityCFR 16 1610 | Class 1 | Class 1 | Same |
| *1: The differences in the materials of inner layer, nose wire and ear loop do not raise additionalquestions for safety and effectiveness. Biocompatibility evaluation has been performed on the finisheddevice which includes all construction materials. Besides, the subject device conforms with ASTM F2100standard and meets level 3 performance specifications. | |||
| *2: The difference in the color does not raise additional questions for safety and effectiveness becausethey are only used in the outer layer of the mask. Biocompatibility evaluation has been performed onthe finished device which includes all construction materials. |
The Savewo ClassicMASK has same indications, same mechanism, similar materials, similar product design, same performance as the predicate devices. The Savewo ClassicMASK is substantially equivalent to the Singleuse Surgical Mask (K200923) as these products conform with ASTM F2100 standard and meet Level 3 performance specifications. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device.
Non-Clinical Testing Summary 8
The proposed 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.
| Item | Test Mothd/ Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 - BiologicalEvaluation of Medical Devices --Part 5: Tests for in VitroCytotoxicity | Non-Cytotoxic | Pass |
| Sensitization | ISO 10993-10:2010 - BiologicalEvaluation of Medical Devices --Part 10: Tests for Irritation and SkinSensitization | Non-sensitizing | Pass |
| Irritation | ISO 10993-10:2010 - BiologicalEvaluation of Medical Devices --Part 10: Tests for Irritation and SkinSensitization | Non-irritating | Pass |
Biocompatibility a)
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510(k) Submission
| Item | Test Method/ Standard | AcceptanceCriteria | Results |
|---|---|---|---|
| Bacterialfiltrationefficiency(BFE) (%) | ASTM F2101-19 - StandardTest Method for Evaluatingthe Bacterial FiltrationEfficiency (BFE) of MedicalFace Mask Materials, Usinga Biological Aerosol ofStaphylococcus aureus | Passed at ≥98% | 3 non-consecutive lots tested,using a sample size of 32/lot.Lot 1: ≥99.9%Lot 2: ≥99.9%Lot 3: ≥99.9% |
| Particulatefiltrationefficiency(PFE) (%) | ASTM F2299/F2299M-03 -Standard Test Method forDetermining the Ini-tialEfficiency of MaterialsUsed in Medical FaceMasks to Penetration byParticulates Using LatexSpheres | Pass at ≥98% | 3 non-consecutive lots tested,using a sample size of 32/lot.Lot 1: ≥99.6%Lot 2: ≥99.7%Lot 3: ≥99.7% |
| Differentialpressure(mmH2O/cm²) | MIL-M-36945C, MilitarySpecifications: SurgicalMask, disposable | Passed at <6mmH2O/cm² | 3 non-consecutive lots tested,using a sample size of 32/lot.Lot 1: <4.11 mmH2O/cm²Lot 2: <4.19 mmH2O/cm²Lot 3: <4.08 mmH2O/cm² |
| Resistance topenetrationby syntheticblood(mmHg) | ASTM F1862/F1862M-17 -Standard Test Method forResistance of Medical FaceMasks to Penetration bySynthetic Blood(Horizontal Projection ofFixed Volume at a KnownVelocity) | Passed at160mm Hg | 3 non-consecutive lots tested,using a sample size of 32/lot.Lot 1: 32 out of 32 Pass at 160mmHgLot 2: 31 out of 32 Pass at 160mmHgLot 3: 31 out of 32 Pass at 160mmHg |
| Flammability | 16 CFR Part 1610 -Standard for theFlammability of ClothingTextiles | Class 1 | 3 non-consecutive lots tested,using a sample size of 32/lot.Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 |
Performance test b)
Accelerated aging test a)
- . ASTM F1980-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Transportation test b)
- . ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems
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Conclusion 9
The conclusions drawn from the non-clinical tests demonstrate that the Savewo ClassicMASK is as safe, as effective, and performs as well as or better than the legally marketed predicate device Single-use Surgical Mask (K200923).
§ 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.