(59 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device, a mask, is intended to protect against exposure to microorganisms and body fluids, not to treat or diagnose a medical condition.
No
The device is a mask intended for protection from microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical mask made of layered materials (spunbond polypropylene, hydrophilic polypropylene/polyethylene non-woven fabric, melt-blown polypropylene) with ear loops and a metal nose strip. The performance studies focus on physical properties like filtration efficiency, pressure, and flammability, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Savewo ClassicMASK is a physical barrier intended to be worn on the face to filter microorganisms, body fluids, and particulate material. It does not perform any tests on samples from the body.
- Intended Use: The intended use clearly states its purpose is for protection and infection control by reducing exposure to blood and body fluids, not for diagnostic testing.
- Device Description: The description details the physical construction and materials of the mask, not components for chemical or biological analysis.
- Performance Studies: The performance studies focus on the physical filtration and barrier properties of the mask (BFE, PFE, differential pressure, synthetic blood penetration), not on the accuracy or reliability of diagnostic test results.
Therefore, based on the provided information, the Savewo ClassicMASK is a medical device, specifically a surgical mask, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient and healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Testing Summary:
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.
-
Biocompatibility:
- Cytotoxicity: ISO 10993-5:2009 - Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity. Results: Pass (Non-Cytotoxic).
- Sensitization: ISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization. Results: Pass (Non-sensitizing).
- Irritation: ISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization. Results: 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. Results: 3 non-consecutive lots tested, using a sample size of 32/lot. 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 Ini-tial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres. Results: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: ≥99.6%, Lot 2: ≥99.7%, Lot 3: ≥99.7%.
- Differential pressure (mmH2O/cm²): MIL-M-36945C, Military Specifications: Surgical Mask, disposable. Results: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1:
§ 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.
0
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
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 Precision | |
| Manufacturer 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 classification | |||
| Name | Surgical apparel | Surgical apparel | Same |
| Regulation number | 878.4040 | 878.4040 | Same |
| Intended Use/ | |||
| Indications for Use | Savewo ClassicMASKs are | ||
| intended to be worn to | |||
| protect both patient and | The Single-use Surgical | ||
| Masks (Model: FE2311) | |||
| are intended to be worn | Same |
5
510(k) Submission
| 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. | | | | to protect both
thepatient and
healthcare personnel
from transfer of
microorganisms, body
fluids and
particulatematerial.
These face masks are
intended for use in
infection control
practices to reduce
thepotential exposure
to blood and body
fluids.
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-blown
polypropylene filter | Same | | | | |
| Inner cover web | 50% polypropylene + 50%
polyethylene Hydrophilic
non-woven fabric | Spunbond polypropylene | Different¹ | | | | |
| Nose wire | 75% polypropylene + 25%
iron nose-strip | Metal Core Plastic | Different1 | | | | |
| Ear loop | 80% polyamide + 20%
spandex ear-loop | Polyester | Different1 | | | | |
| Design Features | | | | | | | |
| Colors | White | Blue | Different2 | | | | |
| 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 filtration
efficiency (BFE) (%)
ASTM F2101 | Passed at ≥98% | Passed at ≥98% | Same | | | | |
| Particulate filtration
efficiency (PFE) (%)
ASTM F2299 | Pass at ≥98% @ 0.1
micron | Pass at ≥98% @ 0.1
micron | Same | | | | |
| Differential pressure
(mmH2O/cm²)
MIL-M36954C | Passed at