(137 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No.
The device description and intended use specify that it is a surgical mask designed to protect against the transfer of microorganisms and body fluids, not to treat or diagnose a disease or condition.
No
The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly states it is a physical surgical mask, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (nonwoven, pleated, 3-ply, etc.). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
The performance studies and key metrics listed (filtration efficiency, differential pressure, resistance to penetration, flammability, biocompatibility) are all related to the physical barrier and safety properties of the mask, not its ability to perform a diagnostic test.
N/A
Intended Use / Indications for Use
BAYLAB 3-Ply Surgical Masks (BEACON I) are 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 infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
BAYLAB 3-Ply Surgical Masks (BEACON I) are nonwoven, pleated, 3-ply, single use, disposable flat surgical masks, manufactured in Bay Blue color. The surgical masks are to be secured on users by means of elastic ear loops.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests, in accordance with ASTM F2100 were conducted for the subject device:
- 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)
- 16 CFR Part 1610 Standard for The Flammability of Clothing Textiles
- EN 14683:2019+AC:2019 Medical face masks Requirements and test methods
- Annex C - Method for determination of breathability (differential pressure)
- ASTM F2299- Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus aureus.
Key Results:
- Bacterial filtration efficiency (ASTM F 2101): Pass at >98% (Acceptance criteria: Level 3: >=98%)
- Differential Pressure (Delta-P) (EN 14683): Delta P 99% (Acceptance criteria: Level 3: >=98%)
- Resistance to penetration by synthetic blood (ASTM F1862): Pass at 160mm Hg (Acceptance criteria: Level 3: 160mm Hg)
- Flammability (16 CFR Part 1610): Class I (Acceptance criteria: Class I)
The following Biocompatibility End points have been identified and tested in accordance appropriate biocompatibility standards:
- Cytotoxicity (ISO 10993-5)
- Irritation or intracutaneous reactivity (ISO 10993-10)
- Sensitization (ISO 10993-10)
Biocompatibility Test Results:
- Cytotoxicity (ISO 10993-5): Pass - ISO 10993-5:2009/ under the conditions of study the subject device was non-cytotoxic. (Acceptance criteria: Non-cytotoxic)
- Irritation and Sensitization (ISO 10993-10): Pass ISO 10993-10:2010/ under the conditions of the study, the subject device was non-irritating and non-sensitizing. (Acceptance criteria: Non-irritating and non-sensitizing)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 7, 2021
Baylab USA, LLC % Vardhini Kirthivas Vice President - Regulatory Services Freyr Solutions Level 4, Building No. H-08, Phoenix SEZ, Phase 2, Gachibowli Hyderabad, Telangana 500081 India
Re: K212302
Trade/Device Name: BAYLAB 3-Ply Surgical Mask (BEACON I) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: November 9, 2021 Received: November 10, 2021
Dear Vardhini Kirthivas:
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.
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
1
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,
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212302
Device Name BAYLAB 3-Ply Surgical Masks (BEACON I)
Indications for Use (Describe)
BAYLAB 3-Ply Surgical Masks (BEACON I) are 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 intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.
| 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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Phone: E-mail:
510(k) Summary K212302
1. Submitter Information:
Application Correspondent (US Agent):
Vardhini Kirthivas Freyr Global Regulatory Solutions and Services Level 4, Building No. H-08, Phoenix SEZ, Phase 2, Gachibowli, Hyderabad, Telangana, India, 500081 +91 - 9940445965 vardhini.kirthivas@FreyrSolutions.com
| Legal Manufacturer: | BAYLAB USA LLC |
|---|---|
| Phone: | 214-907-2527 |
| Contact Person: | Ashley Park |
| E-mail: | Ashley.park@baylabusa.com |
| Fax Number (including area code): | 469-372-0414 |
| Date Prepared: | 22-June-2021 |
2. Device Identification:
| Device Trade Name: | BAYLAB 3-Ply Surgical Masks (BEACON I) |
|---|---|
| Device: | Mask, Surgical |
| Regulation Description: | Surgical Apparel |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Review Panel: | General Hospital |
| Device Class: | II |
| Regulation Number: | 878.4040 |
| Product Code: | FXX |
3. Predicate Devices:
Table 1 - List of Predicate Devices
| Device Name | 510(k) Number |
|---|---|
| DemeMASK | K201479 |
4. Device Description
BAYLAB 3-Ply Surgical Masks (BEACON I) are nonwoven, pleated, 3-ply, single use, disposable flat surgical masks, manufactured in Bay Blue color. The surgical masks are to be secured on users by means of elastic ear loops.
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5. Intended Use & Indications for Use
BAYLAB 3-Ply Surgical Masks (BEACON I) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks 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 provided nonsterile.
5
6. Comparison of Technological Characteristics
Table 2 – Comparison Table
| S.No | Parameters | Predicate Device | Subject device | Comments | |
|---|---|---|---|---|---|
| 1. | Name | DemeMASK | BAYLAB 3-Ply Surgical Masks (BEACON I) | N/A | |
| 2. | 510(k) Number | K201479 | K212302 | N/A | |
| 3. | Manufacturer | DemeTECH Corporation | BAYLAB USA LLC | N/A | |
| 4. | Product Code | FXX | FXX | Same | |
| 5. | Regulation Number | 878.4040 | 878.4040 | Same | |
| 6. | Intended Use/Indications of Use | The Disposable Surgical Face Masks are | |||
| 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 is a single use, disposable device provided | |||||
| nonsterile. | BAYLAB 3-Ply Surgical Masks (BEACON I) are | ||||
| intended to be worn to protect both the patient and | |||||
| healthcare personnel from transfer of | |||||
| microorganisms, body fluids and particulate material. | |||||
| These surgical masks 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 provided nonsterile. | Same | ||||
| 7. | Material of | ||||
| Construction | Inner Layer | Spun-bond Polypropylene | Spunbond polypropylene | Same | |
| Outer Layer | Spun-bond Polypropylene | Spunbond polypropylene | Same | ||
| Middle Layer | Meltblown polypropylene filter | Meltblown polypropylene filter | Same | ||
| Ear loops | Spandex and Nylon- Not made with natural | ||||
| rubber latex | Spandex, Nylon, Polyester - Not made with natural | ||||
| rubber latex | Different, | ||||
| Note 1 | |||||
| Nose Piece | Galvanized wire coated with polyethylene | Plastic (polyethylene) clad aluminum | Different, | ||
| Note 2 | |||||
| 8. | Dimensions | Length: 17.5 cm±1 cm | |||
| Width: 9.5 cm±1 cm | Mask size: 7" x 3 ¾" (17.78 cm x 9.525 cm) | Same | |||
| 9. | Color | Blue | Blue | Same | |
| 10. | Mask Style | Flat - pleated | Flat pleated, 3-ply | Same | |
| 11. | Design Features | Ear loop | Ear loop | Same | |
| 12. | Sterility | Non - Sterile | Non- Sterile | Same | |
| 13. | Use | Single Use | Single Use | Same | |
| S.No | Parameters | Predicate Device | Subject device | Comments | |
| 14. | Latex | Not made with Natural Rubber Latex | Not made with Natural Rubber Latex | Same | |
| 15. | ASTM F2100 Level | Level 3 | Level 3 | Same | |
| 16. | Bacterial filtration efficiency | Pass at ≥ 99% | |||
| (ASTM F2101) | Pass at >98% | ||||
| (ASTM F2101) | Different, | ||||
| Note 3 | |||||
| 17. | Differential pressure (Delta-P) | Average 3.6 mmH2O/cm² | |||
| (MIL-M-36954C) | ΔP 99% | ||||
| (ASTM F2299) | Similar, | ||||
| Note 5 | |||||
| 19. | Resistance to penetration by | ||||
| synthetic blood, minimum pressure | |||||
| in mm Hg for pass result | Pass at 160 mm Hg (ASTM F1862) | Pass at 160 mm Hg (ASTM F1862) | Same | ||
| 20. | Flammability | Class 1 (16 CFR Part 1610) | Class 1 (16 CFR Part 1610) | Same | |
| 21. | Biocompatibility Cytotoxicity, | ||||
| ISO 10993 | |||||
| 5:2009 | Pass ISO 10993-5:2009/ under the conditions of | ||||
| study the subject device was non-cytotoxic. | Pass ISO 10993-5:2009/ under the conditions of | ||||
| study the subject device was non-cytotoxic. | Same | ||||
| Biocompatibility Irritation, | |||||
| ISO 10993- | |||||
| 10:2010 | Pass ISO 10993-10:2010/ under the conditions | ||||
| of the study, the subject device was non-irritating. | Pass ISO 10993-10:2010/ under the conditions of the | ||||
| study, the subject device was non-irritating. | Same | ||||
| Biocompatibility Sensitization, | |||||
| ISO 10993- | |||||
| 10:2010 | Pass ISO 10993-10:2010/ under the conditions | ||||
| of study, the subject device was non-sensitizing. | Pass ISO 10993-10:2010/ under the conditions of | ||||
| study, the subject device was non-sensitizing. | Same |
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Note 1 & Note 2: The differences in the materials do not raisety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials.
Note 3: The performance requirement for BFE as per ASTM F2100 is ≥98%. The performance of the requirements of ASTM F2100 version 2020 which is the revised version of FDA recognized consensus standard [Rec# 6-425] ASTM F2100-19. The subject device meets the criteria.
Note 4: We understand that MIL-M-36954C is the FDA recommended standard for differential pressure, However, the conformance to FDA Recognized consensus standard [Rec# 6-425], ASTM F2100-19 requires that Differential pressure be performed as per EN 14683:2019, Anex C.
We also understand that as per ASTM F2100-19, passing criteria for an ASTM level 3 mask with respect to differential pressure is 98% |
| 2. | EN 14683 | Differential Pressure (Delta-
P) | Level 3: ΔP 99% |
| 4. | ASTM F1862 | Resistance to penetration by
synthetic blood | Level 3: 160mm
Hg | Pass at 160mm Hg |
| 5. | 16 CFR Part 1610 | Flammability | Class I | Class I |
| Table 3 - Performance Testing - summary | |
|---|---|
FDA's guidance, "Surgical Masks - Premarket Notification [510(k)] Submissions ", recommends evaluating the biocompatibility as described in the standard ISO10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for limited contact devices, contacting intact skin.
The following Biocompatibility End points have been identified and tested in accordance appropriate biocompatibility standards.
- Cytotoxicity (ISO 10993-5) -
- Irritation or intracutaneous reactivity (ISO 10993-10) -
- -Sensitization (ISO 10993-10)
| Biological
endpoint | Test
Method | Purpose | Acceptance
criteria | Test Result |
|---------------------------------|---------------------|--------------------------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------------------|
| Cytotoxicity | ISO
10993-5 | Verify
Cytotoxicity
potential of the
subject device | Non-cytotoxic | Pass - ISO 10993-5:2009/ under the
conditions of study the subject
device was non-cytotoxic. |
| Irritation and
Sensitization | ISO
10993-
10 | Verify irritation
and sensitization | Non-irritating
and non-
sensitizing | Pass ISO 10993-10:2010/ under the
conditions of the study, the subject |
| Table 4 - Biocompatibility Testing - summary | |
|---|---|
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Traditional 510(k) BAYLAB 3-Ply Surgical Masks (BEACON I)
| potential of the | device was non-irritating and non- | |
|---|---|---|
| subject device | sensitizing. |
8. Conclusion
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, DemeMASK cleared under K201479.