(25 days)
Not Found
No
The summary describes a physical surgical mask and its performance characteristics based on standard testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a surgical mask intended for infection control practices by reducing exposure to fluids and particulate matter, not for treating a disease or condition.
No
Explanation: The device description and intended use clearly state that this is a surgical mask designed to protect against microorganisms, body fluids, and particulate material. It is a protective barrier, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components (three-layers, ear loops, nosepiece) and materials, indicating it is a physical medical device, not software.
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 mask is for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function.
- Device Description: The description details the physical construction and materials of a surgical mask.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory setting or for point-of-care testing.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration, fluid resistance, flammability, biocompatibility), not on diagnostic accuracy or analytical performance related to biological samples.
Therefore, the Freudenberg Surgical Mask is a medical device, but it falls under the category of a personal protective equipment (PPE) and barrier device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Freudenberg Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is 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 non-sterile.
Product codes
FXX
Device Description
The Freudenberg Surgical Mask is composed of three-layers and is flat-pleated. The Freudenberg Surgical Mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), and inner cover web (polypropylene spunbond, white). Each mask contains polyester spandex blend ear loops to secure the mask over the user's mouth and nose and includes a polyethylene coated wire nosepiece to provide a firm fit over the nose. This face mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.
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
Non-clinical tests were conducted on three non-consecutive lots to verify that the proposed device met all design specifications as the predicate device, or better.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
The following standards have been used to evaluate the Freudenberg Surgical Mask:
- 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)
- 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: Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- EN 14683: Standard Test Method for Differential Pressure
- 16 CFR Part 1610: Standard for the Flammability of Clothing
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
- ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Non-clinical tests were conducted on three non-consecutive lots to verify that the proposed device met all design specifications as the predicate device, or better. The test results demonstrate that the proposed device conforms to the recognized standards ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR Part 1610, and ISO 10993 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Clinical Performance Test:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance Performance:
- Subject Device: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg - ASTM F1862. Lot 698002: 31/32 passed; Lot 697715: 32/32 passed; Lot 697944: 31/32 passed.
- Predicate Device: 32/32 passed at 120 mmHg - ASTM F1862.
- Bacterial Filtration Efficiency:
- Subject Device: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98% - ASTM F2101. Lot 698002: 32/32 passed at 99.9%; Lot 697715: 32/32 passed at 99.9%; Lot 697944: 32/32 passed at 99.9%.
- Predicate Device: pass at 99.6%- ASTM F2101.
- Particulate Filtration Efficiency:
- Subject Device: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98% - ASTM F2299. Lot 698002: 32/32 passed at 99.6±0.1%; Lot 697715: 32/32 passed at 99.5±0.1%; Lot 697944: 32/32 passed at 99.7±0.1%.
- Predicate Device: pass at 99.88% - ASTM F2299.
- Differential Pressure (Delta P):
- Subject Device: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 5, 2021
Freudenberg Performance Materials LP % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K210063
Trade/Device Name: Freudenberg Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: January 8, 2021 Received: January 11, 2021
Dear Prithul Bom:
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/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.
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 (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 Elizabeth F. Claverie-Williams. MS. CAPT, USPHS-CC Assistant Director DHT4B: Division of Infection Controland Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210063
Device Name Freudenberg Surgical Mask
Indications for Use (Describe)
The Freudenberg Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is 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 non-sterile.
Type of Use (Select one or both, as applicable)
| X | X | X | |
| X | X | ||
| X |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
FREUDENBERG PERFORMANCE MATERIALS
Image /page/3/Picture/1 description: The image shows the Freudenberg company logo. The logo consists of the company name "FREUDENBERG" in blue, with a stylized wave graphic to the left. Below the company name is the tagline "innovating together" also in blue.
510(k) Summary
| 510(k) Number: | K210063 |
|---|---|
| Sponsor Information: | Freudenberg Performance Materials LP |
| 3500 Industrial Drive | |
| Durham, NC 27704 | |
| United States | |
| Sponsor Contact: | |
| Eberhard Link | |
| Technical Market Manager - Medical | |
| 919-349-8389 | |
| eberhard.link@freudenberg-pm.com | |
| Contact Person: | Eberhard Link |
| Technical Market Manager - Medical | |
| 919-349-8389 | |
| eberhard.link@freudenberg-pm.com | |
| Date of Summary | |
| Preparation: | February 2, 2021 |
| Trade Name: | Freudenberg |
| Common Name: | Surgical Mask |
| Classification Name : | Surgical Apparel |
| Proprietary Name: | Freudenberg |
| Regulation Medical | |
| Specialty: | General and Plastic Surgery |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Device Classification: | Class II per 21 CFR §878.4040 |
| Predicate Device: | SURGICAL FACE MASK (K182514) - Model Ear Loop |
| Intended Use: | The Freudenberg Surgical Mask is intended to be worn to |
| protect both the patient and healthcare personnel from | |
| transfer of microorganisms, body fluids and particulate | |
| material. This face mask is 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 non-sterile. | |
| Device Description: | The Freudenberg Surgical Mask is composed of three-layers |
| and is flat-pleated. The Freudenberg Surgical Mask materials | |
| consist of an outer cover web (polypropylene spunbond, | |
| white), insertion layer (polypropylene, melt-blown, white), and | |
| inner cover web (polypropylene spunbond, white). Each mask |
4
Image /page/4/Picture/1 description: The image shows the logo for Freudenberg. The logo consists of a blue graphic on the left and the word "FREUDENBERG" in blue on the right. Below the word "FREUDENBERG" is the phrase "INNOVATING TOGETHER" in a smaller font.
contains polyester spandex blend ear loops to secure the mask over the user's mouth and nose and includes a polyethylene coated wire nosepiece to provide a firm fit over the nose. This face mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.
Available Model Number:
FPMD2020
Surgical Mask
Comparison of Proposed and Predicate Devices:
| ltem(s) | Proposed Device
(K210063)
Freudenberg Surgical
Mask | Predicate Device
(K182514)
SURGICAL FACE MASK | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Freudenberg Surgical
Mask is intended to be
worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body
fluids and particulate
material. This face mask is
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 non-
sterile. | 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 non-
sterile. | Same, minor
differences to
correct grammar |
| Type of Use | Over-The-Counter Use (21
CFR 801 Subpart C) | Over-The-Counter Use (21
CFR 801 Subpart C) | Same |
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene
filter | Melt blown polypropylene
filter | Same |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Malleable polyethylene-
coated wire | Malleable aluminum wire | Similar, both
nose pieces are
composed of
malle able metal. |
| Nose piece length | 10.0cm ±1cm | Not provided | - |
| Item(s) | Proposed Device
(K210063)
Freudenberg Surgical
Mask | Predicate Device
(K182514)
SURGICAL FACE MASK | Comparison |
| Ear loops | Polyester spandex blend | Polyester | Similar, both
mask ear loops
use polyester |
| Ear loop length | 14.5cm -1/+2.5cm | Not provided | - |
| Color | White | White | Same |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Length | 17.5cm±1cm | 17.5cm±1cm | Same |
| Width | 9.5cm ±1cm | 9.5cm ±1cm | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| Performance
Testing | Level 3 - ASTM
F2100-19 | Level 2 - ASTM
F2100-11 | Different,
subject devices
exceeded
predicate device
in one
performance
test. ASTM
F2100-19 uses
different test
method for
measuring
Delta-P
(H2O/cm²) |
| Fluid Resistance
Performance | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at 160mmHg
- ASTM F1862
Lot 698002: 31/32 passed
Lot 697715: 32/32 passed
Lot 697944: 31/32 passed | 32/32 passed at 120
mmHg - ASTM F1862 | Similar,
subject device
exceeded fluid
resistance of
predicate device |
| Bacterial
Filtration
Efficiency | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at ≥98% -
ASTM F2101
Lot 698002: 32/32 passed
at 99.9%
Lot 697715: 32/32 passed
at 99.9% Lot 697944:
32/32 passed at 99.9% | pass at 99.6%- ASTM
F2101 | Similar, both
devices meet
ASTM
F2101 |
| Item(s) | Proposed Device
(K210063)
Freudenberg Surgical
Mask | Predicate Device
(K182514)
SURGICAL FACE MASK | Comparison |
| Particulate
Filtration
Efficiency | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at ≥98% -
ASTM F2299
Lot 698002: 32/32 passed
at 99.6±0.1%
Lot 697715: 32/32 passed
at 99.5±0.1%
Lot 697944: 32/32 passed
at 99.7±0.1% | pass at 99.88% - ASTM
F2299 | Similar, both
devices meet
ASTM
F2299 |
| Differential
Pressure (Delta
P) | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at