(217 days)
The 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 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.
The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
The provided document describes the acceptance criteria and performance of Surgical Face Masks (Ear loops and Tie-on) as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove device meets an absolute acceptance criteria.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" but rather "performance requirements" as outlined by recognized standards (ASTM F2100-11 for various levels) and then reports the device's performance against these requirements. It also compares the proposed device's performance to predicate devices.
Acceptance Criteria (Performance Requirements from ASTM F2100-11) and Reported Device Performance
| Test | Level 1 Acceptance Criteria (Per ASTM F2100-11) | Level 1 Reported Device Performance | Level 2 Acceptance Criteria (Per ASTM F2100-11) | Level 2 Reported Device Performance | Level 3 Acceptance Criteria (Per ASTM F2100-11) | Level 3 Reported Device Performance |
|---|---|---|---|---|---|---|
| ASTM F1862 (Fluid Resistance) | Pass at 80 mmHg | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 160 mmHg |
| ASTM F2299 (Particulate Filtration Efficiency) | ≥ 95% | Pass at 99.6% | ≥ 95% | Pass at 99.6% | ≥ 98% | Pass at 99.7% |
| ASTM F2101 (Bacterial Filtration Efficiency) | ≥ 95% | Pass at >98% | ≥ 95% | Pass at >98% | ≥ 98% | Pass at >99% |
| MIL-M36945C (Differential Pressure) | < 5.0 mmH2O/cm² | Pass at 2.0 mmH2O/cm² | < 6.0 mmH2O/cm² | Pass at 1.6 mmH2O/cm² | < 6.0 mmH2O/cm² | Pass at 2.5 mmH2O/cm² |
| 16 CFR 1610 (Flammability) | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 |
| ISO 10993-5 (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| ISO 10993-10 (Irritation) | Non-irritating | Non-irritating | Non-irritating | Non-irritating | Non-irritating | Non-irritating |
| ISO 10993-10 (Sensitization) | Non-sensitizing | Non-sensitizing | Non-sensitizing | Non-sensitizing | Non-sensitizing | Non-sensitizing |
Note: For ASTM F2299 and ASTM F2101, the document reports "Pass at" a certain percentage. The acceptance criteria for these would typically be a minimum percentage, which the reported values exceed.
Note: For Differential Pressure, the acceptance criteria are maximum values (e.g., <5.0 mmH2O/cm²), and the device's reported values fall within these limits.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the individual performance tests (e.g., how many masks were tested for fluid resistance). The nature of these tests (e.g., ASTM F1862, F2299, F2101) typically involves standardized replicates as specified by the respective standards.
The data provenance is from non-clinical tests conducted on the proposed device. The country of origin of the data is not specified, but the applicant is from Japan (SAN-M PACKAGE CO., LTD.) and the US Correspondent is Globizz Corporation. The tests are "non-clinical tests" as opposed to human studies, so the retrospective or prospective nature in the clinical sense is not directly applicable. These are laboratory-based performance tests usually conducted in a controlled environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for these tests are the established performance requirements of the referenced ASTM and ISO standards, which are objective, quantifiable measurements (e.g., pass/fail for fluid penetration, percentage filtration, pressure drop). These are not subjective interpretations requiring expert consensus.
4. Adjudication method for the test set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving subjective assessments by human readers/experts to resolve discrepancies. The performance tests for surgical masks are objective laboratory measurements against predefined standards.
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
This is not applicable. The device is a surgical face mask, not an AI-powered diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical product (surgical face mask), not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for these tests are the established performance requirements defined by recognized international and national standards:
- ASTM F2100-11: 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 Particulate Matter Using a Latex Sphere Aerosol
- ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- MIL-M36945C: General Performance Requirements for Filtering Facepiece Respirators (likely referenced for differential pressure, though the specific ASTM equivalent is often used now)
- 16 CFR 1610: Standard for the Flammability of Clothing Textiles
- ISO 10993 (specifically ISO 10993-5 and ISO 10993-10): Biological evaluation of medical devices for cytotoxicity, irritation, and sensitization.
These standards provide objective, measurable criteria, not expert consensus or pathology on individual cases.
8. The sample size for the training set
This is not applicable. This is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no "training set."
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
San-M Package Co., Ltd. % Takahiro Haruyama President Globizz Corporation 1411 W. 190th St. Toyota Plaza #200 Gardena, CA 90248
Re: K160269
Trade/Device Name: Surgical Face Masks (Ear loops and Tie-on) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 2, 2016 Received: August 4, 2016
Dear Mr. Haruyama:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160269
Device Name Surgical Face Masks (Ear loops and Tie-on)
Indications for Use (Describe)
The 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 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.
Level 1 Face Mask Models: # EL 10000. EL 10010. TO 10000. TO 10010 Level 2 Face Mask Models: # EL 20000, EL 20010, TO 20000, TO 20010 Level 3 Face Mask Models: # EL 30000, EL 30010, TO 30000. TO 30010
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) Owner/Applicant | SAN-M PACKAGE CO., LTD.1086-1 OjiroShimada-City Sizuoka, JAPAN 428-8652 |
|---|---|
| 510(k) Number | K160269 |
| US Correspondent | Takahiro HaruyamaGlobizz Corporation(310) 538-3860register@globizz.net |
| Date Prepared | August 30, 2016 |
| Trade Name | Surgical Face Masks (Ear loops and Tie-on) |
| Common Name | Surgical Mask |
| Classification Name | Masks, Surgical |
| Review Panel | General & Plastic Surgery |
| Product Code | FXX |
| Device Classification | Class II per 21 CFR §878.4040 |
| Predicate Device | The Surgical Face Masks (Ear loops and Tie-on) are substantially equivalent to the Kimberly-Clark KC100 Mask (K110455) and KC200 and KC300 Face Masks (K111402). A comparison between the proposed and predicate devices is shown in Table 5-A below. |
510(k) Summary for Surgical Face Masks (Ear loops and Tie-on)
Table 5-A. Comparison of characteristics.
| Feature | (Proposed Device)Surgical Face Masks(Ear loops and Tie-on) | (Predicate Device) | ||||
|---|---|---|---|---|---|---|
| Level1 | Level2 | Level3 | KC100 MaskLevel1 | KC200 Face MaskLevel2 | KC300 Face MaskLevel3 | |
| 510(k) # | K160269 | K110455 | K111402 | |||
| Manufacturer | San-M Package Co.,Ltd. | Kimberly-Clark | ||||
| CommonName | Surgical Mask | Surgical Mask |
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| Classification | Class II | Class II | Class II | |
|---|---|---|---|---|
| Product Code | FXX | FXX | FXX | |
| Intended Use | The surgical face masksare intended to be wornto protect both thepatient and healthcarepersonnel from transferof microorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single-use,disposable device,provided non-sterile. | The Kimberly-Clark KC100ProcedureMask(s) isintended to beworn to protectboth the patientand healthcarepersonnel fromtransfer ofmicroorganisms,body fluids, andparticulatematerial. Theseface masks areintended for usein infectioncontrol practicesto reduce thepotentialexposure of thewearer to bloodand body fluids.The Kimberly-Clark KC100ProcedureMask(s) is asingle use,disposabledevices,provided non-sterile. | The Kimberly-Clark, KC200and KC300 Face Mask(s) isintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potential exposureof the wearer to blood andbody fluids. The Kimberly-Clark, KC200 and KC300face mask(s) is a single use,disposable device(s), providednon-sterile. | |
| Materials | ||||
| OuterMaterial | Polypropylene | Polypropylenespunbond | Polyestercellulose | Polypropylenespunbond |
| InnerMaterial | Polypropylene | Polyethylene/Polyester | Polyester cellulose | |
| Filter Media | 1. Polypropylenespunbond2. Polypropylenemeltblown | 1. Polypropy-lenemeltblown | 1. Polypropylene spunbond2. Polypropylene meltblown | |
| Nose Clamp | N/A | N/A | ||
| Ear Loops/Tie Tapes | Ear loops: Polyester, polyurethaneSide tapes:Polyester spunbond (ear loops mask only)Tie tapes:Polypropylene spunbond or polyester spunbond | Ear loops:Polyester/lycra knittedTie tapes:Polyester spunlace | Ear loops:Polyester/lycra knittedTie tapes:Polyester spunlace | |
| DesignFeatures | Colors: white or blue Visor option: polyester | Colors: variety Visor option | Colors: variety Visor option | |
| SpecificationsandDimensions | Length: $90 \pm 3$ mmWidth: $175 \pm 5$ mm | Length: $90 \pm 3$ mmWidth: $180 \pm 5$ mm | Length: $102 \pm 19$ mmWidth: $165 \pm 19$ mm | |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | |
| PerformanceTesting(ASTMF2100-11) | Level 1 | Level 2 | Level 3 | |
| FluidResistance | ASTM F1862 | ASTM F1862 | ASTM F1862 | |
| ParticulateFiltrationEfficiency | ASTM F2299 | ASTM F2299 | ASTM F2299 | |
| BacterialFiltrationEfficiency | ASTM F2101 | ASTM F2101 | ASTM F2101 | |
| DifferentialPressure | MIL-M36945C | MIL-M36945C | MIL-M36945C | |
| Flammability | 16 CFR 1610 | 16 CFR 1610 | 16 CFR 1610 | |
| Biocompat-ibility | ISO 10993 | ISO 10993 | ISO 10993 |
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| Device Description | The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile. |
|---|---|
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Intended Use The 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.
| Table 5-B. Surgical Face Mask Model Numbers | |||
|---|---|---|---|
| Mask Style | Ear Loops | Tie-On | |
| Level 1 | EL 10000 | T0 10000 | |
| Level 1 with Visor | EL 10010 | T0 10010 | |
| Level 2 | EL 20000 | T0 20000 | |
| Level 2 with Visor | EL 20010 | T0 20010 | |
| Level 3 | EL 30000 | T0 30000 | |
| Level 3 with Visor | EL 30010 | T0 30010 | |
| TechnologicalCharacteristics | The Surgical Face Masks (Ear loops and Tie-on) are substantiallyequivalent to the current legally marketed predicated devicescleared in K110455 and K111402. The product conforms to therecognized standards ASTM F2100-11, ASTM F1862, ASTMF2101, and ISO 10993 in addition to the requirements stated in theGuidance for Industry and FDA Staff: Surgical Masks-PremarketNotifications [510(k)] Submissions, issued March 5, 2004. | ||
| Performance &Biocompatibility | The Surgical Face Masks (Ear loops and Tie-on) have been testedaccording to the Guidance for Industry and FDA Staff: Surgical |
Testing
Masks-Premarket Notifications [510(k)] Submissions, issued March 5, 2004.
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Performance & Biocompatibility Testing (continued)
| (Proposed Device)Surgical Face Masks (Ear loops andTie-on) | (K110455)KC100Mask | (K111402)KC 200Face MaskKC 300Face Mask | ||||
|---|---|---|---|---|---|---|
| TEST | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| ASTMF2100-11 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| ASTMF1862 | Pass at 80mmHg | Pass at 120mmHg | Pass at 160mmHg | Pass at 80mmHg | Pass at 120mmHg | Pass at 160mmHg |
| ASTMF2299 | Pass at99.6% | Pass at99.6% | Pass at99.7% | Pass at98.4% | Pass at98.4% | Pass at98.4% |
| ASTMF2101 | Pass at>98% | Pass at>98% | Pass at>99% | Pass at99.7% | Pass at99.7% | Pass at99.7% |
| MIL-M36945C | Pass at 2.0mmH2O/cm2 | Pass at 1.6mmH2O/cm2 | Pass at 2.5mmH2O/cm2 | Pass at 3.0mmH2O/cm2 | Pass at 4.5mmH2O/cm2 | Pass at 3.2mmH2O/cm2 |
| 16 CFR1610 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 |
| CytotoxicityISO10993-5 | Under the conditions of the study, thesubject device was non-cytotoxic. | Under theconditionsof the study,the devicewas non-cytotoxic. | Under the conditions ofthe study, the device wasnon-cytotoxic. | |||
| IrritationISO10993-10 | Under the conditions of the study, thesubject device was non-irritating. | Under theconditionsof the study,the devicewas non-irritating. | Under the conditions ofthe study, the device wasnon-irritating. | |||
| SensitizationISO10993-10 | Under the conditions of the study, thesubject device was non-sensitizing. | Under theconditionsof the study,the devicewas non-sensitizing. | Under the conditions ofthe study, the device wasnon-sensitizing. |
| Table 5-C. Comparison of performance and biocompatibility testing. | ||||
|---|---|---|---|---|
| -- | -- | -------------------------------------------------------------------- | -- | -- |
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Conclusions
The product proposed under this premarket notification submission is similar in design, intended use, technological characteristics, and is composed of the same or similar components as the predicate device. The product proposed under this premarket notification submission has the same or similar performance characteristics and conform to the same or similar standards. Differences between the Surgical Face Masks (Ear loops and Tie-on) and predicate devices did not raise any new concerns regarding safety and effectiveness. The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the predicate devices K110455 and K111402.
§ 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.