(164 days)
The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.
The provided document describes the acceptance criteria and performance of the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, in comparison to a predicate device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Models TN01-11 and TN01-12) |
|---|---|---|
| Fluid Resistance | Pass at 160 mmHg (ASTM F1862) | Pass at 160 mmHg (ASTM F1862). Models TN01-11 and TN01-12 meet the requirements of ASTM F1862. |
| Particulate Filtration Efficiency (PFE) | NIOSH Certification (e.g., 84A-5216) | NIOSH Certification Number: TC 84A-3348 (includes TN01-11 & TN01-12) |
| Bacterial Filtration Efficiency (BFE) | NIOSH Certification (e.g., 84A-5216) | NIOSH Certification Number: TC 84A-3348 (includes TN01-11 & TN01-12) |
| Differential Pressure (△ P) | NIOSH Certification (e.g., 84A-5216) | NIOSH Certification Number: TC 84A-3348 (includes TN01-11 & TN01-12) |
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610). Meets 16 CFR 1610 Standard for class 1 flammability. |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating (ISO 10993) | Under the conditions of the study, the device was non-cytotoxic, non-sensitizing, and non-irritating (ISO 10993). |
| - Cytotoxicity | (ISO 10993-5) | Under the conditions of the study, the subject device was non-cytotoxic (ISO 10993-5). |
| - Irritation | (ISO 10993-10) | Under the conditions of the study, the subject device was non-irritating (ISO 10993-10). |
| - Sensitization | (ISO 10993-10) | Under the conditions of the study, the subject device was non-sensitizing (ISO 10993-10). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of masks tested for fluid resistance or flammability). It simply states that the models meet the requirements of the standards. The provenance of the data is not specified beyond indicating it was a submission to the FDA. The tests are described as performance testing and non-clinical tests, which are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to the type of device and testing described. The "ground truth" for N95 masks is established through standardized laboratory performance tests according to recognized standards (e.g., ASTM, NIOSH, ISO) and not through expert consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 are typically used in studies where human readers interpret medical data (e.g., radiology studies) and their findings need to be reconciled. For performance testing of a physical device like an N95 mask, objective laboratory measurements are taken against predefined criteria.
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 information is not applicable. The device is a physical N95 mask, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical N95 mask; there is no algorithm or AI component involved. The testing described is for the physical performance of the mask.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the N95 mask is based on objective measurements against established performance standards set by regulatory bodies and testing organizations. These include:
- ASTM F1862 for Fluid Resistance
- NIOSH Certification (TC 84A-3348) for Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure
- 16 CFR 1610 for Flammability
- ISO 10993 series for Biocompatibility (cytotoxicity, irritation, sensitization)
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of performance testing for a physical medical device like an N95 mask. Training sets are relevant for machine learning or AI models.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device and study.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a single abstract figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2016
San-M Package Co., Ltd. % Takahiro Haruyama President Globizz Corporation 1411 W. 190th St. Toyota Plaza #200 Gardena, CA 90248
Re: K160271
Trade/Device Name: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: June 10, 2016 Received: June 15, 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 device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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) K160271
Device Name
N95 Particulate Respirator and Surgical Masks, Models TN01-11 and TN01-12
Indications for Use (Describe)
The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
| 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) Summary for N95 Particulate Respirator and Surgical Mask
| 510(k) Owner/Applicant | SAN-M PACKAGE CO., LTD.1086-1 OjiroShimada-City Sizuoka, JAPAN 428-8652 |
|---|---|
| US Correspondent | Takahiro HaruyamaGlobizz Corporation(310) 538-3860register@globizz.net |
| Date Prepared | July 15, 2016 |
| Trade Name | N95 Particulate Respirator and Surgical Mask,Models TN01-11 and TN01-12 |
| Common Name | N95 Surgical Respirator |
| Classification Name | Surgical apparel |
| Review Panel | General Hospital |
| Product Code | MSH |
| Device Classification | Class II per 21 CFR §878.4040 |
| Predicate Device | The N95 Particulate Respirator and Surgical Mask, Models TN01-11and TN01-12 are substantially equivalent to the Prestige AmeritechPro Gear N95 Particulate Filter Respirator and Surgical Mask clearedin K102092. A comparison between the proposed and predicatedevice is shown in Table 5-A below. |
Table 5-A. Comparison of characteristics.
| Feature | N95 Particulate Respirator andSurgical Mask (Proposed Device) | Pro Gear N95 Particulate FilterRespirator and Surgical mask(Predicate Device) |
|---|---|---|
| 510(k) # | K160271 | K102092 |
| Manufacturer | San-M Package Co., Ltd. | Prestige Ameritech |
| Common Name | N95 Surgical Respirator | N95 Surgical Respirator |
| Classification # | Class II | Class II |
| Product Code | MSH | MSH |
| Intended Use | The N95 Particulate Respirator andSurgical Mask, Models TN01-11 | The Prestige Ameritech N95Respirator and Surgical Mask |
| and TN01-12 are single-use, non-sterile, disposable devices intendedto be worn by operating roompersonnel or other healthcareworkers to protect both the patientand operating room personnel fromthe transfer of microorganisms,body fluids, and particulatematerial. | RP88020 is a single use non-steriledisposable device intended to beworn in the operating room as wellas dental, isolation and othermedical procedures to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids, and particulatematerial. | |
| Materials | ||
| Outer Material | Polypropylene spunbond | Polypropylene spunbond |
| Inner Material | Polypropylene and polyethylene | Biocomponent nonwoven |
| Filter Media | Two layers of polypropylenemeltblown | Two layers of polypropylenemeltblown |
| Nose Clamp | Polyethylene coated steel wire | Malleable aluminum |
| Headband | Polyurethane, not made with naturalrubber latex | Elastic not made with naturalrubber latex |
| Design Features | Manufactured by ultrasonicbonding, composed of four layersof materials, trapezoid-shaped whenflat-folded, pouched-shaped whenworn, single-use, disposablerespirator, and nose clamp tocontour to the wearer. | Manufactured by ultrasonicbonding, composed of four layersof materials pouched and pleated toform the mask. Held on wearer withan elastic headband and contains amalleable aluminum nosepiecestrip. |
| Specificationsand Dimensions | • Colors: orange or whiteTN01-12 (Small):• Length: 205 ± 5 mm• Width: 75 ± 5 mm• Band length: 205 ± 5 mmTN01-11 (Medium):• Length: 240 ± 5 mm• Width: 75 ± 5 mm• Band length: 240 ± 5 mm | N/A |
| Mask Style | Flat-folded, Pouch | Pouch |
| Sterility | Non-sterile | Non-sterile |
| Performance | ||
| Testing | ||
| Fluid Resistance | Pass at 160 mmHg (ASTM F1862) | Pass at 160 mmHg (ASTM F1862) |
| Particulate | NIOSH Certification #TC 84A-3348 | NIOSH Certification #TC 84A-5216 |
| FiltrationEfficiency(PFE) | (includes TN01-11 & TN01-12) | |
| BacterialFiltrationEfficiency(BFE) | NIOSH Certification #TC 84A-3348(includes TN01-11 & TN01-12) | NIOSH Certification #TC 84A-5216 |
| DifferentialPressure (△ P) | NIOSH Certification #TC 84A-3348(includes TN01-11 & TN01-12) | NIOSH Certification #TC 84A-5216 |
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610) |
| Biocompatibility | Under the conditions of the study,the device was non-cytotoxic, non-sensitizing, and non-irritating.(ISO 10993) | (ISO 10993) |
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Device Description The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.
The N95 Particulate Respirator and Surgical Mask, Models TN01-11 Intended Use and TN01-12 are single-use, disposable devices, provided non-sterile and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
- Model Numbers # TN01-11: N95 Particulate Respirator and Surgical Mask (Medium Size)
-
TN01-12: N95 Particulate Respirator and Surgical Mask (Small Size)
-
Technological The N95 Particulate Respirator and Surgical Mask is substantially equivalent to the current legally marketed. NIOSH-certified Pro Gear Characteristics N95 Particulate Filter Respirator and Surgical Mask (K102092). The product was tested according to the recognized standards ASTM F1862, ASTM F2101, and ISO 10993 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks
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Premarket Notifications [510(k)] Submissions, issued March 5, 2004.
The N95 Particulate Respirator and Surgical Mask, Models TN01-11 Performance Testing and TN01-12 have been tested according to the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notifications [510(k)] Submissions, issued March 5, 2004. Where applicable, NIOSH certification number is provided in lieu of performance testing data as noted in the guidance document:
| Criteria | N95 Particulate Respirator and SurgicalMask Standard Test Results |
|---|---|
| Fluid Resistance | Models TN01-11 and TN01-12 meet therequirements of ASTM F1862. |
| ParticulateFiltrationEfficiency | NIOSH Certification Number: TC 84A-3348(Models TN01-11 and TN01-12) |
| BacterialFiltrationEfficiency | NIOSH Certification Number: TC 84A-3348(Models TN01-11 and TN01-12) |
| DifferentialPressure | NIOSH Certification Number: TC 84A-3348(Models TN01-11 and TN01-12) |
| Flammability | Meets 16 CFR 1610 Standard for class 1flammability. |
| Biocompatibility | Referenced ISO 10993-1 to determinestandard tests required for surface deviceswith limited contact (≤ 24 hours), contactingintact skin. |
| Cytotoxicity | Under the conditions of the study, thesubject device was non-cytotoxic.(ISO 10993-5) |
| Irritation | Under the conditions of the study, thesubject device was non-irritating.(ISO 10993-10) |
| Sensitization | Under the conditions of the study, thesubject device was non-sensitizing.(ISO 10993-10) |
Table 5-B. Conformance to performance testing requirements.
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
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has the same or similar performance characteristics and are both fluid resistant with the flammability of Class 1. Both products are NIOSH certified and the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 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 device K102092.
§ 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.