(58 days)
No reference devices were used in this submission.
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML technology.
No
The device is a surgical mask intended for barrier protection, not for treating a disease or condition.
No
The device is a surgical mask intended to prevent the transfer of microorganisms and body fluids. Its function is protective, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene, elastic ear loops, aluminum wire nose fitter) and performance testing related to these physical properties (filtration efficiency, fluid resistance, flammability), indicating it is a hardware device.
No, 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, and for use in infection control practices. This is a physical barrier function, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical barrier properties of the mask (filtration efficiency, fluid resistance, breathability, flammability) and biocompatibility. These are not diagnostic performance metrics.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such analysis.
The ROKI Surgical Mask is a medical device intended for personal protection and infection control, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ROKI Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The ROKI Surgical 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 nonsterile. Model: L and M, white color, and Level 3 barrier level per ASTM F2100-19.
Product codes
FXX
Device Description
The subject device is white color, and flat pleated type mask, utilizing ear loops' way for wearing, and has nose fitter design for fitting the facemask around the nose. The subject device is consisted of three layers, the inner and outer layers are made with spun-bond polypropylene, and the middle laver is made with melt blown polypropylene. The subject device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are made with polyester and polyurethane. The nose fitter contained in the subject device is in the layers of the mask to allow the user to fit the mask around their nose, which is made of malleable aluminum wire. There are two models of the subject device, Model M. They differ only in the width. Model L is wider than Model M. However, the material formulation, chemical composition, and material 's processing methods are the same. The subject device is a single-use, disposable device, provided non-sterile. The performance of the subject device meets Level 3 requirements per ASTM F2100-19.
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)
Performance testing:
Study Type: Performance evaluation for surgical masks.
Sample Size: A total of 96 samples per lot from three non-consecutive lots, for both models L and M (total 192 samples). Sample size was determined according to a 4% acceptance quality limit (AQL) on the production lot size.
Key Results: All testing results met ASTM F2100-19 Level 3 acceptance criteria.
Tests conducted:
- Fluid Resistance Performance (ASTM 1862/F1862M: 2017): 160mmHg (Pass)
- Particulate Filtration Efficiency (ASTM 2299/F2299M-3:2017): Model L: ≥ 98.09%, Model M: ≥ 98.07% (Pass, ≥98%)
- Bacterial Filtration Efficiency (ASTM F2101-19): Model L: ≥ 98.1%, Model M: ≥ 98.1% (Pass, ≥98%)
- Differential Pressure (Delta-P) (EN14683:2019+AC:2019): Model L:
§ 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 & 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 is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
February 24, 2022
ROKI Co., Ltd. % Mr. Fumiaki Kanai President & CEO MIC International Corp. 4-32-16 Ryogoku Sumida-ku. Tokyo Japan
Re: K214094
Trade/Device Name: ROKI Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 10, 2021 Received: December 28, 2021
Dear Mr. Kanai:
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 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,
Brent L. 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
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Indications for Use
510(k) Number (if known) K214094
Device Name ROKI Surgical Mask
Indications for Use (Describe)
The ROKI Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The ROKI Surgical 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 nonsterile.
Model: L and M, white color, and Level 3 barrier level per ASTM F2100-19.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This summary of 510(k) is prepared in accordance with 21 CFR 807.92.
Date of Preparation: December 10, 2021
SUBMITTER I.
ROKI Co., Ltd. 2396 Futamata, Futamata-cho, Tenryu-ku, Hamamatsu-shi, Shizuoka prefecture, 431-3314, Japan Phone: +81-53-926-0550 (switchboard) +81-53-926-0600 Fax:
Contact person: Fumiaki Kanai President & CEO, MIC International Corp. 4-32-16 Ryogoku, Sumida-ku Tokyo, 130-0026, Japan Email: kanaif(@mici.co.jp Phone: +81-3-6659-5482 +81-3-6659-5463 Fax:
II. DEVICE
Trade name: ROKI Surgical Mask Regulation: 21 CFR 878.4040 - Surgical Apparel Classification Name: Mask, Surgical Regulatory Class: Class II Product Code: FXX
III. PRIMARY PREDICATE DEVICE
Qiqihar Hengxin Medical Supplies, Ltd. Single-Use Surgical Mask (K201924) No reference devices were used in this submission.
4
IV. DEVICE DESCRIPTION
The subject device is white color, and flat pleated type mask, utilizing ear loops' way for wearing, and has nose fitter design for fitting the facemask around the nose.
The subject device is consisted of three layers, the inner and outer layers are made with spun-bond polypropylene, and the middle laver is made with melt blown polypropylene.
The subject device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are made with polyester and polyurethane. The nose fitter contained in the subject device is in the layers of the mask to allow the user to fit the mask around their nose, which is made of malleable aluminum wire.
There are two models of the subject device, Model M. They differ only in the width. Model L is wider than Model M. However, the material formulation, chemical composition, and material 's processing methods are the same. The subject device is a single-use, disposable device, provided non-sterile.
The performance of the subject device meets Level 3 requirements per ASTM F2100-19.
V. INDICATIONS for USE
The ROKI Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The ROKI Surgical 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.
Model: L and M, white color, and Level 3 barrier level as ASTM F2100-19.
5
VI. COMPARISON of TECHNOLOGICAL CHARACTERISTICS with THE PREDICATE DEVICE
a. Substantially Equivalent Comparison
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510K number | K201924 | ||
| Manufacturer | ROKI Co., Ltd. | Qiqihar Hengxin Medical | |
| Supplies, Ltd. | |||
| Trade Name | ROKI Surgical Mask | Single-Use Surgical Mask | Similar |
| Product Code | FXX | FXX | Same |
| Classification | Class II 21 CFR 878.4040 | ||
| Surgical apparel. | Class II 21 CFR 878.4040 | ||
| Surgical apparel. | Same | ||
| Intended Use/ | |||
| Indications for | |||
| Use | The ROKI Surgical Mask is | ||
| intended to be worn to | |||
| protect both the patient and | |||
| healthcare personnel from | |||
| transfer of microorganisms, | |||
| body fluids and particulate | |||
| material. The Surgical 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. | |||
| Model: L and M, white | |||
| color, and Level 3 barrier | |||
| level as ASTM F2100. | The Single-Use Surgical | ||
| Mask is intended to be worn | |||
| to protect both the patient | |||
| and healthcare personnel | |||
| from the transfer of | |||
| microorganisms, body fluids | |||
| and particulate material. The | |||
| Single-Use Surgical Mask | |||
| 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), provided non- | |||
| sterile. | |||
| Model: M and L, blue color, | |||
| and Level 3 barrier level as | |||
| ASTM F2100. | Same | ||
| Model | L, M | L, M | Same |
| Basic Design | Ear Loops, Flat Pleated, | ||
| 3 layers | Ear Loops, Flat Pleated, | ||
| 3 layers | Same | ||
| Materials | |||
| Outer Layer | Spun-bond polypropylene | Spun-bond non-woven fabric | |
| Middle Layer | Melt blown polypropylene | Melt blown non-woven fabric | Same1) |
| Inner Layer | Spun-bond polypropylene | Spun-bond non-woven fabric | |
| Nose Fitter | Malleable aluminum wire | Malleable aluminum wire | |
| Ear Loops | Polyester/ polyurethane | Polyester | Different |
| Table 6.1. Comparison of Technological Characteristics (continued) | |||
| Item | Subject Device | Predicate Device | Remark |
| Design Features | |||
| Color | White | Blue | Different |
| Dimension | |||
| (Width) | Model L : 17.5cm ± 1cm | Model L : 18cm ± 1cm | Similar |
| Model M: 16cm ± 1cm | Model M: 14cm ± 1cm | ||
| Dimension | |||
| (Length) | 9.5cm ±1 cm | 9cm ±1cm | |
| OTC use | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterile | No | No | Same |
Table 6.1. Comparison of Technological Characteristics
6
f Tochnological Charactoristias (gontin ﺮ 11 Tablo 6 1
- The material of each layer of the predicate device is all made of polypropylene, which is also the same as the material of each layer of the corresponding subject device.
The differences in the materials of the ear loop and color do not raise additional questions for safety and effectiveness as a result of performance and biocompatibility testing on the final finished product, including all component materials.
| Item & Standard
(Testing Method) | Subject Device | | Predicate
Device | Remark |
|--------------------------------------------------------------|-----------------|-----------------|---------------------|---------|
| Fluid Resistance Performance
ASTM 1862/F1862M: 2017 | 160mmHg | 160mmHg | 160mmHg | Same |
| Particulate Filtration Efficiency
ASTM 2299/F2299M-3:2017 | ≥ 98.09% | ≥ 98.07% | ≥ 99.03% | Similar |
| Bacterial Filtration Efficiency
ASTM F2101-19 | ≥ 98.1% | ≥ 98.1% | ≥ 99.50% | Similar |
| Differential Pressure (Delta-P)
EN14683:2019+AC:2019 |