ROKI Surgical Mask
Device Facts
| Record ID | K214094 |
|---|---|
| Device Name | ROKI Surgical Mask |
| Applicant | Roki Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Feb 24, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
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.
Device Story
ROKI Surgical Mask is a single-use, disposable, flat-pleated mask; intended for infection control to protect patients and healthcare personnel from microorganisms, body fluids, and particulates. Device consists of three layers: inner and outer spun-bond polypropylene; middle melt-blown polypropylene. Features include malleable aluminum nose fitter and polyester/polyurethane elastic ear loops. Available in two sizes (L and M). Device is non-sterile; worn over mouth and nose. Performance meets ASTM F2100-19 Level 3 barrier requirements. Used in clinical settings; operated by healthcare personnel or patients. Output is physical barrier protection; clinical decision-making involves standard infection control protocols.
Clinical Evidence
No clinical data. Bench testing only. Performance testing included fluid resistance (ASTM F1862), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101), differential pressure (EN14683), and flammability (16 CFR 1610). Biocompatibility testing included cytotoxicity (ISO 10993-5), irritation, and sensitization (ISO 10993-10). All results met ASTM F2100-19 Level 3 criteria.
Technological Characteristics
Three-layer construction: spun-bond polypropylene (inner/outer), melt-blown polypropylene (middle). Malleable aluminum wire nose fitter. Polyester/polyurethane ear loops. Flat-pleated design. Non-sterile. ASTM F2100-19 Level 3 barrier performance. Biocompatibility per ISO 10993-5, ISO 10993-10, and ISO 10993-12.
Indications for Use
Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Single-Use Surgical Mask (K201924)
Submission Summary (Full Text)
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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
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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) | <span></span> |
|----------------------------------------------|---------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |
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# 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.
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#### 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.
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### 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<br>Supplies, Ltd. | |
| Trade Name | ROKI Surgical Mask | Single-Use Surgical Mask | Similar |
| Product Code | FXX | FXX | Same |
| Classification | Class II 21 CFR 878.4040<br>Surgical apparel. | Class II 21 CFR 878.4040<br>Surgical apparel. | Same |
| Intended Use/<br>Indications for<br>Use | The ROKI Surgical Mask is<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. The Surgical Mask<br>is intended for use in<br>infection control practices to<br>reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device, provided<br>non-sterile.<br>Model: L and M, white<br>color, and Level 3 barrier<br>level as ASTM F2100. | The Single-Use Surgical<br>Mask is intended to be worn<br>to protect both the patient<br>and healthcare personnel<br>from the transfer of<br>microorganisms, body fluids<br>and particulate material. The<br>Single-Use Surgical Mask<br>intended for use in infection<br>control practices to reduce<br>the potential exposure to<br>blood and body fluids. This<br>is a single use, disposable<br>device(s), provided non-<br>sterile.<br>Model: M and L, blue color,<br>and Level 3 barrier level as<br>ASTM F2100. | Same |
| Model | L, M | L, M | Same |
| Basic Design | Ear Loops, Flat Pleated,<br>3 layers | Ear Loops, Flat Pleated,<br>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<br>(Width) | Model L : 17.5cm ± 1cm | Model L : 18cm ± 1cm | Similar |
| | Model M: 16cm ± 1cm | Model M: 14cm ± 1cm | |
| Dimension<br>(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
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f Tochnological Charactoristias (gontin ﺮ 11 Tablo 6 1
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<br>(Testing Method) | Subject Device | | Predicate<br>Device | Remark |
|--------------------------------------------------------------|-----------------|-----------------|---------------------|---------|
| Fluid Resistance Performance<br>ASTM 1862/F1862M: 2017 | 160mmHg | 160mmHg | 160mmHg | Same |
| Particulate Filtration Efficiency<br>ASTM 2299/F2299M-3:2017 | ≥ 98.09% | ≥ 98.07% | ≥ 99.03% | Similar |
| Bacterial Filtration Efficiency<br>ASTM F2101-19 | ≥ 98.1% | ≥ 98.1% | ≥ 99.50% | Similar |
| Differential Pressure (Delta-P)<br>EN14683:2019+AC:2019 | < 4.4 mmH2O/cm² | < 3.7 mmH2O/cm² | < 5.1 mmH2O/cm² | Similar |
| Flammability 16 CFR Part 1610-08 | Class 1 | Class 1 | Class 1 | Same |
| ASTM F2100-19 | Level 3 | Level 3 | Level 3 | Same |
Table 6.2. Performance Characteristic Comparison
Although the test results are not identical to each other, but they are similar and they both meet the requirement of Level 3 medical face mask according to the ASTM F2100-19 recognized by FDA as a consensus standard.
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| Item & Standard<br>(Testing Method) | Subject device | Predicate device | Remark |
|-------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------|
| Cytotoxicity<br>ISO 10993-5-09 | Under the conditions of<br>the study, the subject<br>device is non-cytotoxic. | Under the conditions of<br>the study, not<br>cytotoxicity effect as ISO<br>10993-5 | Same |
| Irritation<br>ISO 10993-10-10 | Under the conditions of<br>the study, the subject<br>device is non-irritating. | Under conditions of the<br>study, not an irritant as<br>ISO 10993-10 | Same |
| Sensitization<br>ISO 10993-10-10 | Under the conditions of<br>the study, the subject<br>device is non-sensitizing. | Under the conditions of<br>the study, not a sensitizer<br>as ISO 10993-10 | Same |
Table 6 3 Biocompatibility Comparison
The subject device complies with the same standards as those used in the predicate device. Those three standards are FDA recognized consensus standards.
#### NON - CLINICAL TETING DATA VII.
#### a. Performance testing
The performance evaluation for the subject device was conducted in accordance with the FDA guidance "Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission" March 5, 2004 and ASTM F2100 "Standard Specification for Performance of Materials Used in Medical Face Masks" as recognized by FDA. Performance evaluation included the following tests:
- Fluid Resistance Performance
- · Particulate Filtration Efficiency
- · Bacterial Filtration Efficiency
- · Differential Pressure (Delta-P)
- · Flammability
Both models L and M were used as test samples. Sample size was determined according to a 4% acceptance quality limit (AQL) on the production lot size. A total of 96 samples per lot from three non-consecutive lots, were used under the condition of 4% AQL according to ASTM F2100-19.
Table 6.4 and Table 6.5 shows the results of the testing for model L and M. respectively. All testing results met ASTM F2100-19 Level 3 acceptance criteria as well as the predicate device.
Performance comparison between the subject device and the predicate device are summarized in the Table 6.2.
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| Item & | Model L Results | | | Pass/Fail |
|------------------------------------------------------------------------|----------------------------------|-----------------------|--------------------------------|--------------------------------------------------|
| Testing method<br>(Standard) | Number of<br>Passes out<br>of 32 | Minimum or<br>Maximum | Result | Acceptance criteria:<br>ASTM F2100-19<br>Level 3 |
| Fluid Resistance | Lot 1: 32 | at 160mmHg | | Pass |
| Performance | Lot 2: 32 | at 160mmHg | 96 out of 96 no<br>penetration | ≥29 out of 32 pass/<br>lot |
| ASTM F1862: 2017 | Lot 3: 32 | at 160mmHg | | |
| Particulate Filtration<br>Efficiency<br>ASTM F2299/ F2299M-<br>03:2017 | Lot 1: 32 | ≥ 98.13% | | Pass<br>≥98% |
| | Lot 2: 32 | ≥ 98.09% | ≥ 98.09% | |
| | Lot 3: 32 | ≥ 98.13% | | |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101-2019 | Lot 1: 32 | ≥ 98.7% | | Pass<br>≥98% |
| | Lot 2: 32 | ≥ 98.1% | ≥ 98.1% | |
| | Lot 3: 32 | ≥ 98.2% | | |
| Differential Pressure<br>(Delta-P)<br>EN14683:2019+AC:2019 | Lot 1: 32 | ≤ 4.4mmH2O/cm² | | Pass<br><6.0 mmH2O/cm² |
| | Lot 2: 32 | ≤ 4.1mmH2O/cm² | ≤ 4.4<br>mmH2O/cm² | |
| | Lot 3: 32 | ≤ 4.1mmH2O/cm² | | |
| Flammability class<br>16 CFR 1610:2008 | Lot 1: 32 | No ignition | | Class 1<br>≥3.5 sec. |
| | Lot 2: 32 | No ignition | 96 out of 96 no<br>ignition | |
| | Lot 3: 32 | No ignition | | |
#### Table 6.4. Results and verdict of the performance testing for model L
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| Item<br>&<br>Testing method<br>(Standard) | Number of<br>Passes out<br>of 32 | Minimum or<br>Maximum | Result | Pass/Fail<br>Acceptance<br>criteria:<br>ASTM<br>F2100-19<br>Level 3 |
|-----------------------------------------------------------------------|----------------------------------|-----------------------|-----------------------------|---------------------------------------------------------------------|
| Fluid Resistance<br>Performance<br>ASTM F1862:2017 | Lot 1: 32 | at 160mmHg | 96 out of 96 | Pass |
| Fluid Resistance<br>Performance<br>ASTM F1862:2017 | Lot 2: 32 | at 160mmHg | no<br>penetration | ≥29 out of<br>32 pass/ lot |
| Fluid Resistance<br>Performance<br>ASTM F1862:2017 | Lot 3: 32 | at 160mmHg | | |
| Particulate Filtration<br>Efficiency<br>ASTM F2299/<br>F2299M-03:2017 | Lot 1: 32 | ≥ 98.07% | | Pass<br>≥98% |
| | Lot 2: 32 | ≥ 98.10% | ≥ 98.07% | |
| | Lot 3: 32 | ≥ 98.11% | | |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101-2019 | Lot 1: 32 | ≥ 98.5% | | Pass<br>≥98% |
| | Lot 2: 32 | ≥ 98.3% | ≥ 98.1% | |
| | Lot 3: 32 | ≥ 98.1% | | |
| Differential<br>Pressure (Delta-P)<br>EN14683:2019+AC:<br>2019 | Lot 1: 32 | ≤ 3.5mmH2O/cm² | | Pass |
| Differential<br>Pressure (Delta-P)<br>EN14683:2019+AC:<br>2019 | Lot 2: 32 | ≤ 3.5mmH2O/cm² | ≤ 3.7<br>mmH2O/cm² | < 6.0<br>mmH2O/cm² |
| Differential<br>Pressure (Delta-P)<br>EN14683:2019+AC:<br>2019 | Lot 3: 32 | ≤ 3.7mmH2O/cm² | | |
| Flammability class<br>16 CFR 1610:2008 | Lot 1: 32 | No ignition | | Class 1<br>≥3.5 sec. |
| | Lot 2: 32 | No ignition | 96 out of 96<br>no ignition | |
| | Lot 3: 32 | No ignition | | |
| | Table 6.5. Results and verdict of the performance testing for model M | | |
|--|-----------------------------------------------------------------------|--|--|
| | | | |
The testing results demonstrated that the subject device complies with the following standards:
- · ASTMF2100-2019, Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862/F1862M:2017, 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/F2299M-03:2017, Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
- · ASTM F2101-2019, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- · EN14683:2019+AC:2019, Appendix C, Medical face masks- Requirements and test methods
- 16 CFR 1610-08, Standard for the Flammability of clothing textiles .
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#### b. Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' Guidance for Industry and Food and Drug Administration Staff" September 4, 2020 and ISO 10993-1 as recognized by FDA. Biocompatibility evaluation included the following tests:
- · In vitro Cytotoxicity
- · Irritation
- · Skin Sensitization
Table 6.5 shows the testing results of the subject device. Under the condition of this study, the subject device is non-cytotoxic, non-irritating and non-sensitizing as well as the predicate device. Biocompatibility comparison between the subject and predicate device are summarized in the Table 6.3.
| Item | Standard (Testing Method) | Results |
|--------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------|
| in vitro<br>Cytotoxicity | ISO 10993-5-09<br>MEM elution using L-929<br>mouse fibroblast cell | Pass<br>Under the conditions of the study,<br>no in vitro cytotoxicity observed. |
| Irritation | ISO 10993-10-10<br>Animal irritation test | Pass<br>Under the conditions of the study,<br>no irritation observed. |
| Skin Sensitization | ISO 10993-10-10<br>Guinea pig maximization test | Pass<br>Under the conditions of the study,<br>no skin sensitization observed. |
Table 6.6. Biocompatibility Testing Results
The test results demonstrated that the subject device complies with the following FDA recognized consensus standards:
- · ISO 10993-5-09: Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity
- · ISO 10993-10-10: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- · ISO 10993-12-21: Biological evaluation of medical devices Part 12: Sample preparation and reference materials
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#### c. Summary
The subject device has the same or similar performance characteristics and conform to the same or similar standards as for the predicate device.
#### VIII. CLINICAL TEST CONCLUSION
No clinical study is included in this submission.
#### IX. CONCLUSION
Intended use and indications for use, basic design, materials, design features, and non-clinical testing result of the subject device are same as or similar to the predicate device. The difference between the subject device and the predicate device does not raise any question to safety and effectiveness. Accordingly, it is concluded that the subject device is substantially equivalent to the predicate device K201924.
