(276 days)
The Spin Care Disposable Protective Mask is 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.
The Spin Care Disposable Protective Mask is a single use multi-layer level 2 surgical mask. It houses a meltblown polypropylene filter between an outer and inner layer of Spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. Contact duration is less than 24 hours.
This document describes the acceptance criteria and performance of the "Spin Care Disposable Protective Mask". Since this is a medical device, the acceptance criteria are based on non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
The device is designed to meet the ASTM 2100 Level 2 standard for medical face masks. The table below summarizes the key performance criteria and the results for the Spin Care Disposable Protective Mask, compared to its predicate devices.
| Performance Characteristic | Acceptance Criteria (ASTM 2100 Level 2) | Spin Care Disposable Protective Mask Performance | Primary Predicate (K153496) Performance | Secondary Predicate (K160269) Performance |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 120 mmHg - Pass | 120 mmHg - Pass | 120 mmHg - Pass | 120 mmHg - Pass |
| Particle Filtration Efficiency (ASTM F2299) | ≥ 98% | Average 99.8% - Pass | Average 98.46% - Pass | Average 99.6% - Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Average > 99.9% - Pass | Average 98.7% - Pass | Average > 98% - Pass |
| Flammability Class (16 CFR 1610) | Class I Non-Flammable | Class I Non-Flammable | Class I Non-Flammable | Class I Non-Flammable |
| Delta-P (Differential Pressure) (EN 14683) | < 5.0 mmH2O/cm² (implied for Level 2) | Average 3.79 mmH2O/cm² | Average 4.2 mmH2O/cm² (MIL-M-36954C) | Average 1.6 mmH2O/cm² (MIL-M-36954C) |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Irritation (ISO 10993-10) | Non-irritating | Non-irritating | Non-irritating | Non-irritating |
| Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing | Non-sensitizing | Non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., how many masks were tested for fluid resistance or BFE). However, the tests are performed in accordance with recognized international standards (ASTM, EN, ISO, CFR) which typically define appropriate sample sizes for robust testing.
The data provenance is from non-clinical tests performed to assess the device's physical and biological properties. The country of origin of the data is not specified in the provided text, but it's generated by the manufacturer, SpinTech LLC, for their submission to the U.S. FDA. The data is prospective in the sense that it was generated specifically for the premarket notification to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For non-clinical device testing like this, the "ground truth" is established by adherence to standardized testing protocols and validated measurement techniques as outlined in the referenced standards (e.g., ASTM F2100, ISO 10993, etc.). The expertise lies in:
- Standard Development Bodies: The organizations (ASTM, ISO, CEN) that develop and maintain these standards rely on panels of experts in materials science, microbiology, engineering, and medical device design.
- Testing Laboratories: The testing itself would be conducted by qualified laboratory personnel with expertise in performing these specific tests and interpreting their results according to the standard. The document doesn't mention the specific number or qualifications of these laboratory experts, but their work is governed by the principles of Good Laboratory Practice (GLP) or similar quality systems.
4. Adjudication Method for the Test Set
There's no explicit adjudication method described in the sense of multiple independent reviewers assessing the test results. For non-clinical performance tests, the method is typically based on:
- Objective Measurement: The tests yield quantitative results (e.g., percentage filtration, pressure differential) that are objectively measured.
- Standard Conformance: The results are then compared directly against the quantitative thresholds defined by the relevant standards (e.g., "Pass" if BFE is ≥98%). Deviations or borderline results might necessitate retesting or further investigation by a single expert/team in the lab.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic or imaging devices where human interpretation of results (e.g., reading an X-ray) is involved, and the goal is to assess the impact of AI assistance on human performance. This submission is for a physical medical device (a mask), and thus, this type of clinical study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance assessment was not done. This device does not involve an algorithm or AI component; it is a physical product designed for infection control. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Spin Care Disposable Protective Mask is based on established objective performance standards for medical face masks, including:
- Physical and Chemical Standards: ASTM F2100-19 (general performance), ASTM F1862-17 (fluid resistance), ASTM F2299-03 (particle filtration), ASTM F2101-19 (bacterial filtration), 16 CFR 1610 (flammability), and EN 14683 (differential pressure).
- Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization).
These standards define the acceptable range or threshold for each performance characteristic.
8. The Sample Size for the Training Set
This device does not involve machine learning or AI, so there is no "training set" in the conventional sense. The "training" for such a device is in its design and manufacturing processes to ensure it consistently meets the established performance specifications.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an AI algorithm, this question is not applicable. The design "ground truth" for the device's manufacturing and quality control would be based on the established performance criteria from recognized standards, ensuring that each produced unit meets those specifications.
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March 18, 2021
SpinTech LLC % W. Victoria Rogers Regulatory Affairs Consultant Rogers Consulting 11110 Arranmore Cove Roanoke, Indiana 46783
Re: K201624
Trade/Device Name: Spin Care Disposable Protective Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 8, 2020 Received: December 31, 2020
Dear W. Victoria Rogers:
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,
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K201624
Device Name Spin Care Disposable Protective Mask
Indications for Use (Describe)
The Spin Care Disposable Protective Mask is 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 intention 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Spin Care Disposable Protective Mask 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| 510(k) Number: | K201624 | ||||||
|---|---|---|---|---|---|---|---|
| Sponsor: | SpinTech LLC1920 Flintstone DriveStatesville, North Carolina 28677 USAEstablishment Registration Number: 3016872494 | ||||||
| Contact Person: | Jim JeanReliability ManagerTelephone: (704-929-3596) | ||||||
| Designated Submission Correspondent: | W. Victoria RogersRogers Consulting11110 Arranmore CoveRoanoke, Indiana 46783 USA574-265-8356 | ||||||
| Date: | March 9, 2021 | ||||||
| Subject Device: | Trade Name: Spin Care Disposable Protective MaskCommon Name: Surgical Facemask | ||||||
| Classification Name:• FXX- Surgical Apparel (21 CFR 878.4040) | |||||||
| Predicate Device(s): | K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products., Ltd.K160269Surgical Face Masks (Ear Loops and Tie-on)SAN-M Package Co., LTD. | K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products., Ltd. | K160269 | Surgical Face Masks (Ear Loops and Tie-on) | SAN-M Package Co., LTD. |
| K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products., Ltd. | |||||
| K160269 | Surgical Face Masks (Ear Loops and Tie-on) | SAN-M Package Co., LTD. |
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Purpose and Device The Spin Care Disposable Protective Mask is a single use Description: multi-layer level 2 surgical mask. It houses a meltblown polypropylene filter between an outer and inner layer of Spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. Contact duration is less than 24 hours. Intended Use and The Spin Care Disposable Protective Mask is intended to Indications for Use: 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. Summary of Technological
Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
| Spin Care DisposableProtective Mask | Disposable Surgical FaceMask, K153496 (PrimaryPredicate) | Surgical Face Masks (EarLoops and Tie-on),K160269 | |
|---|---|---|---|
| ASTM 2100 LevelMask | 2 | 2 | 2 |
| Intended Use/Indications forUse | The Spin Care DisposableProtective Mask is intendedto be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.These face masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. Thisis a single use, disposabledevice, provided non-sterile. | The Disposable SurgicalFace Masks are intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.These face masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile. | The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device,provided non-sterile. |
| Materials | |||
| Outer Materials | Polypropylene Spunbond | Spun-bond polypropylene | Polypropylene |
| Filter Media | Polypropylene meltdown | Melt blown polypropylenefilter | 1. PolypropyleneSpunbond2. Polypropylenemeltdown |
| Inner Material | Polypropylene Spunbond | Spun-bond polypropylene | Polypropylene |
| Nose Piece | Malleable metal wire | Malleable Aluminum Wire | Polyethylene coated steel wire |
| Ear Loops | Elastane and nylon | Ear Loop or Tie On - Polyester | Ear Loop or Tie On – Polyester Polyurethane / Polypropylene Spunbond or polyester Spunbond |
| Specifications | Length: 175mmWidth: 95mm | Length: 175 mm +/- 1mmWidth: 95 mm +/- 1mm | Length: 90 ± 3mmWidth: 175 ± 5mm |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated |
| Color | White | Blue | White or Blue |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Performance TestingASTM F2100 – Level 2 | |||
| Fluid resistanceASTM F1862 | 120mm Hg - Pass | 120mm Hg - Pass | 120mm Hg - Pass |
| Particle FiltrationEfficiencyASM F2299 | Average 99.8% - Pass | Average 98.46% - Pass | Average 99.6% - Pass |
| Bacterial FiltrationEfficiencyASTM F2101 | Average >99.9% - Pass | Average 98.7% - Pass | Average > 98% - Pass |
| Flammability Class16 CFR 1610 | Class I Non-Flammable | Class I Non-Flammable | Class I Non-Flammable |
| Delta-P | Average 3.79mmH2O/cm²(EN 14683) | Average 4.2 mmH2O/cm²(MIL-M-36954C) | Average 1.6 mmH2O/cm²(MIL-M-36954C) |
| Biocompatibility Testing | |||
| CytotoxicityISO 10993-5 | Comply with ISO 10993-5.Under the conditions of thestudy, the proposed deviceextract was determined tobe non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| IrritationISO 10993-10 | Comply with ISO 10993-10.Under the conditions of thestudy, the proposed deviceextract was determined tobe non-irritating | Non-irritating | Non-irritating |
| SensitizationISO 10993-10 | Comply with ISO 10993-10.Under the conditions of thestudy, the proposed deviceextract was determined tobe non-sensitizing | Non-sensitizing | Non-sensitizing |
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Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: .
- The product was tested in alignment with o "Guidance for Industry and FDA Staff – Surgical Masks - Premarket Notification [510(k)] Submission" Guidance Document
- o ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- o ASTM F2100-19. Standard Specification For Performance Of Materials Used In Medical Face Masks
- ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- o EN 14683: European standard for face masks
- ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
- ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres:
- o 16 CFR 1610, Standard for the Flammability of clothing textiles.
- Clinical Tests: ●
- No clinical tests were performed. o
Substantial Equivalence Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Spin Care Disposable Protective Mask is as safe, as effective, and performs as well as or better than the predicate devices.
§ 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.