(131 days)
The Spin Care Disposable Protective Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These protective 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 Level 3 is a single use three-layer level 3 surgical mask. It houses a melt blown 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. The mask is provided white, non-sterile and is flat-pleated. Contact duration is less than 24 hours. This device is not made with natural rubber latex.
The provided text is for a 510(k) premarket notification for a disposable protective mask, not an AI/ML medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI/ML device.
Specifically, the document focuses on demonstrating substantial equivalence of the mask to a predicate device through:
- Indications for Use: Matching the intended use of the mask.
- Technological Characteristics: Comparing materials, dimensions, and style.
- Performance Testing: Showing the mask meets established ASTM and ISO standards for fluid resistance, particle filtration efficiency, bacterial filtration efficiency, flammability, differential pressure, and biocompatibility (cytotoxicity, irritation, sensitization).
There is no mention of a software device, AI/ML algorithm, or any associated studies that would involve:
- A table of acceptance criteria for AI performance metrics (e.g., sensitivity, specificity, AUC).
- Test set sample sizes with data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC studies or effect sizes for human reader improvement.
- Standalone algorithm performance.
- Ground truth types like expert consensus or pathology for AI.
- Training set sample sizes or ground truth establishment for training data.
- Any kind of "study" that involves an algorithm's performance on a dataset of patient images or data.
Therefore, I cannot extract the requested information from the provided text. The document describes the testing for a physical medical device (a surgical mask), not a digital or AI-based one.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 14, 2021
SpinTech LLC W. Victoria Rogers Owner Rogers Consulting 11110 Arranmore Cove Roanoke, Indiana 46783
Re: K212109
Trade/Device Name: Spin Care Disposable Protective Mask Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 9, 2021 Received: August 16, 2021
Dear W. 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 mediation-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,
For Clarence W. Murray III, Ph.D. 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) K212109
Device Name
Spin Care Disposable Protective Mask Level 3
Indications for Use (Describe)
Spin Care Disposable Protective Mask Level 3 is intended for to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These protective 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Registration Use (Part 21 CFR 201 Subpart D) | |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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 Level 3, 510(k) premarket notification.
| Sponsor: | SpinTech LLC1920 Flintstone DriveStatesville, North Carolina 28677Establishment Registration Number: 3016872494 |
|---|---|
| Contact Person: | Jim JeanReliability ManagerTelephone: (704-929-3596) |
| Designated SubmissionCorrespondent: | W. Victoria RogersRogers Consulting11110 Arranmore CoveRoanoke, Indiana 46783574-265-8356 |
| Date: | 9 November 2021 |
| Subject Device: | Spin Care Disposable ProtectiveMask Level 3 |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Mask |
| Product Code: | FXX |
| Regulation Number: | (21 CFR 878.4040) |
| Review Panel: | General & Plastic Surgery |
| Regulation Class: | Class II |
| Predicate Devices: | Freudenberg Surgical Mask (K210063) |
| DeviceDescription: | The Spin Care Disposable Protective Mask Level 3is a single use three-layer level 3 surgical mask. It housesa melt blown polypropylene filter between an outer andinner layer of spunbond polypropylene that covers thenose and mouth of the end user and held in place by apliable nose piece and ear loops. The mask is providedwhite, non-sterile and is flat-pleated. Contact duration isless than 24 hours. This device is not made with naturalrubber latex. |
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Intended Use and Indications for Use:
The Spin Care Disposable Protective Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These protective 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 nonsterile.
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Summary of Technological
Characteristics: The rationale for substantial equivalence is based on consideration of the following characteristics:
| Spin Care Disposable ProtectiveMask Level 3K212109 | Predicate device: FreudenbergSurgical MaskK210063 | Remarks | |
|---|---|---|---|
| Intended Use/Indications forUse | The Spin Care Disposable ProtectiveMask Level 3 is intended to be worn toprotect both the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These protectivemasks are intended for use in infectioncontrol practices to reduce thepotential exposure to blood and bodyfluids. This is a single use, disposabledevice, provided non-sterile. | The Freudenberg SurgicalMask is intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. This face mask is intendedfor use in infection control practices toreduce the potential exposure to bloodand body fluids. This is a single use,disposable device, providednonsterile. | Same |
| Outer Materials | Polypropylene spunbond | Spun-bond polypropylene | Same |
| Filter Media | Polypropylene meltdown | Melt blown polypropylene | Same |
| Inner Material | Polypropylene spunbond | Spun-bond polypropylene | Same |
| Nose Piece | Malleable aluminum wire | Malleable polyethylene coated wire | Similar |
| Ear Loops | Polyester | Polyester spandex blend | Similar |
| Dimensions | Length: 175mmWidth: 95mm | Length: 175 mm +/- 1mmWidth: 95 mm +/- 1mm | Same |
| Mask Style | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Same |
| Color | White | White | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
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| Performance TestingASTM F2100 - Level 3 | |||
|---|---|---|---|
| Fluid resistanceASTM F1862 | Passed at 160mmHg | Passed at 160mmHg | Same |
| Particle FiltrationEfficiencyASM F2299 | Passed ≥98% | Passed ≥98% | Same |
| Bacterial FiltrationEfficiencyASTM F2101 | Passed ≥98% | Passed ≥98% | Same |
| Flammability Class16 CFR 1610 | Class I Non-Flammable | Class I Non-Flammable | Same |
| DifferentialPressure Delta-PEN14683 | Passed <6.0 mmH2O/cm2 | Passed <6.0 mmH2O/cm2 | Same |
| Biocompatibility Testing | |||
| CytotoxicityISO 10993-5 | Comply with ISO 10993-5.Under the conditions of the study,the proposed device extract wasdetermined to be non-cytotoxic | Non-cytotoxic | Same |
| IrritationISO 10993-10 | Comply with ISO 10993-10.Under the conditions of the study,the proposed device extract wasdetermined to be non-irritating | Non-irritating | Same |
| SensitizationISO 10993-10 | Comply with ISO 10993-10.Under the conditions of the study,the proposed device extract wasdetermined to be non-sensitizing | Non-sensitizing | Same |
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Summary of Performance Data
. Nonclinical
The product was tested in alignment with "Guidance for Industry and FDA Staff – Surgical Masks – Premarket Notification [510(k)] Submission" Guidance Document
Performance testing was conducted using 32 samples per lot, 3 non-consecutive lots to demonstrate the safety and efficacy of the Spin Care Disposable Protective Mask Level 3 in support of substantial equivalence.
| Standard Numberand Name | Test Criteria forLevel 3 | Result |
|---|---|---|
| ASTM F1862 and ISO 22609(as referenced in EN14683:2019 and AS4381:2015)Fluid Resistance Performance | Pass at 160mg | Pass at 160mmHg |
| ASTM F2299 ParticulateFiltration Efficiency (PFE) | ≥ 98% | Passed ≥98% |
| ASTM F2101 BacterialFiltration Efficiency (BFE) | ≥ 98% | Passed ≥98% |
| Differential Pressure (Delta P)MIL-M-36954C (Military Std) | <6.0 mm H2O /cm² | Passed <6.0 mmH2O/cm2 |
| 16 CFR 1610 Flammability | Class 1 (≥ 3.5 seconds) | Passed - Class 1Non-Flammable |
| Test Report Name and Number | Test Criteria | Results |
|---|---|---|
| In Vitro Cytotoxicity Test -ISO 10993-5Nelson Report No. 135543-S01 / TestArticle 61920AVGOL | ISO 10993-5Part 5: Tests for in vitrocytotoxicity | No potentialcytotoxicity |
| Intracutaneous Injection Test ISOIrritation 10993-10Final GLP Report: 20-02536-G2Nelson Report No. 1315542-S01Test Article 61920AVGOL | ISO 10993-10Part 10: Tests for irritationand skin sensitization. | No significantly greaterbiological reaction thanthe sites injected with thecontrol article. |
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| Kligman Maximization Test | ISO 10993-10 | The test article was |
|---|---|---|
| Sensitization ISO 10993-10 | Part 10: Tests forirritation and skin | classified as a non- |
| Final GLP Report: 20-02536-G1 | sensitization. | sensitizer. |
| Nelson Report No. 1315541-S01 | ||
| Test Article 61920AVGOL |
. Clinical Tests:
- No clinical tests were performed. O
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Spin Care Disposable Protective Mask Level 3 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.