(276 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a surgical mask. There is no mention of any computational or analytical functions that would involve AI or ML.
No
The device is described as a protective mask intended to prevent the transfer of microorganisms, body fluids, and particulate material, and is used in infection control; it does not treat or cure a disease or condition.
No
The device is a protective mask designed to prevent the transfer of microorganisms and body fluids, not to diagnose medical conditions.
No
The device description clearly states it is a multi-layer surgical mask made of physical materials (polypropylene, nose piece, ear loops) and its performance is evaluated through physical and biological tests, not software-based metrics.
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 by being worn on the face. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, filter, nose piece, ear loops). This aligns with a physical barrier device, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific analytes or biomarkers
- Providing diagnostic information about a patient's condition
- Reagents or test kits
The testing performed (fluid resistance, filtration efficiency, flammability, biocompatibility) are all relevant to the performance and safety of a physical barrier device intended for medical use, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare personnel
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)
Non-Clinical Tests:
- The product was tested in alignment with "Guidance for Industry and FDA Staff – Surgical Masks - Premarket Notification [510(k)] Submission" Guidance Document
- 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
- 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)
- 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:
- 16 CFR 1610, Standard for the Flammability of clothing textiles.
Clinical Tests:
- No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid resistance ASTM F1862: 120mm Hg - Pass
- Particle Filtration Efficiency ASM F2299: Average 99.8% - Pass
- Bacterial Filtration Efficiency ASTM F2101: Average >99.9% - Pass
- Flammability Class 16 CFR 1610: Class I Non-Flammable
- Delta-P: Average 3.79mmH2O/cm² (EN 14683)
- Cytotoxicity ISO 10993-5: Comply with ISO 10993-5. Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic
- Irritation ISO 10993-10: Comply with ISO 10993-10. Under the conditions of the study, the proposed device extract was determined to be non-irritating
- Sensitization ISO 10993-10: Comply with ISO 10993-10. Under the conditions of the study, the proposed device extract was determined to be non-sensitizing
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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,
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
2
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) |
CONTINUE ON SEPARATE PAGE IF NEEDED
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 LLC | ||||||
| 1920 Flintstone Drive | |||||||
| Statesville, North Carolina 28677 USA | |||||||
| Establishment Registration Number: 3016872494 | |||||||
| Contact Person: | Jim Jean | ||||||
| Reliability Manager | |||||||
| Telephone: (704-929-3596) | |||||||
| Designated Submission Correspondent: | W. Victoria Rogers | ||||||
| Rogers Consulting | |||||||
| 11110 Arranmore Cove | |||||||
| Roanoke, Indiana 46783 USA | |||||||
| 574-265-8356 | |||||||
| Date: | March 9, 2021 | ||||||
| Subject Device: | Trade Name: Spin Care Disposable Protective Mask | ||||||
| Common 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 Disposable
Protective Mask | Disposable Surgical Face
Mask, K153496 (Primary
Predicate) | Surgical Face Masks (Ear
Loops and Tie-on),
K160269 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM 2100 Level
Mask | 2 | 2 | 2 |
| Intended Use/
Indications for
Use | 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 Disposable Surgical
Face Masks are 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(s), provided non-
sterile. | The Surgical Face Masks
are 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. |
| Materials | | | |
| Outer Materials | Polypropylene Spunbond | Spun-bond polypropylene | Polypropylene |
| Filter Media | Polypropylene meltdown | Melt blown polypropylene
filter | 1. Polypropylene
Spunbond
2. Polypropylene
meltdown |
| 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: 175mm
Width: 95mm | Length: 175 mm +/- 1mm
Width: 95 mm +/- 1mm | Length: 90 ± 3mm
Width: 175 ± 5mm |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated |
| Color | White | Blue | White or Blue |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Performance Testing
ASTM F2100 – Level 2 | | | |
| Fluid resistance
ASTM F1862 | 120mm Hg - Pass | 120mm Hg - Pass | 120mm Hg - Pass |
| Particle Filtration
Efficiency
ASM F2299 | Average 99.8% - Pass | Average 98.46% - Pass | Average 99.6% - Pass |
| Bacterial Filtration
Efficiency
ASTM F2101 | 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 |
| 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 | | | |
| Cytotoxicity
ISO 10993-5 | Comply with ISO 10993-5.
Under the conditions of the
study, the proposed device
extract was determined to
be non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Irritation
ISO 10993-10 | Comply with ISO 10993-10.
Under the conditions of the
study, the proposed device
extract was determined to
be non-irritating | Non-irritating | Non-irritating |
| Sensitization
ISO 10993-10 | Comply with ISO 10993-10.
Under the conditions of the
study, the proposed device
extract was determined to
be non-sensitizing | Non-sensitizing | Non-sensitizing |
5
6
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.