(131 days)
Not Found
No
The 510(k) summary describes a standard surgical mask and does not mention any AI or ML components or functionalities.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a protective mask worn to prevent the transfer of microorganisms, not to treat a medical condition.
No
Explanation: The device is a protective mask intended to prevent the transfer of microorganisms, body fluids, and particulate matter, and is used in infection control practices. It does not diagnose any condition or disease.
No
The device description clearly outlines a physical, multi-layer mask with a filter, nose piece, and ear loops. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Spin Care Disposable Protective Mask Level 3 is a physical barrier device worn on the face to filter airborne particles and fluids. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for protection from transfer of microorganisms, body fluids, and particulate material by being worn on the face.
- Device Description: The description details the physical construction of the mask and its components, not any diagnostic testing capabilities.
The information provided describes a surgical mask, which is a Class II medical device used for personal protection and infection control, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
Device Description
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.
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
Nonclinical testing was conducted using 32 samples per lot, from 3 non-consecutive lots. Tests performed include:
- Fluid resistance (ASTM F1862 and ISO 22609) with a criterion of Pass at 160mmHg. Results: Pass at 160mmHg.
- Particulate Filtration Efficiency (PFE) (ASTM F2299) with a criterion of ≥ 98%. Results: Passed ≥98%.
- Bacterial Filtration Efficiency (BFE) (ASTM F2101) with a criterion of ≥ 98%. Results: Passed ≥98%.
- Differential Pressure (Delta P) (MIL-M-36954C (Military Std)) with a criterion of
§ 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 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
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 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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3
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 LLC
1920 Flintstone Drive
Statesville, North Carolina 28677
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
574-265-8356 |
| Date: | 9 November 2021 |
| Subject Device: | Spin Care Disposable Protective
Mask 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) |
| Device
Description: | 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. |
4
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.
5
Summary of Technological
Characteristics: The rationale for substantial equivalence is based on consideration of the following characteristics:
| | Spin Care Disposable Protective
Mask Level 3
K212109 | Predicate device: Freudenberg
Surgical Mask
K210063 | Remarks |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended Use/
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 non-sterile. | The Freudenberg Surgical
Mask is intended to be
worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body
fluids and particulate
material. This face 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. | 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: 175mm
Width: 95mm | Length: 175 mm +/- 1mm
Width: 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 Testing
| ASTM F2100 - Level 3 | |||
|---|---|---|---|
| Fluid resistance | |||
| ASTM F1862 | Passed at 160mmHg | Passed at 160mmHg | Same |
| Particle Filtration | |||
| Efficiency | |||
| ASM F2299 | Passed ≥98% | Passed ≥98% | Same |
| Bacterial Filtration | |||
| Efficiency | |||
| ASTM F2101 | Passed ≥98% | Passed ≥98% | Same |
| Flammability Class | |||
| 16 CFR 1610 | Class I Non-Flammable | Class I Non-Flammable | Same |
| Differential | |||
| Pressure Delta-P | |||
| EN14683 | Passed |