(387 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The device description indicates it is a surgical mask intended for protection against the transfer of microorganisms, body fluids, and particulate material, not for treating any medical condition.
No
The device is a face mask intended for protection and infection control, not for diagnosis of any medical condition.
No
The device description clearly outlines physical components (Polypropylene, Meltblown, elastic earloops, nosepiece) and the performance studies are focused on material properties and physical filtration, not software functionality.
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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, materials, earloops, nosepiece). There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies: The performance studies listed (Biocompatibility, Flammability, Blood Penetration, Filtration Efficiency, Differential Pressure) are all related to the physical properties and protective capabilities of the mask as a barrier. They are not diagnostic performance metrics like sensitivity, specificity, or AUC which are common in IVD evaluations.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
This device is a medical mask, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Skypro, SP01 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 of the wearer to blood and body fluids. The mask is a single use, disposable device, provided nonsterile.
Product codes
FXX
Device Description
Skypro, SP01 Mask, is a flat pleated procedure or surgical mask. It is 3 layers and composed of Polypropylene and Meltblown, with elastic earloops or Ties in either knitted polyester/lycra or non-woven polyester and A malleable nosepiece is placed within the bindings for comfort and individualized fir around the wearer's nose.
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)
Performance Tests:
- Biocompatibility Test, ISO 10993
- Flammability Test, 16 CFR Part 1610
- Synthetic Blood Penetration Test, ASTM F1862
- Particulate Filtration Efficiency, ASTM F2299
- Bacterial Filtration Efficiency, ASTM F2101-07
- Differential Pressure Testing, MIL-M-36954C
Key results:
Fluid Resistance Performance (mmHg) ASTM F1862: Pass @120mmHg
Particulate Filtration Efficiency Performance ASTM F2299: 99.28%
Bacterial Filtration Efficiency Performance ASTM F2101-07: 99.66%
Differential Pressure(Delta-P) MIL-M-36954C: 3.72 mm H2O/cm2
Flammability class 16 CFR Part 1610: Class 1
Biocompatibility Test ISO 10993: Non-cytotoxic, Non-sensitization, Non-irritating
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance (mmHg) ASTM F1862: Pass @120mmHg
Particulate Filtration Efficiency Performance ASTM F2299: 99.28%
Bacterial Filtration Efficiency Performance ASTM F2101-07: 99.66%
Differential Pressure(Delta-P) MIL-M-36954C: 3.72 mm H2O/cm2
Flammability class 16 CFR Part 1610: Class 1
Biocompatibility Test ISO 10993: Non-cytotoxic, Non-sensitization, Non-irritating
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Skypro Medical Supplies Company Mr. Cyrus Wong General Manager Flat C301, 3/F, Block C, Phase 2, Tsing Yi Industrial Centre, 1-33 Cheung Tat Road, Tsing Yi, New Territories, Hong Kong
Re: K152197
Trade/Device Name: Skypro, SP01 Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: July 21, 2016 Received: July 25, 2016
Dear Mr. Wong:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K152197
Device Name Skypro, SP01 Mask
Indications for Use (Describe)
The Skypro, SP01 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 of the wearer to blood and body fluids. The mask is a single use, disposable device, provided nonsterile.
| Description | Model No. | Color | Size |
|---|---|---|---|
| Gent loop mask | FP3FNWH | White | 175x95mm |
| Lady loop mask | FL3FNWH | White | 145x95mm |
| Tie on mask | FS3FNWH | White | 175x95mm |
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
Skypro Medical Supplies Company
Date prepared: 24th Aug, 2016
Manufacturer: SPRO Medical Products (Xiamen) Co., Ltd 139 Factory Building, TongAn Garden, TongAn Industrial Area, TongAn Xiamen, China. 361100
Official Correspondent and Applicant: Cyrus Wong General Manager Skypro Medical Supplies Company Flat C301, 3/F, Block C, Phase 2, Tsing Yi Industrial Centre, 1-33 Cheung Tat Road, Tsing Yi, New Territories, Hong Kong. Phone Number: 852-27110882 Fax Number: 852--27110116 cyrus@skypro--med.com
US agent and correspondent Wilson Lim 165 North Aspan Ave, Azusa, CA 91702 Phone: 1-626--969--7838 Ext 105 Fax: 1-626-969-7823
Device Trade Name: Skypro, SP01 Mask
Device Classification and Product Code Classification Name: Mask, Surgical (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FXX Device Common Name/ Classification Name: Surgical Mask
Recognized Performance Predicate Device Pasture 60S Surgical Mask K141875
Labels/ Labeling:
Skypro, SP01 Mask will be marketed as single use disposable procedure mask and this product is not made with natural rubber latex for the Intended Use purpose below
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Intended Use:
Skypro, SP01 Mask is a procedure or surgical mask that is indicated as a protective nose and mouth covering for healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids and particulate materials.
Indication for use Statement:
Skypro, SP01 Mask is intended to be worn to protect both 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 of wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
| Description | Model No. | Color | Size |
|---|---|---|---|
| Gent loop mask | FP3FNWH | White | 175x95mm |
| Lady loop mask | FL3FNWH | White | 145x95mm |
| Tie on mask | FS3FNWH | White | 175x95mm |
Device Description:
Skypro, SP01 Mask, is a flat pleated procedure or surgical mask. It is 3 layers and composed of Polypropylene and Meltblown, with elastic earloops or Ties in either knitted polyester/lycra or non-woven polyester and A malleable nosepiece is placed within the bindings for comfort and individualized fir around the wearer's nose.
6
Comparison of Predicated Devices:
| Comparison of Predicated Devices: | ||
|---|---|---|
| Description | Our Device | Predicate K141875 |
| "Skypro SP01 Mask" | "Pasture 60S Surgical Mask" | |
| Materials | ||
| Outer layer | Polypropylene | Polypropylene |
| Middle layer-Filter Media | Meltblown | Meltblown |
| Inner layer | Polypropylene | Polypropylene |
| Nose Piece | Metal wires embedded in | |
| polyester or non-woven | ||
| ties | Combination of zinc wires | |
| and embedded polyester | ||
| Ear Attachment | Eastic earloop or Ties | Synthetic elastic |
| Specification | ||
| and Physical sizes | Gent loop mask size: | |
| 175x95mm | ||
| Lady loop mask size: | ||
| 145x95mm | ||
| Tie on mask size: | ||
| 175x95mm | 184+/-1mmx144+/-1mm | |
| Mask Style | Flat pleated | Flat pleated |
| Design Features: | 3 layers of non-woven fiber | |
| with fiber web in the | ||
| middle | 4 layers of non-woven fiber | |
| containing a filter web | ||
| Color | White | Blue |
| Indications for use | The Skypro, SP01 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 of | ||
| the wearer to blood and body | ||
| fluids. The mask is a single use, | ||
| disposable device, provided non- | ||
| sterile. | Pasture 60S Surgical Mask is a | |
| surgical mask indicated to be | ||
| used by the healthcare personnel | ||
| during procedures to protect | ||
| both the patient and the | ||
| healthcare personnel from the | ||
| transfer of microorganisms, body | ||
| fluids, and particulate material. | ||
| Technological | ||
| Characteristics | No new technological | |
| characteristics are used of | ||
| Skypro SP01 Mask | ||
| Performance | ||
| Characteristics | Skypro SP01 Mask | K141875 |
| Fluid Resistance | ||
| Performance (mmHg) | ||
| ASTM F1862 | Pass @120mmHg | Pass @120mmHg |
| Particulate Filtration | ||
| Efficiency Performance | ||
| ASTM F2299 | 99.28% | 99.4% |
| Bacterial Filtration | ||
| Efficiency Performance | ||
| ASTM F2101-07 | 99.66% | 99.76% |
| Differential | ||
| Pressure(Delta-P) | ||
| MIL-M-36954C | 3.72 mm H2O/cm2 | 3.33 mm H2O/cm2 |
| Flammability class | ||
| 16 CFR Part 1610 | Class 1 | Class 1 |
| Biocompatibility Test | ||
| ISO 10993 | ||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Sensitization | Non-sensitization | Non-sensitization |
| Primary Skin Irritation | Non-irritating | Non-irritating |
| Sterile | Non-sterile | |
| Single Use | Non-sterile | |
| Single Use |
7
Performance Tests:
| Test Performed |
|---|
| 1. Biocompatibility Test, ISO 10993 |
| 2. Flammability Test, 16 CFR Part 1610 |
| 3. Synthetic Blood Penetration Test, ASTM F1862 |
| 4. Particulate Filtration Efficiency, ASTM F2299 |
| 5. Bacterial Filtration Efficiency, ASTM F2101-07 |
| 6. Differential Pressure Testing, MIL-M-36954C |
Conclusion
The test data submitted in this submission demonstrate that the subject device is as safe and as effective as the predicate and technological characteristics do not raise any new questions of safety and as effectiveness. Skypro, SP01 Mask is substantially equivalent to the predicate cleared in K141875.