(162 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 is a surgical mask intended for infection control by preventing the transfer of microorganisms, not for treating any medical condition or disease.
No
The device description indicates that it is a surgical mask, worn to protect against transfer of microorganisms and body fluids. Its intended use is for infection control practices, not for diagnosing any condition. The performance studies listed are tests of material properties (e.g., filtration efficiency, fluid resistance, flammability) of the mask itself, not diagnostic performance metrics.
No
The device description clearly outlines physical components (layers of material, nose strip, ear loops) and performance studies related to material properties and filtration, indicating it is a physical medical device, not software-only.
Based on the provided information, the PointCore Surgical Mask is not an IVD (In Vitro Diagnostic) device.
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. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details the physical construction of the mask, materials, and features like ear loops and a nose piece. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies listed (Synthetic Blood Penetration Resistance, Particle Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure Test, Flammability) are all tests related to the physical barrier and filtration properties of the mask, not diagnostic performance.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The PointCore Surgical Mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The PointCore Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The PointCore Surgical Mask is a surgical mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The ASTM Level of the subject device is ASTM Level 2. The finished size of the mask is 175mm x 95 mm. The masks are comprised of three layers: an outer polyethylene/polyester layer, a meltblown nonwoven filter layer, and an inner polypropylene layer. The mask also includes an adjustable nose strip and flat or round elastic ear loop. The nosepiece is manufactured from a reinforced plastic piece with a metal insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient and 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)
The following testing was completed for the subject device:
- Synthetic Blood Penetration Resistance
- Particle Filtration Efficiency
- Bacterial Filtration Efficiency
- Differential Pressure Test
- Flammability of Clothing Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Passed acceptance criteria of ASTM F1862 (Fluid Resistance)
ASTM F2299 (Particulate Filtration Efficiency)
ASTM F2101 (Bacterial Filtration Efficiency)
MIL-M36945C (Differential Pressure)
16 CFR 1610 (Flammability)
ISO 10993 (Biocompatibility)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 9, 2022
PointCore, Inc. % Mr. Dave McGurl Senior Director, Regulatory Affairs Mcra. LLC 803 7th Street, NW, 3rd Floor Washington, District of Columbia 20001
Re: K220944
Trade/Device Name: PointCore Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 31, 2022 Received: September 8, 2022
Dear Mr. McGurl:
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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220944
Device Name PointCore Surgical Mask
Indications for Use (Describe)
The PointCore Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K220944 Page 1 of 4
510(k) Summary
| Device Trade Name: | PointCore Surgical Mask |
|---|---|
| Manufacturer: | PointCore, Inc. |
| 124 SW Adams | |
| Peoria, IL 61602 | |
| Phone: 309.404.4800 | |
| Contact: | Mr. Dave McGurl |
| Senior Director, Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5798 | |
| dmcgurl@mcra.com | |
| Prepared by: | MCRA, LLC |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5800 | |
| Date Prepared: | August 31, 2022 |
| Regulation Number: | 21 CFR §878.4040 |
| Regulation Name: | Surgical Apparel |
| Regulatory Class: | II |
| Product Code(s): | FXX |
| Primary Predicate: | SAN-M PACKAGE CO., LTD. Surgical Face Masks (Ear loops |
| and Tie-on) (K160269) | |
| Additional Predicate: | N/A |
| Indications For Use: |
The PointCore Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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.
4
Device Description:
The PointCore Surgical Mask is a surgical mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The ASTM Level of the subject device is ASTM Level 2. The finished size of the mask is 175mm x 95 mm. The masks are comprised of three layers: an outer polyethylene/polyester layer, a meltblown nonwoven filter layer, and an inner polypropylene layer. The mask also includes an adjustable nose strip and flat or round elastic ear loop. The nosepiece is manufactured from a reinforced plastic piece with a metal insert.
Predicate Device:
PointCore submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the PointCore Surgical Mask is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to preamendment devices:
Primary Predicate: SAN-M PACKAGE CO., LTD. Surgical Face Masks (Ear loops and Tie-on) (K160269)
Performance Testing Summary:
The following testing was completed for the subject device:
- Synthetic Blood Penetration Resistance
- Particle Filtration Efficiency ●
- Bacterial Filtration Efficiency
- Differential Pressure Test
- Flammability of Clothing Test ●
Substantial Equivalence:
Below is a summary table of the technological characteristics comparison between the subject and predicate devices.
| Information | PointCore Surgical Mask
Subject Device | Surgical Face Masks (Ear
loops and Tie-on)
SAN-M PACKAGE CO.,
LTD.
K160269 | Comparison | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification | II | II | Identical | |
| Regulation | 878.4040 | 878.4040 | Identical | |
| Product Code | FXX | FXX | Identical | |
| Indications | The PointCore Surgical Mask
is intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate | 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 | Identical | |
| | Information | PointCore Surgical Mask
Subject Device | Surgical Face Masks (Ear loops and Tie-on)
SAN-M PACKAGE CO., LTD.
K160269 | Comparison |
| | | material. These surgical 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. | 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. | |
| | Inner Layer | Polyethylene/Polyester White | Polypropylene | |
| | Outer Layer | Polypropylene | Polypropylene | |
| Materials | Middle Layer/ Filter Layer | Meltblown Nonwoven White | Polypropylene spunbond
Polypropylene meltblown | |
| | Ear Loops | Nylon/Spandex - Latex free | Ear loops: Polyester, polyurethane
Side tapes: Polyester spunbond (ear loops mask only)
Tie tapes: Polypropylene spunbond or polyester spunbond | Similar |
| | Nose Piece | Reinforced plastic with metal insert | Polyethylene coated steel wire | |
| | | | | |
| | ASTM Level | Level 2 | Level 1 | Different |
| | Dimensions | $17.5 \pm 0.5$ cm x $9.5 \pm 0.5$ cm | • $17.5 \pm 0.5$ cm x $9 \pm 0.3$ cm
• $18 \pm 0.5$ cm x $9 \pm 0.3$ cm | Similar |
| | Color | White | White or Blue | Similar |
| | Mask Style | Flat pleated, 3-ply | Flat pleated, 3-ply | Identical |
| | Design Features | Ear loop | Ear loop | Identical |
| | Sterility | Non-Sterile | Non-Sterile | Identical |
| | Use | Single Use | Single Use | Identical |
| Information | PointCore Surgical Mask
Subject Device | Surgical Face Masks (Ear
loops and Tie-on)
SAN-M PACKAGE CO.,
LTD.
K160269 | Comparison | |
| Fluid Resistance | Passed acceptance criteria of
ASTM F1862 | Passed acceptance criteria
of ASTM F1862 | Identical | |
| Particulate Filtration
Efficiency | ASTM F2299 | ASTM F2299 | Identical | |
| Bacterial Filtration
Efficiency | ASTM F2101 | ASTM F2101 | Identical | |
| Differential Pressure | MIL-M36945C | MIL-M36945C | Identical | |
| Flammability | 16 CFR 1610 | 16 CFR 1610 | Identical | |
| Biocompatibility | ISO 10993 | ISO 10993 | Identical | |
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6
Conclusion:
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. The PointCore Surgical Mask is as safe, as effective, and performs as well as, or better, than the predicate devices.