(8 days)
The POSE™ Health Care Surgical Mask is 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.
POSE™ Health Care Surgical Mask is composed of three-layers and is flat fold. The mask materials consist of an outer cover web (polypropylene spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.
The provided document is a 510(k) summary for the POSE™ Health Care Surgical Mask. It outlines the device's technical characteristics, performance data, and comparison to a predicate device to demonstrate substantial equivalence to a legally marketed device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Reported Device Performance (POSE™ Health Care Surgical Mask) | Result |
|---|---|---|---|
| Benchtop Performance Testing | |||
| ASTM F1862/ISO 22609 Fluid Resistance | AQL 4%, single sampling plan, 29 out of 32 Pass at 160mmHg | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| ASTM F2299 Particulate Filtration Efficiency | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| Bacterial Filtration Efficiency ASTM F2101 | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| Differential Pressure ASTM F2100/EN 14683:2019 | AQL 4%, single sampling plan, < 6.0 mmH2O/cm2 | Three non-sequential lots of 32 (total of 96) passed at <6mmH2O/cm2 MIL-M36954C. Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| Class 1 Flammability 16 CFR 1610 | Class 1 < 3.5 second burn time | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed Class 1 16 CFR 1610. Lot 1: Class 1, DNI, Lot 2: Class 1, DNI, Lot 3: Class 1, DNI | Pass |
| Biocompatibility Testing | |||
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non-Sensitizing | Non-Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Non-Irritating | Pass |
The study that proves the device meets the acceptance criteria is described as benchtop performance testing and biocompatibility testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Benchtop Testing: For each of the benchtop performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), three non-sequential lots of 32 masks were tested, resulting in a total of 96 masks tested for each parameter.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that the device was tested to conform to specific standards and guidance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes performance testing for a surgical mask (a physical medical device) against established standards (e.g., ASTM, ISO), not a diagnostic or AI-driven device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the objective measurement against the specified standard criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation or subjective assessments, often in diagnostic imaging or clinical trials. The testing for the surgical mask involves objective laboratory measurements against predefined physical and biological criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. MRMC studies are used to evaluate the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. The POSE™ Health Care Surgical Mask is a physical medical device, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question refers to the performance of an algorithm or AI independently. The POSE™ Health Care Surgical Mask is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria of the surgical mask is based on established industry standards and regulatory guidance. These standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, ISO 10993) define the objective measurements and thresholds for a surgical mask to be considered safe and effective for its intended use. For instance, fluid resistance is measured against a specific pressure (160mmHg), and filtration efficiency against a percentage (≥98%). Biocompatibility is assessed against the criteria of being non-cytotoxic, non-sensitizing, and non-irritating.
8. The sample size for the training set
This information is not applicable. Training sets are relevant for machine learning or AI models. The device in question is a physical surgical mask, and its performance is evaluated through benchtop and biocompatibility testing, not through training data for an algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above (point 8).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2022
America's Supply Chains % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K223270
Trade/Device Name: POSE™ Health Care Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: October 22, 2022 Received: October 24, 2022
Dear Prithul Bom:
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,
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) K223270
Device Name POSE™ Health Care Surgical Mask
Indications for Use (Describe)
The POSE™ Health Care Surgical Mask is 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.
| 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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Image /page/3/Picture/1 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in large, bold, blue letters, with the apostrophe replaced by a stylized image of a building with columns and a red roof. Below "America's" is the phrase "Supply Chains" in smaller, sans-serif font. The building image is also present in a small circle above the text.
510(k) Summary
This summary of 510(k) is submitted in accordance with the requirements of 21 CFR 8807.92:
I. SUBMITTER
America's Supply Chains 7555 Warren Pkwy, Unit 486 Frisco, TX 75034 USA
Contact Person:
Paul Park Tel: (617) 800-3602 Email: americasupplychains@gmail.com Date Prepared: October 05, 2022
II. DEVICE
Name of Device: Common or Usual Name: Classification Name: Regulatory Class: Regulation Medical Specialty: 510k Review Panel: Product Code:
POSE™ Health Care Surgical Mask Surgical Mask Surgical Apparel Class II (21 CFR §878.4040) General & Plastic Surgery General Hospital FXX
III. PREDICATE DEVICE
Predicate Manufacturer: Predicate Trade Name: Predicate 510(k): Device Classification Name: Device Name: Regulatory Class: Regulation Number: Classification Product Code: Decision: Regulation Medical Specialty: 510k Review Panel: Type:
YTS GLOBAL INC Technoweb Surgical Mask K172500 mask, surgical Technoweb Surgical Mask Class II (21 CFR §878.4040) 878.4040 FXX Substantially Equivalent (SESE) General & Plastic Surgery General Hospital Traditional
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Image /page/4/Picture/1 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in large, bold letters, with the word "Supply Chains" in smaller letters underneath. Above the text is a small oval containing a stylized image of a building with columns and a roof, suggesting a government or institutional connection. The colors used are primarily blue and red.
IV. DEVICE DESCRIPTION
POSE™ Health Care Surgical Mask is composed of three-layers and is flat fold. The mask materials consist of an outer cover web (polypropylene spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose.
This device is not made from natural rubber latex.
V. INDICATIONS FOR USE
POSE™ Health Care Surgical Mask is 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following characteristics were compared between the subject device and the predicate device in Table 1 below.
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| Description | Subject DevicePOSE™ Health CareSurgical Mask ASTMLevel 3 | Predicate Device (K172500)Technoweb Surgical Mask | Comparison |
|---|---|---|---|
| Intended Use/Indicationsfor Use | is intended to be worn byoperating room personnelduring surgical procedures toprotect both the surgicalpatient and the operatingroom personnel from transferof microorganisms, bodyfluids, and particulatematerial | is intended to be worn byoperating room personnelduring surgical procedures toprotect both the surgicalpatient and the operatingroom personnel from transferof microorganisms, bodyfluids, and particulate material | Same |
| Materials | |||
| Outer CoverWeb | Polypropylene Spunbond,white | felt | similar |
| Filter Web(Middle) | Polypropylene Meltblown,white | felt | similar |
| Inner CoverWeb | Polypropylene Spunbond,white | felt | similar |
| Nose Piece | Polyethylene AluminumWire | Aluminum | similar |
| Ear Loops | Spandex elastic cord | Nylon | similar |
| Style | Flat - Fold | Flat - Fold | Same |
| MultipleLayers | 3-Ply | 3-Ply | Same |
| Colors | White | White | Same |
| Dimension(Width) | 180mm | TM-R is 212mm(W)TM-S is 177.8mm(W) | similar |
| Dimension(Length) | 90mm | TM-R is 74mm(H)TM-S is 138mm(H) | similar |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Similar | |
| Use | Single Use | Single Use | Same |
| ASTM F2100Level | Level 3 | Similar |
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The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2.
| Item | Proposed DevicePOSETM Health CareSurgical MaskASTM Level 3 | ASTM Level 3MaskStandardAcceptanceCriteria | PredicateDevice(K172500)TechnowebSurgical Mask | Result |
|---|---|---|---|---|
| ASTMF1862/ISO22609FluidResistance | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at 160mmHgLot 1: 32 /32 passLot 2: 32 /32 passLot 3: 32 /32 pass | AQL 4%,single samplingplan, 29 out of32 Pass at160mmHg | Pass | |
| ASTM F2299ParticulateFiltrationEfficiency | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at ≥98%Lot 1: 32/32 passLot 2: 32/32 passLot 3: 32/32 pass | ≥ 98% | Pass | |
| BacterialFiltrationEfficiencyASTM F2101 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at ≥98%Lot 1: 32/32 passLot 2: 32/32 passLot 3: 32/32 pass | ≥ 98% | Pass | |
| DifferentialPressureASTMF2100/EN14683:2019 | Three non-sequential lotsof 32 (total of 96) passedat <6mmH2O/cm2MIL-M36954CLot 1: 32/32 passLot 2: 32/32 passLot 3: 32/32 pass | AQL 4%,singlesampling plan,<6.0mmH2O/cm2 | Pass |
[Table 2: Benchtop Performance Testing]
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| Class 1Flammability16 CFR 1610 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed Class 116 CFR 1610Lot 1: Class 1, DNILot 2: Class 1, DNILot 3: Class 1, DNI | Class 1< 3.5 secondburn time | Pass | |
|---|---|---|---|---|
| ---------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------- | -- | ------ |
Sterilization & Shelf-life Testing
Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)
Biocompatibility Testing
Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.
| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non- Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |
[Table 3: Biocompatibility Testing]
[Table 4: Summary of Non-Clinical Performance Testing]
The following standards have been used to evaluate the High Fluid-Resistant Surgical and Procedure Mask:
| ASTMF2101-19/EN14683:2019 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency(BFE) of Medical Face Mask Materials, Using a Biological Aerosol ofStaphylococcus aureus |
|---|---|
| ASTMF1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of Fixed Volumeat a Known Velocity) |
| ASTM F2299-17 | Standard Test Method for Determining the Initial Efficiency ofMaterials Used in Medical Face Masks to Penetration by ParticulatesUsing Latex Spheres |
| ASTM F2100/EN | Standard Test Method for Differential Pressure |
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Image /page/9/Picture/1 description: The image shows the logo for "America's Supply Chains." The word "America's" is in a large, bold, dark blue font, with the apostrophe in the shape of a large "S." Below this, the words "Supply Chains" are in a smaller, dark blue font. Above the text is a small oval shape containing a building with columns, also in blue and red.
| 14683:2019ANNEX C | Standard Specification for Performance of Materials Used in MedicalFace Masks |
|---|---|
| 16 CFR Part 1610EN 14683:2019ANNEX C | Standard for Flammability |
| ISO 10993-5 | ISO 10993-5 Third edition 2009-06-01Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10 | ISO 10993-10 Third Edition 2010-08-01Biological evaluation of medical devices - Part 10: Tests for irritationand skin sensitization |
Software Verification and Validation Testing
Not Applicable (Passive Device)
Electrical safety and electromagnetic compatibility (EMC)
Not Applicable (Passive Device)
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
VIII. CONCLUSIONS
The conclusions drawn from the performance data demonstrate that the subject device is as safe, effective, and performs as well as or better than the legally marketed device K172500, Technoweb Surgical Mask manufactured by YTS GLOBAL INC.
§ 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.