(8 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. The "Not Applicable (Passive Device)" entries further indicate the absence of such technology.
No.
The POSE™ Health Care Surgical Mask is intended to protect operating room personnel and surgical patients from the transfer of microorganisms, body fluids, and particulate material; it does not treat or diagnose any disease or condition.
No
The device is a surgical mask intended to prevent the transfer of microorganisms and fluids, not to diagnose a condition.
No
The device description clearly outlines physical components (three-layer mask, ear loops, nose piece) and the performance studies are benchtop tests on these physical properties, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mask is for protecting both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical components and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) to provide information about a person's health status, diagnose conditions, or monitor treatment. This mask does none of those things.
The information provided describes a Class II medical device intended for infection control through physical barrier protection.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
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.
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
Operating room personnel during surgical procedures.
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 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.
Benchtop Performance Testing:
- ASTM F1862/ISO 22609 Fluid Resistance: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Results: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass. Result: Pass.
- ASTM F2299 Particulate Filtration Efficiency: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Results: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass. Result: Pass.
- Bacterial Filtration Efficiency ASTM F2101: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Results: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass. Result: Pass.
- Differential Pressure ASTM F2100/EN 14683:2019: Three non-sequential lots of 32 (total of 96) passed at
§ 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 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
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
2
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 Device
POSE™ Health Care
Surgical Mask ASTM
Level 3 | Predicate Device (K172500)
Technoweb Surgical Mask | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use/
Indications
for Use | 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 | 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 | Same |
| Materials | | | |
| Outer Cover
Web | Polypropylene Spunbond,
white | felt | similar |
| Filter Web
(Middle) | Polypropylene Meltblown,
white | felt | similar |
| Inner Cover
Web | Polypropylene Spunbond,
white | felt | similar |
| Nose Piece | Polyethylene Aluminum
Wire | Aluminum | similar |
| Ear Loops | Spandex elastic cord | Nylon | similar |
| Style | Flat - Fold | Flat - Fold | Same |
| Multiple
Layers | 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 F2100
Level | Level 3 | | Similar |
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Image /page/7/Picture/1 description: The image shows the title of a document. The title is "AMERICA'S SUPPLY CHAINS". Below the title is the text "VII. PERFORMANCE DATA". The text is in a larger font size than the title.
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 Device
POSETM Health Care
Surgical Mask
ASTM Level 3 | ASTM Level 3
Mask
Standard
Acceptance
Criteria | Predicate
Device
(K172500)
Technoweb
Surgical Mask | Result |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------|--------|
| ASTM
F1862/ISO
22609
Fluid
Resistance | 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 | AQL 4%,
single sampling
plan, 29 out of
32 Pass at
160mmHg | | Pass |
| ASTM F2299
Particulate
Filtration
Efficiency | 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 | ≥ 98% | | Pass |
| Bacterial
Filtration
Efficiency
ASTM F2101 | 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 | ≥ 98% | | Pass |
| Differential
Pressure
ASTM
F2100/EN
14683:2019 | Three non-sequential lots
of 32 (total of 96) passed
at