(207 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of the masks, with no mention of AI or ML.
No
This device is a surgical mask intended for protection from microorganisms, body fluids, and particulate materials, not for therapy or treatment.
No
The device is a surgical/procedure mask intended to protect against transfer of microorganisms, body fluids, and particulate materials, not to diagnose medical conditions.
No
The device description clearly states it is a physical mask made of multiple layers of material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are for protecting healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate materials. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical construction and materials of the masks, designed for filtration and protection.
- Performance Studies: The performance studies evaluate the mask's ability to filter particles, resist fluid penetration, and ensure biocompatibility (cytotoxicity, sensitization, irritation). These are all related to its barrier and protective function, not to diagnosing a condition or analyzing a sample in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
Product codes
FXX
Device Description
PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.
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 and health care personnel in health care setting
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
Non-clinical testing was performed for Bacterial Filtration Efficiency (ASTM F2101), Sub-micron Particulate Filtration (ASTM F3502), Differential Pressure (EN 14683), Resistance to Penetration by synthetic Blood (ASTM F1862), Flammability (16 CFR 1610), Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Irritation (ISO 10993-23). All tests passed their respective acceptance criteria. No clinical testing was performed.
Key Metrics
- Bacterial Filtration Efficiency: Level 1: >= 95%, Level 3: >= 98%
- Sub-micron Particulate Filtration: Level 1: >= 80%, Level 3: >= 85%
- Differential Pressure: Level 1:
§ 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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
August 26, 2024
Primed Medical Products Inc. Mitra Fard Manager, Regulatory Affairs 200, 2003-91 St. SW Edmonton, AB T6X0W8 Canada
Re: K240286
Trade/Device Name: PRIMED Surgical Masks and PRIMED Procedure Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 22, 2024 Received: July 25, 2024
Dear Mitra Fard:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240286
Device Name
PRIMED Surgical Masks and PRIMED Procedure Masks
Indications for Use (Describe)
PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
| 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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4
PRIMED Surgical and Procedure Masks
| Summary Date: | July 22, 2024 |
|---|---|
| Manufacturer: | PRIMED Medical Products Inc. |
| Address: | 200, 2003-91 St. SW, Edmonton, AB, Canada, T6X 0W8 |
| Phone Number | +1.877.877.4633 |
| Fax Number | +1.780.497.7670 |
| mitra.fard@primed.com | |
| Contact person: | Mitra Fard |
| Common name of the device | Mask, Surgical |
| Trade or Proprietary Name: | PRIMED Surgical Masks and PRIMED Procedure Masks |
| Models | PG4-1001: ASTM Level 1, Procedure Ear Loop, Yellow Mask, |
| PG4-1223: ASTM Level 3, Procedure Ear Loops, Black Mask, | |
| PG4-2001: ASTM Level 1, Surgical Ties, Blue Mask, | |
| PG4-4053: ASTM Level 3, Anti-fog Tape, Surgical Ties, Green Mask, | |
| PG4-5033: ASTM Level 3 Soft Mask, Anti-fog, Anti-Glare, Surgical Ties, Visor White, | |
| PG4-5553: ASTM Level 3 Visor Anti-Fog Anti-Glare Surgical Ties Indigo Mask | |
| Regulation Description | Surgical Apparel |
| Review Panel | General and Plastic Surgery |
| Regulation number | 21 CFR 878.4040 |
| Device Class: | 2 |
| Product Code: | FXX |
| Predicate device(s) | PRIMAGARD Surgical Masks, # K081633 |
Device Description:
PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.
Indication for Use:
PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
5
Here below is the summary of the technological characteristics and the proposed device compared to the predicate device.
Table 1: Technological Characteristics Comparison Table
| Elements of
| Comparison | Proposed device | Predicate | comments |
|---|---|---|---|
| Trade name | PRIMED Surgical Masks and PRIMED | ||
| Procedure Masks | PRIMAGARD Surgical Masks | - | |
| 510k number | K240286 | K081633 | - |
| Manufacturer | PRIMED Medical Products Inc. | PRIMED Medical Products Inc. | - |
| Regulation | |||
| number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Product code | FXX | FXX | Same |
| Common name | Mask, Surgical | Mask, Surgical | Same |
| Intended use | PRIMED Surgical Masks and PRIMED | ||
| Procedure Masks are single use, non-sterile | |||
| products intended to be worn by operating | |||
| room and health care personnel in health | |||
| care setting and during surgical procedures to | |||
| protect both the patient and the operating | |||
| room personnel from transfer of | |||
| microorganisms, body fluids and particulate | |||
| materials. | PRIMAGARD Surgical Masks are surgical apparel | ||
| as identified in 21 CFR 878.4040 and are intended | |||
| to be worn by operating room personnel during | |||
| procedures to protect both the surgical patient | |||
| and the operating room personnel from transfer | |||
| of microorganisms, body fluids and particulate | |||
| material. | Similar | ||
| ASTM F2100 level | Level 1 and Level 3 | Level 1, Level 2 and Level 3 | Similar |
| Biocompatibility | Under the conditions of the testing, not a | ||
| sensitizer, not an irritant, and not cytotoxic | Under the conditions of the testing, not a sensitizer, | ||
| not an irritant, and not cytotoxic | Same | ||
| Single use vs. | |||
| reusable | Single Use | Single Use | Same |
| Sterile vs. | |||
| non-sterile | Non-sterile | Non-sterile | Same |
| Outer layer | Spunbond material | PSB PP material | |
| Filter layer | Meltblown PP | Meltblown PP | Similar - PRIMED masks |
| Inner layer | SSS material | ||
| Wetlaid Cellulose | |||
| ES material | Wetlaid Cellulose | have different inner layer | |
| and different basis weight | |||
| of outer and filter layer. | |||
| Ear loop | Spandex Polyester Ear loops | Spandex Polyester Ear loops | The testing demonstrates |
| Head Tie | SSS Head tie | Spunlace viscose | the safety and |
| Nose piece | Annealed Aluminium | ||
| Plastic coated nosepiece | Aluminium nosepiece | effectiveness of the masks | |
| Color | White, Yellow, Green, Blue, Black, Indigo | ||
| colour | Blue, White, Green, Indigo | Similar - masks are | |
| tested. Additional colours | |||
| in the new masks do not | |||
| introduce any additional | |||
| safety or performance | |||
| concern | |||
| Design | Pleated design | ||
| Pleated Omega design | Pleated design | ||
| Pleated Omega design | |||
| Duckbill design | Similar | ||
| Elements of | |||
| Comparison | Proposed device | Predicate | comments |
| Welding | Ultrasonic welding pattern | Ultrasonic welding pattern | same |
| Accessories | Anti-fog, visor | Anti-fog, visor | Same |
6
PRIMED Surgical and Procedure Masks
K240286 - 510(K) Summary
Summary of non-clinical testing:
Table 2: Summary of the Non-Clinical Tests:
| ASTM F2100-23 | |||||
|---|---|---|---|---|---|
| Test Performed | Test method | Acceptance Criteria | Results (Pass/Fail) | ||
| Bacterial Filtration Efficiency | ASTM F2101 | Level 1: ≥ 95%, Level 3: ≥ 98% | Pass | ||
| Sub-micron Particulate Filtration | ASTM F3502 | Level 1: ≥ 80%, Level 3: ≥ 85% | Pass | ||
| Differential Pressure | EN 14683 | Level 1: |