(90 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of a surgical face mask, with no mention of AI or ML.
No.
The device, a surgical face mask, is intended to protect against the transfer of microorganisms and particulate matter, not to treat or cure a disease or condition.
No
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate matter, not to diagnose a condition.
No
The device description clearly outlines physical components like spunbond and melt blown polypropylene, ear loops, and a nose bridge, indicating it is a physical medical device, not software-only.
Based on the provided information, the DWFritz ASM2000 surgical face mask is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect from the transfer of microorganisms, body fluids, and particulate matter. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of a face mask, which is a physical barrier device.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (BFE, PFE, fluid resistance, differential pressure, flammability). These are tests of the device's ability to act as a barrier, not tests related to diagnosing a condition or analyzing a sample in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the DWFritz ASM2000 surgical face mask is classified as a medical device, specifically a surgical mask, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When properly worn, DWFritz ASM2000 surgical face mask is intended to protect both the patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. The device is non-sterile and for single use only.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
DWFritz ASM2000 is a 3-ply, flat-pleated style surgical face mask. The device is manufactured with three layers. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. Each mask contains ear loops made of polyester filament and spandex fiber to secure the mask over the user's face and mouth with galvanized wire nose bridge to fit firmly over the nose.
This device is not made from any natural rubber latex.
The product is sold non-sterile and intended to be disposable for single-use.
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 worker
OTC use.
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)
Non-Clinical Testing:
- Cytotoxicity (ISO 10993-05): Results Grade 1 (slight reactivity) meeting criteria of 3.5 sec (Class 1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial Filtration Efficiency (BFE): 99.9%
- Particulate Filtration Efficiency (PFE): 98.8-99.7%
- Synthetic Blood Fluid Resistance: 30, 31, and 32 pass at 120 mmHg out of 32 test articles in each of three lots
- Differential Pressure (Delta P): 2.9 - 4.7 mmH20/cm2
- Flammability: Class 1
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.
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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.
March 14, 2022
DWFritz Automation, Inc. % John Gillespy President FDA 510k Consultants, LLC 1100 Del Lago Circle Palm Beach Gardens, Florida 33410
Re: K213894
Trade/Device Name: DWFritz ASM2000 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 10, 2021 Received: December 14, 2021
Dear John Gillespy:
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,
Bifeng Qian Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213894
Device Name DWFritz ASM2000
Indications for Use (Describe)
When properly worn, DWFritz ASM2000 surgical face mask is intended to protect both the patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. The device is non-sterile and for single use only.
| 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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3
510(k) Summary_K213894
Prepared in accordance with the requirements of 21 CFR Part 807.92.
| 1. 510(k) Submitter: | DWFritz Automation, Inc.
9600 SW Boeckman Rd., Wilsonville OR 97070
Phone: 503-885-7030
Email: cpsmith@dwfritz.com | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 2. Company Contact: | Curtis Smith, Senior Quality Manager | |
| 3. Date of Submission: | December 10, 2021 | |
| 4. 510(k) Preparer: | John F. Gillespy, MBA
FDA 510k Consulting, LLC
Palm Beach Gardens, FL 33410
Phone: 386-243-4332
Email: john@fda510kconsultants.com | |
| 5. Device Classification: | Trade name:
Common name:
Device:
Class:
Regulation #:
Product Code: | DWFritz ASM2000
Surgical Face Mask
Surgical Mask
II
878.4040
FXX |
| 6. Predicate: | Applicant:
Device:
510(k) Number: | Mexpo International, Inc.
Avianz Surgical Face Mask
K200847 |
7. Device Description
DWFritz ASM2000 is a 3-ply, flat-pleated style surgical face mask. The device is manufactured with three layers. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. Each mask contains ear loops made of polyester filament and spandex fiber to secure the mask over the user's face and mouth with galvanized wire nose bridge to fit firmly over the nose.
This device is not made from any natural rubber latex.
The product is sold non-sterile and intended to be disposable for single-use.
4
8. Indications For Use
When properly worn, DWFritz ASM2000 surgical face mask is intended to protect both the patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The device is intended for OTC use.
9. Comparison To Predicate Device
DWFritz ASM2000 is compared to a predicate device, Avianz Surgical Face Mask (K200847).
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | DWFritz Automation, Inc. | Mexpo International, Inc. | - |
| 510K Number | K213894 | K200847 | - |
| Product Name | Surgical Face Mask | Surgical Face Mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intended Use | When properly worn, | ||
| DWFritz ASM2000 surgical | |||
| face mask is intended to | |||
| protect both the patient | |||
| and healthcare worker from | |||
| transfer of micro- | |||
| organisms, body fluids and | |||
| particulate matter. This | |||
| device is non-sterile and for | |||
| single use only. | When properly worn, the | ||
| surgical face masks are | |||
| intended to protect both | |||
| patient and healthcare | |||
| workers from transfer of | |||
| microorganisms, body fluids | |||
| and airborne particles. This | |||
| device is non-sterile and for | |||
| single use only. | Same | ||
| Model | 3-ply, flat-pleated style with | ||
| ear loops and nose bridge | 3-Ply, Flat-Pleated Style with | ||
| ear loops and nose bridge | Same | ||
| Materials, Dimensions, & Other Features | |||
| Outer Facing | |||
| Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle Layer | Meltblown Polypropylene | Meltblown Polypropylene | Same |
| Inner Facing Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Bridge | Galvanized wire with | ||
| polyester coating | Galvanized wire with | ||
| polyester coating | Same |
Comparison Table
5
| Ear Loops | Not made with natural rubber
latex | Not made with natural rubber
latex | Same |
|-----------------------|---------------------------------------|---------------------------------------|-----------|
| Color | Blue (inner facing) & white | White | Similar |
| Dimension (W X L) | 9.8 X 17.2 ± 0.5cm | 9.5 X 17.5 ± 0.5cm | Similar |
| Use | OTC, single use, disposable | OTC, single use, disposable | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Testing | | | |
| Performance Level: | | | |
| ASTM F2100:2019 | Level 2 | Level 2 | Same |
| Bacterial Filtration | 99.9% | 98% | Both Pass |
| Particle Filtration | 98.4% | 98% | Both Pass |
| Fluid Resistance | 94 of 96 pass @ 120 mmHg | 29 of 32 pass @ 120 mmHg | Both Pass |
| Differential Pressure |
3.5 sec (Class 1) | IBE for all 14 test
articles in each of 3
lots (42 total test
articles) |
11. Patient-Contacting Materials
Materials composition follows:
- Outer facing layer – spunbond polypropylene (blue)
- Middle layer meltblown polypropylene filter (white) ●
- Inner facing layer spunbond polypropylene (white) ●
- Nose bridge – Galvanized wire with polyester coating
- Ear loops – polyester filament & spandex fiber, not made from natural rubber latex (white)
The outer & inner layers and ear loops touch the patient's face and hands. Type and duration of contact with patient follows:
- Surface contact — intact skin
- Limited duration - less than 24 hours
12. Software Verification and Validation... The mask contains no software or firmware.
The conclusion drawn from the nonclinical tests demonstrates that the subject device, DWFritz ASM2000, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200847.