(90 days)
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.
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.
The provided text describes the acceptance criteria and the study conducted for the DWFritz ASM2000 surgical face mask. It does not contain information about an AI/ML powered device, human readers, or ground truth establishment by experts for image analysis. Therefore, I will extract and present the information relevant to the provided text about the surgical mask.
Device: DWFritz ASM2000 Surgical Face Mask
1. Table of Acceptance Criteria and Reported Device Performance
| Test Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-05 | Cytotoxicity | < Grade 2 cytotoxic effect | Grade 1 (slight reactivity) |
| ISO 10993-10 | Skin Sensitization | No sensitization reaction | No sensitization reaction |
| ISO 10993-10 | Skin Irritation | No irritation reaction | No irritation reaction |
| ASTM F2101 | Bacterial Filtration Efficiency (BFE) | 98% | 99.9% |
| ASTM F2299 | Particulate Filtration Efficiency (PFE) | 98% | 98.8-99.7% in 32 test articles in each of three lots (96 total test articles) |
| ASTM F1862 | Synthetic Blood Fluid Resistance | 29 out of 32 pass at 120 mmHg | 30, 31, and 32 pass at 120 mmHg, out of 32 test articles in each of three lots (96 total test articles) |
| MIL-M-36954C | Differential Pressure (Delta P) | < 5.0 mmH2O/cm2 | 2.9 - 4.7 mmH2O/cm2 in 32 test articles in each of three lots (96 total test articles) |
| 16 CFR 1610 | Flammability | IBE = Test article ignited but extinguished, burn time > 3.5 sec (Class 1) | IBE for all 14 test articles in each of 3 lots (42 total test articles) |
2. Sample Sizes Used for the Test Set and Data Provenance
The sample sizes for the testing (not an AI/ML test set) are provided within the table above:
- Particulate Filtration Efficiency (PFE): 32 test articles in each of three lots (96 total test articles).
- Synthetic Blood Fluid Resistance: 32 test articles in each of three lots (96 total test articles).
- Differential Pressure (Delta P): 32 test articles in each of three lots (96 total test articles).
- Flammability: 14 test articles in each of 3 lots (42 total test articles).
The provenance of this data is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but it refers to non-clinical testing performed on the manufactured device.
3. Number of Experts and Qualifications for Ground Truth Establishment
This information is not applicable as the document describes a physical medical device (surgical mask) and its performance testing, not an AI/ML device requiring expert-established ground truth from medical images.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Testing involves objective measurements against established standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the document describes a physical medical device (surgical mask) and its performance testing, not an AI/ML device that assists human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This information is not applicable as the document describes a physical medical device (surgical mask), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this medical device is established by objective measurements against recognized industry standards (e.g., ISO, ASTM, MIL specifications, CFR codes) for physical and biological properties. This is not derived from expert consensus, pathology, or outcomes data in the context of diagnostic performance.
8. Sample Size for the Training Set
This information is not applicable as there is no mention of a training set, as the device is a physical product and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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.
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
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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,
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
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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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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 97070Phone: 503-885-7030Email: 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, MBAFDA 510k Consulting, LLCPalm Beach Gardens, FL 33410Phone: 386-243-4332Email: john@fda510kconsultants.com | |
| 5. Device Classification: | Trade name:Common name:Device:Class:Regulation #:Product Code: | DWFritz ASM2000Surgical Face MaskSurgical MaskII878.4040FXX |
| 6. Predicate: | Applicant:Device:510(k) Number: | Mexpo International, Inc.Avianz Surgical Face MaskK200847 |
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.
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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 surgicalface mask is intended toprotect both the patientand healthcare worker fromtransfer of micro-organisms, body fluids andparticulate matter. Thisdevice is non-sterile and forsingle use only. | When properly worn, thesurgical face masks areintended to protect bothpatient and healthcareworkers from transfer ofmicroorganisms, body fluidsand airborne particles. Thisdevice is non-sterile and forsingle use only. | Same |
| Model | 3-ply, flat-pleated style withear loops and nose bridge | 3-Ply, Flat-Pleated Style withear loops and nose bridge | Same |
| Materials, Dimensions, & Other Features | |||
| Outer FacingLayer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle Layer | Meltblown Polypropylene | Meltblown Polypropylene | Same |
| Inner Facing Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Bridge | Galvanized wire withpolyester coating | Galvanized wire withpolyester coating | Same |
Comparison Table
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| Ear Loops | Not made with natural rubberlatex | Not made with natural rubberlatex | 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 | < 4.7 mmH2O/cm2 | < 5.0 mmH2O/cm2 | Both Pass |
| Flammability | Class 1 | Class 1 | Same |
| Biocompatibility: | |||
| Cytotoxicity | Not Cytotoxic | Not Cytotoxic | Same |
| Sensitization | Not Skin Sensitive | Not Skin Sensitive | Same |
| Irritation | Not Skin Irritating | Not Skin Irritating | Same |
DWFritz ASM2000 is comparable to the predicate device (K200847) in terms of materials, performance, and biocompatibility.
10. Summary Of Non-Clinical Testing
The following performance data has been provided to demonstrate that DWFritz ASM2000 meets the acceptance criteria in the standard.
Non-Clinical Testing Table
| Test Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-05 | Cytotoxicity | < Grade 2cytotoxic effect | Grade 1(slight reactivity) |
| ISO 10993-10 | Skin Sensitization | No sensitizationreaction | No sensitizationreaction |
| ISO 10993-10 | Skin Irritation | No irritation reaction | No irritation reaction |
| ASTM F2101 | Bacterial FiltrationEfficiency (BFE) | 98% | 99.9% |
| ASTM F2299 | Particulate FiltrationEfficiency (PFE) | 98% | 98.8-99.7% in 32 testarticles in each ofthree lots (96 totaltest articles) |
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| ASTM F1862 | Synthetic Blood FluidResistance | 29 out of 32 pass at120 mmHg | 30, 31, and 32 pass at120 mmHg, out of 32test articles in each ofthree lots (96 totaltest articles) |
|---|---|---|---|
| MIL-M-36954C | Differential Pressure(Delta P) | < 5.0 mmH20/cm2 | 2.9 - 4.7 mmH20/cm2in 32 test articles ineach of three lots (96total test articles) |
| 16 CFR 1610 | Flammability | IBE = Test articleignited but exting-uished, burn time >3.5 sec (Class 1) | IBE for all 14 testarticles in each of 3lots (42 total testarticles) |
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.
§ 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.