(186 days)
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
The TIDI® Facemask, are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% SBPP or 100% medical grade tissue paper. The ear loops are made of latex free elastic. The nosepieces are made of malleable aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The mask covers the nose and mouth, and is secured to the face using the attached ear loops. The TIDI® Facemasks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of microorganisms, body fluids and particulate material.
The document provided describes the TIDI® Facemask, a surgical mask, and its nonclinical testing to demonstrate substantial equivalence to predicate devices, rather than a novel AI/software medical device. As such, most of the requested information regarding AI device evaluation (e.g., sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training data) is not applicable to this submission.
However, I can extract the acceptance criteria and performance data for the TIDI® Facemask as presented in the document.
Acceptance Criteria and Reported Device Performance
The study referenced is a nonclinical test performed to demonstrate that the TIDI® Facemask meets the specified acceptance criteria of ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face Mask. This standard defines requirements for different performance classes (Low Barrier, Moderate Barrier, High Barrier). The TIDI® Facemask was tested against these criteria.
| Performance Characteristics | Acceptance Criteria (High Barrier) | TIDI® Facemask Test Results Summary |
|---|---|---|
| Bacterial Filtration Efficiency Performance (%) (ASTM 2101) | ≥98 | >99.9 |
| Differential Pressure (Delta-P) (mm H2O/cm²) (MIL-M 36954C) | <4.0 | 3.4 |
| Sub-micron Particulate Filtration Efficiency at 0.1 micron Performance (%) (ASTM F 2299) | ≥98 | 99.6 |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass results. (ASTM F 1862) | 160 (for High Barrier) | Pass @ 80 mm Hg |
| Flammability Class (16CFR Part 1610) | Class 1 | Class 1 |
Additional Information (Not applicable to AI devices, but relevant to this submission):
- Sample sized used for the test set and the data provenance: Not specified, as it refers to performance testing of physical materials, not an AI model. The tests are for the mask material itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for masks is established by standardized physical/biological tests.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable, as this is a physical medical device (surgical mask), not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Standardized laboratory test results for physical properties and filtration efficacy.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows a logo for TIDL Products. The logo features a stylized letter "T" with swooping lines above it. Below the "T" is the word "TIDL" in bold, followed by "PRODUCTS" in a smaller font. The tagline "Care with Confidence" is written in a cursive font below the main text.
Certified in 190 9001:2000, EN/ISO 13485:2003, European CE Mark
510(k) Summary TIDI® Facemask
FEB 2 8 2010
To: Whom it may concern
Date: February 12, 2010
Submitter/ Contact - Name and Address
Dion J. Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah WI 54956 Telephone: (920) 751-4386 (920) 751-4370 Fax:
FDA Registration Number: 2182318
Device Details:
Trade Name: TIDI® Facemasks or Customer trade names Common Name: Surgical Mask Classification Name: Mask, Surgical Product Code: FXX Regulation Number: 878.4040
Equivalent Legally Marketed Device:
The TIDI® Facemasks are similar to the predicate device in material composition, design, style and dimensions. The similarities in materials, design, style along with performance testing supports that the TIDI® Facemasks are substantially equivalent to the predicate device. The comparison table on the following page out-lines the similarities and any differences between the TIDI® Facemask and the predicate device.
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Predicate Devices
- A.R. Medicom Non-Sterile Surgical Mask 2) Crosstex Isolite Surgical Mask
.
| Description | TIDI® Facemask | Predicate:Non-Sterile Surgical MaskK051291 and K012602 |
|---|---|---|
| Materials | ||
| Outer layer | Polypropylene Spun-bond | Same |
| Filter Media | Melt-blown polypropylene | Same |
| Inner Layer | Polypropylene Spun-bond | Same |
| Nose Piece | Malleable aluminum | Same |
| Ear Attachment | Elastic | Same |
| Anti-Fog | Foam | N/A |
| Dimensions | ||
| Length | 7.0 inches | Same |
| Width | 3.5 inches | Same |
| Design | ||
| Style | Flat, Pleated | Same |
| Fluid resistant | Same | |
| Elastic Ear loops | Same | |
| Sterile | No | Same |
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DESCRIPTION OF THE DEVICE:
The TIDI® Facemask, are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% SBPP or 100% medical grade tissue paper. The ear loops are made of latex free elastic. The nosepieces are made of malleable aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The mask covers the nose and mouth, and is secured to the face using the attached ear loops. The TIDI® Facemasks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of microorganisms, body fluids and particulate material.
The following is a list of models of the TIDI® Facemasks with a description.
Model 9010 -This is the standard facemask model with ear loop attachments.
Model 9020-This facemask model is supplied with an anti-fog strip of polyurethane foam. The foam is attached over the nose wire on the inside of the mask.
INTENDED USE:
The TIDI® Facemask intended use is: Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Page 3 of 5
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Device and Predicate Device Technical Characteristics:
| Description | TIDI® | Predicate Device | Predicate Device | |||||
|---|---|---|---|---|---|---|---|---|
| Facemask | K012602 | K051291 | ||||||
| Crosstex® Ultra | Safe+Mask® Premier | |||||||
| Fluid Resistant No- | Elite Ear loop Mask | |||||||
| Fog® Ear Loop Face | ||||||||
| Mask | ||||||||
| Material Composition | ||||||||
| Type of fabric: | ||||||||
| Outer Layer | Polypropylene | Polypropylene | Polypropylene | |||||
| Spun-bond | Spun-bond | Spun-bond | ||||||
| Filter Media | Melt-blown | Melt-blown | Melt-blown | |||||
| polypropylene | polypropylene | polypropylene | ||||||
| Inner Layer | Polypropylene | Polypropylene | Polypropylene | |||||
| Spun-bond | Spun-bond | Spun-bond | ||||||
| Other Materials: | ||||||||
| Nose Piece: | Aluminum | Aluminum | Aluminum | |||||
| Lar | Elastic | Elastic | Elastic | |||||
| Attachment: | ||||||||
| Anti-Fog | Polyester | Polyester Urethane | none | |||||
| Urethane foam | foam | |||||||
| The difference of the anti fog material is the polyester urethane foam. The | ||||||||
| polyester foam material has been used in medical application on facemask for | ||||||||
| an anti-fog strip without any toxicity or biological compatibility issues. It has | ||||||||
| been proven to be non-toxic, non-sensitizing, and non-irritating. | ||||||||
| Specification and Dimensions: | ||||||||
| Dimensions: | ||||||||
| Length: | 7.0 inches | 7.0 inches | 7.0 inches | |||||
| Width: | 3.5 inches | 3.5 inches | 3.5 inches | |||||
| Design | Ear Loop | Ear Loop | Ear Loop | |||||
| Features: | ||||||||
| Mask Style: | Flat Pleated | Flat Pleated | Flat Pleated | |||||
Page 4 of 5
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Nonclinical Tests Performed for Determination of Substantial Equivalents are as Follows:
The following is a list of test methods for the TIDI® Facemask in accordance with ASTM 2100 specification for surgical masks. It was our conclusion that testing was conducted and met the specified acceptance criteria of ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face Mask.
| Face Mask Requirements byPerformance Class (ASTM F 2100-07) | ||||
|---|---|---|---|---|
| Performance Characteristics | LowBarrier | ModerateBarrier | High Barrier | TIDI® FacemaskTest ResultsSummary |
| Bacterial Filtration EfficiencyPerformance (%) (ASTM2101) | ≥95 | ≥98 | ≥98 | >99.9 |
| Differential Pressure (Delta-P)(mm H2O/cm²) (MIL-M36954C) | <4.0 | <4.0 | <4.0 | 3.4 |
| Sub-micron ParticulateFiltration Efficiency at 0.1micron Performance (%)(ASTM F 2299) | Notrequired | ≥98 | ≥98 | 99.6 |
| Resistance to penetration bysynthetic blood, Minimumpressure in mmHg for passresults. (ASTM F 1862) | 80 | 120 | 160 | Pass@ 80 mm Hg |
| Flammability Class(16CFR Part 1610) | Class 1 | Class 1 | Class 1 | Class 1 |
Conclusion:
The TIDI® Facemask has the same intended use and technological characteristics as the predicate devices. Product testing and FMEA risk analysis performed did not identify any other risks on the safety or effectiveness associated with surgical masks, other then identified in the Guidance for Industry and FDA Staff: Surgical Masks- Premarket Notification [510(k)] Submission: Guidance for Industry and FDA issued on: March 5, 2004. The TIDI® Facemask are substantially equivalent to the predicate device.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three arms reaching upwards, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Dion J. Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah, Wisconsin 54956
FEB 2 8 2010 -
Re: - K092580 Trade/Device Name: TIDI® Facemask Regulation Number: 21CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: December 7, 2009 Received: December 7, 2009
Dear Ms. Brandt:
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. 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.
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.
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Page 2- Ms. Brandt
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sean Runser
Anthony D. Watson, BS, MS, MBA Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kogas 80
Medical Devices
Indications for Use Form
Indications for Use
510(K) Number (if Known): K092580
Device Name: TIDI® Facemask
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Prescription use (Part 21 CFR 801 Subpart D) AND/OR Over- The Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elijabeth F. Slaviero Wills
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K092580
§ 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.