(279 days)
This product is indicated for infection control practices in the health care industry. When worn properly, The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
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This document is a 510(k) summary for "The New Medical Mask", comparing it to a predicate device, the TIDI Facemask (K092580). The study provided is a comparison of performance characteristics against a widely accepted standard (ASTM F 2100 - 07).
Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets those criteria:
Description of Acceptance Criteria and the Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "The New Medical Mask" are defined by its ability to meet the requirements of ASTM F 2100 - 07, Standard Specification for Performance of Materials Used in Medical Face Mask. The reported performance of the device and its predicate (TIDI Facemask, K092580) are presented in the table below. The acceptance is based on achieving performance levels comparable to or exceeding those of the predicate device, thereby demonstrating substantial equivalence.
| Performance Characteristics | Acceptance Criteria (Predicate K092580 Performance) | The New Medical Mask Performance | Meets Criteria? |
|---|---|---|---|
| Bacterial Filtration Efficiency Performance (%) (ASTM F 2101) | >99.9% (High Barrier) | >99.9% (High Barrier) | Yes |
| Differential Pressure (Delta-P) (mm H2O/cm²) (MIL-M-36954C) | 3.4 mm H2O/cm² (Low Barrier) | 2.7 mm H2O/cm² (Low Barrier) | Yes (Better) |
| Sub-micron Particulate Filtration Efficiency at 0.1 micron Performance (%) (ASTM F 2299) | 99.6% (High Barrier) | 99.9% (High Barrier) | Yes (Better) |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass results. (ASTM F 1862) | Pass at 80 mmHg | Pass at 160 mmHg | Yes (Better) |
| Flammability Class (16 CFR Part 1610) | Class 1 | Class 1 | Yes |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify the sample sizes used for each individual test (e.g., how many masks were tested for BFE, Delta-P, etc.). It only provides the performance results.
- Data Provenance: The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided text. However, since the device is being submitted for 510(k) clearance in the US, it implies the tests were conducted according to US-recognized standards (ASTM, MIL-M, CFR), likely by laboratories compliant with these standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to the "The New Medical Mask" submission. The ground truth for performance characteristics of a medical mask is established through standardized laboratory testing protocols (e.g., ASTM F 2101 for BFE, ASTM F 1862 for synthetic blood resistance), not through expert consensus or interpretation of medical images. The tests themselves provide objective numerical results.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human interpretation or clinical outcomes require consensus among experts. For objective lab tests of physical properties of a medical device like a mask, the test results are directly measured and do not require expert adjudication in this manner.
5. 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
This information is not applicable. MRMC studies are typically performed for diagnostic devices (e.g., AI in radiology) where human readers interpret medical cases. "The New Medical Mask" is a physical barrier device, and its performance is evaluated through material property tests, not human interpretation of cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question refers to the performance of artificial intelligence (AI) algorithms without human intervention. "The New Medical Mask" is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of "The New Medical Mask" is established through objective, standardized laboratory measurements against internationally recognized performance standards. Specifically:
- Bacterial Filtration Efficiency (BFE): Measured according to ASTM F 2101.
- Differential Pressure (Breathability): Measured according to MIL-M-36954C.
- Sub-micron Particulate Filtration Efficiency: Measured according to ASTM F 2299.
- Synthetic Blood Penetration Resistance: Measured according to ASTM F 1862.
- Flammability: Measured according to 16 CFR Part 1610.
These standards define the methodologies and acceptable limits for each characteristic.
8. The Sample Size for the Training Set
This information is not applicable. A "training set" is relevant for machine learning algorithms. This submission pertains to a physical medical device, and its development does not involve training data in the AI sense. The design and materials are chosen to meet the standards, and performance is verified through testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. There is no training set or ground truth in the context of an AI algorithm for this device.
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JUL 1 4 2010
510(k) SUMMAR Y
510(k) Number:
Submitted by Owner:
Jong T. Huang, MD, FACP President H & H Research Company 1245 Wilshire Blvd., No. 501 Los Angeles, CA 90017 Fax: 213-977-9071 Tel: 213-977-1257 Email: drihuang@gmail.com
June 9, 2010 Date of Preparation:
Name of Device:
The New Medical Mask
Classification Name and Product Code: Medical Mask; Surgical Apparel (21CFR878.4040) Product Code: FXX
SUMMARY STATEMENT:
Predicate Products: TIDI™ Facemask, Tidi Products, LLC: K092580 Spunguard Mask, Kimberly-Clark: K823078 3M Particulate Respirator and Surgical Mask Model 1870: K063023
Comparison of Intended Use:
This product is indicated for infection control practices in the health care industry.
When worn properly. The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms. body fluids and particulate material.
Predicates:
TIDI Facemask - The TIDI Facemasks by Tidi Products, LLC, are surgical masks 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.
Spunguard - The Spunguard mask is intended to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material.
3M Particulate Respirator and Surgical Mask Model 1870 - As a respirator, it is intended to help reduce wearer exposure to certain airborne particles including those generated by
510(k) K093179 The New Medical Mask
H & H Research Company
13
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electrocautery, laser surgery, and other powered medical instruments. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials.
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510(k) K093179 The New Medical Mask
H & H Research Company
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| Comparison of Design Characteristics: Predicate = TIDI Facemask | |||||
|---|---|---|---|---|---|
| -- | -- | ----------------------------------------------------------------- | -- | -- | -- |
| Feature | The New Medical Mask | Predicate (K092580) |
|---|---|---|
| Style | flat | flat pleated |
| Attachment | non-latex elastic ear bands | non-latex elastic ear loops |
| Nose | adhesive tape | malleable aluminum |
| Filter Material | polypropylene | polypropylene |
| Covering | polypropylene | polypropylene |
| Length | 7.1 inches (18 cm) | 7.0 inches |
| Width | 3.9 inches (10 cm) | 3.5 inches |
| Sterile | No | No |
| Single Use | Yes | Yes |
Comparison of Performance Characteristics: Predicate = TIDI Facemask
Both products meet the requirements of ASTM F 2100 - 07, Standard Specification for Performance of Materials Used in Medical Face Mask, as demonstrated below:
| Performance Characteristics | The New MedicalMask | PredicateK092580 |
|---|---|---|
| Bacterial Filtration EfficiencyPerformance (%) (ASTM F 2101) | >99.9%High Barrier | >99.9%High Barrier |
| Differential Pressure (Delta-P) (mmH2O/cm²) (MIL-M-36954C) | 2.7 mm H2O/cm²Low Barrier | 3.4 mm H2O/cm²Low Barrier |
| Sub-micron Particulate FiltrationEfficiency at 0.1 micron Performance(%) (ASTM F 2299) | 99.9%High Barrier | 99.6%High Barrier |
| Resistance to penetration by syntheticblood, Minimum pressure in mmHg forpass results. (ASTM F 1862) | Pass at 160 mmHg | Pass at80mmHg |
| Flammability Class(16 CFR Part 1610) | Class 1 | Class 1 |
510(k) K093179 The New Medical Mask
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Conclusion:
The New Medical Mask has the same intended use as the predicate devices. It has the same design and performance characteristics as the TIDI Facemask and presumably of any other mask that meets the Standard Specification, ASTM F 2100 and which followed the FDA Guidance - Surgical Mask Premarket Notification [510(k)] Submission; Guidance for Industry and FDA (3/5/05, 9/14/07) during development.
510(k) K093179 The New Medical Mask
H & H Research Company
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jong Huang President H & H Research Company 1245 Wilshire Boulevard #501 Los Angeles, California 90017
JUL 1 4 2010
Re: K093179
Trade/Device Name: The New Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: June 9, 2010 Received: June 17, 2010
Dear Mr. Huang:
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. 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.
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Page 2- Mr. Huang
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 yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K093179
Device Name:
The New Medical Mask
Indications For Use:
This product is indicated for infection control practices in the health care industry.
When worn properly, The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms, 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)
Page 1 of
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices 11
510(k) K093179 The New Medical Mask
H & H Research Company
KD93199 : 510(k) Number: J
§ 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.