The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

Device Description

The Moldex-Metric type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.

AI/ML Overview

The provided document is a 510(k) summary for the Moldex-Metric Model 1712 N95 Healthcare Particulate Respirator and Surgical Mask. It describes the device, its intended use, and performance tests conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Test Method	Acceptance Criteria	Device Performance (Model 1712)
Fluid Resistance	ASTM 1862 - 00a	32 of 32 pass	32 of 32 pass
Flammability	16 CFR 1610	Flame spread must be within upper and lower limits / No flame spread on 10 of 10 samples, meets Class I	No flame spread on 10 of 10 samples, meets Class I
Filter Efficiency (%)	NIOSH, 42 CFR Part 84	> 95% Efficient	Average 98.95% efficient of 20 samples
Inhalation Breathing Resistance (mm H2O)	NIOSH, 42 CFR Part 84	< 35.0 mm H2O @ 85 lpm	Average 8.9 mm H2O @ 85 lpm of 3 samples
Exhalation Breathing Resistance (mm H2O)	NIOSH, 42 CFR Part 84	< 25.0 mm H2O @ 85 lpm	Average 8.9 mm H2O @ 85 lpm of 3 samples
Biocompatibility (Cytotoxicity)	ISO 10993-1	Score of 2 or less	Score of 0
Biocompatibility (Sensitization)	ISO 10993-1	Grade 1 (no different than control)	Grade 1
Biocompatibility (Primary Skin Irritation)	ISO 10993-1	Negligible	Negligible
Bacterial Filtration Efficiency	Modified Greene and Vesley Method	> 99.9%	> 99.9%

2. Sample Size Used for the Test Set and Data Provenance

Fluid Resistance: 32 samples were tested. Data provenance is not explicitly stated (e.g., country of origin), but the test was conducted in accordance with ASTM F 1862, a recognized international standard. The test appears to be prospective for the Model 1712.
Flammability: 10 samples were tested. Data provenance is not explicitly stated, but the test was conducted in accordance with 16 CFR 1610. The test appears to be prospective for the Model 1712.
Filter Efficiency: 20 samples were tested. Data provenance is not explicitly stated, but the test was conducted by NIOSH in accordance with 42 CFR Part 84, suggesting a U.S. regulatory context. The test appears to be prospective; the device was certified by NIOSH.
Breathing Resistance (Inhalation and Exhalation): 3 samples were tested for each. Data provenance is not explicitly stated, but the test was conducted by NIOSH in accordance with 42 CFR Part 84, suggesting a U.S. regulatory context. The test appears to be prospective; the device was certified by NIOSH.
Biocompatibility (Cytotoxicity, Sensitization, Primary Skin Irritation): The document states these tests were conducted on predicate devices made from the same material. The specific number of samples for these predicate device tests is not detailed in this summary.
Bacterial Filtration Efficiency: The document states this test was conducted using the Modified Greene and Vesley Method. The specific sample size is not detailed for the Model 1712 directly, but it indicates "Greater than 99.9%" results derived from "Test results show a bacterial filtration efficiency greater than 99.9%." It also notes that this test was "conducted using the Modified Green and Vesley Method... for the predicate devices."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document describes the performance testing of a physical device (respirator mask) against established technical standards and regulatory requirements. It does not involve human expert interpretation of medical images or data where "ground truth" is established by medical experts in the traditional sense (e.g., radiologists interpreting images). The "ground truth" here is objective measurement against specified physical and biological performance standards.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements and compliance with numerical or categorical standards (e.g., "32 of 32 pass," ">95% efficient," "Score of 0"). There is no subjective interpretation requiring an adjudication process for consensus among experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a physical product (respirator mask), not an AI algorithm for diagnostic interpretation that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, the device's performance was evaluated in a standalone manner against objective performance criteria. The tests (fluid resistance, flammability, filter efficiency, breathing resistance, biocompatibility, bacterial filtration efficiency) assess the physical and biological characteristics of the mask itself, without human-in-the-loop performance being a variable in these specific tests.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described are:

Objective physical and biological measurements: This includes quantified values (e.g., percentage efficiency, pressure measurements in mm H2O) and qualitative assessments (e.g., pass/fail for fluid resistance, flame spread classification, biocompatibility scores) against established industry and regulatory standards (ASTM, NIOSH, CFR, ISO).
Predicate device performance data: For some tests (like biocompatibility and bacterial filtration efficiency), the ground truth for the new device's substantial equivalence is established by demonstrating that it performs similarly to or better than a legally marketed predicate device, which itself met regulatory ground truth requirements.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and the testing described does not involve machine learning or AI that would require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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K102173
5-1

June 16, 2010

Section 5. 510(k) Summary

Submitter:

Moldex-Metric, Inc. 10111 W. Jefferson Blvd. Culver City, CA 90232-3509

Contact:

SEP 1 3 2010

Mark Meinecke Director Quality Assurance Telephone: 310-837-6500 x705 Fax: 310-837-0468 E-mail: mmeinecke@moldex.com

Trade Name:

Model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask

Common Name:

Health Care N95 Particulate Respirator and Surgical Mask.

Classification:

Name - Surgical Apparel, as described in 21 CFR 878.4040. Device Class - Class II Product Code - MSH CFR Section - 21 CFR 878.4040

Substantial Equivalency:

The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask is found to be substantially equivalent to Moldex-Metric Health Care N95 Particulate Respirators models 1511, 1512, 1513, 1517 [(510(k) K061859] and models 3001N95-S, 3002N95-M, 3003N95-L, & 3004N95-LP [(510(k) K051182)] . These products have also been tested and approved by NIOSH as N95 Respirators.

Guidance Documents

Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA.

Device Description, Intended Use, Limitations, Comparisons of Predicate Devices, Risks to Health, Exclusions from Standards, & Performance Tests have all been included in this Summary Report as per the Guidance Document.

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510(k) Summary (Continued)

Description:

The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask is approved by NIOSH in accordance with 42 CFR Part 84. The certification numbers is TC-84A-5227.

The type N95 must meet the prescribed test criteria which specifies the use of 0.055 to 0.095 micron diameter challenge and requiring a 95% efficiency or better and was tested by NIOSH in accordance with 42 CFR Part 84. The masks are resistant to synthetic blood as per ASTM F 1862 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood. Breathing resistance was tested by NIOSH in accordance to 42 CFR Part 84. The device has a Bacterial Filtration Efficiency greater than 99.9%. Testing was conducted using the Modified Green and Vesley Method for evaluation of bacterial filtration efficiency of surgical masks for the predicate devices.

Intended Use:

Limitations:

This product does not eliminate the wearer from any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids.

Comparison of Predicate Devices:

The outside cover of the previously cleared devices models 3001N95-S, 3002N95-M, 3003N95-L & 3004N95-LP incorporate a non-woven polypropylene material with a layer of an extruded plastic mesh and the Moldex-Metric models 1511, 1512, 1513, 1517 and new submitted model 1712 incorporate an extruded plastic mesh without the nonwoven material on the outer cover. The head strap color of the cleared device is the same as the Moldex-Metric device models for which clearance is being requested.

Moldex-Metrix model 1712 is only differs from the previously submitted models in that it has been designed as a flat fold type.

The Moldex-Metric type N95 Healthcare Particulate Respirators and Surgical Masks incorporate a highly efficient filter media and is 95% efficiency or better against aerosols that have a count median diameter of 0.055 - 0.095 microns which was scientifically established as the most penetrating particle size. The legally marketed devices previously cleared 510(k) are manufactured from similar materials.

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Description	Moldex-Metric Health Care N95Particulate Respirator andSurgical Mask, model 1712	Moldex-Metric Health Care N95Particulate Respirators andSurgical Masks, models 1511,1512, 1513, 1517(510k #K061859)	Moldex-Metrix Health Care N95Particulate Respirators and SurgicalMasks, models 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP(510k #K051182)
MaterialsOuter Cover Fabrics	Spunbond polypropylene,Meltblown polypropylene	Spunbond polypropylene,Meltblown polypropylene	Spunbond polypropylene, Meltblownpolypropylene
Nosepiece	Polyethylene foam	Polyethylene foam	Polyethylene foam
Headband	Various colors elastic, latex free	Various colors elastic, latex free	Various colors elastic, latex free
Specification &Dimensions	Medium/Large size (5 1/2" x 51/16")	Various sizes (4.75" - 5.625"circumference)	Various sizes (4.75" - 5.625"circumference)
Mask Style	Molded Cup/Flat Fold	Molded Cup	Molded Cup
Design Features	Dual synthetic rubber	Dual synthetic rubber	Dual synthetic rubber
NIOSH Certification#	TC-84A-5227	TC-84A-0013	TC-84A-4102
Intended Use	The model 1712 Moldex-MetricType N95 HealthcareParticulate Respirator andSurgical Mask meets CDCGuidelines for TB ExposureControl within healthcarefacilities. This device is alsointended to be worn byhealthcare personnel duringsurgical procedures to protectboth the patient and healthcarepersonnel from the transfer ofmicroorganisms, body fluids andparticulate material.	The various models of Moldex-Metric Type N95 HealthcareParticulate Respirators andSurgical Masks meet CDCGuidelines for TB ExposureControl within healthcarefacilities. These devices are alsointended to be worn byhealthcare personnel duringsurgical procedures to protectboth the patient and healthcarepersonnel from the transfer ofmicroorganisms, body fluids andparticulate material.	The various models of Moldex-MetricType N95 Healthcare ParticulateRespirators and Surgical Masks meetCDC Guidelines for TB ExposureControl within healthcare facilities.These devices are also intended to beworn by healthcare personnel duringsurgical procedures to protect both thepatient and healthcare personnel fromthe transfer of microorganisms, bodyfluids and particulate material.

nd Predicate Devices Descriptions/ Comparisons Dovice

Risks to Health

PerformanceCharacteristics	Test Method	Acceptance criteria/ Results	Predicate Device Results	Predicate Device Results
		Moldex-Metric Health CareN95 Particulate Respirator andSurgical Mask	Moldex-Metric Health CareN95 Particulate Respiratorsand Surgical Masks variousmodels (4)	Moldex-Metrix Health CareN95 Particulate Respiratorsand Surgical Masks variousmodels (4)
Fluid ResistancePerformance	ASTM 1862- 00a	Model 171232 of 32 pass	Models 1511, 1512, 1513 and151732 of 32 pass	Models 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP32 of 32 pass
FlammabilityClass *	16 CFR 1610	*Flame spread must be withinupper and lower limits/ Noflame spread on 10 of 10samples, meets Class I	Flame spread must be withinupper and lower limits/ Noflame spread on 10 of 10samples, meets Class I	Flame spread must be withinupper and lower limits/ Noflame spread on 10 of 10samples, meets Class I
Filter Efficiency(%)	NIOSH, 42CFRPart 84	> 95% Efficient/ average98.95% efficient of 20 samples	> 95% Efficient/ average98.58% efficient of 17 samples	> 95% Efficient/ average99.11% efficient of 20 samples
InhalationBreathingResistance(mm H2O)	NIOSH, 42CFRPart 84	< 35.0 mm H2O @ 85 lpm/average 8.9 mm H2O @ 85Ipm of 3 samples	< 35.0 mm H2O @ 85 lpm/average 10.3 mm H2O @ 85Ipm of 3 samples	< 35.0 mm H2O @ 85 lpm/average 11.3 mm H2O @ 85Ipm of 3 samples
ExhalationBreathingResistance(mm H2O)	NIOSH, 42CFR Part 84	< 25.0 mm H2O @ 85 lpm/average 8.9 mm H2O @ 85Ipm of 3 samples	< 25.0 mm H2O @ 85 lpm/average 9.9 mm H2O @ 85Ipm of 3 samples	< 25.0 mm H2O @ 85 Ipm/average 16.9 mm H2O @ 85Ipm of 5 samples
Biocompatibility *	ISO 10993-1	CytotoxicityScore of 2 or less/score of 0	CytotoxicityScore of 2 or less/score of 0	Cytotoxicity, score of 2 or less/Score of 0
		Sensitization, Grade 1 (nodifferent than control)/Grade 1	Sensitization, Grade 1 (nodifferent than control)/Grade 1	Sensitization, Grade 1 (nodifferent than control)/ Grade 1
		Primary Skin IrritationNegligible/Negligible	Primary Skin IrritationNegligible/Negligible	Primary Skin Irritation,Negligible/Negligible
Bacterial FiltrationEfficiency *	ModifiedGreene andVesleyMethod. JBacteriol93:663.667	Test results show a bacterialfiltration efficiency greaterthan 99.9%	Test results show a bacterialfiltration efficiency greaterthan 99.9%	Greater than 99.9%

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Risk analysis is the same as the predicate devices. Approved under K061859 and K051182 the surgical mask device and the predicate device are made from the same material. The design of the mask with fold features was tested for Fluid Resistant in accordance with ASTM F 1862@ 160mmHg. All 32 of 32 pass and any risks would have been exposed at Fluid Resistant Testing.

Exclusions from Standards*

In accordance with ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and Testing (Third Edition, 2003-08-01), Table 1 - Initial evaluation of tests for consideration, since contact duration is A-Limited (<24 h), only the Cytotoxicity, Sensitization, and Irritation or Intracttaneous Reactivity tests were performed.

Performance Tests:

This product was tested and certified by NIOSH as an approved N95 Respirator. It meets all the requirements prescribed in 42 CFR Part 84 and is assigned TC-84A-5227

Tests Performed

1. Fluid Resistance Resistance of Liquid (Synthetic Blood Penetration Resistance) ASTM F 1862.
1. Filtration Efficiency (Particulate and Bacterial) 42 CFR Part 84
1. Differential Pressure (Delta P) Breathing Resistance 42 CFR Part 84
1. Flammability* 16 CFR 1610 (Class 1)
Biocompatibility* (tested on predicate devices) న్.
- Cytotoxicity .
- Sensitization .
- Irritation .
Bacterial Filtration Efficiency* Modified Greene and Vesley Method. J રું. Bacteriol 83:663-667.

Tests were conducted on Predicate Devices which are made from the same material as models identified in this 510(k) submission.

Safety/ Effectiveness:

The device has a fittration equivalent to the previously cleared Moldex-Metric N9S Particulate Respirator and The uevice has a mination opervation to the provised on the vare NOSH approved and meet the CDC guidelines for TB exposure control.

Conclusion:

The basic construction and material used in the cleared devices are the same as in the new device. The cleared devices and the new device are also approved by NTOSH, and meets all other required tosts. The Moldex-Metric type N95 Healthcare Paticulate Respirator and Surgical Mask is substantially equivalent to those listed on page 11 - 4.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Moldex/Metric, Incorporated C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

SEP 1 3 2010

Re: K102173

Trade/Device Name: Model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II

Product Code: MSH

Dated: August 26, 2010 Received: August 31, 2010

Dear Mr. Lehtonen:

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. Lehtonen

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 (OS) 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.

h 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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Section 4. Indications for Use

SEP 1 8 2010

K102173

4 - 1

510(k) Number (if known):

Device Name: Model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask

Indications for Use: The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D)

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)

Edith F. Clavise-Wille

(Division Sign-Off) (Division Sign-Un)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anton Control, Dental Devices

510(k) Number: K102173

Regulation Number and Section

§ 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.