Aearo Surgical N95 Respirators, N9504C, N9504CS and N9514 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. This includes use as a procedure mask. isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

Device Description

These masks are molded cup masks, with a center layer of polypropylene meltblown material sandwiched by inner and outer layers of nonwoven material. The mask has 2 elastic headbands. No fiberglass media is used in this product.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Test Method	Acceptance Criteria	Reported Device Performance (N9504C, N9504CS, N9514C)	Predicate Device Results (Gerson Isolair APR Model 2735)
Fluid Resistance	ASTM F-1862 @ 80 mmHg	29 of 32 show no fluid penetration (from narrative) / 32 of 32 pass (from table)	32 of 32 pass	32/32 pass
Flammability Class	21 CFR Part 58	Flame spread must be within upper and lower control limits / Meets Class I	No flame spread on 10 of 10 samples, meets Class I	Meets Class I
Filter Efficiency	NIOSH, 42CFR Part 84	≥95% Efficient	Average 97.36% (N9514C), 97.66% (N9504C), and 97.83% (N9504CS) efficient of 20 samples	Average 96.86% efficient of 20 samples
Breathing Resistance (Inhalation)	NIOSH 42CFR Part 84 (Inhalation)	≤35.0 mm H2O @ 85 lpm (implied as max for inhalation)	Average 6.2 mm H2O (N9514C), 7.6 mm H2O (N9504C), and 8.0 mm H2O (N9504CS) @ 85 lpm (average of 3 samples each)	Average 15.2 mm H2O on 3 samples
Biocompatibility - Cytotoxicity	ISO-10993-1 / Agar Overlay	Score of 2 or less	Score of 0	N/A (not provided for predicate)
Biocompatibility - Sensitization	ISO-10993-1 / Closed Patch Test	No visible change, Score of 0	No visible change, Score of 0	N/A (not provided for predicate)
Biocompatibility - Primary Skin Irritation	ISO-10993-1 / 16 CFR 1500 (rabbits)	Negligible, Score of 0	Negligible, Score of 0	N/A (not provided for predicate)
Bacterial Filtration Efficiency (BFE)	ASTM F2101-01	Not explicitly stated as acceptance criteria in the table, but narrative states "showed a percent BFE of greater than 99.9% on all samples tested" for adequacy of mask as a respiratory barrier for bacteria.	Greater than 99.9% on all samples tested (using Staphylococcus aureus biological aerosol)	N/A (not explicitly provided for predicate, likely covered by NIOSH certification for predicate as well)

Notes on Acceptance Criteria:

The document sometimes states the acceptance criteria in the narrative and sometimes directly in the table. The table combines this information.
For Fluid Resistance, the narrative states "29 of 32 show no fluid penetration," while the table states "32 of 32 pass." The reported performance of "32 of 32 pass" clearly meets both.
The breathing resistance acceptance criteria are derived from NIOSH 42CFR Part 84, which specifies maximum allowed resistance for inhalation and exhalation. The provided data are for inhalation.

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

Fluid Resistance: 32 masks
Flammability Class: 10 samples
Filter Efficiency: 20 samples
Breathing Resistance: 3 samples for each model (N9514C, N9504C, N9504CS), totaling 9 samples.
Bacterial Filtration Efficiency (BFE): "all samples tested" (specific number not given, but described using a biological aerosol of Staphylococcus aureus)
Biocompatibility - Cytotoxicity: "None of the mask samples tested" (specific number not given)
Biocompatibility - Primary Skin Irritation: 3 rabbits
Biocompatibility - Delayed Hypersensitivity: Albino guinea pigs (specific number not given, but based on ISO 10993-10, 2002 requirements)

Data Provenance: The studies were conducted by various laboratories, including Nelson Laboratories and AppTec Laboratory Services. The location of these labs (e.g., country of origin) is not specified. The studies appear to be prospective tests performed specifically for this 510(k) submission, confirming the device's performance against established standards.

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

This section is not applicable to this type of device (N95 respirators) and testing. The "ground truth" for these performance characteristics (fluid resistance, flammability, filtration efficiency, biocompatibility) is established by adherence to standardized, objective test methods (e.g., ASTM, NIOSH, ISO) and laboratory measurements, not by expert consensus or interpretations of complex data like medical images. The expertise lies in conducting the tests according to the specified protocols and interpreting the objective results.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies where individual expert assessments need to be combined or resolved, such as in clinical image interpretation or diagnostic evaluations. The tests performed for this device are objective laboratory measurements with numerical or categorical outcomes (e.g., pass/fail, percentage, score of X).

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 section is not applicable. MRMC studies are used to evaluate the diagnostic performance of medical devices that involve human interpretation, often assisted by AI. This submission is for an N95 respirator, which is a physical barrier device, not a diagnostic tool requiring human interpretation or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This section is not applicable. "Standalone performance" refers to the performance of an AI algorithm without human involvement. As stated above, this device is not an AI algorithm or a diagnostic tool.

7. The Type of Ground Truth Used:

The ground truth for these tests is based on objective, standardized laboratory measurements and physical property assessments using internationally recognized standards (ASTM, NIOSH, ISO).

Fluid Resistance: Direct measurement of liquid penetration.
Flammability: Observation of flame spread under controlled conditions.
Filter Efficiency: Measurement of particle penetration through the material.
Breathing Resistance: Measurement of pressure drop across the respirator.
Bacterial Filtration Efficiency: Measurement of bacterial penetration.
Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization on rabbits/guinea pigs) biological responses as per ISO standards.

8. The Sample Size for the Training Set:

This section is not applicable. The N95 respirator is a manufactured physical product, not a learning algorithm. Therefore, there is no "training set" in the context of machine learning or AI.

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

This section is not applicable for the same reason as point 8.

Summary

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Abbreviated 510(K) For Aearo Company

K070168

N9504C, N9504CS and N9514C Surgical N95 Respirators

ll 510(k) Summary

APR 1 0 2007

Company Name and Address

Aearo Company 90 Mechanic Street Southbridge, MA 01550

Contact Person

Ann Phillips Quality Assurance Manager Telephone 508-764-5713 Fax 508-764-5242 E-Mail ann phillips@aearo.com

Manufacturing Facility

Available from Company

Date Prepared

January 12, 2007

Device Name

Trade Name - N9504C, N9504CS and N9514C N95 Respirators Common Name - Surgical Mask or Surgical N95 Respirator

Classification

CFR Section - 21 CFR 878,4040 Device Class - Class II Product Code - MSH - Surgical N95 Respirator

Device Description

Intended Use

These masks are intended for single use by operating room personnel or general health care workers for protection against microscopic organisms, body fluids and particulates. This would include use as a procedure mask, isolation mask or dental face mask.

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Abbreviated 510(K) For Aearo Company N9504C, N9504CS and N9514C Surgical N95 Respirators

ll 510(k)Summary (cont.)

N95 Respirators, N9504C, N9504CS and N9514C have been used in the industrial setting for over a year. They are NIOSH approved N95 respirators. approval numbers TC-84A-3715 and TC-84A-4272. OSHA regulations and the concerns relating to exposure of health care personnel to bloodborne pathogens have brought these types of products into the medical and dental care arenas.

Risk analysis was conducted as recommended in the Guidance Document for Surgical Masks. Adequacy of the fluid resistance was evaluated using ASTM 1862-00a. Testing was conducted at 80 mmHg. Acceptance criteria for this test is that 29 of 32 show no fluid penetration. Test results for these masks showed 32 of the 32 masks tested had no fluid penetration. Adequacy of the Mask for air exchange and as a respiratory barrier for bacteria were evaluated at the time of NIOSH certification. In addition, we conducted tests according to ASTM F2101-01, Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureas at Nelson Laboratories which showed a percent BFE of greater than 99.9% on all samples tested. Assessment of flammability of the mask was conducted according to 21 CFR Part 58 and it met Class I requirements showing no flame spread in the tests conducted by Nelson Laboratories. This conforms to the recommendation in the Guidance Document that only class I and class II flammability materials be used in surgical masks intended for use in the operating room. Finally, since surgical masks have parts that come into contact with the skin, biocompatibility was evaluated as described in ISO-10993. Three tests were conducted. Cytotoxicity was evaluated by Nelson Laboratories using the agar overlay method. None of the mask samples tested showed any detectable reactivity. Primary skin irritation was evaluated by AppTec Laboratory Services using rabbits, according to 16 CFR 1500 modified to use 3 animals instead of 6. No irritation was evident on intact or abraded skin after 24 or 72 hours. Delayed Hypersensitivity was evaluated by Northview Pacific Laboratories using the closed patch test NV SOP 16G-60. Albino guinea pigs were used for the test as required by ISO 10993-10, 2002. None of the Pleats Plus patched animals had any visible change at the test site 48 hours after the challenge dose.

This product meets the requirements of the tests recommended for evaluation and risk analysis outlined in the Guidance Document for Surgical Masks. Summary tables with test results for Pleats Plus and the predicate device (including acceptance criteria) and a comparison of the construction of Pleats Plus vs. the predicate device can be found on page 5. Copies of the test reports are in the appendix.

Pleats Plus N95 Respirators are substantially equivalent to the Gerson Isolair APR, type N95, Model 2735, 510(k) K960778, which is marketed for use as a Surgical Mask.

Aearo Company 510(k) 1/12/07

Page 4

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Abbreviated 510(K) For Aearo Company N9504C, N9504CS and N9514C Surgical N95 Respirators

510(k) Summary (cont.)Device and Predicate Device Descriptions/Comparisons
Description	N9504C, N9504CS and N9514CType N95 Masks	Gerson Isolair APRType N95 Model 2735, 510(K) K960778
Fabrics	White nonwoven polyester, meltblown polypropylene	White nonwoven polyester, meltblown polypropylene
Nosepiece	Aluminum	Aluminum
Headband	Yellow Elastic	Yellow Elastic
Specification and Dimensions	Small (13.5" circumference),Large (15.5" circumference)	Small (13.75" circumference)
Mask Style	Cup	Cup
Design Features	Dual elastic head strap	Dual elastic head strap
NIOSH Certification #	TC-84A-3715 (N9504C & N9504CS)TC-84A-4272 (N9514C)	TC-84A-160
Risks to Health
PerformanceCharacteristics	Test Method	Acceptance Criteria/ Results	Predicate Device Results
		N9504C, N9504CS and N9514CType N95 Masks	Gerson Isolair APRType N95 Model 2735,510(K) K960778
Fluid resistancePerformance ( mmHg)	ASTM F-1862@ 80 mmHg	32 of 32 pass/ 32 of 32 pass	32/32 pass
Flammability class	21 CFR Part 58	Flame spread must be withinupper and lower control limits/Noflame spread on 10 of 10 samples,meets Class I	Meets Class I
Filter efficiency	NIOSH, 42CFR Part 84	≥95% Efficient /Average 97.36% (N9514C),97.66%(N9504C), and97.83%(N9504CS)efficient of 20 samples	Average 96.86% efficientof 20 samples
Breathing resistance:	NIOSH 42CFR Part 84	≤35.0 mm H20 @ 85 lpm/average 6.2 mm H20 (N9514C),7.6 mm H20 (N9504C), and8.0 mm H20 (N9504CS) @85 lpmaverage of 3 samples each	Average 15.2 mm H20 on3 samples
Biocompatibility	ISO-10993-1	Cytotoxicity, score of 2 or less/score of 0	N/A
		Sensitization, / No visible change,Score of 0	N/A
		Primary Skin Irritation/Negligible, Score of 0	N/A

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its wings, symbolizing strength and progress. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann L. Phillips Quality Assurance Manager Aearo Company 90 Mechanic Street Southbridge, Massachusetts 01550

APR 1 8 2007

Re: K070168

Trade/Device Name: Surgical N95 Respirators N9504C, N9504CS and N9514C Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: March 22, 2007 Received: March 23, 2007

Dear Ms. Phillips:

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 such 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. Phillips

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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):

Device Name: Surgical N95 Respirators N9504C, N9504CS and N9514C

Indications For Use:

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)

Shula A. Murphy, M.D.

Contri

ospital.

k) Alumber

Page 1 of 1

Aearo Company 510(k)

1/12/07

Page 6

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.