The Pleats Plus™ 1050 and 1050S N95 Respirators and Surgical Masks 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 pleated, 3-ply masks, with a center layer of polypropylene meltblown material sandwiched by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearers nose. No fiberglass media is used in this product.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Aearo Company Pleats Plus™ Surgical N95 Respirators, based on the provided text:

Acceptance Criteria and Reported Device Performance

Performance Characteristics	Test Method	Acceptance Criteria/Results (Pleats Plus 1050 and 1050S)	Predicate Device Results (Gerson Isolair APR, Type N95 Model 2735)
Fluid resistance Performance	ASTM 1862-00a @ 120mmHg	Acceptance Criteria: 29 of 32 show no fluid penetration. Reported Performance: 31 of 32 pass	32/32 pass
Flammability class	16 CFR 1610	Acceptance Criteria: Flame spread must be within upper and lower control limits. Reported Performance: No flame spread on 10 of 10 samples, meets Class I	Meets Class I
Filter efficiency	NIOSH, 42CFR Part 84	Acceptance Criteria: ≥95% Efficient Reported Performance: Average 99.11% efficient of 20 samples	Average 96.86% efficient of 20 samples
Breathing resistance	NIOSH 42CFR Part 84	Acceptance Criteria: ≤35.0 mm H20 @ 85 lpm Reported Performance: Average 3.5 mm H20 @ 85 lpm of 3 samples	Average 15.2 mm H20 of 3 samples
Biocompatibility: Cytotoxicity	ISO-10993-1 / agar overlay	Acceptance Criteria: Score of 2 or less Reported Performance: Score of 0	N/A (Not Applicable as it was not evaluated for the predicate device in this table)
Biocompatibility: Sensitization	ISO-10993-1 / closed patch	Acceptance Criteria: No visible change Reported Performance: Score of 0	N/A
Biocompatibility: Primary Skin Irritation	ISO-10993-1 / modified 16 CFR 1500	Acceptance Criteria: Negligible Reported Performance: Score of 0	N/A
Bacterial Filtration Efficiency (BFE)	ASTM F2101-01 (using Staphylococcus aureus)	Acceptance Criteria: Not explicitly stated but the reported performance exceeds the Filter efficiency criteria of ≥95%. Reported Performance: Greater than 95.5% on all samples tested.	Not explicitly stated in the comparison table.

Study Details:

Sample sizes used for the test set and the data provenance:
- Fluid resistance: 32 masks were tested. (Provenance not specified, but implied to be from Aearo Company products).
- Flammability class: 10 samples were tested. (Provenance not specified).
- Filter efficiency: 20 samples were tested. (Provenance not specified).
- Breathing resistance: 3 samples were tested. (Provenance not specified).
- Bacterial Filtration Efficiency (BFE): "All samples tested" showed >95.5% BFE. The number of samples for BFE is not explicitly stated, but it was conducted by Nelson Laboratories.
- Cytotoxicity: Samples of Pleats Plus were tested by Nelson Laboratories.
- Primary skin irritation: 3 rabbits were used, tested by NAMSA.
- Delayed Hypersensitivity (Sensitization): Albino guinea pigs were used, tested by Northview Pacific Laboratories.
All tests appear to be prospective to demonstrate the device's performance against specific standards. The country of origin for the data is implied to be the United States, given the testing organizations (Nelson Laboratories, NAMSA, Northview Pacific Laboratories) and the submission to the FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document describes performance testing against established standards (e.g., ASTM, NIOSH, CFR, ISO). The "ground truth" for these tests is implicitly defined by the accepted methodologies and criteria of these standards. There is no mention of human experts establishing a subjective ground truth for the performance test set. The results are objective measurements against defined thresholds.
Adjudication method for the test set:
Not applicable. The tests are objective measurements against published standards and acceptance criteria. There is no mention of physician or expert adjudication as would be seen in diagnostic imaging studies.
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:
No, an MRMC comparative effectiveness study was not done. This document focuses on the physical barrier and material properties of a surgical N95 respirator, not on the performance of an AI-assisted diagnostic tool or human decision-making.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense, the entire performance testing is "standalone" in that it assesses the device's physical performance independent of human interaction for diagnostic purposes. The device itself, a respirator, is the "algorithm" here, and its performance is measured directly against physical and biological challenges. There's no AI algorithm involved.
The type of ground truth used:
The ground truth is based on established engineering and biological standards and their defined acceptance criteria. For example, fluid resistance is measured against a specific pressure (120 mmHg) using ASTM, filter efficiency against NIOSH standards, and biocompatibility against ISO-10993. The "ground truth" is a pass/fail against these objective criteria.
The sample size for the training set:
Not applicable. This notice describes the testing of a physical medical device (respirator), not a machine learning model. Therefore, there is no "training set" in the context of an AI algorithm.
How the ground truth for the training set was established:
Not applicable. As there is no AI algorithm and no training set, the establishment of ground truth for such a set is irrelevant to this submission.

Summary

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K041855

NOV 1 0 2004

Abbreviated 510(K) For Aearo Company Pleats Plus™ Surgical N95 Respirators

510(k) Summary ll

Company Name and Address

Aearo Company 90 Mechanic Street Southbridge, MA 01550 (submitter and manufacturing site)

Contact Person

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

Date Prepared

August 31, 2004 Modifications October 6,2004

Device Name

Trade Name - Pleats Plus N95 Respirator 1050 and 1050S 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

Pleats Plus is 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.

Acaro Company 510(k) 8/3 ] /04

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Abbreviated 510(K) For Aearo Company Pleats Plus™ Surgical N95 Respirators

510(k)Summary (cont) ll

Pleats Plus N95 Respirators have been used in the industrial setting for over 5 Pleats Pills N95 Respirators nave been used in the virus of health care years. It is a NIOST rapproved Noorrespiting to exposure of health care OSHA regulations and the consume have brought these types of products into the medical and dental care arenas.

Risk analysis was conducted as recommended in the Guidance Document for Risk analysis was conducted as rouinments and evaluated using ASTM Surgical Masks. Adequated at 120 mmHg. Acceptance criteria for this Tooz-ova. Testing was concession. Test results for Pleats Plus test is that 29 of 52 show no fluid penetration. Adequacy of the showed 31 of the oz maons tostoosspiratory barner for bacteria were evaluated at Mask for an exchange una in addition, we conducted tests according to the time of NYOU. 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 Staphylocoss aurous all samples tested. Assessment of flammability of the greater than 95.5% on on Sampled 16 CFR 1610 and it met Class | requirements mask was obnews spread in the tests conducted by Nelson Laboratories. This showing 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 operating room. This is in Indian as described in ISO-10993. Three tests were conducted. Cytotoxicity was evaluated by Nelson Laboratories using the agar overlay method. None of the Pleats Plus samples tested showed any detectable reactivity. Primary skin irritation was evaluated by NAMSA 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.

8/31/04 Acaro Company 510(k)

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Abbreviated 510(K)

For Aearo Company

510(k) Summary (cont) ll

Device and Predicate Device Descriptions/Comparisons

Description	Pleats Plus 1050 and 1050S	Gerson Isolair APRType N95 Model 2735 , 510(K)K960778
Materials
Fabrics	White spunbond polypropylene,meltblown polypropylene	White nonwoven polyester,meltblown polypropylene
Nosepiece	Tie wire	Aluminium
Headband	White Elastic	Yellow Elastic
Specification and Dimensions	Small (13.5" circumference),Large (15,5" circumference)	Small (13.75" circumference)
Mask Style	Flat pleated	Cup
Design Features	Dual elastic head strap	Dual elastic head strap
NIOSH Certification #	TC-84A-2630	TC-84A-160

Risks to Health

PerformanceCharacteristics	Test Method	Acceptance Criteria/ Results	Predicate DeviceResults
		Pleats Plus 1050 and 1050S	Gerson Isolair APRType N95 Model 2735,510(K) K960778
Fluid resistancePerformance (mmHg)	ASTM 1862-00a @120mmHg	29 of 32 pass/ 31 of 32 pass	32/32 pass
Flammability class	16 CFR 1610	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 Part84	≥95% Efficient / Average 99.11%efficient of 20 samples	Average 96.86% efficientof 20 samples
Breathing resistance:	NIOSH 42CFR Part84	≤35.0 mm H20 @ 85 lpm/average 3.5 mm H20 @85 lpm of3 samples	Average 15.2 mm H20 of3 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

: "

Aearo Company 510(k)

: |

Page 5

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2004

Aearo Company C/O Mr. Bahram Barzideh Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747-3081

Re: K041855

Trade/Device Name: Pleats Plus™ N95 Respirator 1050 and 1050S Surgical N95 Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: October 8, 2004 Received: October 26, 2004

Dear Mr. Barzideh:

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 vour 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. Barzideh

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Suith Mchive MD. FOR DR. CHIU LIN

ACTING CHIRF, INFECTION CONTROL BRA. 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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Abbreviated 510(K) For Aearo Company Pleats Plus™ Surgical N95 Respirators

Intended Use:

510(k) Number: KOH 1 855

Device Name: Pleats PlusTM N95 Respirator 1050 and 1050S Surgical N95 Respirator

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Juette y. Michin mo MD. FOR DR. CHIU LIN
ACTING CHIEF, INFECTION CONTROL

(Division Sign-Off) ( Charan Olyn-Old)
Division of Anesthesiology, General Hospital, and aron of Anestheslology, Gene

510(k) Number -40418

Page 1 of

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.