(60 days)
The Pleats Plus ™ 1054 and 1054S 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.
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.
The Abbreviated 510(K) for Aearo Company Pleats Plus™ 1054 and 1054S Surgical N95 Respirators (K063013) describes the acceptance criteria and the studies performed to demonstrate that the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristics | Test Method | Acceptance Criteria / Predicate Device Results | Reported Device Performance (Pleats Plus 1054 and 1054S) |
|---|---|---|---|
| Fluid Resistance Performance | ASTM 1862-00a @ 120mmHg | 29 of 32 to pass / PASS | PASS |
| Flammability Class | 21 CFR part 58 | Flame spread must be within upper and lower control 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, 42CFR Part 84 | ≥95% Efficient / Average 99.11% efficient of 20 samples | Average 98.45% efficient for 20 samples |
| Breathing Resistance | NIOSH 42CFR Part 84 | ≤35.0 mm H2O @ 85 lpm / average 3.5 mm H2O @ 85 lpm for 3 samples | Average 1.1 mm H2O @ 85 lpm for 3 samples |
| Biocompatibility: Cytotoxicity | ISO-10993-1, Agar overlay method | Score of 2 or less / Score of 0 | Score of 0 |
| Biocompatibility: Sensitization | ISO 10993-10:2002 (study based on) | No visible change, Score of 0 | Score of 0 |
| Biocompatibility: Primary Skin Irritation | ISO 10993-10:2002 (rabbits) | Negligible, Score of 0 | Score of 0 |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-01 (Staphylococcus aureus) | (Not specified as acceptance criteria in table, but reported as an additional test) | Greater than 99.9% on all samples tested |
2. Sample Sizes Used for Each Test and Data Provenance
| Test / Performance Characteristic | Sample Size Used | Data Provenance / Testing Body |
|---|---|---|
| Fluid Resistance Performance | 32 samples (implied from "29 of 32 to pass") | Not explicitly stated, likely Nelson Laboratories (common for such tests) |
| Flammability Class | 10 samples | Nelson Laboratories |
| Filter Efficiency | 20 samples | NIOSH (for certification), specific lab not stated for comparative |
| Breathing Resistance | 3 samples | NIOSH (for certification), specific lab not stated for comparative |
| Biocompatibility: Cytotoxicity | Not specified | Nelson Laboratories |
| Biocompatibility: Sensitization | Not specified | AppTec Laboratory Services (rabbits) |
| Biocompatibility: Primary Skin Irritation | Not specified | AppTec Laboratory Services (rabbits) |
| Bacterial Filtration Efficiency (BFE) | Not specified | Nelson Laboratories |
The data provenance is from laboratory testing (e.g., Nelson Laboratories, AppTec Laboratory Services, NIOSH certification). These are prospective tests performed specifically for device evaluation. The country of origin for the manufacturing facility is Handan Hengyong Protective & Clean Products Co., LTD. Jiankang East Street Yongnian County High-Tech Development Area Hebei province, P.R. China, however, the testing laboratories are US-based (Nelson Labs and AppTec).
3. Number of Experts and Qualifications for Establishing Ground Truth
This document describes the testing of a physical medical device (N95 respirator) against established performance standards and methods. It does not involve a "ground truth" expert consensus in the same way a diagnostic imaging AI algorithm would. Instead, the "ground truth" is defined by:
- Standardized test methods: ASTM 1862-00a, 21 CFR part 58, NIOSH 42CFR Part 84, ISO-10993-1, ASTM F2101-01.
- Regulatory bodies and accredited laboratories: NIOSH approval TC-84A-4320, Nelson Laboratories, AppTec Laboratory Services.
Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications (like radiologists) is not applicable here. The "experts" are the scientists and technicians in the accredited labs performing the standardized tests according to the protocols set by regulatory bodies.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1, 3+1) is typically relevant for studies where human interpretation or consensus is required (e.g., medical image reading). For the physical testing of the N95 respirator, the results are quantitative and objective measurements against predefined acceptance criteria. Therefore, no adjudication method as described is applicable or performed in this context. The results are reported directly from the laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, typically in diagnostic tasks. This submission is for a physical device (N95 respirator), not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, this question is not applicable as the device is a physical N95 respirator, not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.
7. Type of Ground Truth Used
For this device, the "ground truth" is based on:
- Standardized physical and chemical test results: Objective measurements demonstrating performance against established industry standards and regulatory requirements (e.g., ASTM, NIOSH, ISO, CFR).
- Predicate device comparison: The device's performance is also compared against a legally marketed predicate device (Pleats Plus 1050), establishing substantial equivalence based on meeting similar performance characteristics.
8. Sample Size for the Training Set
This question is not applicable as the device is a physical N95 respirator, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical N95 respirator and does not use a training set in the context of machine learning.
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Abbreviated 510(K) For Aearo Company Pleats Plus™ 1054 and 1054S Surgical N95 Respirators
Page 1 of 3
DEC - 1 2006
ll 510(k) Summary
Company Name and Address
Aearo Companv 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
Handan Hengyong Protective & Clean Products Co., LTD. Jiankang East Street Yongnian County High-Tech Development Area Hebei province, P.R. China
Date Prepared
September 29, 2006
Device Name
Trade Name - Pleats Plus N95 Respirator 1054 and 1054S 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
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.
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.
Aearo Company 510(k) 9/29/06
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Page 2 of 3
= 510(k)Summary (cont.)
Pleats Plus N95 1054 and 1054S Respirators are manufactured to the same specifications as Pleats Plus 1050 which have been used in the industrial setting for over 5 years. The Pleats Plus 1054 and 1054S is a NIOSH approved N95 respirator, approval number TC-84A-4320. 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 120 mmHg and 80mmHg. Test results showed that the Pleats Plus 1054 passed. 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 16 CFR 1610 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 Pleats Plus samples tested showed any detectable reactivity. Primary skin irritation was evaluated by AppTec Laboratory Services using rabbits, according to ISO 10993-10:2002. No irritation was evident on intact or abraded skin after 24 or 72 hours. Delayed Hypersensitivity was evaluated by AppTec Laboratory Services using a study based upon the procedures described in 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 1054 N95 Respirators are substantially equivalent to the Pleats Plus 1050 N95 Respirators, which are marketed for use as a Surgical Mask.
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page 3 of 3
Abbreviated 510(K) For Aearo Company Pleats Plus™ 1054 Surgical N95 Respirators
II 510(k) Summary (cont.)
Device and Predicate Device Descriptions/Comparisons
| Description | Pleats Plus 1050 and 1050S | Pleats Plus 1054 and 1054S |
|---|---|---|
| Materials | ||
| Fabrics | White spunbond polypropylene,meltblown polypropylene | White nonwoven polyester,meltblown polypropylene |
| Nosepiece | Tie wire | Tie wire |
| Headband | White Elastic | White Elastic |
| Specification and Dimensions | Small (13.5" circumference),Large (15.5" circumference) | Small (13.5" circumference),Large (15.5" circumference) |
| Mask Style | Flat pleated | Flat Pleated |
| Design Features | Dual elastic head strap | Dual elastic head strap |
| NIOSH Certification # | TC-84A-2630 | TC-84A-4320 |
Risks to Health
| PerformanceCharacteristics | Test Method | Acceptance Criteria/Predicate Device Results | Results |
|---|---|---|---|
| Fluid resistancePerformance (mmHg) | ASTM 1862-00a @120mmHg | 29 of 32 to pass/ PASS | Pleats Plus 1054 and 1054SPASS |
| Flammability class | 21 CFR part 58 | Flame spread must be withinupper and lower controllimits/No flame spread on 10 of10 samples, meets Class I | No flame spread on 10 of 10samples, meets Class I |
| Filter efficiency | NIOSH, 42CFR Part84 | ≥95% Efficient / Average99.11% efficient of 20 samples | Average 98.45% efficientfor 20 samples |
| Breathing resistance: | NIOSH 42CFR Part84 | ≤35.0 mm H20 @ 85 lpm/average 3.5 mm H20 @85 lpmfor 3 samples | Average 1.1 mm H20@85 lpm for 3 samples |
| Biocompatibility | ISO-10993-1 | Cytotoxicity, score of 2 or less/Score of 0 | Score of 0 |
| Sensitization, / No visiblechange, Score of 0 | Score of 0 | ||
| Primary Skin Irritation/Negligible, Score of 0 | Score of 0 |
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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann L. Phillips Quality Assurance Manager Aearo Company 90 Mechanic Street Southbridge, Minnesota 01550
DEC - 1 2006
Re: K063013
Trade/Device Name: Pleats Plus™ N95 Respirator 1054 and 1054S Surgical N95 Respirator Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: November 13, 2006 Received: November 15, 2006
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Kung
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 .
KO 63013
KOS3643 510(k) Number (if known):
Pleats Plus™ N95 Respirator 1054 and 1054S Device Name: Surgical N95 Respirator
Indications For Use:
The Pleats Plus ™ 1054 and 1054S 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.
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)
Shalie A. Murphy, bo
tion of Anesthesiology, General Hospical Con Control, Dental Devices
Number. K063013
§ 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.