(60 days)
Not Found
Not Found
No
The device is a physical respirator/surgical mask and the summary focuses on material properties and performance metrics related to filtration, fluid resistance, flammability, and biocompatibility. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No
The intended use of the device is to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials, which aligns with protective equipment rather than therapeutic treatment.
No
The device description clearly states its purpose is for protection against transfer of microorganisms and particulate materials, not for diagnosing medical conditions.
No
The device description and performance studies clearly indicate this is a physical medical device (respirator/surgical mask) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for protecting healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical construction of a mask, which is consistent with a personal protective equipment (PPE) device, not an IVD.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on properties like fluid resistance, flammability, filter efficiency, breathing resistance, and biocompatibility. These are all relevant to the protective function of a mask and are not related to diagnostic testing.
IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform any such function.
N/A
Intended Use / Indications for 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.
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.
Product codes
MSH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel or general health care workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid resistance: 29 of 32 to pass; Pleats Plus 1054 and 1054S PASS
- Flammability class: No flame spread on 10 of 10 samples, meets Class I
- Filter efficiency: Average 98.45% efficient for 20 samples
- Breathing resistance: Average 1.1 mm H20 @85 lpm for 3 samples
- Biocompatibility:
- Cytotoxicity: Score of 0
- Sensitization: Score of 0
- Primary Skin Irritation: Score of 0
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
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
| Performance
Characteristics | Test Method | Acceptance Criteria/
Predicate Device Results | Results |
|--------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Fluid resistance
Performance (
mmHg) | ASTM 1862-00a @
120mmHg | 29 of 32 to pass/ PASS | Pleats Plus 1054 and 1054S
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 H20 @ 85 lpm/
average 3.5 mm H20 @85 lpm
for 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 visible
change, Score of 0 | Score of 0 |
| | | Primary Skin Irritation/
Negligible, Score of 0 | Score of 0 |
3
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.
4
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
5
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