(124 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of the mask, with no mention of AI or ML.
No.
The device is an N95 Respirator and Surgical Mask, which is used for protection from transfer of microorganisms and particulate matter, not for treating a disease or condition.
No
The device is described as a respirator and surgical mask intended to protect against transfer of microorganisms and particulate materials. There is no mention of it being used to diagnose any disease or condition.
No
The device description clearly indicates a physical, multi-layered mask with headbands and a nosepiece, and the performance studies focus on physical properties like filtration efficiency, flammability, and biocompatibility. There is no mention of software components.
No, 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 physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction of a mask, not a device designed to analyze biological samples.
- Performance Studies and Key Metrics: The studies and metrics focus on the physical properties and performance of the mask as a barrier (filter efficiency, breathing resistance, fluid resistance, flammability, biocompatibility), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
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.
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)
Fluid resistance performance at 120mmHg: 29 of 32 pass (acceptance criteria), 31 of 32 pass (Pleats Plus results).
Flammability class per 16 CFR 1610: Flame spread must be within upper and lower control limits (acceptance criteria), No flame spread on 10 of 10 samples, meets Class I (Pleats Plus results).
Filter efficiency per NIOSH, 42CFR Part 84: ≥95% Efficient (acceptance criteria), Average 99.11% efficient of 20 samples (Pleats Plus results).
Breathing resistance per NIOSH 42CFR Part 84: ≤35.0 mm H20 @ 85 lpm (acceptance criteria), average 3.5 mm H20 @85 lpm of 3 samples (Pleats Plus results).
Biocompatibility per ISO-10993-1:
Cytotoxicity: score of 2 or less (acceptance criteria), score of 0 (Pleats Plus results).
Sensitization: No visible change, Score of 0 (Pleats Plus results).
Primary Skin Irritation: Negligible, Score of 0 (Pleats Plus results).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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
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.
Acaro Company 510(k) 8/3 ] /04
1
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)
2
Abbreviated 510(K)
For Aearo Company
ت
--
510(k) Summary (cont) ll
Device and Predicate Device Descriptions/Comparisons
| Description | Pleats Plus 1050 and 1050S | Gerson Isolair APR
Type 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
| Performance
Characteristics | Test Method | Acceptance Criteria/ Results | Predicate Device
Results |
|----------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| | | Pleats Plus 1050 and 1050S | Gerson Isolair APR
Type N95 Model 2735,
510(K) K960778 |
| Fluid resistance
Performance (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 within
upper and lower control limits/No
flame spread on 10 of 10 samples,
meets Class I | Meets Class I |
| Filter efficiency | NIOSH, 42CFR Part
84 | ≥95% Efficient / Average 99.11%
efficient of 20 samples | Average 96.86% efficient
of 20 samples |
| Breathing resistance: | NIOSH 42CFR Part
84 | ≤35.0 mm H20 @ 85 lpm/
average 3.5 mm H20 @85 lpm of
3 samples | Average 15.2 mm H20 of
3 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
3
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.
4
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
5
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:
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.
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