Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Device Description

Pasture F550S and Pasture F550CS respirators are disposable duck bill shaped N95 respirators with NIOSH certification number TC-84A-7504. They contain 5 layers composed of polypropylene, with a nose cushion, a synthetic elastic loop or strap, and a nosepiece which is the combination of zinc wires and embedded polyester inside of layers. F550CS is the same respirator as the F550S, but F550CS contains an adjustable buckle on the headband.

Pasture A520S and Pasture A520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7454. They contain 4 layers composed of polypropylene with a synthetic elastic loop or a strap. A520CS is the same respirator as the A520S, but A520CS contains an adjustable buckle on the headband.

Pasture E520S and Pasture E520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7453. They contain 4 layers composed of polypropylene with a nose cushion, synthetic elastic loop or strap, and an aluminum nosepiece. E520CS is the same respirator as E520S, but E520CS contains an adjustable buckle on the headband.

AI/ML Overview

This document describes the premarket notification for several models of Pasture Surgical N95 Respirators (F550S, F550CS, A520S, A520CS, E520S, E520CS). The provided information is insufficient to answer all parts of the request as it pertains to medical device AI/ML performance studies. However, I can extract the relevant information from the document regarding the acceptance criteria and performance of these N95 respirators. The questions asked are typically for AI/ML devices, not for surgical respirators.

Here's an analysis based on the provided text, adapted to the context of a physical medical device (N95 respirator) and its regulatory submission.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for these N95 respirators are based on various performance standards and regulatory requirements for surgical masks and N95 respirators. The document primarily demonstrates substantial equivalence to a predicate device (WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095) through performance testing.

Acceptance Criteria (Test Performed)	Standard/Requirement	Reported Device Performance
Fluid Resistance	ASTM F1862 (for K070139, listed as 120mmHg; E520S is listed as 160mmHg in the main table)	Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS met the requirements of ASTM F1862. (F550S/F550CS/A520S/A520CS: Pass 120mmHg; E520S/E520CS: Pass 160mmHg)
Flammability	16 CFR 1610	Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS met the requirements of 16 CFR 1610 (Class 1).
Particulate Filtration Efficiency	NIOSH Certification (N95 standard)	F550S and F550CS: NIOSH Certification: TC-84A-7504A520S and A520CS: NIOSH Certification: TC-84A-7454E520S and E520CS: NIOSH Certification: TC-84A-7453 (These are N95 certified, meaning ≥95% filtration efficiency)
Bacterial Filtration Efficiency	NIOSH Certification (implied by N95 for healthcare)	F550S and F550CS: NIOSH Certification: TC-84A-7504A520S and A520CS: NIOSH Certification: TC-84A-7454E520S and E520CS: NIOSH Certification: TC-84A-7453
Differential Pressure	NIOSH Certification (implied by N95 for breathability)	F550S and F550CS: NIOSH Certification: TC-84A-7504A520S and A520CS: NIOSH Certification: TC-84A-7454E520S and E520CS: NIOSH Certification: TC-84A-7453
Cytotoxicity	(Conditions of the study, likely ISO 10993-5)	Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS were non-cytotoxic under the conditions of the study.
Irritation	(Conditions of the study, likely ISO 10993-10)	Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS were non-irritating under the conditions of the study.
Sensitization	(Conditions of the study, likely ISO 10993-10)	Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS were non-sensitizing under the conditions of the study.

The following questions are not applicable to the provided document, as it concerns a physical medical device (N95 respirator) and not an AI/ML algorithm or software as a medical device (SaMD). The document does not describe a study involving readers, ground truth establishment by experts, or training/test sets in the context of an AI/ML device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document describes a 510(k) premarket notification for physical N95 respirators, not an AI/ML device or its test set. Performance testing is typically conducted on a sample of manufactured devices according to established test methods for physical properties and biocompatibility. The specific sample sizes for each test (e.g., fluid resistance, flammability) are not detailed in this summary but would be specified in the full test reports referenced by the NIOSH certification and ASTM standards. The provenance of the data would be from the laboratories that performed these physical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth in the context of expert consensus is relevant for diagnostic AI/ML algorithms. For N95 respirators, the "ground truth" is determined by physical and chemical test results against a defined standard (e.g., NIOSH standards, ASTM F1862). Expert qualifications would pertain to the technicians conducting these standardized tests, ensuring they follow protocols, not to clinical interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML performance studies to resolve discrepancies in expert interpretations to establish a robust ground truth. For N95 respirators, performance is objectively measured by standardized tests, not by expert consensus on clinical findings.

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

Not Applicable. MRMC studies are designed to assess the impact of AI assistance on human reader performance, typically in diagnostic imaging. This document does not pertain to an AI device.

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

Not Applicable. This question relates to the performance of an AI algorithm in isolation. The product is a physical N95 respirator.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For physical devices like N95 respirators, the "ground truth" for performance is defined by adherence to established industry standards and regulatory requirements (e.g., NIOSH N95 certification, ASTM F1862 for fluid resistance, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility). The tests objectively measure specific characteristics.

8. The sample size for the training set

Not Applicable. Training sets are used for machine learning algorithms. This document describes a hardware device.

9. How the ground truth for the training set was established

Not Applicable. As above, training sets are not relevant to this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 28, 2015

Pasture Pharma Pte, Ltd C/O Ms. Sarah Hassan US MedPharm 38129 Spring Canyon Drive Murrieta, CA 92563

Re: K141876

Trade/Device Name: Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: October 15, 2015 Received: October 16, 2015

Dear Ms. Hassan,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K141876

Device Name

Pasture F550S Surgical N95 Respirator, Pasture F50CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator

Indications for Use (Describe)

Pasture F550S, Pasture F550CS, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

This 510(K) Summary is being submitted in accordance with requirements of 21 CFR 807.92(c)

The assigned 510(k) number is: K141876

Submitter Name and Address:

Pasture Pharma Pte, Ltd 8 Boon Lay Way #04-01 Trade Hub 21, Singapore 609964 Lloyd Soong, President & CEO Contact: +65-6515-6561 lloyd@pasturegroup.com

US agent and correspondent:

Mrs. Sarah Hassan US Med Pharm Supplies, Inc 38129 Spring Canyon Drive Murrieta, CA 92563 Phone: 951-239-1933 Fax: 951-239-1933 E-mail: sarah@usmedpharm.com

Date Prepared: October 27, 2015

Proprietary Name:

Common name: Surgical N95 NIOSH certified Respirator

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Device Classification and Product Code

Classification Name: Surgical Apparel Regulation: 21 CFR §878.4040 Class: Class II Classification panel: General and Plastic Surgery Product Code: MSH

Predicate Device: K070139 WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 SURVIVAIR, INC

Intended Use:

Device Description:

Pasture E520S and Pasture E520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7453. They contain 4 layers composed of polypropylene with a

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nose cushion, synthetic elastic loop or strap, and an aluminum nosepiece. E520CS is the same respirator as E520S, but E520CS contains an adjustable buckle on the headband.

	Predicate	Pasture	Pasture	Pasture	Pasture	Pasture	Pasture	Test	K070139	F550S	A520S	E520S
Description	K070139	F550S	F550CS	A520S	A520CS	E520S	E520CS			F550CS	A520CS	E520CS
NIOSH	N95	N95	N95	N95	N95	N95	N95	NIOSH	N95	N95	N95	N95
certificationnumber	TC-84A-4516	TC-84A-7504	TC-84A-7504	TC-84A-7454	TC-84A-7454	TC-84A-7453	TC-84A-7453	Certification	TC-84A-4516	TC-84A-7504	TC-84A-7454	TC-84A-7453
Outer layer	Polyester	PolypropyleneSpunbond	PolypropyleneSpunbond	PolypropyleneSpunbond	PolypropyleneSpunbond	PolypropyleneSpunbond	PolypropyleneSpunbond	Fluid Resistance(ASTM F1862)	Not available	Pass 120mmHg	Pass 120mmHg	Pass 160mmHg
FilterMedia	Polypropylene	PolypropyleneMeltblown	PolypropyleneMeltblown	PolypropyleneMeltblown	PolypropyleneMeltblown	PolypropyleneMeltblown	PolypropyleneMeltblown	Flammability(16 CFR 1610)	Not available	Class 1	Class 1	Class 1
Inner layer	Polypropylene	PolypropyleneSpunbond	PolypropyleneSpunbond	PolypropyleneSpunbond	PolypropyleneSpunbond	PolypropyleneSpunbond	PolypropyleneSpunbond	In vitro cytotoxicity	Not available	Non-cytotoxic underconditions of study	Non-cytotoxic underconditions of study	Non-cytotoxic underconditions of study
Nose Piece	NotApplicable	combinationof zinc wiresand embeddedpolyester	combinationof zinc wiresand embeddedpolyester	NotApplicable	NotApplicable	aluminum	aluminum	Sensitization	Not available	Non-sensitizer underconditions of study	Non-sensitizer underconditions of study	Non-sensitizer underconditions of study
EarAttachment	syntheticelastic	syntheticelastic	syntheticelastic	syntheticelastic	syntheticelastic	syntheticelastic	syntheticelastic	Irritation	Not available	Non-irritant underconditions of study	Non-irritant underconditions of study	Non-irritant underconditions of study
Respiratorstyle	cup shaped	duckshaped	billshaped	cup shaped	cup shaped	cup shaped	cup shaped	Size		90±3200±395±3mm	150±3130±360±3mm	140±3125±350±3mm
Designfeatures	3 layersmolded-conewith filter webin the middle	5 layers ofnon-wovenfibercontainingfilter web inthe middle	5 layers ofnon-wovenfibercontainingfilter web inthe middle	4 layersmolded-conewith filter webin the middle	4 layersmolded-conewith filter webin the middle	4 layersmolded-conewith filter webin the middle	4 layersmolded-conewith filter webin the middle	Sterility	Non-sterileSingle use	Non-sterileSingle use	Non-sterileSingle use	Non-sterileSingle use
Adjustablebuckle	NotApplicable		AcrylonitrileButadieneStyrene		AcrylonitrileButadieneStyrene		AcrylonitrileButadieneStyrene	Indication for Use	Please seebelow *1	Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

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1 The Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a NIOSH-approved N95 single use respirator intended for use by healthcare personnel during medical/ surgical procedures to protect both the wearer against the spatter of blood and other potentially infectious materials and reducing the transfer of microorganisms and other airborne particulate matter.

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Comparison to Predicated Device:

Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S and Pasture E520CS respirators are substantially equivalent to WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095.

Performance Testing

Test Performed	Result
Fluid Resistance	The Pasture F550S, Pasture F550CS, Pasture A520S, PastureA520CS, Pasture E520S, and Pasture E520CS met therequirements of ASTM F1862.
Flammability	The Pasture F550S, Pasture F550CS, Pasture A520S, PastureA520CS, Pasture E520S, and Pasture E520CS met therequirements of 16 CFR 1610.
Particulate Filtration Efficiency	NIOSH Certification: TC-84A-7504 (F550S and F550CS)NIOSH Certification: TC-84A-7454 (A520S and A520CS)NIOSH Certification: TC-84A-7453 (E520S and E520CS)
Bacterial Filtration Efficiency	NIOSH Certification: TC-84A-7504 (F550S and F550CS)NIOSH Certification: TC-84A-7454 (A520S and A520CS)NIOSH Certification: TC-84A-7453 (E520S and E520CS)
Differential Pressure	NIOSH Certification: TC-84A-7504 (F550S and F550CS)NIOSH Certification: TC-84A-7454 (A520S and A520CS)NIOSH Certification: TC-84A-7453 (E520S and E520CS)

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Cytotoxicity	The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS were non-cytotoxic under the conditions of the study.
Irritation	The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS were non-irritating under the conditions of the study.
Sensitization	The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS were non-sensitizing under the conditions of the study.

Conclusions:

The test data submitted in this submission demonstrate that the subject device is as safe and as effective as the predicate and technological characteristics do not raise any new questions of safety and effectiveness. Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S and Pasture E520CS are substantially equivalent to the predicate device cleared in K070139.

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.