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

• K Number: K141876
• 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
• Manufacturer: PASTURE PHARMA PTE LTD
• Date Cleared: 2015-10-28 ( 474 days)
• Product Code: MSH
• Regulation Number: 878.4040

Intended Use

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.

Predicate Devices

K070139

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of the respirator, with no mention of AI or ML.

Therapeutic

No
This device, an N95 respirator, is a protective device used by healthcare personnel to filter airborne particles and bodily fluids, not to treat a medical condition.

Diagnostic

No
Explanation: The device is a NIOSH certified N95 respirator, intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as layers of polypropylene, nose cushions, straps, nosepieces made of zinc wires and aluminum, and adjustable buckles. The performance studies also focus on physical properties like fluid resistance, flammability, and filtration efficiency, which are characteristic of hardware devices. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is a respirator used by healthcare personnel to protect against the transfer of microorganisms, body fluids, and particulate material. This is a barrier device for personal protection, not a device used to examine specimens taken from the human body.
• Device Description: The description details the physical components and materials of a respirator. It does not describe any components or functions related to analyzing biological samples.
• Performance Studies: The performance studies focus on characteristics relevant to a respirator's function, such as fluid resistance, flammability, filtration efficiency, and biocompatibility (cytotoxicity, irritation, sensitization). These are not studies related to diagnostic performance on biological specimens.
• Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on biological specimens.

In summary, the provided information describes a personal protective device (a respirator) and its performance characteristics as such. It does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MSH

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 in the headband.

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

healthcare personnel

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)

Test Performed: Fluid Resistance; Result: The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS met the requirements of ASTM F1862.
Test Performed: Flammability; Result: The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS met the requirements of 16 CFR 1610.
Test Performed: Particulate Filtration Efficiency; Result: NIOSH Certification: TC-84A-7504 (F550S and F550CS), NIOSH Certification: TC-84A-7454 (A520S and A520CS), NIOSH Certification: TC-84A-7453 (E520S and E520CS)
Test Performed: Bacterial Filtration Efficiency; Result: NIOSH Certification: TC-84A-7504 (F550S and F550CS), NIOSH Certification: TC-84A-7454 (A520S and A520CS), NIOSH Certification: TC-84A-7453 (E520S and E520CS)
Test Performed: Differential Pressure; Result: NIOSH Certification: TC-84A-7504 (F550S and F550CS), NIOSH Certification: TC-84A-7454 (A520S and A520CS), NIOSH Certification: TC-84A-7453 (E520S and E520CS)
Test Performed: Cytotoxicity; Result: The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS were non-cytotoxic under the conditions of the study.
Test Performed: Irritation; Result: The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS were non-irritating under the conditions of the study.
Test Performed: Sensitization; Result: The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS were non-sensitizing under the conditions of the study.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K070139

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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 [phone] or [phone] 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 [phone] or [phone] 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)
-------------------------------------------------	--

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: [phone] [e-mail]

US agent and correspondent:

Mrs. Sarah Hassan US Med Pharm Supplies, Inc 38129 Spring Canyon Drive Murrieta, CA 92563 Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date Prepared: October 27, 2015

Proprietary 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

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:

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

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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
certification
number	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	Polypropylene
Spunbond	Polypropylene
Spunbond	Polypropylene
Spunbond	Polypropylene
Spunbond	Polypropylene
Spunbond	Polypropylene
Spunbond	Fluid Resistance
(ASTM F1862)	Not available	Pass 120mmHg	Pass 120mmHg	Pass 160mmHg
Filter
Media	Polypropylene	Polypropylene
Meltblown	Polypropylene
Meltblown	Polypropylene
Meltblown	Polypropylene
Meltblown	Polypropylene
Meltblown	Polypropylene
Meltblown	Flammability
(16 CFR 1610)	Not available	Class 1	Class 1	Class 1
Inner layer	Polypropylene	Polypropylene
Spunbond	Polypropylene
Spunbond	Polypropylene
Spunbond	Polypropylene
Spunbond	Polypropylene
Spunbond	Polypropylene
Spunbond	In vitro cytotoxicity	Not available	Non-cytotoxic under
conditions of study	Non-cytotoxic under
conditions of study	Non-cytotoxic under
conditions of study
Nose Piece	Not
Applicable	combination
of zinc wires
and embedded
polyester	combination
of zinc wires
and embedded
polyester	Not
Applicable	Not
Applicable	aluminum	aluminum	Sensitization	Not available	Non-sensitizer under
conditions of study	Non-sensitizer under
conditions of study	Non-sensitizer under
conditions of study
Ear
Attachment	synthetic
elastic	synthetic
elastic	synthetic
elastic	synthetic
elastic	synthetic
elastic	synthetic
elastic	synthetic
elastic	Irritation	Not available	Non-irritant under
conditions of study	Non-irritant under
conditions of study	Non-irritant under
conditions of study
Respirator
style	cup shaped	duck
shaped	bill
shaped	cup shaped	cup shaped	cup shaped	cup shaped	Size		90±3200±395±3mm	150±3130±360±3mm	140±3125±350±3mm
Design
features	3 layers
molded-cone
with filter web
in the middle	5 layers of
non-woven
fiber
containing
filter web in
the middle	5 layers of
non-woven
fiber
containing
filter web in
the middle	4 layers
molded-cone
with filter web
in the middle	4 layers
molded-cone
with filter web
in the middle	4 layers
molded-cone
with filter web
in the middle	4 layers
molded-cone
with filter web
in the middle	Sterility	Non-sterile
Single use	Non-sterile
Single use	Non-sterile
Single use	Non-sterile
Single use
Adjustable
buckle	Not
Applicable		Acrylonitrile
Butadiene
Styrene		Acrylonitrile
Butadiene
Styrene		Acrylonitrile
Butadiene
Styrene	Indication for Use	Please see
below *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, Pasture
A520CS, Pasture E520S, and Pasture E520CS met the
requirements of ASTM F1862.
Flammability	The Pasture F550S, Pasture F550CS, Pasture A520S, Pasture
A520CS, Pasture E520S, and Pasture E520CS met the
requirements 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.