(87 days)
Not Found
No
The device description and intended use clearly describe a physical filtering facepiece respirator with no mention of software, algorithms, or data processing that would indicate AI/ML technology. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The "Intended Use / Indications for Use" states that the device is a "disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies," which are used for protection from airborne particles, not for therapeutic intervention.
No
Explanation: The document describes the device as a "disposable filtering facepiece respirators" intended for use as protective equipment, not for diagnosing medical conditions. It serves as a respirator, which is a prophylactic device.
No
The device description clearly indicates it is a physical filtering facepiece respirator made of various materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies". This describes a device used to filter air and protect the wearer from airborne particles, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components of a respirator (layers, nose cushion, elastic loops, etc.). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Any of the typical characteristics of an IVD.
Therefore, this device is a personal protective equipment (PPE) designed for respiratory protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for use by the general public health medical emergencies
Product codes
NZJ
Device Description
Pasture F550G respirator is a duck bill mask as described in NIOSH N95 standard It 1s in 5 layers and composed of spunbond, meltblown and polyester, also with nose cushion, elastic loops and/or strip and nosepiece which is the combination of zinc wires and embedded polyester inside of layers
Pasture A520G respirator is a cone shaped mask as described in NIOSH N95 standard It is in 4 layers and composed of spunbond, meltblown and polyester, also with synthetic rubber band which is coated with polyester and free of latex
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 designed for children.
Intended User / Care Setting
general public in public health medical emergencies
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)
Not Found
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
§ 880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.
(a)
Identification. A filtering facepiece respirator for use by the general public in public health medical emergencies is a device that is a disposable half-facepiece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency. The device is made of polymeric materials and is intended to fit closely to the face and to function by filtering particulate material.(b)
Classification. Class II (special controls). The special controls are:(1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84.
(2) The FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies.” See § 880.1(e) for information on obtaining a copy of this guidance document.
0
510(K) SUMMARY
JAN 2 3 2009
. _
【
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807 92
The assigned 510(k) number is
Manufacturer:
CHAMPAK ENTERPRISE CO , LTD 27-1, Jhaiming St , Dası Township, Taoyuan County, 335, Tarwan (ROC)
Official Correspondent:
Lloyd Soong President & CEO Pasture Pharma Pte, Ltd 8 Boon Lay Way #04-01 Trade Hub 21, Sıngapore 609964
US agent and correspondent:
Mrs Sarah Hassan 29266 Via Fronter Murrieta, CA 92563 USA Tel 8603715604 E-mail ssfmhassan@yahoo com
Date of Submission:
OCT/20/2008
Classification name:
Filtering Facepiece Respirator for Use by the General Public Health Medical Emergencies Class II
Proprietary Name:
Pasture™ F550G & A520G Respirators
Common name:
Filtering Facepiece Respirator for use by the general public health medical emergencies
Regulatory Reference: 21 CFR 880 6260
Predicate Device:
3M 8612F & 8670F
1
Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies K062070
Labels/ Labeling:
This device will be marketed NIOSH-certified N95 respirator for use by the general public in public health medical emergencies for the Intended Use purpose below
Intended Use:
This device is intended for use by the general public health medical emergencies
Device Description:
Pasture F550G respirator is a duck bill mask as described in NIOSH N95 standard It 1s in 5 layers and composed of spunbond, meltblown and polyester, also with nose cushion, elastic loops and/or strip and nosepiece which is the combination of zinc wires and embedded polyester inside of layers
Pasture A520G respirator is a cone shaped mask as described in NIOSH N95 standard It is in 4 layers and composed of spunbond, meltblown and polyester, also with synthetic rubber band which is coated with polyester and free of latex
Comparison to Predicated Devices:
F550G and A520G are substantially equivalent in safety and effectiveness compared to 3M 8612F and 8670F respirators for the same intended use
| Predicate (3M) | F550G | A520G | |
|---|---|---|---|
| Intended Use | For use by general | ||
| public in public | |||
| health emergencies | Same | Same | |
| NIOSH Certification | N95 TC-84A-4516 | N95 TC-84A-4665 | N95 TC-84A-4664 |
| Fluid resistant | Yes | yes | Yes |
| Fit Assessment Test | done | done | Done |
| Biocompatibility | |||
| Test | Cytotoxicity | Cytotoxicity | |
| Dermal | |||
| sensitization | Dermal | ||
| sensitization | Dermal sensitization | ||
| Skın ırrıtatıon | Skin irritation | Skın ırrıtatıon |
Conclusions:
F550G and A520G have the same intended use as the predicate devices The test data submitted in this submission demonstrate that the subject devices are as safe and effective as the predicate and technological characteristics do not raise any new questions of safety and effectiveness F550G and A520G are substantially equivalent to the 3M respirators cleared in K062070
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pasture Pharma PTE Limited C/o Ms. Sarah Hassan US Medpharm 29266 Via Fronter Murrieta, California 92563
JAN 2 3 2009
K083176 Re:
Trade/Device Name: Pasture™ A520G & Pasture™F550G Respirators Regulation Number: 21 CFR 880.6260 Regulation Namber 21 CA 800182011 - 195, for Use General Public in Public Health Medical Emergencies Regulatory Class: II Product Code: NZJ Dated: January 15, 2009 Received: January 15, 2009
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.
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 Eederal Register.
3
Page 2 Ms. Hassan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I'DA 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 (OS) 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 procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
inthen D, Wister, Ja
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Pasture™ A520G & Pasture™F550G
Indications for Use:
This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies - Pasture™ A520G Respirator and Pasture™ F550G Respirator Not designed for children.
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter-Use_X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila A. Murphy, RD
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K083176