(308 days)
Not Found
No
The device description and intended use clearly describe a physical respirator/surgical mask with filtration and fluid resistance properties. There is no mention of any software, data processing, or AI/ML capabilities.
No.
The device description indicates it is a respirator and surgical mask, explicitly stating its purpose is to protect operating room personnel and surgical patients from the transfer of microorganisms, body fluids, and particulate material, not to treat a disease or condition.
No
The document describes a respirator and surgical mask, which is used for protection from transfer of microorganisms and particulate material, not for diagnosing a condition or disease.
No
The device description clearly identifies the device as a physical respirator and surgical mask, which is a hardware product, 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 to protect operating room personnel and surgical patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective function, not a diagnostic one.
- Device Description: The description focuses on its function as a particulate respirator and surgical mask, highlighting features like filtration efficiency, fluid resistance, and bacterial filtration efficiency. These are all related to physical protection and barrier function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis or treatment decisions based on in vitro analysis.
IVD devices are used to examine specimens derived 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
3M™ VFlex™Health Care Particulate Respirator and Surgical Mask 1805/1805S is 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.
Product codes
MSH
Device Description
The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1805/1805S is an N95 particulate respirator. Particulate respirators help reduce wearer exposure to certain airborne particles, including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols free of oil . As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials+ and meets > 99% bacterial filtration efficiency (BFE) *. It is cleared to be worn in surgery. It can fit a wide range of face sizes.
This respirator contains no components made from natural rubber latex.
- Tested against 0.3 micron particles (mass median aerodynamic diameter) per U.S. 42 CFR 84.
- Meets ASTM Fluid Resistant Challenge F1862.
- Meets ASTM Standard Test Method for Bacterial Filtration Efficiency F2101.
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 / operating room
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
§ 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
3M Center, Bldg. 0275-05-W-06 St. Paul. MN 55144-1000 651 733 1110
K121069
510(k) Summary
FEB 1 1 2013
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c)
February 11, 2013
Jizhong Jin, RAC
1805/1805S
Class II
MSH
Surgical Respirator
Surgical Apparel
21 CFR 878.4040
Tel: Fax:
Regulatory Affairs Specialist 651-733-6655
651-737-5320 e-mail: jjin1@mmm.com
3M™ VFlex™ Health Care Particulate
Respirator and Surgical Mask, Model
Date Prepared:
Applicant:
3M Health Care Building 275 - 5W - 06 3M Center St. Paul, MN 55144 Establishment registration number: 2110898
Official Correspondent:
Trade/Proprietary Name:
Common Name:
Classification Name:
Device Class:
Requlation Number:
Product Code:
Predicate Device Name:
3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870
Description of Device:
The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1805/1805S is an N95 particulate respirator. Particulate respirators help reduce wearer exposure to certain airborne particles, including those generated by electrocautery, laser surgery and other powered medical instruments. This
1
respirator has a filter efficiency level of at least 95% against particulate aerosols free of oil . As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials+ and meets > 99% bacterial filtration efficiency (BFE) *. It is cleared to be worn in surgery. It can fit a wide range of face sizes.
This respirator contains no components made from natural rubber latex.
- Tested against 0.3 micron particles (mass median aerodynamic diameter) per U.S. 42 CFR 84.
- Meets ASTM Fluid Resistant Challenge F1862.
- Meets ASTM Standard Test Method for Bacterial Filtration Efficiency F2101.
Intended use:
3M™ VFlex™Health Care Particulate Respirator and Surgical Mask 1805/1805S is 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.
Technological Characteristics:
The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S substantially equivalent to the 3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870. The product proposed under this premarket notification submission is composed of the same or similar components, has same or similar performance features, same intended use and indications for use as the predicate device. There are no new questions of safety or effectiveness.
Table of Comparison of the 3M™ VFlex™Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S and the 3M Health Care Particulate Respirator and Surgical Mask, Model 1870
| Description | Predicate Device | Subject Device |
|---|---|---|
| 3M™ Health Care | ||
| Particulate Respirator | ||
| and Surgical Mask, | ||
| Model 1870 (K063023) | 3M™ VFlex™ Health | |
| Care Particulate | ||
| Respirator and Surgical | ||
| Mask, Model | ||
| 1805/1805S | ||
| Intended Use | Surgical Mask/Respirator | Surgical Mask/Respirator |
2
| Materials
Construction
| Technology | ||
|---|---|---|
| Outside cover web | Multi-Layer | |
| Polypropylene spunbond | Multi-Layer | |
| Polypropylene spunbond | ||
| Stiffener web | Polypropylene spunbond | NA |
| Filter web | Polypropylene | Polypropylene |
| Inner web | Polypropylene | Polypropylene |
| Nose-Clip | Aluminum | Aluminum |
| Staple | Steel | Steel |
| Headband | Polyisoprene | Polyisoprene |
| Nose foam | Polyurethane | NA |
| Specifications and | ||
| Dimensions | ||
| Audit of NaCl Load Test |