(74 days)
No
The device description and intended use clearly describe a physical respiratory protective device (mask) with no mention of software, data processing, or AI/ML capabilities.
No
This device is a protective mask designed to prevent exposure to particulates and bodily fluids, not to treat a condition or disease.
No
This device is a respirator and surgical mask, intended for protection against particulates and fluids, not for diagnosing medical conditions.
No
The device description clearly describes a physical respirator and surgical mask made of various material layers and components like a nose clip and elastic headband. There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect the healthcare practitioner from blood, body fluids, and particulates. This is a protective barrier device, not a device used to diagnose a condition by examining samples from the body.
- Device Description: The description details a respiratory protective device with filter layers and a mask structure. It focuses on filtration efficiency and fit, which are characteristics of personal protective equipment, not diagnostic tools.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to prevent exposure, not to diagnose.
N/A
Intended Use / Indications for Use
The Delta N95 Respirator and Surgical Mask will be used for the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CIX' TB Prevention Guidelines.
Product codes
Not Found
Device Description
DELTA N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory protective device. This disposable Surgicul mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner serim hayer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer, outer scrim layer and clastic band. DELTA N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #TC-84A-0003) and has a filtration efficiency level of 95% and is effective against particulate acrosols free of oil. DELTA N95 RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, small, medium and large. The nose clip and elustic headband ensures effective face to mask seal.
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
Health care practitioner
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
Not Found
Key Metrics
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
RACAL HEALTH & SAFETY INC. PREMARKET SUBMISSION
DELTA N95 RESPIRATOR AND SURGICAL MASK 510(K) K964722
510(k) SUMMARY - K964122
FEB - 7 1997
DELTA N95 RESPIRATOR & SURGICAL MASK
January 29, 1997
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), Premarket Notification, was in accordance with 21 CFR 807.87.
儿. Submitter of 510(k):
| Company Name: | Racal Health & Safety Inc.
7305 Executive Way
Frederick, Maryland
U.S.A. 21704-8368 |
|-------------------------|----------------------------------------------------------------------------------------------|
| Contact Person (U.S.A.) | Mr. J. Randall Hoggle |
| Telephone: | (301)695-8200 |
| Fax: | (301)695-4413 |
| Contact Person (Canada) | John Campbell |
| Telephone: | (613)345-0111 |
| Fax | (613)345-2639 |
| Name of Device | |
| Trade/Proprietary Name: | DELTA N95 RESPIRATOR AND SURGICAL MASK |
| Common/Usual Name: | Masks, Surgical |
| Classification Name: | 21 CFR 878.4040 "Surgical Apparel", Class II |
3. Legally Marketed Predicute Devices
DELTA N95 RESPIRATOR AND SURGICAL MASK is substantially equivalent to many legally marketed Surgical masks, including those listed in Table 1 below.
CONFIDENTIAL
1
RACAL HEALTH & SAFETY INC. PREMARKET SUBMISSION
DELTA N95 RESPIRATOR AND SURGICAL MASK 510(K) K964722
PREMARKET SUBMISS
510(k) SUMMARY
TABLE I COMPARISON OF TECHNOLOGICAL CHARACTERISTICS PREDICATE DEVICES AND DELTA N95 RESPIRATOR AND SURGICAL MASK
| Manufacturers | Racal Health & Safety | 3M | Louis M Gerson |
|---|---|---|---|
| Device | DELTA N95 | ||
| Respirators | Model 1860 Health Care | ||
| Respirators | Isolair APR Type N95 | ||
| Respirators | |||
| 510(k) Number | K964722 | K955382 | K960778 |
| Standards Met | Performance | ||
| Code of Federal Regulations, | |||
| Title 42 Part 84 | |||
| for N95-class of | |||
| Respiratory Protective | |||
| Devices | |||
| Meets CDC guidelines for | |||
| preventing transmission of | |||
| Mycobacterium tuberculosis | Performance | ||
| Code of Federal Regulations, | |||
| Title 42,Part 84 | |||
| for N95-class of | |||
| Respiratory Protective | |||
| Devices | |||
| Meets CDC guidelines for | |||
| preventing transmission of | |||
| Mycobacterium tuberculosis | Performance | ||
| Code of Federal Regulations, | |||
| Title 42, Part 84 | |||
| for N95 - class of | |||
| Respiratory Protective | |||
| Devices | |||
| Meets CDC guidelines for | |||
| preventing transmission of | |||
| Mycobacterium tuberculosis | |||
| NIOSH Approval Number | TC-84A-003 | TC-84A-006 | TC-84A-160 |
| Device Description | N95 Class particulate | ||
| Respirator | |||
| Multi-Layer Filtering | |||
| media | |||
| Fluid resistant barrier | |||
| Wire nose clip | |||
| Foam nose piece inside | |||
| mask | |||
| Elastic Headband | |||
| Mint colored | N95 Class particulate | ||
| Respirator | |||
| Multi-Layer Filtering | |||
| media | |||
| Fluid resistant barrier | |||
| Wire nose clip | |||
| Foam nose piece inside | |||
| mask | |||
| Elastic Headband | |||
| Blue colored | N95 Class particulate | ||
| Respirator | |||
| Multi-Layer Filtering | |||
| media | |||
| Fluid resistant barrier | |||
| Wire nose clip | |||
| Foam nose piece inside | |||
| mask | |||
| Elastic Headband | |||
| Blue-green colored | |||
| Intended Use | Respiratory Protection of | ||
| Health Care workers | Respiratory Protection of | ||
| Health Care of workers | Respiratory Protection of | ||
| Health Care workers |
র্ণ : Device Description
DELTA N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory protective device. This disposable Surgicul mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner serim hayer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer, outer scrim layer and clastic band. DELTA
CONFIDENTIAL
2
--JJ
PAGE
RACAL HEALTH & SAFETY INC. PREMARKET SUBMISSION
DELTA N95 RESPIRATOR AND SURGICAL MASK 510(K) K964722
N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #TC-84A-0003) and has a filtration efficiency level of 95% and is effective against particulate acrosols free of oil. DELTA N95 RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, small, medium and large. The nose clip and elustic headband ensures effective face to mask seal. Based on the information provided, DELTA N95 RESPIRATOR AND SURGICAL MASK is substantially equivalent to legally marketed predicate devices.
ട. Indications For Use
The Delta N95 Respirator and Surgical Mask will be used for the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CIX' TB Prevention Guidelines.
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