(74 days)
Not Found
No
The 510(k) summary describes a physical respiratory protection device (N95 mask) and does not mention any software, algorithms, or AI/ML components.
No.
The device description indicates it is a respiratory protective device designed to filter particulates, not to treat a medical condition.
No
This device is a respirator and surgical mask, intended for respiratory protection and to protect healthcare practitioners from blood, body fluids, and particulates. It does not perform any diagnostic function.
No
The device description clearly outlines physical components like filter material, scrim layer, netting layer, meltblown protection layer, elastic band, and nose clip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for respiratory protection for healthcare practitioners from blood, body fluids, and particulates, and to meet TB prevention guidelines. This is a protective function, not a diagnostic one.
- Device Description: The description details a physical mask designed for filtration and sealing to prevent inhalation of airborne particles. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly described as a respiratory protective device and a surgical mask, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Racal 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 / CDC TB Prevention Guidelines.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
RACAL N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory proceetive device. This disposable Surgical mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner scrim layer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer and elastic band. RACAL N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #IC-84A-0008) and has a filtration efficiency level of 95% and is effective against particulate aerosols free of oil. RACAL NYS RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, medium and large, The nose clip and elastic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
§ 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
RACAL N95 RESPIRATOR AND SURCICAL MASK 510(K) K964723
510(k) SUMMARY - KQ 6 4723
3 - 7 1997
RACAL 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.
1 -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: RACAL N95 RESPIRATOR AND SURGICAL MASK Common/Usual Name: Masks, Surgical Classification Name: 21 CFR 878.4040 "Surgical Apparel", Class II
3. Legally Marketed Predicate Devices
RACAL N95 RESPIRATOR AND SURGICAL MASK is substantially equivalent to many legally marketed Surgical masks, including those listed in Table I below.
Page 1 of 3
CONFIDENTIAL
1
RACAL HEALTH & SAFETY INC. PREMARKET SUBMISSION
RACAL N95 RESPIRATOR AND SURGICAL MASK 510(K) K964723
510(k) SUMMARY
TABLE 1 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS PREDICATE DEVICES AND DELTA N95 RESPIRATOR AND SURGICAL MASK
| Manufacturers | Racal Health & Safety | 3M | Louis M Gerson |
|---|---|---|---|
| Device | RACAL N95 | ||
| Respirators | Model 1860 Health Care | ||
| Respirators | Isolair APR Type N95 | ||
| Respirators | |||
| 510(k) Number | K964723 | 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-008 | 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 | |||
| Peach 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 |
4. Device Description
RACAL N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory proceetive device. This disposable Surgical mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner scrim layer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer and elastic band. RACAL
Page 2 of 3
CONFIDENTIAL
2
ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
RACAL HEALTH & SAFETY INC. PREMARKET SUBMISSION
RACAL N95 RESPIRATOR AND SURGICAL MASK 510(K) K964723
N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #IC-84A-0008) and has a filtration efficiency level of 95% and is effective against particulate aerosols free of oil. RACAL NYS RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, medium and large, The nose clip and elastic headband ensures effective face to mask seal. Based on the information provided, RACAL N9S RESPIRATOR AND SURGICAL MASK is substantially equivalent to legally marketed predicate devices.
હ. Indications For Use
The Racal 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 / CDC TB Prevention Guidelines.
Page 3 of 3