(113 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a surgical face mask, with no mention of AI or ML technology.
No
A therapeutic device is used to treat or cure a disease or condition. This device, a surgical face mask, is intended to prevent the transfer of microorganisms and reduce exposure to bodily fluids, which is a preventive measure, not a treatment.
No.
The device is a surgical face mask intended to filter microorganisms and particulate material, not to diagnose medical conditions.
No
The device description clearly outlines physical components like spun-bond polypropylene non-woven fabric, melt blown filter media, PVC coated aluminum wire, and knitted elastic ear loops or tie back strings. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical face masks are for protecting the wearer and healthcare workers from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask, which are consistent with a barrier device.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, pressure, flammability, biocompatibility). These are not diagnostic performance metrics.
- FDA Product Code: The FDA product code FXX is for "Mask, Surgical". This classification is for a general medical device, not an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not perform any such function.
N/A
Intended Use / Indications for Use
When properly worn, the surgical face masks are intent and healthcare workers from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
Magnum is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in a single color – blue.
The inner and outer layers are made of spun-bond polypropylene non-woven fabric, and the middle layer is made of melt blown filter media. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PVC coated aluminum wire.
The model 2200 is level 2 surgical face mask and the model 2300 is level 3 surgical face mask. Both these models are provided with ear loops to hold and fit the face mask in place over the user's mouth and nose. The ear loops are made of knitted elastic.
The model 1200 is level 2 surgical face mask and the model 1300 is level 3 surgical face mask. Both these models are provided with tie back to hold and fit the face mask in place over the user's mouth and nose. The tie back string is made of spun-bond polypropylene non-woven fabric.
The dimensions of the test item are: length- 172 ± 3 mm and width- 95 ± 3 mm.
The surgical masks are single-use, disposable devices, provided non-sterile.
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
Not Found
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)
Performance Tests
Magnum is subjected to the following performance tests according to the requirements provided in the guidance Surgical Masks - Premarket Notification [510(k)] Submissions and is found to be safe and efficient with respect to its intended use:
- Fluid resistance
- Bacterial filtration efficiency
- Particulate filtration efficiency
- Differential pressure
- Flammability
The performance testing of the proposed device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant methods cited below:
- ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2101-19: Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- ASTM F2299/F2299M - 03(2017): Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- EN 14683 (Annex C): 2019: Medical Face Masks – Requirements And Test Methods
- ASTM F1862/F1862M-17: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- 16 CFR 1610: Standard for the Flammability of clothing textiles
Key results are summarized in Table 2 (for Models 1300 and 2300) and Table 2 (for Models 1200 and 2200, but in the document it is named Table 2 too). All models passed the acceptance criteria for their respective classifications (Level 2 or 3) across all tested parameters.
Biocompatibility
The materials used in the Magnum are biocompatibility tested according to the guidance Surgical Masks - Premarket Notification [510(k)] Submissions:
- In-vitro Cytotoxicity
- Skin irritation
- Skin Sensitization
These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process.
The biocompatibility testing of the proposed device was conducted to adequately demonstrate the safety of the device in accordance with the relevant methods cited below:
- ISO 10993-5: 2009: Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-23: 2021: Biological Evaluation Of Medical Devices - Part 23: Tests For Irritation.
- ISO 10993-10: 2021: Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization.
Key results are summarized in Table 3: Biocompatibility Test Summary. All models were found to be non-cytotoxic, non-irritating, and non-sensitizing under the study conditions, passing all tests.
Clinical Test Data
Clinical study was not conducted as clinical data is not needed for surgical mask.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For Models 1300 and 2300 (Level 3):
- Fluid resistance: Pass at 160 mmHg
- Particulate Filtration Efficiency (PFE): > 98%
- Bacterial Filtration Efficiency (BFE): > 98%
- Differential pressure (ΔP): 98%
- Bacterial Filtration Efficiency (BFE): > 98%
- Differential pressure (ΔP):
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 28, 2022
Magnum Health And Safety Pvt Ltd % Manoj Zacharias US Agent Liberty Management Group Ltd. 75 Executive Drive, Suite 114 Aurora, Illinois 60504
Re: K220670
Trade/Device Name: Magnum Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 31, 2022 Received: June 2, 2022
Dear Manoj Zacharias:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220670
Device Name Magnum
Indications for Use (Describe)
When properly worn, the surgical face masks are intent and healthcare workers from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.
| 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
I. APPLICANT INFORMATION
| Submitter's Name | Magnum Health And Safety Pvt Ltd |
|---|---|
| Submitter's Address | Unit No. 21, 22, 23, Supreme Industrial Estate, Lucky |
| Compound, Near Bhajanlal Dairy, Chinchoti Naka, Village | |
| Devdal, Taluka - Vasai, Dist - Palghar, Maharashtra, | |
| India - 401208 | |
| Name of Contact Person | Mr. Rakesh Bhagat |
| Designation | Director |
| Contact Number | +91 9820050482 |
| Contact E-mail | rakesh@magnumohs.com |
| Date of Summary Prepared | 11 February 2022 |
II. DEVICE DETAILS
| Device Trade Name | Magnum |
|---|---|
| Device Common Name | Surgical Face Mask |
| Model(s) | 2200 (Level 2, 3ply with ear loop) |
| 2300 (Level 3, 3ply with ear loop) | |
| 1200 (Level 2, 3ply with tie back) | |
| 1300 (Level 3, 3ply with tie back) | |
| Device Classification name | Mask, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |
4
PREDICATE DEVICE DETAILS III.
| Device Trade Name | Surgical Face Mask | |
|---|---|---|
| Device Manufacturer Name | Anhui Tiankang Medical Technology Co.,Ltd. | |
| Model(s) | Model No. | Model Description |
| WKKZ.R.LEVEL1-001 | Level 1, Ear loop, Flat pleated, 3 layers | |
| WKKZ.R.LEVEL2-001 | Level 2, Ear loop, Flat pleated, 3 layers | |
| WKKZ.R.LEVEL3-001 | Level 3, Ear loop, Flat pleated, 3 layers | |
| WKKZ.J.LEVEL1-001 | Level 1, Tie-on, Flat pleated, 3 layers | |
| WKKZ.J.LEVEL2-001 | Level 2, Tie-on, Flat pleated, 3 layers | |
| WKKZ.J.LEVEL3-001 | Level 3, Tie-on, Flat pleated, 3 layers | |
| 510(k) Number | K212368 | |
| Regulation Number | 21 CFR 878.4040 | |
| Device Class | Class II | |
| Product Code | FXX |
DEVICE DESCRIPTION IV.
Magnum is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in a single color – blue.
The inner and outer layers are made of spun-bond polypropylene non-woven fabric, and the middle layer is made of melt blown filter media. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PVC coated aluminum wire.
The model 2200 is level 2 surgical face mask and the model 2300 is level 3 surgical face mask. Both these models are provided with ear loops to hold and fit the face mask in place over the user's mouth and nose. The ear loops are made of knitted elastic.
The model 1200 is level 2 surgical face mask and the model 1300 is level 3 surgical face mask. Both these models are provided with tie back to hold and fit the face mask in place over the user's mouth and nose. The tie back string is made of spun-bond polypropylene non-woven fabric.
The dimensions of the test item are: length- 172 ± 3 mm and width- 95 ± 3 mm.
The surgical masks are single-use, disposable devices, provided non-sterile.
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INTENDED USE V.
The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This device is disposable, non-sterile and for single use only.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Table 1: General Comparison
| SI.
No | Features
compared | Proposed Device | Predicate Device | Result | |
|----------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------|
| General Information | | | | | |
| 1. | 510(k) Number | | K212368 | - | |
| 2. | Manufacturer | Magnum Health And Safety Pvt
Ltd | Anhui Tiankang Medical
Technology Co.,Ltd. | - | |
| 3. | Common Name | Surgical face mask | Surgical face mask | Same | |
| 4. | Classification Name | Mask, Surgical | Mask, Surgical | Same | |
| 5. | Classification and
Regulation number | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Same | |
| 6. | Product Code | FXX | FXX | Same | |
| 7. | Indications For Use | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only. | The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | Same | |
| SI.
No | Features
compared | Proposed Device | Predicate Device | Result | |
| 8. | Model specifications | 2200 (Level 2, Ear Loops, Flat
Pleated, 3 layers) | WKKZ.R.LEVEL2-001 (Level 2,
Ear loop, Flat pleated, 3 layers) | Same | |
| | | 2300 (Level 3, Ear Loops, Flat
Pleated, 3 layers) | WKKZ.R.LEVEL3-001 (Level 3,
Ear loop, Flat pleated, 3 layers) | | |
| | | 1200 (Level 2, Tie back, Flat
Pleated, 3 layers) | WKKZ.J.LEVEL2-001 (Level 2,
Tie-on, Flat pleated, 3 layers) | | |
| | | 1300 (Level 3, Tie back, Flat
Pleated, 3 layers) | WKKZ.J.LEVEL3-001 (Level 3,
Tie-on, Flat pleated, 3 layers) | | |
| Materials | | | | | |
| 9. | Outer layer | Spun bond polypropylene | Spun-bond polypropylene | Same | |
| 10. | Filter layer | Melt blown filter media | Melt blown polypropylene filter | Same | |
| 11. | Inner layer | Spun bond polypropylene | Spun-bond polypropylene | Same | |
| 12. | Nose wire | PVC coated aluminum wire | PP coated steel wire | Different1 | |
| 13. | Ear loop | For model(s): 2200 and
2300
Ear Loop: Knitted elastic | For model(s):
WKKZ.R.LEVEL2-001 and
WKKZ.R.LEVEL3-001
Ear Loop: Nylon and spandex | Different2 | |
| 14. | Tie back | For model(s): 1200 and
1300 | For model(s):
WKKZ.J.LEVEL2-001 and
WKKZ.J.LEVEL3-001 | Same | |
| | | Tie back: Spun-bond
polypropylene non-woven
fabric | Tie back: PP nonwoven | | |
| 15. | Mask color | Blue | Blue | Same | |
| 16. | Dimensions | Length- 172 ± 3 mm
Width- 95 ± 3 mm | Length- 175 ± 5 mm
Width- 95 ± 2.85 mm | Similar | |
| 17. | OTC Use | Yes | Yes | Same | |
| 18. | Sterility | Non-sterile | Non-sterile | Same | |
| 19. | Reusability | Single use | Single use | Same | |
| 20. | ASTM F2100 Level | Level 2 & 3 | Level 2 & 3 | Same | |
| SI.
No | Features
compared | Proposed Device | Predicate Device | Result | |
| Non Clinical Testing | | | | | |
| 21. | Fluid resistance | Level 2 models
Pass at 120 mmHg | Level 2 models
Pass at 120 mmHg | Same | |
| | | Level 3 models
Pass at 160 mmHg | Level 3 models
Pass at 160 mmHg | Same | |
| 22. | Flammability | All models – Class I | All models – Class I | Same | |
| 23. | Particulate Filtration
Efficiency (PFE) | Level 2 models
Pass at >98% | Level 2 models
Pass at ≥98% | Same | |
| | | Level 3 models
Pass at >98% | Level 3 models
Pass at ≥98% | Same | |
| 24. | Bacterial Filtration
Efficiency (BFE) | Level 2 models
Pass at >98% | Level 2 models
Pass at ≥98% | Same | |
| | | Level 3 models
Pass at >98% | Level 3 models
Pass at ≥98% | Same | |
| 25. | Differential pressure
(ΔΡ) | Level 2 models
Pass at 98% | > 98% | ≥ 98% | Pass |
| 3. | Bacterial Filtration Efficiency (BFE)
ASTM F2101-19 | > 98% | > 98% | ≥ 98% | Pass |
| 4. | Differential pressure (ΔP)
EN 14683 (Annex C): 2019 | 98% | > 98% | ≥ 98% | Pass |
| 3. | Bacterial Filtration Efficiency (BFE)
ASTM F2101-19 | > 98% | > 98% | ≥ 98% | Pass |
| 4. | Differential pressure (ΔP)
EN 14683 (Annex C): 2019 |