(144 days)
Not Found
No
The description focuses on the physical construction and filtration properties of a surgical mask, with no mention of AI or ML capabilities.
No.
The device is described as a surgical mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or diagnose a disease or condition.
No
Explanation: The device description states it is a surgical face mask intended to be worn for protection against microorganisms and fluids during surgical procedures. There is no mention of it being used to diagnose any condition or disease. Its performance studies focus on physical characteristics like filtration efficiency and fluid resistance, not diagnostic accuracy.
No
The device description clearly states it is a physical surgical face mask made of polypropylene layers, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description details a surgical face mask with layers of material designed for filtration and protection. This aligns with a personal protective equipment (PPE) device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on barrier properties like fluid resistance, filtration efficiency, and breathability, which are relevant to PPE, not IVDs.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This surgical face mask does not perform any such function.
N/A
Intended Use / Indications for Use
This device 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 (comma separated list FDA assigned to the subject device)
FXX
Device Description
The IMC Surgical Face Mask devices are surgical apparel 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. The surgical masks feature either tie-on or ear loop attachment mechanisms.
This device is a flat pleated 3 ply mask. The inner and outer layer of the mask is made of polypropylene, sandwiching a middle layer made of melt-blown polypropylene filter media. The outer layer of the mask is offered in a yellow color.
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
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 Characteristics:
Fluid Resistance Performance (mmHg)
Particulate Filtration Efficiency Performance (%)
Bacterial Filtration Efficiency Performance (%)
Different Pressure (Delta-P) (mmH2O/cm²)
Flammability
Test Method:
ASTM F1862-07 (2007)
ASTM F2299-03 (2003)
ASTM F2101-07 (2007)
MIL-M36945C 4.4.1.1.1 (1975)
16 CFR Part 1610 (1998)
Acceptance Criteria:
Low=80 Moderate = 120 High = 160
≥98%
Low: ≥95 Moderate: ≥98% High: ≥98%
≤4 mmH2O/cm2
Class 1
IMC Surgical Face Mask K100846 Results:
Meets Standard Criteria
Meets Standard Criteria
Meets Standard Criteria
Meets Standard Criteria
Class 1
Key Results: All performance characteristics for the IMC Surgical Face Mask met the standard criteria, demonstrating substantial equivalence to the predicate devices.
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
AUG 1 6 2010
Trade Name: IMC Surgical Face Mask (non-sterile and sterile, yellow) Common Name: Surgical Face Mask 21 CFR 878.4040 (b): Surgical Apparel Classification Name: Submitter Information: International Medsurg Connection 935 N Plum Grove Rd, STE F Schaumburg, Illinois 60173 Summary Prepared By: Peter Kim Quality Manager International Medsurg Connection 935 N Plum Grove Rd, STE F Schaumburg, Illinois 60173 Telephone: 847-619-9926 Fax: 847-619-9927 e-mail: peterkim(@intlmedsurg.com Date Prepared: June 7, 2010 Predicate Devices: . Medline Prohibit Series Surgical Mask With Fluid Shield (K991559) Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green (K012602)
510(K) SUMMARY
Device Name(s):
IMC Surgical Face Mask (non-sterile and sterile, yellow)
Classification Panel:
General and Plastic Surgery
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:
International Medsurg Connections, Inc is claiming substantial equivalence of the IMC Surgical Mask with the currently marketed:
| Description | 510(k) Number | Clearance Date |
|---|---|---|
| Medline Prohibit Series Surgical Mask With Fluid | ||
| Shield | K991559 | 08/23/1999 |
| Crosstex Isolite Earloop, Crosstex Isofluid Earloop | ||
| Face Masks. | K012602 | 01/22/2002 |
Device Description
The IMC Surgical Face Mask devices are surgical apparel 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. The surgical masks feature either tie-on or ear loop attachment mechanisms
1
This device is a flat pleated 3 ply mask. The inner and outer layer of the mask is made of polypropylene, sandwiching a middle layer made of melt-blown polypropylene filter media. The outer layer of the mask is offered in a yellow color.
Statement of Intended Use
Indications For Use: This device 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.
| Name/Description | Sterility |
|---|---|
| • IMC Surgical face mask Yellow with Ear loop | Sterile |
| • IMC Surgical face mask Yellow with Tie-on | Sterile |
| • IMC Surgical face mask Yellow with Ear loop | Non-Sterile |
| • IMC Surgical face mask Yellow with Tie-on | Non-Sterile |
The IMC Surgical Mask and the predicate devices (Medline Prohibit Series Surgical Mask With Fluid Shield and the Crosstex series: Isolite Earloop Face Masks and Isofluid Earloop Face Masks) 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.
| Feature/
Characteristic | IMC Surgical Face Mask
K100846 | Medline
K991559
(Predicate) | Crosstex
K012602
(Predicate) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------|
| Layer 1 - Outer | These materials were tested
in accordance with ISO
10993-5, 10993-10, and
10993-11 test methods and
were found to be acceptable
for the intended use | Same | Same |
| Layer 2 - Middle | These materials were tested
in accordance with ISO
10993-5, 10993-10, and
10993-11 test methods and
were found to be acceptable
for the intended use | Same | Same |
| Layer 3 - Inner | These materials were tested
in accordance with ISO
10993-5, 10993-10, and
10993-11 test methods and
were found to be acceptable
for the intended use | Same | Same |
| Ear loop | These materials were tested
in accordance with ISO
10993-5, 10993-10, and
10993-11 test methods and
were found to be acceptable
for the intended use | Same | Same |
2
| Feature/
Characteristic | IMC Surgical Face Mask
K100846 | Medline
K991559
(Predicate) | Crosstex
K012602
(Predicate) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------|
| Tie-on | These materials were tested
in accordance with ISO
10993-5, 10993-10, and
10993-11 test methods and
were found to be acceptable
for the intended use | Same | Same |
| Nose Piece | These materials were tested
in accordance with ISO
10993-5, 10993-10, and
10993-11 test methods and
were found to be acceptable
for the intended use | Same | Same |
| colors | | | |
| Yellow | These materials were tested
in accordance with ISO
10993-5, 10993-10, and
10993-11 test methods and
were found to be acceptable
for the intended use | Same | Same |
| Specification and Dimensions: | | | |
| Dimension | | | |
| • Length | 7 inches | Similar | Same |
| • Width | 3.5 inches | Similar | Same |
| Mask Style | Ear loop | Same | Same |
| Tie-on | Tie-on | Same | Same |
Performance Data:
827
| Performance
Characteristics | Test Method | Acceptance
Criteria | IMC Surgical
Face Mask
K100846 | Medline
K991559
(Predicate) | Crosstex
K012602
(Predicate) |
|------------------------------------------------------|------------------------------------|------------------------------------------|--------------------------------------|-----------------------------------|------------------------------------|
| Fluid Resistance
Performance (mmHg) | ASTM F1862-07
(2007) | Low=80
Moderate = 120
High = 160 | Meets Standard
Criteria | Same | Same |
| Particulate Filtration
Efficiency Performance (%) | ASTM F2299-03
(2003) | ≥98% | Meets Standard
Criteria | Same | Same |
| Bacterial Filtration
Efficiency Performance (%) | ASTM F2101-07
(2007) | Low: ≥95
Moderate: ≥98%
High: ≥98% | Meets Standard
Criteria | Same | Same |
| Different Pressure (Delta-P)
(mmH2O/cm²) | MIL-M36945C
4.4.1.1.1
(1975) | ≤4 mmH2O/cm2 | Meets Standard
Criteria | Same | Same |
| Flammability | 16 CFR Part 1610
(1998) | Class 1 | Class 1 | Same | Same |
:
:
3
Conclusions:
The indications for use, technology, specification, safety of the IMC Surgical Face Masks and the two predicate devices K991559 and K012602 are essentially the same. The differences between the face masks are minor and do not raise new issues of safety or effectiveness. Hence, the IMC Surgical Face Masks are substantially equivalent to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping, curved lines that resemble a human form or a flowing design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
International MedSurg Connection C/O Mr. Peter Kim 935 North Plum Grove Road, Suite F Schaumburg, Illinois 60173
AUG 1 6 2010
Re: K100846
Trade/Device Name: IMC Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: July 28, 2010 Received: August 2, 2010
Dear Mr. Kim:
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. 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.
5
Page 2- Mr. Kim
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the ·MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
th for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure _
6
Indications for Use
510(k) Number : K100846
Device Name: IMC Surgical Face Mask
Indications For Use: This device 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.
| Name/Description | Sterility |
|---|---|
| • IMC Surgical face mask Yellow with Ear loop | Sterile |
| • IMC Surgical face mask Yellow with Tie-on | Sterile |
| • IMC Surgical face mask Yellow with Ear loop | Non-Sterile |
| • IMC Surgical face mask Yellow with Tie-on | Non-Sterile |
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elaine S. Mayhall for Elizabeth F. Claverie
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K 100846 510(k) Number: _______________________________________________________________________________________________________________________________________________________________