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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the IMC Surgical Face Mask, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Test Method	Acceptance Criteria	IMC Surgical Face Mask K100846
Fluid Resistance Performance (mmHg)	ASTM F1862-07 (2007)	Low=80, Moderate = 120, High = 160	Meets Standard Criteria
Particulate Filtration Efficiency (%)	ASTM F2299-03 (2003)	≥98%	Meets Standard Criteria
Bacterial Filtration Efficiency (%)	ASTM F2101-07 (2007)	Low: ≥95, Moderate: ≥98%, High: ≥98%	Meets Standard Criteria
Differential Pressure (Delta-P) (mmH2O/cm²)	MIL-M36945C 4.4.1.1.1 (1975)	≤4 mmH2O/cm²	Meets Standard Criteria
Flammability	16 CFR Part 1610 (1998)	Class 1	Class 1

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the performance tests (e.g., how many masks were tested for each characteristic). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The tests are described as being conducted "in accordance with" specific ASTM and MIL standards, implying standard laboratory testing rather than clinical studies with human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the type of device and testing described. The "ground truth" for the performance characteristics of a surgical mask (e.g., fluid resistance, filtration efficiency) is established by the specified test methods and their defined parameters, not by expert consensus or interpretation of imagery.

4. Adjudication Method for the Test Set

Not applicable. The performance testing of a surgical mask involves objective measurements against established standards, not interpretation by multiple experts requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes the performance characteristics of a physical product (a surgical mask).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is not an algorithm or AI system. The performance studies are laboratory tests of the physical mask's material properties.

7. Type of Ground Truth Used

The ground truth used for this device's performance evaluation is established by objective test standards and defined acceptance criteria. These are standardized test methods (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M36945C, 16 CFR Part 1610) that measure specific physical properties of the mask. The "ground truth" is that a mask either meets or does not meet the specified quantitative threshold for each characteristic (e.g., ≥98% for particulate filtration efficiency).

8. Sample Size for the Training Set

Not applicable. This device is a physical product and not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Study That Proves the Device Meets the Acceptance Criteria:

The device's compliance with the acceptance criteria is demonstrated through a series of performance characteristic tests conducted according to recognized industry standards. The summary states that for each performance characteristic (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), the "IMC Surgical Face Mask K100846" was found to "Meets Standard Criteria" or "Class 1" (for Flammability).

The predicate devices (Medline K991559 and Crosstex K012602) are also listed as meeting the "Same" standards, indicating that the new device replicates the performance of already legally marketed devices. The document implies that reports from these tests were submitted to the FDA to demonstrate substantial equivalence to the predicate devices. The listed Test Methods are the studies that prove the device meets the acceptance criteria.

Summary

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K100846

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 FluidShield	K991559	08/23/1999
Crosstex Isolite Earloop, Crosstex Isofluid EarloopFace Masks.	K012602	01/22/2002

Device Description

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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 MaskK100846	MedlineK991559(Predicate)	CrosstexK012602(Predicate)
Layer 1 - Outer	These materials were testedin accordance with ISO10993-5, 10993-10, and10993-11 test methods andwere found to be acceptablefor the intended use	Same	Same
Layer 2 - Middle	These materials were testedin accordance with ISO10993-5, 10993-10, and10993-11 test methods andwere found to be acceptablefor the intended use	Same	Same
Layer 3 - Inner	These materials were testedin accordance with ISO10993-5, 10993-10, and10993-11 test methods andwere found to be acceptablefor the intended use	Same	Same
Ear loop	These materials were testedin accordance with ISO10993-5, 10993-10, and10993-11 test methods andwere found to be acceptablefor the intended use	Same	Same

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Feature/Characteristic	IMC Surgical Face MaskK100846	MedlineK991559(Predicate)	CrosstexK012602(Predicate)
Tie-on	These materials were testedin accordance with ISO10993-5, 10993-10, and10993-11 test methods andwere found to be acceptablefor the intended use	Same	Same
Nose Piece	These materials were testedin accordance with ISO10993-5, 10993-10, and10993-11 test methods andwere found to be acceptablefor the intended use	Same	Same
colors
Yellow	These materials were testedin accordance with ISO10993-5, 10993-10, and10993-11 test methods andwere found to be acceptablefor 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

PerformanceCharacteristics	Test Method	AcceptanceCriteria	IMC SurgicalFace MaskK100846	MedlineK991559(Predicate)	CrosstexK012602(Predicate)
Fluid ResistancePerformance (mmHg)	ASTM F1862-07(2007)	Low=80Moderate = 120High = 160	Meets StandardCriteria	Same	Same
Particulate FiltrationEfficiency Performance (%)	ASTM F2299-03(2003)	≥98%	Meets StandardCriteria	Same	Same
Bacterial FiltrationEfficiency Performance (%)	ASTM F2101-07(2007)	Low: ≥95Moderate: ≥98%High: ≥98%	Meets StandardCriteria	Same	Same
Different Pressure (Delta-P)(mmH2O/cm²)	MIL-M36945C4.4.1.1.1(1975)	≤4 mmH2O/cm2	Meets StandardCriteria	Same	Same
Flammability	16 CFR Part 1610(1998)	Class 1	Class 1	Same	Same

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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.

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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.

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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 _

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K100846

Indications for Use

510(k) Number : K100846

Device Name: IMC Surgical Face Mask

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: _______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.