This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter.

Device Description

Surgical Gowns including various sizes and material.

AI/ML Overview

The provided document describes the safety and effectiveness of the IMC Surgical Gown. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical way for each test. Instead, it lists the tests performed and the standards they adhere to, implying that meeting these standards constitutes acceptable performance. The document states "All material used in the fabrication of the IMC Surgical Gowns were evaluated for:" followed by the table. This suggests the reported device performance is that it met these standards.

Test	Standard	Reported Device Performance (Implied)
Cytotoxicity	ISO 10993 - Part 5	Met standard
Skin Irritation	ISO 10993 - Part 10	Met standard
Skin Sensitivity	ISO 10993 - Part 11	Met standard
Systemic Toxicity	ISO 10993 - Part 11	Met standard
Flammability	16 CFR Part 1610	Met standard
Hydrostatic Pressure	AATCC 127	Met standard
Impact Penetration	AATCC 42	Met standard
Lint	IST 160.1	Met standard
Tensile Strength	ASTM D5034	Met standard

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for the biological (cytotoxicity, irritation, sensitivity, systemic toxicity) and physical (flammability, hydrostatic pressure, impact penetration, lint, tensile strength) tests performed on the surgical gown material.

The data provenance is not explicitly mentioned. It's an FDA submission in the USA, so it's likely the testing was conducted to meet US regulatory requirements, but the origin of the raw data/testing facilities is not stated. The document does not indicate if the data is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the evaluation relies on standardized laboratory tests and not expert consensus on medical images or clinical outcomes. The "ground truth" for these tests are the established parameters and methodologies defined by the cited ISO, CFR, AATCC, IST, and ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. The methods for evaluating the material properties are defined by the referenced standards (e.g., ISO 10993, AATCC 127), which involve specific measurement techniques rather than expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its evaluation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical product (surgical gown), not an algorithm or software. Its performance is evaluated through material testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's performance relies on objective measurements and procedures defined by established industry and regulatory standards. For example:

Biological Endpoints: The "ground truth" for cytotoxicity, skin irritation, skin sensitization, and systemic toxicity is determined by the specific protocols and criteria outlined in various parts of ISO 10993.
Physical Properties: The "ground truth" for flammability, hydrostatic pressure, impact penetration, lint, and tensile strength is based on the quantitative measurements and methodology described in standards like 16 CFR Part 1610, AATCC 127 & 42, IST 160.1, and ASTM D5034.

8. The sample size for the training set:

This is not applicable. The document describes the evaluation of a physical medical device (surgical gown) through laboratory testing, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established:

This is not applicable as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters, which appear to be 'K052550'. The characters are written in a bold, somewhat stylized font, with varying stroke thicknesses. The overall impression is that of a handwritten code or identifier.

NOV 1 7 2005

SUMMARY OF THE SAFETY AND EFFECTIVENESS 10.0

International Medsurg Connection Surgical Gown

Manufacturer:	International Medsurg Connection, Inc.935 N Plum Grove Road, Suite FSchaumburg, Illinois 60173-4770
Regulatory Contact:	Manny GuptaVice President / General ManagerInternational Medsurg Connection, Inc.935 N Plum Grove Road, Suite FSchaumburg, Illinois 60173-4770
Telephone:	847-619-9929
Date Summary Prepared	August 5, 2005
Product Trade Name:	IMC Surgical Gowns - Multiple
Common Name:	Surgical Gown.
Classification:	Class II
Predicate:	Surgical Gowns, Reference K030364owned by DeRoyal Industries.
Description:	Surgical Gowns including various sizesand material.

Intended Use:

International Medsurg Connection's Surgical Gown is intended to be used as Patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

Substantial Eguivalence:

The International Medsurg Connection Surgical Gowns are substantially equivalent to the Surgical Gown sold by DeRoyal Industries, Reference K030364.

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IMC GOWN LIST

Catalog Number	Description
Surgical Gowns
260-2001	Non reinforced Large
260-2002	Non reinforced X-Large
260-2003	Non reinforced XX-Large
260-2101	Fabric reinforced Large
260-2102	Fabric reinforced X-Large
260-2103	Fabric reinforced XX-Large
260-2201	Poly-reinforced Large
260-2202	Poly-reinforced X-Large
260-2203	Poly-reinforced XX-Large
260-2301	Breathable Large, Extra Long
260-2302	Breathable X-Large, Extra Long
260-2303	Breathable XX-Large, Extra Long
260-9211	Fabric reinforced Large, Extra Long
260-9212	Fabric reinforced X-Large, Extra Long
260-9115	Non reinforced Large, Extra Long
260-9116	Non reinforced X-Large, Extra Long

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K052556

They provide the following characteristics: Intended use is the same Similar configurations Similar materials

Summary of testing:

Comments of the country and secures with and

All material used in the fabrication of the IMC Surgical Gowns were evaluated for:

Test	Standard
Cytotoxicity	ISO 10993 - Part 5
Skin Irritation	ISO 10993 - Part 10
Skin Sensitivity	ISO 10993 - Part 11
Systemic Toxicity	ISO 10993 - Part 11
Flammability	16 CFR Part 1610
Hydrostatic Pressure	AATCC 127
Impact Penetration	AATCC 42
Lint	IST 160.1
Tensile Strength	ASTM D5034

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The bird is facing to the right.

Public Health Service

NOV 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Manny Gupta Vice President/General Manager International Medsurg Connection, Incorporated 935 North Plum Glove Road, Suite F Schaumburg, Illinois 60173-4770

Re: K052550

Trade/Device Name: IMC Surgical Gowns-Various Sizes and Configurations, Per Attached List Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 3, 2005 Received: November 7, 2005

Dear Mr. Gupta:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. Gupta

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sujite H. Michie Dnd

Čhiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510K Number : _ K O52550

Device name: IMC Surgical Gowns – Various sizes and configurations per attached list

Indication For Use:

This submission includes Surgical Gowns that will be sold both sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Prescription Use X (Partb21 CFR 801 Subpart D) AND/OR

Over-The counter Use (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)

Shinda H. Murphy, KD 11/17/05
(Division Sign-off)

Division of anesthesiology, General Hospital. Infection Control Dental Devices

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.