These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.

Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSIIAMMIIISO 11135

Device Description

The IMC Surgical Drape devices are patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is made of non-latex rubber.

The Bladder Suspension Drape, the GYN Drape and the TUR drape have the same features and same materials but have different dimension of drape and aperture.

AI/ML Overview

The provided text describes a 510(k) submission for the IMC Surgical Drape and focuses on establishing substantial equivalence to predicate devices. It does not present a study designed to evaluate the device's performance against specific acceptance criteria in the context of clinical or diagnostic accuracy. Instead, it outlines the device's characteristics and compares them to predicate devices, referencing performance tests for material properties.

Therefore, many of the requested details about acceptance criteria and study design are not applicable to the information provided.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists performance characteristics and test methods for material properties, demonstrating that the IMC Surgical Drape "Meets Intended use" for each. These are implicitly the acceptance criteria for those specific material properties, equating to being "acceptable for the intended use" or meeting the specified standard.

Performance Characteristics	Test Method	Acceptance Criteria (Implicit)	Reported Device Performance (IMC Surgical Drape K100991)
Flammability of Clothing Textiles	16 CFR Part 1610	Class I	Class I
Hydrostatic Pressure	AATCC 127-2008	Meets Intended Use (as per predicate)	Meets Intended use
Impact Penetration	AATCC 42-2007	Meets Intended Use (as per predicate)	Meets Intended use
Determine Lint and Other particles	ISO 9073-10	Meets Intended Use (as per predicate)	Meets Intended use
General Tensile Testing of Fabric	ASTM D5034-2009	Meets Intended Use (as per predicate)	Meets Intended use

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

Sample Size: Not specified for the performance tests. The document only states that "These materials were tested." It does not detail how many samples of each material were tested.
Data Provenance: Not specified. It's likely that the testing was conducted by the manufacturer or a contracted lab, but the location or whether it was retrospective/prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This device is a surgical drape, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set. The "ground truth" for material properties is determined by standardized test methods and their defined pass/fail criteria (e.g., Class I for flammability, meeting "intended use" for hydrostatic pressure).

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

Not Applicable. As above, this is a material property evaluation, not an interpretation task requiring adjudication by experts.

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

Not Applicable. This is not an AI-assisted diagnostic device.

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

Not Applicable. This is not an algorithm.

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

Material Standard Compliance: For the performance characteristics listed, the "ground truth" is adherence to established industry standards and test methods (e.g., 16 CFR Part 1610 for flammability, AATCC 127-2008 for hydrostatic pressure, ISO 10993-x for biocompatibility). The claim is that the materials "were found to be acceptable for the intended use" based on these tests.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device requiring a training set.

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

Not Applicable. This is not an AI/machine learning device.

In summary: The provided 510(k) summary for the IMC Surgical Drape focuses on demonstrating substantial equivalence to predicate devices through comparisons of material composition, design features, and performance characteristics as measured by established material testing standards. It is not an AI-driven or diagnostic device, and therefore, many of the requested details related to "acceptance criteria" in a clinical/diagnostic context and associated study methodologies (like expert review, sample sizes for test/training sets, MRMC studies) are not pertinent to this submission.

Summary

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K100991 510(K) SUMMARY

Trade Name:	IMC Surgical Drape
Common Name:	Surgical Drape
Classification Name:	Surgical Drape and Drape Accessories(21 CFR subpart E §878.4370)
Submitter Information:	International Medsurg Connection935 N Plum Grove Rd, STE FSchaumburg, Illinois 60173	OCT 5 2010
Summary Prepared By:	Peter KimQuality ManagerInternational Medsurg Connection935 N Plum Grove Rd, STE FSchaumburg, Illinois 60173Telephone: 847-619-9926Fax: 847-619-9927e-mail: peterkim@intlmedsurg.com
Date Prepared:	June 7, 2010
Predicate Devices:	• 3M Steri-Drape™ (K031287)• Medline (K003755)

Device Name(s):

IMC Surgical Drape

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 Drape with the currently marketed:

Description	510(k) Number	Clearance Date
3M Steri-DrapeTM	K031287	9/10/2003
Medline BlockadeTM and ResistatTM Non-SterileSurgical Gowns and Surgical Drapes	K003755	2/16/2001

Device Description

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K 100991

The Bladder Suspension Drape, the GYN Drape and the TUR drape have the same features and same materials but have different dimension of drape and aperture.

Statement of Intended Use

Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSI/AMMI/ISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSI/AMMI/ISO 11135

Catalog Number	Description
31-0051	Bladder Suspension Drape
31-0051NS	Bladder Suspension Drape
61-0091	GYN Drape
61-0091NS	G YN Drape
81-0011	TUR Drape
81-0011NS	TUR Drape

New Devices as Compared to Marketed Device(s)

The IMC Surgical Drape and the predicate devices (3M Steri Drape TM, and Medline Blockade™ and Resistat™ Non-Sterile Surgical Gowns and Surgical Drapes) to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot.

Feature/Characteristic	IMC Surgical Drape K100991	3M Steri-DrapeTMK031287(Predicate)	MedlineK003755(Predicate)
Material CompositionAperture for surgicalsite	These materials were tested inaccordance with ISO 10993-5:2009, 10993-10:2002/Amd.1:2006, and10993-11:2006(E) testmethods and were found to beacceptable for the intended use	Similar	Similar
Absorbent PreventionFabric	These materials were tested inaccordance with ISO 10993-5:2009, 10993-10:2002/Amd.1:2006, and10993-11:2006(E) testmethods and were found to be	Same	Same

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510(h) Summery K100991

Feature/Characteristic	IMC Surgical Drape K100991	3M Steri-DrapeTMK031287(Predicate)	MedlineK003755(Predicate)
Finger Cot	acceptable for the intended useThese materials were tested inaccordance with ISO 10993-5:2009, 10993-10:2002/Amd.1:2006, and10993-11:2006(E) testmethods and were found to beacceptable for the intended use	Same	same
Color Additive	These materials were tested inaccordance with ISO 10993-5:2009, 10993-10:2002/Amd.1:2006, and10993-11:2006(E) testmethods and were found to beacceptable for the intended use	Same	Same
Design FeatureFinger Cot	Bladder Suspension Drape,GYN Drape,TUR Drape	Same	Same
Fluid CollectionBag	Bladder Suspension Drape,GYN Drape,TUR Drape	Same	Same
ApertureBladderSuspension	40cm (15.7") x 41cm (16.1")	Similar	Similar
GYN	25cm (9.8") x 25 cm (9.8")	Similar	Similar
TUR	12.5cm (4.9") x 7.5cm (2.95")	Similar	Similar

Performance Data:

10 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

ាច្រើន ប្រ

100 million in the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st

PerformanceCharacteristics	Test Method	IMC SurgicalDrape K100991	3M Steri-DrapeTMK031287(Predicate)	MedlineK003755(Predicate)
Flammability of ClothingTextilesSection 11	16 CFR Part 1610	Class I	Same	Same
Hydrostatic PressureSection 12	AATCC 127-2008	Meets Intendeduse	Same	Same
Impact PenetrationSection 13	AATCC 42-2007	Meets Intendeduse	Same	Same
Determine Lint and OtherparticlesSection 14	ISO 9073-10	Meets Intendeduse	Same	Same
General Tensile Testing ofFabricSection 15	ASTM D5034-2009	Meets Intendeduse	Same	Same

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Conclusions:

The indications for use, technology, specification, safety of the IMC Surgical Drapes and the two predicate devices K031287 and K003755 are essentially the same. The differences between the drapes are minor and do not raise new issues of safety or effectiveness. Hence, the IMC Surgical Drapes 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 two main elements: the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three abstract shapes resembling arms or limbs extending upwards. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DCT 5 2010

International Medsurg Connection C/O Mr. Peter Kim 935 N. Plum Grove Road, Suite F Schaumberg, Illinois 60173

Re: K100991

Trade/Device Name: IMC Surgical Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 16, 2010 Received: September 20, 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.htm 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.

Wh fer

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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Indications for Use Form

510(k) Number (if known): K100991

Device Name: IMC Surgical Drape

Indications for Use:

Catalog Number	Description
31-0051	Bladder Suspension Drape
31-0051NS	Bladder Suspension Drape
61-0091	GYN Procedure Drape
61-0091NS	GYN Procedure Drape
81-0011	TUR Procedure Drape
81-0011NS	TUR Procedure Drape

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Elizabeth F. (Laurie) Weller

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

510(k)

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.