Exact Medical Manufacturing Surgical Drape SMS w/PE Sides are sterile or non-sterile single use devices 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 Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Device Description

Exact Medical Manufacturing Surgical Drapes Surgical Drape SMS w/PE Sides are sterile or non-sterile single use devices 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.

Exact Medical Manufacturing Surgical Drapes SMS w/PE Sides are comprised of a single layer of SMS (spunbond/meltblown/spunbond polypropylene), PE Layer, 3M Medical Adhesive Tape.

AI/ML Overview

The provided text is for a 510(k) Summary for a medical device called "EMM Surgical Drape SMS w/PE Sides." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a novel AI or diagnostic device.

Therefore, many of the requested items related to AI/diagnostic device studies (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size of AI assistance, standalone performance, and how ground truth was established) are not applicable to this type of submission.

However, I can extract the acceptance criteria and the summary of testing performed to demonstrate that the device met these criteria, in comparison to a predicate device.

Acceptance Criteria and Reported Device Performance

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

Acceptance Criteria (from Predicate Device/Industry Standards)	Reported Device Performance (EMM Surgical Drape SMS w/PE Sides)
Indications for Use: Protective patient covering to isolate a site of surgical incision from microbial and other contamination.	Substantially Equivalent (Same indications for use)
Classification: KKX, Surgical Drapes, 21CFR878.4370, Class II	Substantially Equivalent (Same classification)
Materials & Construction: SMS, absorbent reinforcement, 3M medical grade adhesive	Substantially Equivalent (SMS, Polyethylene, Absorbent Reinforcement, 3M medical grade adhesive)
Barrier properties (AAMI PB70:2003 /(R)2009): Hydrostatic head = 30.5 cm (Predicate)	Hydrostatic Head =/> 50 cm (meets AAMI PB70 Level 3)
Sterility: Non-sterile (Predicate)	Sterile (via EO Gas) ISO 11135-1:2007 (also available non-sterile)
Biocompatibility (ISO 10993-5:1999, ISO 10993-10:2002): Cytotoxicity, Irritation, Sensitization PASS	Substantially Equivalent (Cytotoxicity, Irritation, Sensitization tests PASS)
Tear Strength (ASTM D5587-08): Md=1.83 lbs, Cd= 3.24 lbs (Predicate)	Substantially Equivalent (Md and Cd within general industry tolerance +/- 20%)
Tensile Strength (ASTM D5034-09): Md=13.8 lbs, Cd=18.8 lbs (Predicate)	Substantially Equivalent (Md and Cd within general industry tolerance +/- 20%)
Flammability (16CFR1610:2010): Class 1 (Predicate)	Substantially Equivalent (Class 1 - PASS)
Lint and other Particles (ISO 9073-10:2003): No test specified for predicate	Test performed (Not Applicable for direct comparison against predicate criteria as predicate had no test)
Sterile Packaging: Not Applicable (Predicate)	Chevron peel pouch (coated paper, PET12/PE40 film construction), individual CSR internal wrap

Note: The reported device performance often states "Substantially Equivalent" indicating that the EMM Surgical Drape met or exceeded the performance characteristics of the predicate device, or adhered to recognized standards. For Barrier Properties, the EMM device reports a higher hydrostatic head, meeting a higher level (Level 3) compared to the stated predicate value, which implies it exceeds the predicate's performance.

Study Details (as applicable for this type of submission)

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

Not Applicable in this context. This submission is for a physical medical device (surgical drape) and relies on laboratory-based performance testing rather than clinical data or a diagnostic test set with patient data. The "test set" here refers to samples of the surgical drape material. The document does not specify sample sizes for each physical test, beyond stating that "All results of the testing met acceptance criteria." Data provenance (country of origin, retrospective/prospective) is not mentioned or relevant for these types of material property tests.

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. Ground truth, in the sense of expert review for diagnostic accuracy, is not relevant here. The "ground truth" for material properties is established by defined physical and chemical testing standards (e.g., ISO, ASTM, AATCC) and the results obtained from those standardized tests.

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

Not Applicable. Adjudication methods are typically for subjective expert review of medical images or clinical cases. The testing for the surgical drape involves objective physical property measurements.

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 a physical medical device, not an AI or diagnostic tool.

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

Not Applicable. This is a physical medical device, not an AI or diagnostic algorithm.

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

The "ground truth" for this device's performance is established by objective measurements against recognized industry standards and regulatory requirements for material properties and biocompatibility. This includes compliance with standards such as ISO 10993 (Biocompatibility), AAMI PB:70 (Barrier properties), ASTM D5587 (Tear Strength), ASTM D5034 (Tensile Strength), 16CFR1610 (Flammability), and ISO 9073-10 (Linting). The predicate device's established performance also serves as a benchmark for "substantial equivalence."

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of physical medical device testing for substantial equivalence.

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

Not Applicable. No training set is used.

Summary

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K101598

Sec. 6: 510(k) Summary - EMM Surgical Drape SMS w/PE Sides

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510(k) Summary for Exact Medical Manufacturing Inc., EMM Surgical Drape – SMS w/PE Sides

Date Summary was Prepared	July 29, 2010 (rev.1)
510(k) Submitter	David Nowicki, PresidentExact Medical Manufacturing Inc.4917 William Street, Suite CLancaster, NY 14086dnowicki@exactmm.com(p)716-681-0866, (f) 716-681-4110
Primary Contact for this 510(k) Submission	David Nowicki, PresidentExact Medical Manufacturing Inc.4917 William StreetLancaster, NY 14086dnowicki@exactmm.com(p)716-681-0866, (f) 716-681-4110
Device Common Name	Surgical Drape
Trade Name	EMM Surgical Drape SMS w/PE Sides, Model 13-005
Device Product Codes andClassification Name	KKX, 21CFR878.4370, Surgical Drape and Drape accessories, Class II
Predicate Device	Primeline (Primagard) Surgical drapes 510(k)021864
Device Description	Exact Medical Manufacturing Surgical Drapes Surgical Drape SMS w/PE Sides are sterile ornon-sterile single use devices made of natural or synthetic materials intended to be used asa protective patient covering, such as to isolate a site of surgical incision from microbial andother contamination.Exact Medical Manufacturing Surgical Drapes SMS w/PE Sides are comprised of a singlelayer of SMS (spunbond/meltblown/spunbond polypropylene), PE Layer, 3M MedicalAdhesive Tape.
Intended Use	Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides are sterile ornon-sterile single use devices made of natural or synthetic materials intended to be used asa protective patient covering, such as to isolate a site of surgical incision from microbial andother contamination.The Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides are alsosold as bulk non-sterile, single use items, to repackager/relabeler establishments for furtherpackaging and ethylene oxide sterilization
Technological Characteristics	Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides has the samedesign, material and performance characteristics of the predicate device. Additionalsummary and explanation of technological characteristics is included in the followingAddendum A
Summary of Testing	Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides issubstantially equivalent and meets the same acceptance criteria as the predicatedevice/gown in K021864. Non-clinical performance testing includes: Biocompatibility(cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrierproperties AAMI PB:70 Level 3, tensile, tear strength, flammability, linting and sterility. Allresults of the testing met acceptance criteria. Additional summary and explanation ofnon-clinical testing is included in the following Addendum B.
Substantial Equivalence	The surgical drapes described in this 510(k) submission are substantially equivalent in allspecifications and performance compared to the predicate device indentified in K021864except for minor variations in the widths and lengths.

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xact Medical Manufacturing, Inc.

K/01598

Addendum A

Summary and Explanation of Technological Characteristics: EMM SURGICAL DRAPE SMS w/PE Sides Predicate Device Comparison Table

Exact Medical Manufacturing - Surgical DrapeSMS w/PE SidesModel # 13-005	SubstantiallyEquivalent	Primeline (Primagard) Surgical Drapes510(k)021864PREDICATE DEVICE
Indications for Use: Exact Medical ManufacturingSurgical Drape SMS w/PE Sides are sterile ornon-sterile single use devices made of natural orsynthetic materials intended to be used as aprotective patient covering, such as to isolate asite of surgical incision from microbial and othercontamination.	SubstantiallyEquivalent	devices made of natural or synthetic materialsintended to be used as a protective patientcovering, such as to isolate a site of surgicalincision from microbial and other contamination.
Classification & Code: KKX, Surgical Drapes,21CFR878.4370, Class II	SubstantiallyEquivalent	Classification & Code: KKX, Surgical Drapes.21CFR878.4370, Class II
Materials & Construction: SMS(spunbond/meitblown/spunbond polypropylene),Polyethylene, Absorbent Reinforcement, 3Mmedical grade adhesive	SubstantiallyEquivalent	SMS, absorbent reinforcement, 3M medical gradeadhesive
Barrier properties AATCC 42:2007, AATCC127:2008: Liquid Barrier Performance andClassification of Protective Apparel and Drapesintended for Use in Health Care Facilities, AAMIPB70:2003 /(R)2009, Level 3. Hydrostatic Head=/> 50 cm	SubstantiallyEquivalent	Hydrostatic head = 30.5 cm
Sterile (via EO Gas) ISO 11135-1:2007,Sterilization of health care products - EthyleneOxide - Part 1	Not Applicable	Non-sterile
Non-Sterile	SubstantiallyEquivalent	Non-sterile
Sterile Packaging: Chevron peel pouch (coatedpaper (73gsm), PET12/PE40 film construction),individual CSR internal wrap	Not Applicable	Not Applicable
Biocompatibility: cytotoxicity, irritation andsensitization - ISO 10993-5:1999, Cytotoxicity,ISO 10993-10:2002, Skin Irritation, ISO 10993-10:2002, Sensitization.Cytotoxicity, Irritation, Sensitization testsPASS	SubstantiallyEquivalent	Cytotoxicity, Irritation, Sensitization PASS
Tear Strength - ASTM D5587-08 (no rev.)Standard Test Method for Tearing Strength ofFabrics by Trapezoid Procedure.Tensile Strength for Md and Cd within generalindustry tolerance +/- 20%	SubstantiallyEquivalent	Md=1.83 IbsCd= 3.24 lbs
Tensile Strength - ASTM D5034-09 (no rev.)Standard Test Method for Breaking Strength andElongation of Textile Fabrics (Grab Test)Tensile Strength for Md and Cd within generalindustry tolerance +/- 20%	SubstantiallyEquivalent	Md=13.8 lbsCd=18.8 lbs
Flammability - 16CFR1610:2010, Flammability ofClothing TextilesClass 1 - PASS	SubstantiallyEquivalent	Class 1
Lint and other Particles generated in the drystate - ISO 9073-10:2003	Not Applicable	No test

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol with three curved lines, resembling a human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Exact Medical Manufacturing, Incorporated C/O Mr. Robert O. Dean Compliance Systems International, LLC 1083 Delaware Avenue Buffalo, New York 14209

OCT 4 2010

Re: K101598

Trade/Device Name: Exact Medical Manufacturing Surgical Drape SMS w/PE Sides, Model 13-005 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape-and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 17, 2010 Received: September 24, 2010

Dear Mr. Dean:

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. Dean

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 yours,

h 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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Indications for Use Form

Indications for Use:

510(k) Number (if known): K101598

Device Name: Exact Medical Manufacturing Surgical Drape SMS w/PE Sides, Model 13-005

Indications for Use: Exact Medical Manufacturing Surgical Drape SMS w/PE Sides are sterile or non-sterile single use devices 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 Exact Medical Manufacturing Surgical Drape SMS w/PE Sides are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Prescription Use (Part 21 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 OF NEEDED)

s Elizabeth F. Clarence-William

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

510(k) Number: 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.