Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate equipment from microbial and other contamination.

The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.

Device Description

Exact Medical Manufacturing Equipment Cover- Polyethylene are single use, disposable equipment cover used in the OR as a protective covering, for the operating equipment, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Equipment Covers - Polyethylene are comprised Polyethylene with absorbent polypropylene. The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "EMM Equipment Cover - Polyethylene." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's diagnostic or therapeutic performance. As such, many of the typical elements requested for an AI/diagnostic device study (like sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training data) are not applicable or present in this context.

However, I can extract the acceptance criteria and reported device performance from the provided "Non-Clinical Testing Summary."

1. Table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Water Resistance: Impact Penetration Test, Level 3	<1.0 gm Blotter water weight gain	Pass
Water Resistance: Hydrostatic Pressure Test, Level 3	=/> 50 cm hydrostatic resistance	Pass
Flammability of Clothing Textiles - Class 1	Class 1 =/> 3.5 sec. average flame spread	Pass
Tearing Strength of Fabrics by Trapezoid Procedure	Acceptance criteria not established in recognized standard. Tear Strength for Md and Cd within general industry tolerance of +/- 20%	Pass
Breaking Strength and Elongation of Textile Fabrics (Grab Test)	Acceptance criteria not established in recognized standard. Tensile Strength for Md and Cd within general industry tolerance of +/- 20%	Pass
Sterilization of health care products - Ethylene oxide - Part 1	SAL of > 10-6	Pass
Lint and other particles generation in the dry state	Acceptance criteria not established in the recognized standard	Pass

2. Sample sized used for the test set and the data provenance:

Sample Size: The document does not specify the sample size for each test. It refers to a "Finished Good Lot Number: 0980APA3" for multiple tests, implying that samples were drawn from this lot.
Data Provenance: The tests were conducted at "Nelson Labs, Utah, USA" and "SCDC, Shanghai, CN, LexaMed, Ohio, USA." This indicates the tests were conducted in the USA and China, presumably using newly manufactured equipment covers. These are non-clinical (laboratory/performance) tests, not clinical data sets.

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

This information is not applicable. The device is an equipment cover, and the "ground truth" is established by laboratory performance standards and measurements, not by expert interpretation of clinical data.

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

This information is not applicable. The tests are based on objective physical and chemical properties measured according to established standards, not on expert adjudication of ambiguous cases.

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 information is not applicable. The device is an equipment cover and not an AI-powered diagnostic tool. No MRMC study was conducted.

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

This information is not applicable. The device is an equipment cover and does not involve an algorithm.

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

The "ground truth" for this device's performance is defined by adherence to recognized international and national standards for material properties, barrier performance, flammability, and sterility. These are objective, measurable criteria, not subjective interpretations.

8. The sample size for the training set:

This information is not applicable. This is a manufactured product undergoing non-clinical performance testing, not a machine learning model requiring a training set.

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

This information is not applicable. As there is no training set, there is no ground truth establishment process for it.

Summary

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xact Medical Manufacturing, Inc.

Sec. 6 510(k) Summary – EMM Equipment Cover- Polyethylene

510(k) Summary for Exact Medical Manufacturing Inc., EMM Equipment Cover–Polyethylene :

Date Summary was Prepared	June 10, 2010	Exact Medical Manufacturing - EquipmentCover - Polyethylene	SubstantiallyEquivalent	Kimberly-Clark KC-100 Surgical Drapes& Equipment Covers - K083234PREDICATE DEVICE
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	Indications for Use: Exact MedicalManufacturing Equipment Cover -Polyethylene are sterile single use devicesmade of natural or synthetic materialsintended to be used as a protective equipmentcovering, such as to isolate equipment frommicrobial and other contamination.The Exact Medical Manufacturing EquipmentCovers-Polyethylene are also sold as bulknon-sterile, single use items, torepackager/relabeler establishments forfurther packaging and ethylene oxidesterilization.	SubstantiallyEquivalent	Intended Use: Kimberly-Clark intends tomarket the sterile KC100 SurgicalEquipment Covers which are protectivebarrier covers that are intended to be usedto cover surgical equipment and provide aprotective barrier for that equipment.
Primary Contact for this 510(k)Submission	David Nowicki, PresidentExact Medical Manufacturing Inc.4917 William Street, Suite CLancaster, NY 14086dnowicki@exactmm.com(p)716-681-0866, (f) 716-681-4110	Classification and Code: Code KKX,21CFR878.4370, Class II	SubstantiallyEquivalent	Classification & Code, Class II, MMP
Device Common Name	Equipment Cover	Materials & Construction: Polyethylene,absorbent polypropylene	SubstantiallyEquivalent	Materials & Construction: Bluepolyethylene, with air laid reinforcement
Trade Name	Equipment Cover- Polyethylene, Model # 14-001	Sterile: ISO 11135-1:2007, Sterilization ofhealth care products - Ethylene oxide - Part 1	SubstantiallyEquivalent	Sterile
Device Product Codes and	MMP, 21CFR878.4370, Surgical Drape and Drape accessories, Class II	Sterile Packaging: Chevron peel pouch(coated paper (73gsm), PET12/PE40 filmconstruction), individual CSR internal wrap	SubstantiallyEquivalent	Sterile Packaging: Chevron peel pouch(coated paper, PE film construction),individual CSR internal wrap
Classification Name		Non-Sterile	SubstantiallyEquivalent	Non-Sterile
Predicate Device	K083234 Kimberly-Clark KC100 Surgical Drapes and Equipment Covers	Barrier properties - AATCC 42:2007,AATCC 127:2008: Liquid Barrier Performanceand Classification of Protective Apparel andDrapes intended for Use in Health CareFacilities, AAMI PB70:2003 /(R)2009), Level 3compliant	SubstantiallyEquivalent	Barrier properties: References AATCC127:2008, INDA IST 80.6 (98), ISO 811-1981, ISO 139-1973
Device Description	Exact Medical Manufacturing Equipment Cover- Polyethylene are singleuse, disposable equipment cover used in the OR as a protective covering,for the operating equipment, from the transfer of microorganisms, bodyfluids and particulates. Exact Medical Manufacturing Equipment Covers -Polyethylene are comprised Polyethylene with absorbent polypropylene.The Exact Medical Manufacturing Equipment Covers-Polyethylene are alsosold as bulk non-sterile, single use items, to repackager/relabelerestablishments for further packaging and ethylene oxide sterilization.	Tear strength - ASTM D5587-08 (no rev.)Standard Test Method for Tearing Strength ofFabrics by Trapezoid Procedure. Tearstrength for Md and Cd within generalindustry tolerance of +/- 20%	SubstantiallyEquivalent	Tensile strength: NFPA 1999, 1997, ASTMD5733-99:2002, ASTM D1004-03:2003
Intended Use	Exact Medical Manufacturing Equipment Cover - Polyethylene are sterilesingle use devices made of natural or synthetic materials intended to beused as a protective equipment covering, such as to isolate equipment frommicrobial and other contamination. The Exact Medical ManufacturingEquipment Covers-Polyethylene are also sold as bulk non-sterile, singleuse items, to repackager/relabeler establishments for further packaging andethylene oxide sterilization	Tensile strength - ASTM D5034-09 (no rev.)Standard Test Method for Breaking Strengthand Elongation of Textile Fabrics (Grab Test)Tensile strength for Md and Cd withingeneral industry tolerance of +/- 20%	SubstantiallyEquivalent	Grab Test: ASTM D 5034-95: 2001
Technological Characteristics	Exact Medical Manufacturing Equipment Cover- Polyethylene has the samedesign, material and performance characteristics of the predicate device.Additional Summary and explanation of technological characteristicsis included in the following Addendum A.	Flammability - 16CFR1610:2010,Flammability of Clothing Textiles, Class 1PASS	SubstantiallyEquivalent	Flammability: 16CFR1610
Summary of Testing	Exact Medical Manufacturing Equipment Cover- Polyethylene issubstantially equivalent and meets the same acceptance criteria as thepredicate device/gown in K083234. Non-clinical performance testingincludes: barrier properties- Level 3, tensile, tear strength, flammability,linting and sterility. All results of the testing met acceptance criteria.Additional Summary and explanation of non-clinical testing isincluded in the following Addendum B.	Lint and other particles generation in the drystate - ISO 9073-10:2003	Not Applicable	No test
Substantial Equivalence	The equipment covers described in this 510(k) submission are substantiallyequivalent in all specifications and performance compared to the predicatedevice indentified in K083234 except for minor variations in the widths andlengths.

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Addendum A.

Sec. 10: EQUIPMENT COVER Polyethylene - Predicate Device Comparison Table

•

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Addendum B

Non-Clinical Testing Summary: EMM Equipment Cover, Model # 14-001

TestArticle	FinishedGood LotNumber	ReferenceStandard(s)	Description	Accept - RejectCriteria	Pass/Fail	Test Lab
Model No.14-001Sterile	0980APA3	AATCC 42:2007(AAMI PB70:2003/(R)2009)	Water Resistance: ImpactPenetration Test, Level 3	<1.0 gm Blotterwater weight gain	Pass	Nelson Labs,Utah, USA
Model No.14-001Sterile	0980APA3	AATCC 127:2008(AAMI PB70:2003/(R)2009)	Water Resistance: HydrostaticPressure Test, Level 3	=/> 50 cmhydrostaticresistance	Pass	Nelson Labs,Utah, USA
Model No.14-001Sterile	0980APA3	16CFR1610:2010	Flammability of Clothing Textiles- Class 1	Class 1 =/> 3.5 sec.average flamespread	Pass	Nelson Labs,Utah, USA
Model No.14-001Sterile	0980APA3	ASTM D5587-08(no rev.)	Standard Test Method forTearing Strength of Fabricsby Trapezoid Procedure	Acceptance criterianot established inrecognizedstandard. TearStrength for Md andCd within generalindustry tolerance of+/- 20%	Pass	Nelson Labs,Utah, USA
Model No.14-001Sterile	0980APA3	ASTM D5034-09(no rev.)	Standard Test Method forBreaking Strength andElongation of Textile Fabrics(Grab Test)	Acceptance criterianot established inrecognizedstandard. TensileStrength for Md andCd within generalindustry tolerance of+/- 20%	Pass	Nelson Labs,Utah, USA
Model No.14-001		ISO 11135-1:2007	Sterilization of health careproducts - Ethylene oxide - Part1	SAL of > 10-6	Pass	SCDC, Shanghai,CN LexaMed,Ohio, USA
Model No.14-001Sterile	0980APA3	ISO 9073-10:2003	Lint and other particlesgeneration in the dry state	Acceptance criterianot established inthe recognizedstandard	Pass	Nelson Labs,Utah, USA

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

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

SEP 2 0 2016

Re: K101689

Trade/Device Name: Exact Medical Manufacturing Equipment Cover-Polyethylene, Model # 14-001 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: August 20, 2010 Received: August 23, 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 prémarket 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 (OS) 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,

Anthony D. owens

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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Sec. 7: Intended Use

KID1689

Indications for Use Form

SEP 2 0 2010

Indications for Use:

510(k) Number (if known): K101689

Device Name: Exact Medical Manufacturing Equipment Cover -- Polyethylene, Model #14-001

Indications for Use: Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate equipment from microbial and other contamination.

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)

Edith H. Claussen-Williams

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

510(k) Number: K101689

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.