Who is the manufacturer of EMM EQUIPMENT COVER-POLYTHYLENE?

Exact Medical Manufacturing, Inc. filed the 510(k) submission for EMM EQUIPMENT COVER-POLYTHYLENE (K101689).

What is the FDA product code for EMM EQUIPMENT COVER-POLYTHYLENE?

KKX. It is classified under 21 CFR 878.4370 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for EMM EQUIPMENT COVER-POLYTHYLENE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EMM EQUIPMENT COVER-POLYTHYLENE?

Kimberly-Clark KC-100 Surgical Drapes & Equipment Covers (K083234).

Who can help prepare an FDA 510(k) submission like EMM EQUIPMENT COVER-POLYTHYLENE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EMM EQUIPMENT COVER-POLYTHYLENE

K101689 · Exact Medical Manufacturing, Inc. · KKX · Sep 20, 2010 · General, Plastic Surgery

Device Facts

Record ID	K101689
Device Name	EMM EQUIPMENT COVER-POLYTHYLENE
Applicant	Exact Medical Manufacturing, Inc.
Product Code	KKX · General, Plastic Surgery
Decision Date	Sep 20, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

Intended 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. 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.

Device Story

Single-use, disposable equipment cover; constructed from polyethylene and absorbent polypropylene. Used in operating rooms to provide protective barrier for surgical equipment against microorganisms, body fluids, and particulates. Prevents cross-contamination. Sold as sterile finished goods or bulk non-sterile items for repackaging/sterilization. Healthcare providers apply cover manually to equipment. Benefits include reduced risk of equipment contamination and simplified OR cleanup.

Clinical Evidence

Bench testing only. No clinical data. Testing included barrier properties (AATCC 42, AATCC 127, AAMI PB70 Level 3), tensile strength (ASTM D5034), tear strength (ASTM D5587), flammability (16CFR1610), lint generation (ISO 9073-10), and sterility (ISO 11135-1). All results met established acceptance criteria.

Technological Characteristics

Materials: Polyethylene and absorbent polypropylene. Barrier performance: AAMI PB70 Level 3. Standards: AATCC 42:2007, AATCC 127:2008, ASTM D5587-08, ASTM D5034-09, 16CFR1610:2010, ISO 9073-10:2003. Sterilization: Ethylene oxide (ISO 11135-1:2007). Packaging: Chevron peel pouch (coated paper/PET/PE film).

Indications for Use

Indicated for use as a protective barrier covering for surgical equipment to isolate it from microbial and other contamination in healthcare settings. Available as sterile single-use devices or bulk non-sterile items for further processing.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Kimberly-Clark KC-100 Surgical Drapes & Equipment Covers (K083234)

Related Devices

K961699 — EQUIPMENT COVERS · United States Surgical, A Division of Tyco Healthc · Aug 23, 1996
K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 · Valumed · Feb 4, 2003
K111458 — GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS · Gri Medical & Electronic Technology Co., Ltd. · Dec 1, 2011
K083234 — KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 · Kimberly-Clark Corp. · Mar 25, 2009
K041224 — FOOTHILLS SURGICAL DRAPES · Foothills Industries, Inc. · Feb 3, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ 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 - Equipment Cover - Polyethylene | Substantially Equivalent | Kimberly-Clark KC-100 Surgical Drapes & Equipment Covers - K083234 PREDICATE DEVICE | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Submitter | David Nowicki, President Exact Medical Manufacturing Inc. 4917 William Street, Suite C Lancaster, NY 14086 dnowicki@exactmm.com (p)716-681-0866, (f) 716-681-4110 | 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. 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. | Substantially Equivalent | Intended Use: Kimberly-Clark intends to market the sterile KC100 Surgical Equipment Covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment. | | Primary Contact for this 510(k) Submission | David Nowicki, President Exact Medical Manufacturing Inc. 4917 William Street, Suite C Lancaster, NY 14086 dnowicki@exactmm.com (p)716-681-0866, (f) 716-681-4110 | Classification and Code: Code KKX, 21CFR878.4370, Class II | Substantially Equivalent | Classification & Code, Class II, MMP | | Device Common Name | Equipment Cover | Materials & Construction: Polyethylene, absorbent polypropylene | Substantially Equivalent | Materials & Construction: Blue polyethylene, with air laid reinforcement | | Trade Name | Equipment Cover- Polyethylene, Model # 14-001 | Sterile: ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1 | Substantially Equivalent | 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 film construction), individual CSR internal wrap | Substantially Equivalent | Sterile Packaging: Chevron peel pouch (coated paper, PE film construction), individual CSR internal wrap | | Classification Name | | Non-Sterile | Substantially Equivalent | Non-Sterile | | Predicate Device | K083234 Kimberly-Clark KC100 Surgical Drapes and Equipment Covers | Barrier properties - AATCC 42:2007, AATCC 127:2008: Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for Use in Health Care Facilities, AAMI PB70:2003 /(R)2009), Level 3 compliant | Substantially Equivalent | Barrier properties: References AATCC 127:2008, INDA IST 80.6 (98), ISO 811- 1981, ISO 139-1973 | | 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. | Tear strength - ASTM D5587-08 (no rev.) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure. Tear strength for Md and Cd within general industry tolerance of +/- 20% | Substantially Equivalent | Tensile strength: NFPA 1999, 1997, ASTM D5733-99:2002, ASTM D1004-03:2003 | | Intended 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. 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 | Tensile strength - ASTM D5034-09 (no rev.) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) Tensile strength for Md and Cd within general industry tolerance of +/- 20% | Substantially Equivalent | Grab Test: ASTM D 5034-95: 2001 | | Technological Characteristics | Exact Medical Manufacturing Equipment Cover- Polyethylene has the same design, material and performance characteristics of the predicate device. Additional Summary and explanation of technological characteristics is included in the following Addendum A. | Flammability - 16CFR1610:2010, Flammability of Clothing Textiles, Class 1 PASS | Substantially Equivalent | Flammability: 16CFR1610 | | Summary of Testing | Exact Medical Manufacturing Equipment Cover- Polyethylene is substantially equivalent and meets the same acceptance criteria as the predicate device/gown in K083234. Non-clinical performance testing includes: 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 is included in the following Addendum B. | Lint and other particles generation in the dry state - ISO 9073-10:2003 | Not Applicable | No test | | Substantial Equivalence | The equipment covers described in this 510(k) submission are substantially equivalent in all specifications and performance compared to the predicate device indentified in K083234 except for minor variations in the widths and lengths. | | | | {1}------------------------------------------------ ### Addendum A. : # Sec. 10: EQUIPMENT COVER Polyethylene - Predicate Device Comparison Table • {2}------------------------------------------------ ## Addendum B ## Non-Clinical Testing Summary: EMM Equipment Cover, Model # 14-001 · . | Test Article | Finished Good Lot Number | Reference Standard(s) | Description | Accept - Reject Criteria | Pass/ Fail | Test Lab | |--------------------------------|--------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------------------------------------------| | Model No. 14-001 Sterile | 0980APA3 | AATCC 42:2007 (AAMI PB70:2003 /(R)2009) | Water Resistance: Impact Penetration Test, Level 3 | <1.0 gm Blotter water weight gain | Pass | Nelson Labs, Utah, USA | | Model No. 14-001 Sterile | 0980APA3 | AATCC 127:2008 (AAMI PB70:2003 /(R)2009) | Water Resistance: Hydrostatic Pressure Test, Level 3 | =/> 50 cm hydrostatic resistance | Pass | Nelson Labs, Utah, USA | | Model No. 14-001 Sterile | 0980APA3 | 16CFR1610:2010 | Flammability of Clothing Textiles - Class 1 | Class 1 =/> 3.5 sec. average flame spread | Pass | Nelson Labs, Utah, USA | | Model No. 14-001 Sterile | 0980APA3 | ASTM D5587-08 (no rev.) | Standard Test Method for 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 | Nelson Labs, Utah, USA | | Model No. 14-001 Sterile | 0980APA3 | ASTM D5034-09 (no rev.) | Standard Test Method for 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 | Nelson Labs, Utah, USA | | Model No. 14-001 | | ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1 | SAL of > 10-6 | Pass | SCDC, Shanghai, CN LexaMed, Ohio, USA | | Model No. 14-001 Sterile | 0980APA3 | ISO 9073-10:2003 | Lint and other particles generation in the dry state | Acceptance criteria not established in the recognized standard | Pass | Nelson Labs, Utah, USA | : . : {3}------------------------------------------------ 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. {4}------------------------------------------------ ### 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 {5}------------------------------------------------ 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. 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. 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