Who is the manufacturer of EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004?

Exact Medical Manufacturing, Inc. submitted the Traditional clearance for EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 (K101688).

What is the FDA product code for EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004?

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 SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004?

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

What are the predicate devices for EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004?

Medline (Proxima) Surgical Drapes (K964142).

EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004

K101688 · Exact Medical Manufacturing, Inc. · KKX · Sep 20, 2010 · General, Plastic Surgery

Device Facts

Record ID	K101688
Device Name	EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
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 Surgical Drape -Spunlace 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-Spunlace 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 Story

Surgical drape composed of spunlace, polyethylene, and 3M medical adhesive tape; functions as physical barrier to isolate surgical incision sites from microbial contamination. Used in clinical settings to cover patients during surgical procedures. Device provides barrier protection; prevents cross-contamination between patient and surgical environment. Manufactured as sterile or non-sterile single-use items; bulk non-sterile versions processed by third-party repackagers/relabelers via ethylene oxide sterilization. Healthcare providers apply drape over patient; provides sterile field maintenance; reduces infection risk.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10, -7), barrier properties (AATCC 42, AATCC 127, AAMI PB70 Level 3), tensile/tear strength (ASTM D5034, D5587), flammability (16CFR1610), and lint generation (ISO 9073-10). All tests met acceptance criteria.

Technological Characteristics

Materials: Spunlace, polyethylene, 3M medical adhesive tape. Barrier performance: AAMI PB70 Level 3. Sterilization: Ethylene oxide (ISO 11135-1). Standards: ISO 10993 (biocompatibility), ASTM D5587 (tear), ASTM D5034 (tensile), 16CFR1610 (flammability).

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination. Suitable for sterile or non-sterile single-use applications; bulk non-sterile items intended for further packaging and EO sterilization by repackagers/relabelers.

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

Medline (Proxima) Surgical Drapes (K964142)

Related Devices

K101598 — EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) · Exact Medical Manufacturing, Inc. · Oct 4, 2010
K050508 — HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES · Haywood Vocational Opportunities · Apr 27, 2005
K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES · 3M Healthcare · Aug 18, 2014
K043015 — 3L SURGICAL DRAPES · 3l Medical Products Co., Ltd. · Aug 15, 2005
K031131 — KLINIDRAPE SURGICAL DRAPES · Molnlycke Health Care · Jun 10, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ #### SEP 2 0 2010 EMM al Manutacturing, Inc #### Sec. 6 510(k) Summary – EMM Surgical Drape-Spunlace w/PE Sides K101688 ## 510(k) Summary for Exact Medical Manufacturing Inc., EMM Surgical Drape-Spunlace w/PE Sides | Date Summary was Prepared | June 10,2010 | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | | | 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 | | | Device Common Name | Surgical Drape | | | Trade Name | EMM Surgical Drape-Spunlace w/PE Sides, Model 13-004 | | | Device Product Codes and Classification Name | KKX, 21CFR878.4370, Surgical Drape and Drape Accessories, Class II | | | Predicate Device | Medline (Proxima) Surgical Drapes 510(k)964142 | | | Device Description | Exact Medical Manufacturing Surgical Drape -Spunlace 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-Spunlace w/PE Sides are comprised of Spunlace, Polyethylene, 3M Medical Adhesive Tape. | | | Intended Use | Exact Medical Manufacturing Surgical Drape -Spunlace 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-Spunlace w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization. | | | Technological Characteristics | Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides 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 | | | Summary of Testing | Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides are substantially equivalent and meet the same acceptance criteria as the predicate device/gown in K964142 Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties, Level 2, 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. | | | Substantial Equivalence | The surgical drapes described in this 510(k) submission are substantially equivalent in all specifications and performance compared to the predicate device indentified in K964142 except for minor variations in the widths and lengths. | | | Exact Medical Manufacturing - Surgical Drape- Spunlace w/PE Sides Model #13-004 | Substantially Equivalent | PREDICATE DEVICE Medline (Proxima) Surgical Drapes 510(k)964142 | | Indications for Use: Exact Medical Manufacturing Surgical Drape -Spunlace 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- Spunlace w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization. | Substantially Equivalent | Indications for 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. | | Classification & Code: KKX, Surgical Drapes, 21CFR878.4370, Class II | Substantially Equivalent | Classification & Code: KKX, Surgical Drapes, 21CFR878.4370, Class II | | Materials & Construction: Spunlace, Polyethylene, Absorbent Reinforcement, 3M Medical adhesive tape | Substantially Equivalent | Materials & Construction: Spunlace, Absorbent reinforcement with impervious polyethylene backing, 3M Medical adhesive tape | | 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, 'el 2 Electrostatic Head = 231 cm PASS | Substantially Equivalent | Hydrostatic head = 19.5 cm | | Sterile (via EO Gas) ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1 | Not Applicable | | | Sterile Packaging: Chevron peel pouch (coated paper (73gsm), PET12/PE40 film construction), individual CSR internal wrap | Not Applicable | Not Applicable | | Non-sterile | Substantially Equivalent | Non-sterile | | Biocompatibility: cytotoxicity, irritation and sensitization - ISO 10993-5:1999, Cytotoxicity, ISO 10993-10:2002, Skin Irritation, ISO 10993-10:2002, Sensitization Cytotoxicity, Irritation, Sensitization test PASS | Substantially Equivalent | Biocompatibility: Cytotoxicity, Irritation, Sensitization; PASS | | Tear strength - ASTM D5587-08 (no rev.) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure Tear strength for Md and Cd exceeds predicate performance | Substantially Equivalent | Md = 2.5 lbs Cd= 1.4 lbs | | 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 exceeds predicate performance | Substantially Equivalent | Md = 23 lbs Cd = 12.1 lbs | | Flammability - 16CFR1610:2010, Flammability of Clothing Textiles Class 1 - PASS | Substantially Equivalent | Class 1 | | Lint and other Particles generated in the dry state - | Not Applicable | No Test | 4917 William Street, Suite C, Lancaster, New York 14086 USA telephone (716) 681-0866 fax (716) 681-4110 {1}------------------------------------------------ #### Addendum A Summary and Explanation of Technical Characteristics: EMM SURGICAL DRAPE Spunlace w/PE Sides Predicate Device Comparison Table . {2}------------------------------------------------ ### Addendum B ## Non-Clinical Testing Summary: EMM Surgical Drape – Spunlace w/PE Sides, Model # 13-004 | Test Article | Finished Good Lot Number | Reference Standard(s) | Description | Accept - Reject Criteria | Pass/ Fail | Test Lab | |--------------------------------|--------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------|---------------------------------------------| | Model No. 13-004 Sterile | 0980APA2 | 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.13-004 Sterile | 0980APA2 | 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.13-004 Sterile | 0980APA2 | ISO 10993-5:1999 | Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | Evidence of cell lysis or toxicity < 2 | Pass | LexaMed, Ohio, USA | | Model No.13-005 Sterile | 0980APA2 | ISO 10993-10:2002 | Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity (Skin Irritation) | No (0) edema or erythema observed | Pass | LexaMed/NAMSA, Ohio, USA | | Model No. 13-004 Sterile | 0980APA2 | ISO 10993-10:2002 | Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (Skin Sensitization) | No evidence of causing delayed dermal contact sensitization | Pass | LexaMed/NAMSA, Ohio, USA | | Model No.13-004 Sterile | 0980APA2 | 16CFR1610:2010 | Flammability of Clothing Textiles - Class 1 | Class 1 =/> 3.5 sec. average flame spread | Pass | Nelson Labs, Utah, USA | | Model No. 13-004 Sterile | 0980APA2 | ASTM D5587-08 (no rev.) | Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure | Acceptance criteria not established in recognized standard. Exceeds predicate performance | Pass | Nelson Labs, Utah, USA | | Model No.13-004 Sterile | 0980APA2 | 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. Exceeds predicate performance | Pass | Nelson Labs, Utah, USA | | Model No. 13-004 | 0980APA2 | 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. 13-004 Sterile | 0980APA2 | ISO 10993-7:2008 | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals | Average daily dose of EO/ECH shall not exceed 4mg/9mg | Pass | GOALS Sterilization Co. Jiaxing, CN | | Model No.13-004 Sterile | 0980APA2 | 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. 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 2010 Re: K101688 Trade/Device Name: Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides, Model 13-004 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 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. {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 (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, Anthony D. Graham 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}------------------------------------------------ # Indications for Use Form SEP 2 0 2010 Indications for Use: 510(k) Number (if known): K101688 Device Name: Exact Medical Manufacturing Surgical Drape – Spunlace w/PE Sides, Model 13-004 Indications for Use: Exact Medical Manufacturing Surgical Drape - Spunlace 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 - Spunlace w/PE Sides are also sold as bulk non-sterile, 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 X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Eliz. 476. F. Claverie-Well 1 (Division Sign-Off) (Division of Anesthesiology. General Hospital Division of Anesthesiology. General Devices Division of Anesthestology . Infection Control, Dental Devices 510(k) Number: