SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
Device Facts
| Record ID | K121919 |
|---|---|
| Device Name | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV |
| Applicant | Exact Medical Manufacturing, Inc. |
| Product Code | KKX · General, Plastic Surgery |
| Decision Date | Feb 14, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4370 |
| Device Class | Class 2 |
Indications for Use
Exact Medical Manufacturing Surgical Drape AAMI Level 4 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 EMM Surgical Drapes AAMI Level 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007.
Device Story
Surgical drape; protective patient covering; isolates surgical incision sites from microbial/other contamination. Three-layer composite fabric: polypropylene spunbond outer layers; co-extruded PE film inner layer (AAMI PB:70 Level 4 compliant). Thermally bonded. Single-use; disposable. Provided sterile (EO gas) or non-sterile (bulk for repackaging/relabeling). Used in clinical/surgical settings by healthcare professionals. Barrier performance meets AAMI PB70 Level 4 standards. Protects patient and sterile field by preventing fluid/microbial strike-through.
Clinical Evidence
Bench testing only. No clinical data. Testing included biocompatibility (cytotoxicity, irritation, sensitization per ISO 10993), barrier performance (AAMI PB:70 Level 4, ASTM F1670), physical properties (tensile/tear strength per ASTM D5587/D5034), flammability (16CFR1610), and linting (ISO 9073-10). All results met acceptance criteria.
Technological Characteristics
Three-layer composite: polypropylene spunbond outer layers, co-extruded PE film inner layer. Thermally bonded. AAMI PB:70 Level 4 barrier performance. Sterilization: Ethylene Oxide (ISO 11135-1:2007). Physical testing: ASTM F1670 (synthetic blood penetration), ASTM D5587 (tear strength), ASTM D5034 (breaking strength), 16CFR1610 (flammability), ISO 9073-10 (linting). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization).
Indications for Use
Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination. Suitable for use in sterile or non-sterile surgical environments. No specific patient population or contraindications defined.
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 Corporation Surgical Drapes with AAMI Liquid Barrier Level 4 claim (K102666)
Submission Summary (Full Text)
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## K121919
| Date Summary was Prepared | Sec. 6: 510(k) Summary - EMM Surgical Drape with AAMI Liquid Barrier Level IV | Exact Medical Manufacturing Surgical Drape with AAMI<br>Liquid Barrier Level IV | Substantially<br>Equivalent | Kimberly Clark Corporation<br>Surgical Drapes with AAMI Liquid Barrier Level 4 claim<br>510(k)102666<br>PREDICATE DEVICE |
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| June 26, 2012 | | Intended Use: Exact Medical Manufacturing Surgical Drape<br>AAMI Level 4 are sterile or non-sterile single use devices<br>made of natural or synthetic materials intended to be used as<br>a protective patient covering, such as to isolate a site of<br>surgical incision from microbial and other contamination. The<br>EMM Surgical Drapes AAMI Level 4 are also sold as bulk<br>non-sterile, single use items, to repackager/relabeler<br>establishments for further packaging and ethylene oxide<br>sterilization according to ISO 11135-1:2007. | Substantially<br>Equivalent | Intended Use: The Kimberly-Clark* Surgical Drapes with AAMI<br>Liquid Barrier Level 4 claim are devices made of natural or<br>synthetic material intended to be used as a protective patient<br>covering, such as to isolate a site of surgical incision from<br>microbial and other contamination. These drapes meet the Level<br>4 requirements of the AAM! Liquid Barrier Classifications. The<br>Kimberly-Clark" Surgical Drapes with AAMI Liquid Barrier Level<br>4 claim are also sold as bulk non-sterite, single use items, to<br>repackager/relabeler establishments for further packaging and<br>Ethylene Oxide (EtO) sterilization. |
| 510(k) Submitter | David Nowicki, President<br>Exact Medical Manufacturing Inc.<br>4917 William Street, Suite C<br>Lancaster, NY 14086<br>dnowicki@exactmm.com<br>(p)716-681-0866, (f) 716-681-4110<br>FEB 14 2013 | Classification & Code: Surgical Drapes and Drape<br>Accessories, KKX, 21CFR878.4370, Class II | Substantially<br>Equivalent | Classification & Code: Surgical Drapes and Drape Accessories,<br>KKX, 21CFR878.4370, Class II |
| Primary Contact for this 510(k)<br>Submission | David Nowicki, President<br>Exact Medical Manufacturing Inc.<br>4917 William Street, Suite C<br>Lancaster, NY 14086<br>dnowicki@exactmm.com<br>(p)716-681-0866, (f) 716-681-4110 | Single Use - Disposable | Substantially<br>Equivalent | Single Use - Disposable |
| Device Common Name | Surgical Drape | Barrier Performance: AAM! PB70: Level 4. ASTM F1670 -<br>08, Standard Test Method for Resistance of Materials Used in<br>Protective Clothing to Penetration by Synthetic Blood | Substantially<br>Equivalent | Barrier Performance: AAMI PB70: Level 4 |
| Trade Name | Surgical Drape with AAMI Liquid Barrier Level IV | Materials & Construction: The base sheet fabric is a three<br>layer composite comprised of polypropylene spunbond and a<br>co-extruded PE film. Layers are thermally bonded together<br>producing a single layer with various basis weights. The outer<br>layers are non-woven fabric, the inner layer is AAMI PB:70<br>Level 4 capable PE film. | | Materials & Construction:<br>The base sheet fabric is a three layer laminate<br>comprised of polypropylene spunbond / polypropylene<br>meltblown/polypropylene spunbond. Layers are thermally<br>embossed together producing a single layer with varlous basis<br>weights. Fabric is topically treated to enhance water repellency<br>and to assure static dissipation. |
| Device Product Codes and<br>Classification Name | KKX, 21CFR878.4370, Surgical Drape and Drape Accessories | Materials Weight per square meter<br>Weight/m2<br>PN<br>Ref.<br>Description<br>112005196-961<br>1<br>196cm/PMC04/Blue SMS<br>43<br>2<br>213408097<br>97cm/PMC02 BiLam Mtl<br>45<br>3<br>213408152<br>152cm/ BiLam Mtl<br>45<br>4<br>210401148-900 PSB3030 Pad<br>80<br>4<br>PE<br>25 | Substantially<br>Equivalent | Unknown |
| Predicate Device | Kimberly Clark Corporation Surgical Drapes with AAMI Liquid Barrier Level 4 claim - K102666 | Color: Blue<br>Dye: Blue Colorant B373 (FB 1007) | | Color: Blue<br>Dye: Unknown |
| Device Description | Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices<br>made of natural or synthetic materials intended to be used as a protective patient covering, such as to<br>isolate a site of surgical incision from microbial and other contamination.<br>Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level The base sheet fabric is a<br>three layer composite comprised of polypropylene spunbond and a co-extruded PE film. Layers are<br>thermally bonded together producing a single layer with various basis weights. The outer layers are non<br>woven fabric, the inner layer is AAMI PB:70 Level 4 capable PE film. | Sterile (via EO Gas) ISO 11135-1:2007, Sterilization of health<br>care products - Ethylene oxide - Part 1 | Substantially<br>Equivalent | Sterile via EO Gas |
| Intended Use | Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices<br>made of natural or synthetic materials intended to be used as a protective patient covering, such as to<br>isolate a site of surgical incision from microbial and other contamination. The EMM Surgical Drapes AAMI<br>Level 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for<br>further packaging and ethylene oxide sterilization according to ISO 11135-1:2007 | Sterile Packaging: Chevron peel pouch (coated paper<br>(73gsm), PET12/PE40 film construction), individual CSR<br>Internal wrap | Substantially<br>Equivalent | Flexible unit pouch |
| Technological Characteristics | Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV has the same design,<br>material and performance characteristics and intended use as the predicate device. | Non-Sterile bulk pack (alternate offering) | Substantially<br>Equivalent | Non-sterile built pack |
| Summary of Testing | Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV is substantially equivalent<br>and meets the same acceptance criteria as the predicate device/Drape in K102666 Non-clinical<br>performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the<br>methods of ISO 10993, Barrier properties- AAMI PB:70 Level 4, tensile, tear strength, flammability, linting<br>and sterility. All results of the testing met acceptance criteria. | Biocompatibility: ISO 10993-5:2009 Cytotoxicity, ISO<br>10993-10:2002, Skin Irritation, ISO 10993-10:2002,<br>Sensitization | Substantially<br>Equivalent | tested for biocompatibility using cytotoxicity, primary skin irritation<br>tests and sensitization testing. |
| Substantial Equivalence | The surgical Drapes described in this 510(k) submission are substantially equivalent in all specifications<br>and performance compared to the predicate device indentified in K102666. | Tear strength - ASTM 5587-08 (no rev.) Standard Test<br>Method for Tearing Strength of Fabrics by Trapezoid<br>Procedure<br>19.4 lbs & 9.7 lbs | Substantially<br>Equivalent | Tear strength - Unknown |
| Breaking strength - ASTM D5034-09 (no rev.) Standard Test<br>Method for Breaking Strength and Elongation of Textile<br>Fabrics (Grab Test)<br>24.4 lbs & 15.9 lbs | Substantially<br>Equivalent | Breaking strength - unknown | | |
| Flammability - 16CFR1610:2007, Flammability of Clothing<br>Textiles - Class 1 | Substantially<br>Equivalent | Class 1 | | |
| Linting - ISO 9073-10:2003, Lint and other particles<br>generated in the dry state | Substantially<br>Equivalent | Linting - Unknown | | |
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#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
#### February 14. 2013
Exact Medical Manufacturing, Incorporated C/O Mr. Robert O. Dean President Compliance Systems International, Limited Liability Company 1083 Delaware Avenue BUFFALO NY 14209
Re: K121919
Trade/Device Name: Exact Medical Manufacturing Surgical Drape with AAMI Level IV Liquid Barrier, Model #20-121, Blue Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: January 7, 2013 Received: January 30, 2013
#### 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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary S. Runner
Susan Runner, DDS, MA 2013.02.21
DE
13:25:05 -05'00'
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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): K121919
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| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF | |
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| Elizabeth F. Claverie NEEDED) | |
| | 2013.02.15 18:16:47 -05'00' |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital nfection Control, Dental Devices | |
| 510(k) Number: | K121919 |
