(269 days)
MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.
MediClear™ PreOp can be left on the preoperative incision site for up to 7 days.
MediClear™ PreOp is intended to be used on intact skin and for external use only.
MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination.
MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance.
MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.
The document describes the acceptance criteria for the MediClear™ PreOp device and the studies performed to demonstrate that it meets these criteria.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Antimicrobial Activity (In Vitro) | ISO 22196:2010 - Measurement of Antimicrobial Activity on Plastic Surface (for 7-day and Minimum Effective Concentration) | "In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear." |
| Cytotoxicity | ISO 10993-5:2009 - Tests for in vitro Cytotoxicity | "Under the conditions of the studies employed, the device is non-cytotoxic..." |
| Skin Irritation | ISO 10993-10:2010 - Tests for irritation and skin sensitization | "...non-irritating..." |
| Sensitization (Guinea Pig Maximization) | ISO 10993-10:2010 - Tests for irritation and skin sensitization | "...not a potential skin sensitizer" (implied, per predicate comparison which explicitly states this) |
| Acute Systemic Toxicity | ISO 10993-11:2006 - Tests for systemic toxicity | "...does not induce acute...toxicity..." |
| Subacute Toxicity (4-week Subcutaneous implantation) | ISO 10993-6:2007 - Tests for local effects after implantation & ISO 10993-11:2006 - Tests for systemic toxicity (for subcutaneous implantation) | "...does not induce...subacute toxicity..." |
| Material-mediated Pyrogenicity | ISO 10993-11:2006 - Tests for systemic toxicity & USP 30 <151> Pyrogenicity Test | "...is non-pyrogenic as per the rabbit pyrogen test." |
| Liquid Barrier Performance | AAMI PB-70-2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities & ASTM F1670/F1670M-08(Reapproved 2014) Standard test method for resistance of material used in protective clothing to penetration by synthetic blood | "Level 4" |
| Moisture Vapor Transmission Rate (MVTR) | E96/E96M-05 Standard Test Methods for Moisture Transmission of Materials & EN 13726-2-2002 Test methods for primary wound dressings. Part 2: Moisture Vapour Transmission Rate of Permeable Film Dressings | Not explicitly stated as a pass/fail, but the device is described as "breathable" and the test method is listed as performed. |
| Real-time Aging/Stability | ICH Q1A Stability Testing of New Drug Substances and Products | Tested (implies satisfactory performance for shelf-life claims). |
| EO Sterilization | ANSI/AAMI/ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide – Part 1: Requirements for development, validation, and routine control & ANSI/AAMI/ISO 10993-7:2008 - Biological Evaluation of Medical Devices Part 7: Ethylene oxide sterilization residuals | "Ethylene Oxide (ETO) sterilized, 10-6 SAL per ISO 11135" |
| Distribution Simulation (Journey Hazards) | ISTA Project 2A (2008); Performance Test for Individual Packaged- Products 150 lb. or Less. & ASTM D 4169-09; Performance Testing of Shipping Containers and Systems | Tested (implies satisfactory performance). |
| Microbial Strikethrough | Not explicitly stated, but listed under "Performance Testing". | Tested (implies satisfactory performance). |
| Operational Qualification | Not explicitly stated, but listed under "Performance Testing" including visual, functional, and additional criteria. | Tested (implies satisfactory performance). |
*Note: The document explicitly states: "In vitro effectiveness does not predict clinical performance." This is an important disclaimer for the antimicrobial activity results.
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not provide specific sample sizes for any of the non-clinical tests mentioned. All tests listed are in vitro or bench tests conducted in a laboratory setting. There is no indication of human or animal data provenance (e.g., country of origin, retrospective/prospective) for these non-clinical tests.
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 as the studies described are non-clinical bench and in vitro tests. Ground truth in this context would typically refer to the reference standards or control groups used in the laboratory experiments, as well as the expertise of the scientists performing and interpreting the tests according to the cited ISO and ASTM standards. The document does not specify the number or qualifications of these scientific personnel.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies described are non-clinical bench and in vitro tests. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies involving human readers/interpreters where disagreements need to be resolved.
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:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The device is a physical surgical drape, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone algorithm-only performance study was not performed. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the antimicrobial activity, the "ground truth" or reference for evaluating reduction would be the initial microbial counts before exposure to the device, as measured by standard microbiological assays. For biocompatibility tests, the ground truth refers to established biological responses to control materials or the absence of adverse effects as defined by the ISO 10993 series. For barrier performance, it's the ability to prevent penetration under defined conditions specified by ASTM/AAMI standards. These are laboratory-based ground truths derived from scientific standards and experimental controls.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical device and does not involve AI or machine learning algorithms that require 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 for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2017
Covalon Technologies, Inc. Kim Crooks VP Of Operations 1660 Tech Avenue Unit 5 Mississsauga, L4W 5S7 CA
Re: K163556
Trade/Device Name: Mediclear PreOp Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: August 17, 2017 Received: August 18, 2017
Dear Kim Crooks:
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 mav publish further announcements concerning your device in the Federal Register.
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
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Tara A. Ryan -S
Lori Wiggins, MPT, CLT Acting 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
510(k) Number (if known) K163556
Device Name MediClear™ PreOp
Indications for Use (Describe)
MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.
MediClear™ PreOp can be left on the preoperative incision site for up to 7 days.
MediClear™ PreOp is intended to be used on intact skin and for external use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR 807.92, the following information is provided for Covalon's MediClear PreOp antimicrobial self-adherent silicone film drape for pre-operative skin with chlorhexidine and silver 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued August 12, 2005.
l. Sponsor Information
| Contact Address: | Covalon Technologies, Inc.1660 Tech Avenue, Unit 5Mississauga, Ontario, Canada L4W 5S7 |
|---|---|
| Contact Person:Title: | Kim CrooksVP of Operations |
| Phone Number: | 905-568-8400 x265 |
| Fax Number: | 905-568-5200 |
| Date of Summary: | September 07, 2017 |
II. Device Name and Classification
| Device Name: | MediClear™ PreOp |
|---|---|
| Common Name: | Surgical Drape and Drape Accessories |
| FDA Panel: | General & Plastic surgery |
| Product Code: | KKX |
| Class: | II |
| Model No(s).: | 7000404; 7000630; 7001012 |
lll. Predicate Devices
| Manufacturer: | 3M Healthcare Company | 3M Healthcare Company |
|---|---|---|
| Device: | 3M™ Steri-Drape™ CHGAntimicrobial Incise Drape | 3M™ loban™ 2 AntimicrobialIncise Drape |
| 510(k): | K140250 | K801550 |
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IV. Reference Devices
| Manufacturer: | Covalon Technologies, Inc. | Covalon Technologies, Inc. |
|---|---|---|
| Device: | SurgiClear™ AntimicrobialClear Silicone AdhesiveDressing with Chlorhexidineand Silver | IV Clear™ Antimicrobial ClearSilicone Adhesive Dressing withChlorhexidine and Silver |
| 510(k): | K121819 | K112549 |
V. Device Description
MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination.
MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance.
MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.
VI. Indications for Use
MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape providing continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.
MediClear™ PreOp may be left on the pre-operative incision site for up to 7 days.
MediClear™ PreOp is intended to be used on intact skin and for external use only.
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VII. Performance Testing
The following tests were conducted to evaluate performance of the subject device*:
-In vitro microbial log reduction; -Real time aging and stability; -Distribution simulation (journey hazards); -Biocompatibility including cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogen, and subacute toxicity; -Operational qualification including visual, functional, and additional criteria; -Microbial strikethrough: - Liquid barrier ASTM F1670.
- In vitro effectiveness does not predict clinical performance.
VIII. Substantial Equivalence
Performance testing, including bench, biocompatibility, shelf life, log-reduction, and human clinical studies, confirms that MediClear™ PreOp is substantially equivalent in that it has similar technological characteristics as its predicate devices, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ Ioban™ 2 Antimicrobial Incise Drape pursuant to section 510(k).
MediClear™ PreOp has an intended use equivalent to its predicates, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ Ioban™ 2 Antimicrobial Incise Drape and aligns with the drape and drape accessory definition per FDA requlation 878.4370 which states that this device is intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination. MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape providing continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination. MediClear™ PreOp and its predicates, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3MTM Ioban™ 2 Antimicrobial Incise Drape are all intended for use as drapes with continuous antimicrobial activity. Both MediClear™ PreOp and its predicates 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ loban™ 2 Antimicrobial Incise Drape are intended for external use only.
The use of MediClear™ PreOp, a device similar in all technological characteristics to its predicates 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ Ioban™ 2 Antimicrobial Incise Drape raises no new or different issue(s) of safety and effectiveness. Please refer to Table VIII-1 for the comparison between the subject device and the predicate devices.
| Table VIII-1 Predicate device comparison table | |||
|---|---|---|---|
| Device name | MediClear™ PreOpantimicrobial self-adherent silicone film forpreoperative skin withchlorhexidine and silver | 3M™ Steri-Drape™CHG AntimicrobialIncise Drape (Predicate#1) | 3M™ Ioban™ 2Antimicrobial InciseDrape (Predicate #2) |
| Manufacturer | Covalon Technologies, | 3M Company | 3M Company |
| Inc. | |||
| 510(k) | Subject device | K140250 | K801550 |
| Class | Class II | Class II | Class II |
| Product code | KKX | KKX | KKX |
| Classification | General and plastic | General and plastic | General and plastic |
| panel | surgery | surgery | surgery |
| Common | Surgical Drape and Drape | Surgical Drape and Drape | Surgical Drape and Drape |
| name | Accessories | Accessories | Accessories |
| Intended Use | MediClear™ PreOp is | 3M™ Steri-Drape™ is | 3M™ loban™ is indicated |
| indicated for use as a pre- | indicated for use as an | for use as an incise drape | |
| operative | incise drape with | with continuous | |
| (incision/insertion) drape | continuous antimicrobial | antimicrobial activity. | |
| providing continuous | activity. | ||
| antimicrobial activity to | It is intended for external | It is intended for external | |
| reduce the risk of | use only. | use only. | |
| contamination of the skin | |||
| site by acting as anexternal barrier to | |||
| microbial and other | |||
| contamination. | |||
| MediClear™ PreOp may | |||
| be left on the pre-operative | |||
| incision site for up to 7 | |||
| days. | |||
| MediClear™ PreOp is | |||
| intended to be used on | |||
| intact skin and for external | |||
| use only. | |||
| Used on intact | Used on intact skin | Used on incision site | Used on incision site |
| skin or | |||
| incision site | |||
| General | MediClear™ PreOp is a | 3M™ Steri-Drape™ is an | 3M™ loban™ is an |
| design | clear polyurethane film | antimicrobial impregnated | antimicrobial impregnated |
| coated with an | adhesive coated on a | adhesive coated on a | |
| antimicrobial silicone | breathable film with | breathable film with | |
| adhesive. | silicone-coated release | silicone-coated release | |
| liner. | liner. | ||
| Active | Chlorhexidine diacetate | Chlorhexidine gluconate | Iodine |
| antimicrobial | and silver sulfate | (CHG) | |
| agents | |||
| PackagingASTM F1670 | Tyvek Pouch | Film/Tyvek Pouch | Foil Pouch |
| Liquid Barrier | Level 4 | Level 4 | Level 4 |
| Performance | |||
| Biocompatible | Under the conditions of the | Not cytotoxic, slight | Not cytotoxic, slight |
| per | studies employed, the | irritant, not a potential skin | irritant, not a potential skin |
| ISO 10993 | device is non-cytotoxic, | sensitizer | sensitizer |
| non-irritating, does not | |||
| induce acute or subacute | |||
| toxicity and is non- | |||
| pyrogenic as per the rabbit | |||
| pyrogen test. | |||
| Sold Sterile | Yes | Yes | Yes |
| Sterilization | Ethylene Oxide (ETO)sterilized, 10-6 SAL per ISO11135 | ETO sterilized, 10-6 SALper ISO 11135 | Gamma sterilized, 10-6SAL per ISO 11137 |
| Single use | Yes | Yes | Yes |
| Over theCounter | Yes | Yes | Yes |
Table VIII-1 Predicate device comparison table
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In addition, MediClear™ PreOp, is a device similar in all technological characteristics and performance specifications to the previously FDA cleared reference devices SurgiClear™ (K121819) and IV Clear™ (K112549) with exception of silver salt identity and other minor variations. Please refer to Table VIII-2 for the comparison between the subject device and the reference devices.
| Device name | MediClear™ PreOpantimicrobial self-adherent silicone filmdrape for preoperativeskin with chlorhexidineand silver | SurgiClear™antimicrobial clearsilicone adhesivedressing withchlorhexidine and silver | IV Clear™ antimicrobialclear silicone adhesivedressing withchlorhexidine and silver |
|---|---|---|---|
| Manufacturer | Covalon Technologies,Inc. | Covalon Technologies,Inc. | Covalon Technologies,Inc. |
| 510(k) | Subject device | K121819 | K112549 |
| Class | Class II | Unclassified | Unclassified |
| Product code | KKX | FRO | FRO |
| Classification | General and plastic | General and plastic | General and plastic |
| panel | surgery | surgery | surgery |
| Common | Surgical Drape and DrapeAccessories | Dressing, wound, drug | Dressing, wound, drug |
| name | |||
| Indications for | MediClear™ PreOp is | SurgiClear™ is intended | IV Clear™ is intended to |
| Use statement | indicated for use as a pre-operative(incision/insertion) drapeproviding continuousantimicrobial activity toreduce the risk ofcontamination of the skinsite by acting as anexternal barrier tomicrobial and othercontamination.MediClear™ PreOp maybe left on the pre-operative incision site forup to 7 days.MediClear™ PreOp isintended to be used onintact skin and for externaluse only. | to cover and protect awound caused bypercutaneous medicaldevices such as drains,chest tubes, orthopedicpins, fixtures, and wires.SurgiClear™ may also beused to cover and secureprimary dressings.SurgiClear™ inhibitsmicrobial growth within thedressing and preventsexternal contamination. | cover and protect insertionsites, and secure devicesto skin. Commonapplications include IVcatheters, central venouslines, PICCs, suctioncatheters, epiduralcatheters, hemodialysiscatheters, orthopedic pins,other intravascularcatheters andpercutaneous devices. IVClear™ inhibits microbialgrowth within the dressingand prevents externalcontamination. |
| Used on intactor breachedskin | Used on intact skin | Used on breached skin | Used on insertion site |
| General | MediClear™ PreOp is a | SurgiClear™ is a clear film | The clear film allows |
| design | clear polyurethane filmcoated with anantimicrobial siliconeadhesive. | which allows the site orthe wound to beconstantly monitored andassessed. The dressing isself-adhesive andbreathable, allowing forgood moisture vaporexchange. | continual site observation,and is breathable, allowingmoisture vapor exchange. |
Table VIII-2 Reference device comparison table
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| Activeantimicrobialagents | Chlorhexidine diacetateand silver sulfate | Chlorhexidine diacetateand silver acetate | Chlorhexidine diacetateand silver acetate |
|---|---|---|---|
| Dressingconstruct | MediClear™ PreOp is aclear polyurethane filmcoated with anantimicrobial siliconeadhesive containing 3%w/w chlorhexidine and0.5% w/w silver salts. | SurgiClear™ is a clearpolyurethane film coatedwith an antimicrobialsilicone adhesivecontaining 3% w/wchlorhexidine and 0.5%w/w silver salts. | The dressing consists of aclear polyurethane filmcoated with a siliconeadhesive containing 3%w/w chlorhexidine and0.5% w/w silver salts. |
| Wear time | Up to 7 days | Up to 7 days | Up to 7 days |
| Transparent | Yes | Yes | Yes |
| ASTM F1670Liquid BarrierPerformance | Level 4 | N/A | N/A |
| Microbialbarrier | Yes | Yes | Yes |
| BiocompatibleperISO 10993 | Under the conditions ofthe studies employed, thedevice is non-cytotoxic,non-irritating, does notinduce acute or subacutetoxicity and is non-pyrogenic as per the rabbitpyrogen test. | Cytotoxic, not a dermalsensitizer, not a dermalsensitizer, no systemictoxicity, no subacutetoxicity, | Cytotoxic, not a dermalsensitizer, not a dermalsensitizer, no systemictoxicity, no subacutetoxicity, |
| Sterilization | Ethylene Oxide (ETO) | ETO | ETO |
| Single use | Yes | Yes | Yes |
IX. Non-clinical testing summary
The following non-clinical tests have been conducted to support the safety and efficacy of the subject device:
| Test item | Refence standard/test method |
|---|---|
| 7-day Antimicrobialactivity | ISO 22196:2010-Plastic-Measurement of Antimicrobial Activity onPlastic Surface |
| Minimum EffectiveConcentration (MEC)of antimicrobial activity | ISO 22196:2010-Plastic-Measurement of Antimicrobial Activity onPlastic Surface |
| Cytotoxicity | ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5:Tests for in vitro Cytotoxicity |
| Skin Irritation | ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part10: Tests for irritation and skin sensitization |
| Guinea PigMaximizationSensitization | ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part10: Tests for irritation and skin sensitization |
| Acute SystemicToxicity | ISO 10993-11:2006 Biological Evaluation of Medical Devices- Part11: Tests for systemic toxicity |
| Subacute Toxicity Test- 4-week | ISO 10993-6: 2007 Biological Evaluation of Medical Devices Part 6Tests for local effects after implantation |
| Subcutaneousimplantation | ISO 10993-11:2006 Biological Evaluation of Medical Devices- Part11: Tests for systemic toxicity |
| Implantation | ISO 10993-6: 2007 Biological Evaluation of Medical Devices Part 6Tests for local effects after implantation |
| Material-mediated | ISO 10993-11:2006 Biological Evaluation of Medical Devices- Part |
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| pyrogencity | 11: Tests for systemic toxicityUSP 30 <151> Pyrogenicity Test |
|---|---|
| Liquid barrier | AAMI PB-70-2012 Liquid barrier performance and classification ofprotective apparel and drapes intended for use in health carefacilities & ASTM F1670/F1670M-08(Reapproved 2014) Standardtest method for resistance of material used in protective clothing topenetration by synthetic blood |
| MVTR | E96/E96M-05 Standard Test Methods for Moisture Transmission ofMaterialsEN 13726-2-2002 Test methods for primary wound dressings. Part2: Moisture Vapour Transmission Rate of Permeable FilmDressings |
| Real time aging | ICH Q1A Stability Testing of New Drug Substances and Products |
| EO sterilization | ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products- Ethylene oxide – Part 1: Requirements for development,validation, and routine control of a sterilization process for medicaldevicesANSI/AAMI/ISO 10993-7:2008 Biological Evaluation of MedicalDevices Part 7: Ethylene oxide sterilization residuals |
| Distribution simulation(journey hazards) | ISTA Project 2A (2008); Performance Test for Individual Packaged-Products 150 lb. or Less.ASTM D 4169-09; Performance Testing of Shipping Containers andSystems |
X. Clinical Testing
Clinical testing was not needed for this device.
XI. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.
§ 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.