(76 days)
Whitney Medical Solutions equipment drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. These drapes are used to protect the equipment from contamination during various procedures.
The Whitney Medical Solutions' eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
Here's an analysis of the acceptance criteria and study information for the Whitney Medical Solutions eShield, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 10993-1 Biological evaluation of medical devices - Part 1: general requirements | Under the conditions of the study, the device is not a sensitizer, an irritant, is non-toxic and Non-cytotoxic. | Device is not an irritant, not a sensitizer, non-cytotoxic, non-toxic (stated under "Biocompatible" in the substantial equivalence table, implying it meets the criteria). |
| ASTM F1886 Standard test method for determining integrity of seals for flexible packaging (sterility) | Product meets inspection requirements of standard for visual defects found. | "Product meets inspection requirements of standard for visual defects found." (Implied Pass) |
| AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices - part 1 | Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-6 | "Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-6" (Implied Pass) |
| ASTM F88/F88M Standard test method for seal strength of flexible barrier materials | Meets or exceeds minimum internal acceptance criteria of 1 PLI after ASTM F1980 and ASTM D4169. | "Meets or exceeds minimum internal acceptance criteria of 1 PLI after ASTM F1980 and ASTM D4169." (Implied Pass) |
| ASTM F 2096 Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test) | Meets performance criteria set by standard for maintaining pressure for 5 seconds under 1" of water after ASTM F1980 and ASTM D4169. | "Meets performance criteria set by standard for maintaining pressure for 5 seconds under 1" of water after ASTM F1980 and ASTM D4169" (Implied Pass) |
| AAMI/ANSI/ISO 11137-2 Sterilization of healthcare products - radiation - part 2 establishing the sterilization dose | Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-0 (Note: Typo in document, likely 10^-6) | "Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-0" (Implied Pass, assuming 10^-6 intended) |
| AAMI/ANSI/ISO 11737-1,2 Sterilization of medical devices - microbial methods part 1: determination of the population of microorganisms on product; part 2: tests of sterility performed in the definition, validation and maintenance of a sterile process | Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-6 | "Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-6" (Implied Pass) |
| ASTM F1671/F1671M Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using phi-x174 bacteriophage penetration as a test system. | Under the conditions of the study, the device does not allow viral penetration nor plaque formation. | "Pass" (Under "Viral Penetration ASTM F1671" in the substantial equivalence table, indicating it met the criteria). |
| ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities | The device meets the acceptance criteria set by the standard (AQL 4% and RQL of 20%) and up to one plaque growth per 13 samples. | "The device meets the acceptance criteria set by the standard (AQL 4% and RQL of 20%) and up to one plaque growth per 13 samples." (Implied Pass) |
| ASTM D882 Standard test methods for tensile properties of thin plastic sheeting. (Ophthalmic) | The device meets the tensile acceptance criteria set by the standard for equivalence when the films are within 400 psi of each other. | "Pass" (Under "Tensile Test ASTM D882" in the substantial equivalence table, indicating it met the criteria). |
| ASTM D1004 Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting | The device meets the tear acceptance criteria set by the standard for equivalence when the films are within 89.53 grams in machine direction and 42.6 grams in transverse direction | "Pass" (Under "Tear ASTM D1004" in the substantial equivalence table, indicating it met the criteria). |
| ASTM D3420 Standard Test Method for Pendulum Impact Resistance of Plastic Film1 | The device meets the puncture acceptance criteria set by the standard for equivalence when the films within 9.4%. | "Pass" (Under "Puncture Test ASTM D3420" in the substantial equivalence table, indicating it met the criteria). |
| 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles | The device meets the flammability acceptance criteria set by the standard for a Class 1 rating with a burn time of >3.5 seconds. | "Class 1" (Under "Flammability 16 CFR Part 1610" in the substantial equivalence table, indicating it met the criteria for a Class 1 rating). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of drapes tested for tensile strength, number of samples for biocompatibility). The document describes studies that were performed, but not the specific sample sizes required by those standards.
Regarding data provenance, the document does not specify the country of origin. The studies appear to be laboratory-based standardized tests (e.g., ASTM, ISO standards), which are typically performed in a controlled environment. The studies are retrospective in the sense that they were completed to demonstrate conformity for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of device and testing described. The "Whitney Medical Solutions eShield" is a surgical drape, and its performance is evaluated against engineering and biological standards (e.g., material strength, sterility, biocompatibility). These properties are determined through standardized laboratory tests, not typically by expert consensus of human interpretation, as would be the case for an imaging diagnostic device. Therefore, there is no "ground truth" in the sense of expert human interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
Not applicable. As described above, the tests are objective, laboratory-based measurements against established standards, not subjective interpretations requiring adjudication.
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
Not applicable. This is not an AI-powered diagnostic device or a device involving human readers for interpretation. It is a physical medical device (surgical drape).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is defined by the objective pass/fail criteria established within the referenced national and international standards (e.g., ISO, ASTM, AAMI, CFR). For example:
- Biocompatibility: Absence of sensitization, irritation, toxicity, and cytotoxicity.
- Seal Integrity: Meeting visual inspection requirements or maintaining pressure for a specified time.
- Sterility Assurance: Achieving a Sterility Assurance Level (SAL) of 10^-6.
- Material Strength (Tensile, Tear, Puncture): Meeting specified force/resistance values or equivalence to a reference.
- Flammability: Achieving a Class 1 rating with a burn time >3.5 seconds.
- Viral Penetration: No viral penetration or plaque formation.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set. The performance is based on physical and biological testing of the product itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a winged staff with two snakes entwined around it, often used as a symbol of medicine. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2014
Whitney Medical Solutions C/O Mr. Mark Job Regulatory Technology Services LLC 1349 25th Street NW Buffalo, MN 55313
Re: K141438 Trade/Device Name: Whitney Medical Solutions eShield Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape Regulatory Class: Class II Product Code: KKX Dated: July 16, 2014 Received: July 22, 2014
Dear Mr. Job,
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. Job
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 -S
Erin I. Keith, M.S. 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 Statement
Indications for Use Statement is provided on the following page.
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Page 1 of 1
Indications for Use Statement
K141438 510(k) Number (if known): _
Device Name: Whitney Medical Solutions eShield
Indications for Use:
Whitney Medical Solutions equipment drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. These drapes are used to protect the equipment from contamination during various procedures.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary for the Whitney Medical Solutions eShield
The 510(k) Summary is provided on the following pages.
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510(k) Summary Whitney Medical Solutions eShield
| 510(k)Summary | This 510(k) summary is being submitted in accordance with the requirements of21 C.F.R § 807.92. | |||
|---|---|---|---|---|
| Applicant | Whitney Medical Solutions | |||
| Submitter | Whitney Medical Solutions6153C West Mulford StreetNiles, IL 60714Tel: 847-966-6161Fax: 847-966-6168 | |||
| ContactPerson | Saagar Patel | |||
| DatePrepared | August 7, 2014 | |||
| Device/Trade Name | Whitney Medical Solutions eShield | |||
| DeviceCommonName | Surgical Drape | |||
| RegulationName | Surgical Drape and Drape Accessories | |||
| RegulationNumber | 21 CFR 878.4370 | |||
| RegulatoryClass | Class II | |||
| ProductCode | KKX | |||
| ClassificationPanel | General and Plastic Surgery | |||
| PredicateDevices | K050322 | |||
| Intended use | Whitney Medical Solutions equipment drapes are to be used to cover a variety ofsurgical and non-surgical equipment in various settings throughout the clinicalsetting. These drapes are used to protect the equipment from contaminationduring various procedures. | |||
| DeviceDescription | The Whitney Medical Solutions' eShield consists of polyethylene film (and anadhesive pad in some models) with tear guide tape and a zipper that allows thecover to be torn fairly straight across it. There is also a double sided tape belowthe zipper that is used as a redundant closure method with the cover beingfolded twice and sealed against it. The device is provided to the user sterile, islabeled for single use only and not intended for resterilization or reprocessing.The sterile eShield is sterilized using a validated irradiation sterilization method. |
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| Part Name | Part Number | W (in) | H (in) | Adhesive ring |
|---|---|---|---|---|
| Cell Phone Size | EC2100 | 9 | 14 | No |
| Digital Camera Size | EC2200 | 9 | 14 | Yes |
| Tablet Size | EC2300 | 14 | 18 | No |
| SLR Camera Size | EC2400 | 14 | 22 | Yes |
| Cell Phone Size with Zipper | EC2500 | 9 | 14 | No |
| Digital Camera Size with Zipper | EC2600 | 9 | 14 | Yes |
| Tablet Size with Zipper | EC2700 | 14 | 18 | No |
| SLR Camera Size with Zipper | EC2800 | 14 | 21 | Yes |
eShield Model Configurations
Whitney Medical Solutions' eShield was tested to and meets the performance Performance data specifications for the tests listed below. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
| Standard | Acceptance Criteria |
|---|---|
| ISO 10993-1 Biological evaluation ofmedical devices - Part 1: generalrequirements | Under the conditions of the study, the device is not a sensitizer, an irritant, isnon-toxic and Non-cytotoxic. |
| ASTM F1886 Standard test method fordetermining integrity of seals forflexible packaging(sterility) | Product meets inspection requirements of standard for visual defects found. |
| AAMI/ANSI/ISO 11607-1 Packagingfor terminally sterilized medicaldevices - part 1 | Used as guideline for sterilization process. Adhered to specifiedrequirements and test methods. Device sterilization dose will maintain a SAL10-6 |
| ASTM F88/F88M Standard testmethod for seal strength of flexiblebarrier materials | Meets or exceeds minimum internal acceptance criteria of 1 PLI after ASTMF1980 and ASTM D4169. |
| ASTM F 2096 Standard test methodfor detecting gross leaks in packagingby internal pressurization (bubble test) | Meets performance criteria set by standard for maintaining pressure for 5seconds under 1" of water after ASTM F1980 and ASTM D4169 |
| AAMI/ANSI/ISO 11137-2Sterilization of healthcare products -radiation - part 2 establishing thesterilization dose | Used as guideline for sterilization process. Adhered to specifiedrequirements and test methods. Device sterilization dose will maintain a SAL10-0 |
| AAMI/ANSI/ISO 11737-1,2Sterilization of medical devices-microbial methods part 1: | Used as guideline for sterilization process. Adhered to specifiedrequirements and test methods. Device sterilization dose will maintain a SAL10-6 |
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| determination of the population ofmicroorganisms on product; part 2:tests of sterility performed in thedefinition, validation and maintenanceof a sterile process | |
|---|---|
| ASTM F1671/F1671M Standard testmethod for resistance of materials usedin protective clothing to penetration byblood-borne pathogens using phi-x174bacteriophage penetration as a testsystem. | Under the conditions of the study, the device does not allow viral penetrationnor plaque formation. |
| ANSI/AAMI PB70 Liquid barrierperformanceand classification ofprotective apparel and drapesintended for use inhealth care facilities | The device meets the acceptance criteria set by the standard (AQL 4% andRQL of 20%) and up to one plaque growth per 13 samples. |
| ASTM D882 Standard test methodsfor tensile properties of thin plasticsheeting. (Ophthalmic) | The device meets the tensile acceptance criteria set by the standard forequivalence when the films are within 400 psi of each other. |
| ASTM D1004 Standard Test MethodforTear Resistance (Graves Tear) ofPlastic Film and Sheeting | The device meets the tear acceptance criteria set by the standard forequivalence when the films are within 89.53 grams in machine direction and42.6 grams in transverse direction |
| ASTM D3420 Standard Test Methodfor Pendulum Impact Resistance ofPlastic Film1 | The device meets the puncture acceptance criteria set by the standard forequivalence when the films within 9.4% . |
| 16 CFR Part 1610 Standard for theFlammability of Clothing Textiles | The device meets the flammability acceptance criteria set by the standard fora Class 1 rating with a burn time of >3.5 seconds |
Summary of Substantial Equivalence
The Whitney Medical Solutions eShield utilizes substantially equivalent performance attributes and safety components as the predicate device. It shares the following similarities to the predicate device:
- They have the same intended use ●
- They have the same or similar physical and mechanical ● specifications
- The materials of construction are the same ●
- . They have the same principle of operation and performance
- They both meet applicable performance requirements ●
- . They are both biocompatible
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| Design Feature | Whitney MedicalSolutions' eShield(K14XXXX) | MICROTEK MEDICAL, INC.(K050322) | Substantial Equivalence |
|---|---|---|---|
| Indications for Use | Whitney MedicalSolutions equipmentdrapes are to be usedto cover a variety ofsurgical and non-surgical equipmentin various settingsthroughout theclinical setting.These drapes areused to protect theequipment fromcontaminationduring variousprocedures. | Microtek Medical equipmentdrapes are to be used to cover avariety of surgical and non-surgicalequipment in various settingsthroughout the clinical setting.These drapes are used to protectthe equipment from contaminationduring various procedures. | SAME. The proposeddevice and the predicatedevices have the identicalclaim of protectingequipment in the clinicalsetting from contaminationduring various procedures. |
| Principle of Operation | The proposed deviceis used to provide acontaminationbarrier between avariety of surgicaland non-surgicalequipment in variousclinical settings. | The predicate device is used toprovide a contamination barrierbetween a variety of surgical andnon-surgical equipment in variousclinical settings. | SAME. |
| Single UseMaterial | YesPolyethylene | YesPolyethylene | SAME.SAME. |
| Disposable AdhesiveRing | Yes | No | Differences do not raisenew questions of safety andeffectiveness. |
| Viral PenetrationASTM F1671 | Pass | Unknown | SAME. |
| Tensile TestASTM D882 | Pass | Unknown | Differences do not raisenew questions of safety andeffectiveness. |
| TearASTM D1004 | Pass | Unknown | Differences do not raisenew questions of safety andeffectiveness. |
| Puncture TestASTM D3420 | Pass | Unknown | SAME. |
| Flammability16 CFR Part 1610 | Class 1 | Class 1 | SAME. |
| Physical Specifications –all models | Width: range 9 –14 inchesHeight: range 14 –22 inches | Width: 15 inchesHeight: 13 inches4 models: 20" circular | SAME. Differences do notraise new questions ofsafety and effectiveness. |
| Packaging - pouch | Single barrierTyvek/-LDPE film | LDPE Film with Tyvek | SAME. Differences do notraise new questions ofsafety and effectiveness. |
| Sterilization | Gamma | ETO/some models provided non- | SAME. Both sterilization |
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| $10^{-6}$ SAL. Differences donot raise new questions ofsafety and effectiveness. | |||
|---|---|---|---|
| Labeling | Sterile, Single Use,Disposable | Sterile/Non-sterile, Single Use,Disposable | SAME. Differences do notraise new questions ofsafety and effectiveness. |
| Instruction for Use | Provided | Not provided, these drapes havegenerally known usages andinstructions. | SAME. Differences do notraise new questions ofsafety and effectiveness. |
| Biocompatible | Under the conditionsof the study, not anirritant. Underconditions of thestudy, not asensitizer. Underconditions of thestudy, non-cytotoxic.Under conditions ofthe study, non-toxic. | Unknown | SAME. |
The conclusion drawn from the nonclinical tests demonstrate that the device is Conclusion as safe as effective as the predicate device. Whitney Medical Solutions believes the Whitney Medical Solutions eShield is substantially equivalent to the Microtek Medical, Inc. (K050322).
§ 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.