WHITNEY MEDICAL SOLUTIONS ESHIELD

K141438 · Whitney Medical Solutions · KKX · Aug 14, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141438
• Device Name: WHITNEY MEDICAL SOLUTIONS ESHIELD
• Applicant: Whitney Medical Solutions
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Aug 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

The eShield is a sterile, single-use polyethylene film drape designed to cover surgical and non-surgical equipment. It features a tear guide tape, a zipper for straight-line opening, and an optional adhesive pad for securing the drape. Some models include a double-sided tape for redundant closure. The device is used in clinical settings by healthcare personnel to provide a contamination barrier. It is sterilized via irradiation. The drape protects equipment from fluids and contaminants, potentially reducing the risk of equipment-related cross-contamination during procedures.

Clinical Evidence

Bench testing only. Testing included ISO 10993-1 (biocompatibility: non-sensitizing, non-irritant, non-toxic, non-cytotoxic), ASTM F1671 (viral penetration: pass), ASTM D882 (tensile), ASTM D1004 (tear), ASTM D3420 (puncture), 16 CFR 1610 (flammability: Class 1), and packaging/sterility validation (ASTM F1886, ASTM F88, ASTM F2096, AAMI/ANSI/ISO 11137-2, 11607-1, 11737-1,2).

Technological Characteristics

Materials: Polyethylene film. Form factor: Various sizes (9x14 to 14x22 inches) with optional adhesive rings and zippers. Sterilization: Gamma irradiation (SAL 10^-6). Standards: ISO 10993-1, ASTM F1886, AAMI/ANSI/ISO 11607-1, ASTM F88/F88M, ASTM F2096, AAMI/ANSI/ISO 11137-2, AAMI/ANSI/ISO 11737-1,2, ASTM F1671, ANSI/AAMI PB70, ASTM D882, ASTM D1004, ASTM D3420, 16 CFR 1610.

Indications for Use

Indicated for covering surgical and non-surgical equipment in clinical settings to protect against contamination during procedures.

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

• Microtek Medical, Inc. (K050322)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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### 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)<br>Summary | This 510(k) summary is being submitted in accordance with the requirements of<br>21 C.F.R § 807.92. | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Applicant | Whitney Medical Solutions | | | |
| Submitter | Whitney Medical Solutions<br>6153C West Mulford Street<br>Niles, IL 60714<br>Tel: [phone]<br>Fax: [phone] | | | |
| Contact<br>Person | Saagar Patel | | | |
| Date<br>Prepared | August 7, 2014 | | | |
| Device/<br>Trade Name | Whitney Medical Solutions eShield | | | |
| Device<br>Common<br>Name | Surgical Drape | | | |
| Regulation<br>Name | Surgical Drape and Drape Accessories | | | |
| Regulation<br>Number | 21 CFR 878.4370 | | | |
| Regulatory<br>Class | Class II | | | |
| Product<br>Code | KKX | | | |
| Classification<br>Panel | General and Plastic Surgery | | | |
| Predicate<br>Devices | K050322 | | | |
| Intended use | Whitney Medical Solutions equipment drapes are to be used to cover a variety of<br>surgical and non-surgical equipment in various settings throughout the clinical<br>setting. These drapes are used to protect the equipment from contamination<br>during various procedures. | | | |
| Device<br>Description | The Whitney Medical Solutions' eShield consists of polyethylene film (and an<br>adhesive pad in some models) with tear guide tape and a zipper that allows the<br>cover to be torn fairly straight across it. There is also a double sided tape below<br>the zipper that is used as a redundant closure method with the cover being<br>folded twice and sealed against it. The device is provided to the user sterile, is<br>labeled for single use only and not intended for resterilization or reprocessing.<br>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 of<br>medical devices - Part 1: general<br>requirements | Under the conditions of the study, the device is not a sensitizer, an irritant, is<br>non-toxic and Non-cytotoxic. |
| ASTM F1886 Standard test method for<br>determining integrity of seals for<br>flexible packaging(sterility) | Product meets inspection requirements of standard for visual defects found. |
| AAMI/ANSI/ISO 11607-1 Packaging<br>for terminally sterilized medical<br>devices - part 1 | Used as guideline for sterilization process. Adhered to specified<br>requirements and test methods. Device sterilization dose will maintain a SAL<br>10-6 |
| ASTM F88/F88M Standard test<br>method for seal strength of flexible<br>barrier materials | Meets or exceeds minimum internal acceptance criteria of 1 PLI after ASTM<br>F1980 and ASTM D4169. |
| ASTM F 2096 Standard test method<br>for detecting gross leaks in packaging<br>by internal pressurization (bubble test) | Meets performance criteria set by standard for maintaining pressure for 5<br>seconds under 1" of water after ASTM F1980 and ASTM D4169 |
| AAMI/ANSI/ISO 11137-2<br>Sterilization of healthcare products -<br>radiation - part 2 establishing the<br>sterilization dose | Used as guideline for sterilization process. Adhered to specified<br>requirements and test methods. Device sterilization dose will maintain a SAL<br>10-0 |
| AAMI/ANSI/ISO 11737-1,2<br>Sterilization of medical devices-<br>microbial methods part 1: | Used as guideline for sterilization process. Adhered to specified<br>requirements and test methods. Device sterilization dose will maintain a SAL<br>10-6 |

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| determination of the population of<br>microorganisms on product; part 2:<br>tests of sterility performed in the<br>definition, validation and maintenance<br>of a sterile process | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F1671/F1671M Standard test<br>method for resistance of materials used<br>in protective clothing to penetration by<br>blood-borne pathogens using phi-x174<br>bacteriophage penetration as a test<br>system. | Under the conditions of the study, the device does not allow viral penetration<br>nor plaque formation. |
| ANSI/AAMI PB70 Liquid barrier<br>performance<br>and classification of<br>protective apparel and drapes<br>intended for use in<br>health care facilities | The device meets the acceptance criteria set by the standard (AQL 4% and<br>RQL of 20%) and up to one plaque growth per 13 samples. |
| ASTM D882 Standard test methods<br>for tensile properties of thin plastic<br>sheeting. (Ophthalmic) | The device meets the tensile acceptance criteria set by the standard for<br>equivalence when the films are within 400 psi of each other. |
| ASTM D1004 Standard Test Method<br>for<br>Tear Resistance (Graves Tear) of<br>Plastic Film and Sheeting | The device meets the tear acceptance criteria set by the standard for<br>equivalence when the films are within 89.53 grams in machine direction and<br>42.6 grams in transverse direction |
| ASTM D3420 Standard Test Method<br>for Pendulum Impact Resistance of<br>Plastic Film1 | The device meets the puncture acceptance criteria set by the standard for<br>equivalence when the films within 9.4% . |
| 16 CFR Part 1610 Standard for the<br>Flammability of Clothing Textiles | The device meets the flammability acceptance criteria set by the standard for<br>a 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 Medical<br>Solutions' eShield<br>(K14XXXX) | MICROTEK MEDICAL, INC.<br>(K050322) | Substantial Equivalence |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Whitney Medical<br>Solutions equipment<br>drapes are to be used<br>to cover a variety of<br>surgical and non-<br>surgical equipment<br>in various settings<br>throughout the<br>clinical setting.<br>These drapes are<br>used to protect the<br>equipment from<br>contamination<br>during various<br>procedures. | Microtek Medical equipment<br>drapes are to be used to cover a<br>variety of surgical and non-surgical<br>equipment in various settings<br>throughout the clinical setting.<br>These drapes are used to protect<br>the equipment from contamination<br>during various procedures. | SAME. The proposed<br>device and the predicate<br>devices have the identical<br>claim of protecting<br>equipment in the clinical<br>setting from contamination<br>during various procedures. |
| Principle of Operation | The proposed device<br>is used to provide a<br>contamination<br>barrier between a<br>variety of surgical<br>and non-surgical<br>equipment in various<br>clinical settings. | The predicate device is used to<br>provide a contamination barrier<br>between a variety of surgical and<br>non-surgical equipment in various<br>clinical settings. | SAME. |
| Single Use<br>Material | Yes<br>Polyethylene | Yes<br>Polyethylene | SAME.<br>SAME. |
| Disposable Adhesive<br>Ring | Yes | No | Differences do not raise<br>new questions of safety and<br>effectiveness. |
| Viral Penetration<br>ASTM F1671 | Pass | Unknown | SAME. |
| Tensile Test<br>ASTM D882 | Pass | Unknown | Differences do not raise<br>new questions of safety and<br>effectiveness. |
| Tear<br>ASTM D1004 | Pass | Unknown | Differences do not raise<br>new questions of safety and<br>effectiveness. |
| Puncture Test<br>ASTM D3420 | Pass | Unknown | SAME. |
| Flammability<br>16 CFR Part 1610 | Class 1 | Class 1 | SAME. |
| Physical Specifications –<br>all models | Width: range 9 –<br>14 inches<br>Height: range 14 –<br>22 inches | Width: 15 inches<br>Height: 13 inches<br>4 models: 20" circular | SAME. Differences do not<br>raise new questions of<br>safety and effectiveness. |
| Packaging - pouch | Single barrier<br>Tyvek/-LDPE film | LDPE Film with Tyvek | SAME. Differences do not<br>raise new questions of<br>safety and effectiveness. |
| Sterilization | Gamma | ETO/some models provided non- | SAME. Both sterilization |

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| | | | $10^{-6}$ SAL. Differences do<br>not raise new questions of<br>safety and effectiveness. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Labeling | Sterile, Single Use,<br>Disposable | Sterile/Non-sterile, Single Use,<br>Disposable | SAME. Differences do not<br>raise new questions of<br>safety and effectiveness. |
| Instruction for Use | Provided | Not provided, these drapes have<br>generally known usages and<br>instructions. | SAME. Differences do not<br>raise new questions of<br>safety and effectiveness. |
| Biocompatible | Under the conditions<br>of the study, not an<br>irritant. Under<br>conditions of the<br>study, not a<br>sensitizer. Under<br>conditions of the<br>study, non-cytotoxic.<br>Under conditions of<br>the 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).