Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterility of a polyethylene film drape, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is described as equipment drapes used to cover surgical and non-surgical equipment to protect it from contamination, not to treat or diagnose a medical condition in a patient.

Diagnostic

No
Explanation: The device is an equipment drape used to cover surgical and non-surgical equipment for protection from contamination. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product made of polyethylene film with adhesive, tear guide tape, and a zipper. The performance studies also focus on physical properties and sterilization, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is to cover surgical and non-surgical equipment to protect it from contamination. This is a physical barrier function, not a diagnostic one.
Device Description: The device is a polyethylene film with features for covering and sealing. It does not contain reagents, calibrators, or other components typically associated with IVDs.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide information about a patient's health status.
Performance Studies: The performance studies focus on the physical properties of the drape (sterility, seal strength, barrier properties, flammability, etc.), which are relevant to its function as a protective cover, not a diagnostic tool.

IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease. This device does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KKX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Whitney Medical Solutions' eShield was tested to and meets the performance 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.

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.
ASTM F1886 Standard test method for determining integrity of seals for flexible packaging (sterility): Product meets inspection requirements of standard for visual defects found.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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%.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K050322

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

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.

1

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

2

Indications for Use Statement

Indications for Use Statement is provided on the following page.

3

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)

4

510(k) Summary for the Whitney Medical Solutions eShield

The 510(k) Summary is provided on the following pages.

5

510(k) Summary Whitney Medical Solutions eShield

| 510(k)
Summary | This 510(k) summary is being submitted in accordance with the requirements of
21 C.F.R § 807.92. | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Applicant | Whitney Medical Solutions | | | |
| Submitter | Whitney Medical Solutions
6153C West Mulford Street
Niles, IL 60714
Tel: 847-966-6161
Fax: 847-966-6168 | | | |
| Contact
Person | Saagar Patel | | | |
| Date
Prepared | August 7, 2014 | | | |
| Device/
Trade Name | Whitney Medical Solutions eShield | | | |
| Device
Common
Name | Surgical Drape | | | |
| Regulation
Name | Surgical Drape and Drape Accessories | | | |
| Regulation
Number | 21 CFR 878.4370 | | | |
| Regulatory
Class | Class II | | | |
| Product
Code | KKX | | | |
| Classification
Panel | General and Plastic Surgery | | | |
| Predicate
Devices | K050322 | | | |
| 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
Description | 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. | | | |

6

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
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.
ASTM F1886 Standard test method for
determining integrity of seals for
flexible packaging(sterility)	Product meets inspection requirements of standard for visual defects found.
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
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.
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
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
AAMI/ANSI/ISO 11737-1,2
Sterilization of medical devices-
microbial methods part 1:	Used as guideline for sterilization process. Adhered to specified
requirements and test methods. Device sterilization dose will maintain a SAL
10-6

7

| determination of the population of
microorganisms on product; part 2:
tests of sterility performed in the
definition, validation and maintenance

of a sterile process
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.
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.
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.
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
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% .
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

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

8

| Design Feature | Whitney Medical
Solutions' eShield
(K14XXXX) | MICROTEK MEDICAL, INC.
(K050322) | Substantial Equivalence |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Microtek Medical 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. | SAME. The proposed
device and the predicate
devices have the identical
claim of protecting
equipment in the clinical
setting from contamination
during various procedures. |
| Principle of Operation | The proposed device
is used to provide a
contamination
barrier between a
variety of surgical
and non-surgical
equipment in various
clinical settings. | The predicate device is used to
provide a contamination barrier
between a variety of surgical and
non-surgical equipment in various
clinical settings. | SAME. |
| Single Use
Material | Yes
Polyethylene | Yes
Polyethylene | SAME.
SAME. |
| Disposable Adhesive
Ring | Yes | No | Differences do not raise
new questions of safety and
effectiveness. |
| Viral Penetration
ASTM F1671 | Pass | Unknown | SAME. |
| Tensile Test
ASTM D882 | Pass | Unknown | Differences do not raise
new questions of safety and
effectiveness. |
| Tear
ASTM D1004 | Pass | Unknown | Differences do not raise
new questions of safety and
effectiveness. |
| Puncture Test
ASTM D3420 | Pass | Unknown | SAME. |
| Flammability
16 CFR Part 1610 | Class 1 | Class 1 | SAME. |
| Physical Specifications –
all models | Width: range 9 –
14 inches
Height: range 14 –
22 inches | Width: 15 inches
Height: 13 inches
4 models: 20" circular | SAME. Differences do not
raise new questions of
safety and effectiveness. |
| Packaging - pouch | Single barrier
Tyvek/-LDPE film | LDPE Film with Tyvek | SAME. Differences do not
raise new questions of
safety and effectiveness. |
| Sterilization | Gamma | ETO/some models provided non- | SAME. Both sterilization |

9

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