The intended use of the Endodrape™ surgical and diagnostic procedure drape manufactured by Vortek Surgical is for patients receiving and/or medical professionals performing a non-sterile diagnostic procedure for colonoscopies to help protect the patient and staff from bodily secretions and to maintain a cleaner procedural site. The device is a single use disposable drape that is provided non-sterile. The device can, however, be EtO (ethylene oxide) sterilized by the end user prior to use.

Device Description

The Endodrape™ surgical and diagnostic procedure drapes manufacture by Vortek Surgical, Inc. are non-sterile, single use, disposable barriers intended to be used by medical professionals as a protective patient covering; to protect clinical staff and equipment from patient secretions; and help maintain a cleaner procedural site. The drapes are blue in color and are a non-woven fabric that will be manufactured under private label to Vortek Surgical. The Endodrape™ fabric itself is a repellant treated, non-woven fabric manufactured under the trade name of Sontara by the contract manufacturer to Vortek Surgical, Inc. There are no reinforced areas of the drape. The drape is 0.13 inch thick and measures 43" x 49" and is without any areas of reinforcement. The fibers used in the drape are mechanically bonded together.

AI/ML Overview

The provided document is a 510(k) summary for the Endodrape™ Surgical and Diagnostic Procedure Drape, a physical medical device (non-sterile surgical drape), not a software or AI-powered device. Therefore, many of the requested categories related to AI performance, such as multi-reader multi-case studies, standalone algorithm performance, training set details, and expert ground truth establishment for a test set, are not applicable.

However, I can extract information related to the acceptance criteria and the studies performed to demonstrate equivalence for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

The device is assessed for substantial equivalence to predicate devices based on various physical, mechanical, liquid barrier penetration, and biocompatibility characteristics. The acceptance criterion for each characteristic is generally "Same or similar" to the predicate devices.

Product Characteristic	Acceptance Criteria (compared to predicate)	Reported Device Performance (Endodrape™)
Physical/Mechanical
Weight	Same or similar	1.9 oz/yd²
Grab Tensile Strength	Same or similar	22 lb/in
Water Impact	Same or similar	1.5 g
Water Hydrostatic	Same or similar	22 cm
Surface Wetting Spray	Same or similar	90 (range: 0-100)
Alcohol Repellency	Same or similar	9 (range: 0-10)
Flame Retardancy	Same or similar	DNI - Class I
Biocompatibility
Cytotoxicity	Non cytotoxic	Non cytotoxic
Skin Irritation	Non skin irritant	Non skin irritant
Skin Sensitivity	Non skin sensitizing agent	Non skin sensitizing agent
Liquid Barrier Classification
AAMI Liquid Barrier Classification	Same or similar	Level 1 (≤ 4.5 g)
Other Characteristics
Indications for Use	Same or similar	For non-sterile diagnostic colonoscopies to protect patient/staff from bodily secretions and maintain a cleaner procedural site. Single-use, disposable, non-sterile (can be EtO sterilized by end user).
Contraindications	NA (No contraindications)	NA
Environment Where Used	Same or similar	Surgical and diagnostic centers
Number of Uses	Same or similar	Single
Provided & Used Non-Sterile	Yes/No (EtO for predicate)	Yes/Yes
Sizes	Same or similar	43" x 49" (only)
Thickness	Same or similar	0.13 inch
Material Description	Same or similar	Non-woven fabric; various man-made and synthetic fibers (e.g., Sontara), Color: blue.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for each specific bench test performed on the Endodrape™. However, it indicates that "All physical and mechanical testing was performed in accordance with the applicable standards and regulations" set forth by ASTM, INDA, US CFR, AATCC, and ISO.

The data provenance is from non-clinical performance (bench testing) conducted by the contract manufacturer to Vortek Surgical, Inc. The location of the testing is not specified beyond being performed by the contract manufacturer. The data is prospective in the sense that these tests were specifically carried out for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a physical device being evaluated through bench testing against industry standards and comparison to predicate devices, not requiring expert ground truth for a test set in the conventional sense of clinical or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to the bench testing of the physical characteristics. Adjudication in the context of expert consensus is not relevant. The performance is objectively measured against established standards.

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 device or an imaging device requiring human reader performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance (bench testing) is based on:

Established Industry Standards: Reference to ASTM, INDA, US CFR, AATCC, and ISO standards (e.g., for physical, mechanical, and liquid barrier properties).
Predicate Device Characteristics: The comparison of the Endodrape™'s performance against the known characteristics of the predicate devices (HVO, Inc. surgical drapes and Medical Concepts Development's ColoShield Colonoscopy Drape Model E2000).
Biocompatibility Testing: Results from specific biocompatibility tests (Cytotoxicity, Sensitization, Irritation) conducted in accordance with ISO 10993-1:2003.

8. The Sample Size for the Training Set

Not applicable. This is a physical device. There is no training set in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for a physical device.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is the Non-Clinical Performance (Bench Testing).

Study Design: Comprehensive bench testing covering Physical, Mechanical, Liquid Barrier Penetration, and Biocompatibility.
Standards Followed: Testing was performed in accordance with applicable industry-recognized test methods and standards from ASTM, INDA, US CFR, AATCC, and ISO, and followed recommendations from the FDA Guidance Document for Surgical Gowns and Surgical Drapes, August 1993. Biocompatibility testing followed ISO 10993-1:2003.
Comparison Basis: The results of these tests were compared to the characteristics of legally marketed predicate devices (HVO, Inc. surgical drapes and Medical Concepts Development's ColoShield Colonoscopy Drape Model E2000).
Key Findings: The Endodrape™ surgical and diagnostic procedure drapes were found to have physical, mechanical, and liquid barrier properties that are "Same or similar" to the predicate devices. Furthermore, biocompatibility testing (cytotoxicity, skin irritation, and skin sensitivity) confirmed the device was non-cytotoxic, non-irritating, and non-skin sensitizing, even under worst-case EtO sterilized conditions.
Conclusion of Study: The results of the non-clinical performance testing demonstrated that the Endodrape™ drapes are acceptable for their intended use and are substantially equivalent to the predicate devices, not raising any new questions regarding safety or effectiveness.

Summary

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K070406

JUL 3 0 2007

SECTION 5 - SUMMARY OF SAFETY AND EFFECTIVNESS

This summary of 510(k) safety and effectiveness information is 510(k) being submitted in accordance with the requirements of 21 C.F.R. Summary ട്ട 807.92.

This summary is applicable to Nonsterile Surgical Drapes and Surgical Drape and Surgical Accessories.

SubmissionApplicant:	Vortek Surgical, Inc.1426 West 29th St.Suite 300Indianapolis, IN 46208
Phone:	888. 867 8351
Fax:	317. 921.8108
Contact:	Tom Szymczak, President
E-mail:	tszymczak@vorteksurgical.com
SubmissionCorrespondent:	Emergo Group, Inc.2454 McMullen Booth RoadSuite 427Clearwater, FL 33759
Phone:	727.797.4727
Fax:	727.797.4757
Contact:	Ian Gordon
E-mail:	igordon@emergogroup.com
Date Prepared:	October 3, 2006

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Endodrape™ Name of device: Drape, Surgical Classification Name: Device Classification: 2 KKX Product Code: Predicate Device 510(k): K050508, K020581

Predicate Device

There are several predicated devices currently on the market that have similar function and are made from the same or similar materials. Vortek Surgical, Inc. considers the surgical drapes manufactured by HVO, Inc and Medical Concepts Development to be substantially equivalent in composition, function and indented use to its Endodrape™ surgical and diagnostic procedure drapes.

Device Description

Surgical and diagnostic drapes have been manufactured and marketed for a number of years that are made from the same or similar materials and have been used successfully under the same or similar conditions. The Endodrape™ surgical and diagnostic procedure drapes are blue in color; non-woven, nonsterile, single uses drapes.

Indications for Use

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help protect the patient and staff from bodily secretions and to maintain a cleaner procedural site. The device is a single use disposable drape that is provided nonsterile. The device can, however, be EtO (ethylene oxide) sterilized by the end user prior to use.

Clinical Performance

Clinical performance for non-sterile, disposable surgical drapes is not applicable for this product. Numerous predicated devices (surgical drapes) exist and have been used extensively for a number of years that are made from the same or similar materials.

Non-Clinical Performance (Bench Testing)

Non-clinical performance (bench) testing of the Endodrape™ surgical and diagnostic procedure drapes consisted of Physical, Mechanical, Liquid Barrier Penetration and Biocompatibility, in accordance with applicable industry recognized test methods. The Endodrape™ surgical and diagnostic procedure drapes were found to be acceptable for its intended use.

Product characteristics for the Endodrape™ drapes and the predicate surgical drapes manufactured by HVO and Medical Concepts Development are shown in the following Substantial Equivalence Comparison Table. The fabric properties for Endodrape™ surgical and diagnostic and are believed to be identical to those properties found in HVO's and Medical Concepts Development's surgical drapes.

All physical and mechanical testing was performed in accordance with the applicable standards and requlations set forth by ASTM (American Society for Testing and Materials), INDA (Association of the Non-woven Fabrics Industry), the US Code of Federal Regulations (CFR), the American Association of Textile Chemist and Colorists (AATCC) and the International Organization for Standardization (ISO), and follow the recommendations established in the FDA Guidance Document for Surgical Gowns and Surgical Drapes, August 1993.

The materials used to manufacture Endodrape™ surgical and diagnostic procedure drapes are well-known and commonly used materials to manufacture other surgical drapes and have been in use for many years. Refer to Section 18 of this premarket notification submission for further information.

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Substantial Equivalence Comparison Vortek Surgical, Inc. vs. HVO, Inc. and Medical Concepts Development

PRODUCTCHARACTERISTIC	PROPOSEDDEVICE	PREDICATEDEVICE	PREDICATEDEVICE
510(k) Number	TBD	K050508	K020581
Manufacturer	Vortek Surgical,Inc.	HVO, Inc.	MedicalConceptsDevelopment
Product Name	Endodrape™	Various	ColoShieldColonoscopyDrape ModelE2000
Indications for Use	The intended use ofthe Endodrape™surgical anddiagnostic proceduredrape manufacturedby Vortek Surgical isfor patients receivingand/or medicalprofessionalsperforming a non-sterile diagnosticprocedure forcolonoscopies to helpprotect the patient anstaff from bodilysecretions and tomaintain a cleanerprocedural site. Thedevice is available asPrescription Use.The device is a singleuse disposable drapethat is providednon-sterile. Thedevice can, however,be EtO sterilized bythe end user priorto use.	The intended useof the non-sterilesurgical drapesmanufactured byHVO is as aprotective patientcovering, such asto isolate surgicalincisions frommicrobial and othercontamination.These proposeddevices areintended toundergosterilization by thecustomer prior touse in the sterilesetting.	The intendeduse of thesurgicaldrapesmanufacturedby MedicalConceptsDevelopmentis duringcolonoscopyprocedures toprotest theclinical stafffrom patientsecretions andto helpmaintain acleanerproceduralsite.
Contraindications	NA	NA	NA

EnvironmentWhere Used	Surgical anddiagnostic centers	Surgical anddiagnostic centers	Surgical anddiagnostic centers
Number of UsesProvided and UsedNon-Sterile	singleYes/Yes	singleYes/No (ETO)	singleYes/No (ETO)
Sizes	43" x 49" (only)	various	various
Thickness	0.13 inch	Same or similar	Same or similar
Material Description	Non-woven fabric;various man-madeand synthetic fibers:(e.g., Sontara,Krayton Velcro,cellulose, polyester,LDPE, medicalgrade tapes, SMS,adhesives andpolyfoam, etc.).Color: blue.for Sontara	Same or similarmaterials	Same orsimilarmaterials
MaterialCharacteristics:			Same orsimilar
• Weight	1.9 oz/yd	Same or similar	Same orsimilar
• Grab TensileStrength	22lb/in	Same or similar	Same orsimilar
• Water Impact	1.5 g	Same or similar	Same orsimilar
• WaterHydrostatic	22 cm	Same or similar	Same orsimilar
• Surface WettingSpray	90(range: 0-100)	Same or similar	Same orsimilar
• AlcoholRepellency	9(range: 0-10)	Same or similar	Same orsimilar
• FlameRetardency	DNI - Class I	Same or similar	Same orsimilar

Biocompatibility:
• Cytotoxicity	Non cytotoxic	Same or similar	Same orsimilar
• Skin Irritation	Non skin irritant	Same or similar	Same orsimilar
• Skin Sensitivity	Non skin sensitizingagent	Same or similar	Same orsimilar
AAMI Liquid BarrierClassification	Level 1≤ 4.5 g	Same or similar	Same orsimilar

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Vortek Surgical, Inc. t Show Subject Submission

Traditional 510(k) Premarket Submission
Endodrape™ Surgical Drapes

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Packaging and Sterilization

The Endodrape™ surgical and diagnostic procedure drapes will be manufactured under private label to Vortek Surgical, Inc. The drapes are supplied non-sterile to the customer. Each drape is precut and measures 43" x 49" in size. This is only size drape for this submission. Each surgical drape is individually packaged in a heat sealed poly bag and will be shipped to the customer in quantities of 20 per box.

The Endodrape™ surgical and diagnostic procedure drapes are single use disposable drapes that are provided non-sterile and ARE NOT INTENDED TO BE STERILIZED BY THE END USER. The device can, however, be EtO (ethylene oxide) sterilized by the end user if they choose to sterilize it prior to use using the instructions provided by Vortek Surgical in the package insert.

Biocompatibility

The Endodrape™ surgical and diagnostic procedure drapes are intended to be used such that they have limited skin contact with the patient, less than 24 hours, as defined in ISO 10993-1:2003. The materials used to manufacture the Endodrape™ are well-known and commonly used for other surgical drapes and the predicate devices. As such, only Cytotoxicity, Sensitization and Irritation testing are required to be performed on the material. Testing of the material was performed by the contract manufacturer to Vortek Surgical, Inc. and was done in accordance with ISO 10993-1:2003. Refer to Section 15 of this premarket notification submission for further information. The Endodrape™ surgical and diagnostic procedure drapes were found to be non-cytotoxic, non-irritating and non-skin sensitizing.

The biocompatibility testing that was performed on the surgical and diagnostic procedure drapes manufactured for Vortek Surgical, Inc. (by its contract

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manufacturer) was done so on product that had been subjected to EtO sterilization, as some of the medical device companies that also purchase these surgical and diagnostic procedure drapes (from the same contract manufacturer) may or may not indicate that the product is to be sterilized prior to use.

Therefore, biocompatibility testing that was performed on these surgical and diagnostic procedure drapes manufactured for Vortek Surgical, Inc. (by its contract manufacturer) represent worst case conditions compared to identical product that has not been EtO sterilized, as there is the possibility of residual EtO by-products being left in the material. See attached biocompatibility statement memo from the contract manufacturer.

Conclusion

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics. But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device do not raise different questions regarding safety and effectiveness as compared to the predicate device.

The differences between the Endodrape™ surgical and diagnostic procedure drapes and the predicate device cited do not raise any different questions regarding its safety and effectiveness.

The Endodrape™ surgical and diagnostic procedure drapes, as designed, is as safe and effective as the predicate device and the device and therefore is determined to be substantially equivalent to the referenced predicate device.

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Image /page/7/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2007

Vortek Surgical, LLC C/O Mr. Jay Y. Kogoma Third Party Reviewer Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K070406

Trade/Device Name: Endodrape™ Surgical and Diagnostic Procedure Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 17, 2007 Received: July 18, 2007

Dear Mr. Kogoma:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. Kogoma

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sayite y. Michie ms.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Endodrape™ surgical and diagnostic procedure drape.

Indications for Use: The intended use of the Endodrape™ surgical and diagnostic procedure drape manufactured by Vortek Surgical is for patients receiving and/or medical professionals performing a non-sterile diagnostic procedure for colonoscopies to help protect the patient and staff from bodily secretions and to maintain a cleaner procedural site. The device is a single use disposable drape that is provided non-sterile. The device can, however, be EtO (ethelene oxide) sterilized by the end user prior to use.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shade H. Murphy, MD

(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page _ of _

510(k) Number:

020404

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.