The intended use of the ENDODRAPE™ Upper Endoscopy Drape is to protect patients, staff and equipment from bodily secretions and to maintain a cleaner procedural site during non-sterile upper gastrointestinal endoscopic procedures. 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 Vortek Surgical ENDODRAPE™ Upper Endoscopy Drape is a single use, disposable covering intended for use in non-sterile surgical and diagnostic procedures. The ENDODRAPE™ Upper Endoscopy Drape consists of a non-woven surgical drape measuring 38" x 54" (97cm X 137cm), similar to other surgical drapes currently being marketed. As with the predicate colonoscopy drape, the ENDODRAPE™ Upper Endoscopy Drape is intended to protect patients, staff, and equipment from bodily secretions present during non sterile endoscopic procedures, with the only variation in size and configuration to provide optimal protection for upper gastrointestinal endoscopic procedures. The ENDODRAPE™ Upper Endoscopy Drape consist of materials commonly used for medical drape manufacturing including commercially available non-woven surgical drape fabric, Krayton, Velcro, LDPE, medical grade tapes, SMS, medical grade adhesives, hot melt, cold glue. The drape is intended for non-sterile use by the end-user and is supplied in individual heat sealed polybags.

AI/ML Overview

The provided text describes the ENDODRAPE™ Upper Endoscopy Drape and its substantial equivalence to a predicate device, focusing on physical, biocompatibility, and liquid barrier properties. It does not describe an AI/ML powered device, therefore no information is available for certain sections of your request.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Test Standard	Acceptance Criteria (Implied)	Reported Device Performance
Weight	ASTM D3776	Identical to predicate	Identical
Grab Tensile Strength	ASTM D5034	Identical to predicate	Identical
Water Impact	INDA IST 80.3	Identical to predicate	Identical
Water Hydrostatic	INDA IST 80.4	Identical to predicate	Identical
Surface Wetting Spray	INDA IST 80.1 (range 0-100)	Identical to predicate	Identical
Alcohol Repellency	INDA IST 80.6 (range 0-10)	Identical to predicate	Identical
Flame Retardency (rated Class I)	16 CFR Part 1610.4	Identical to predicate	Identical
Cytotoxicity (MEM Elution)	ISO 10993-1:2003	Identical to predicate	Identical
Skin Irritation	ISO 10993-1:2003	Identical to predicate	Identical
Skin Sensitivity	ISO 10993-1:2003	Identical to predicate	Identical
AAMI Liquid Barrier Classification	AAMI PB 70:2003, Level 2	Identical to predicate (Level 2)	Identical (Level 2)

Study Proving Device Meets Acceptance Criteria:

A "Non-Clinical Performance (Bench Testing)" study was conducted. This testing covered "Physical, Mechanical, Liquid Barrier Penetration and Biocompatibility" in accordance with applicable industry recognized test methods. The study found the ENDODRAPE™ Upper Endoscopy Drape to be "acceptable for its intended use and identical to the predicate device." The primary method for proving acceptance was comparison to a legally marketed predicate device (ENDODRAPE™ Surgical and Diagnostic Procedure Drape used in colonoscopy). Since the new device demonstrated identical performance across all tested properties to the predicate, it was deemed substantially equivalent for its intended use.

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

The document does not specify the sample size for the test set used in the bench testing.
The data provenance is from bench testing carried out by Vortek Surgical, LLC. No country of origin for the data is explicitly mentioned beyond the company's US location (Indianapolis, IN). The data is retrospective in the sense that it's a comparison to an already marketed predicate device and likely represents testing performed on a sample batch of the new device.

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

This information is not applicable as the study described is physical and biocompatibility bench testing, not a diagnostic study involving human interpretation or ground truth established by experts in that context. The "ground truth" here is objective measurements against established standards and comparison to a predicate device's known performance.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is physical and biocompatibility bench testing, which involves objective measurements against standards, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study relates to diagnostic performance with human readers, which is not relevant for a surgical drape.

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

This information is not applicable. The device is a physical surgical drape, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

Established industry standards and test methods: ASTM, INDA IST, 16 CFR, ISO 10993-1, AAMI PB 70.
Performance of a legally marketed predicate device: The ENDODRAPE™ Surgical and Diagnostic Procedure Drape (K070406). The performance of the new device was evaluated against the established performance of this predicate device across various physical and biological properties.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of physical product testing for a surgical drape, as it's not an AI/ML device.

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

This information is not applicable. There is no "training set" for this device.

Summary

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SECTION 5: SUMMARY OF SAFETY AND EFFECTIVENESS (Revision July 9, 2008)

Premarket 510(K) Summary of Safety and Effectiveness

Submitter Information

Vortek Surgical, LLC 1426 W. 29th St. Suite 300 Indianapolis, IN 46208 (317) 921-1000 Phone (317) 921-8108 FAX Contact Person: Thomas E. Szymczak Email: tszymczak@vorteksurgical.com

JUL 2 1 2008

Date Submitted: February 8, 2008

Device Name

Proprietary Name: ENDODRAPETM Upper Endoscopy Drape Common Name: non-sterile surgical/procedure drape Classification Name: Surgical Drape and Drape Accessories Regulation Number: 21 CFR 878.4370 Regulatory Class: II Classification Code: KKX

Statement of Substantial Equivalence:

The Vortek Surgical ENDODRAPE™ Upper Endoscopy Drape

is equivalent to ENDODRAPE™ Surgical and Diagnostic Procedure Drape used in colonoscopy.

Applicant Device	Predicate Device	Manufacturer	510(k)Predicate
ENDODRAPE™Upper Endoscopy Drape	ENDODRAPE™Surgical and DiagnosticProcedure Drape	Vortek Surgical,LLC	K070406

Description of Device: The Vortek Surgical ENDODRAPE™ Upper Endoscopy Drape is a single use, disposable covering intended for use in non-sterile surgical and diagnostic procedures. The ENDODRAPE™ Upper Endoscopy Drape consists of a non-woven surgical drape measuring 38" x 54" (97cm X 137cm), similar to other surgical drapes currently being marketed. As with the predicate colonoscopy drape, the ENDODRAPE™ Upper Endoscopy Drape is intended to protect patients, staff, and equipment from bodily secretions present during non sterile endoscopic procedures, with the only variation in size and configuration to provide optimal protection for upper gastrointestinal endoscopic procedures. The ENDODRAPE™ Upper Endoscopy Drape consist of materials commonly used for medical drape manufacturing including commercially available non-woven surgical drape fabric, Krayton, Velcro, LDPE, medical grade tapes, SMS, medical grade adhesives, hot melt, cold glue. The drape is intended for non-sterile use by the end-user and is supplied in individual heat sealed polybags.

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Vortek Surgical, LLC 510(k) Number K080341 ENDODRAPE™ Upper Endoscopy Drape

Indications for Use: The intended use of the ENDODRAPE™ Upper Endoscopy Drape is to protect patients, stall and equipment from bodily secretions and to maintain a cleaner procedural site during non-sterile upper gastrointestinal endoscopic procedures. 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.

Technological Characteristics: The proposed ENDODRAPE™ Upper Endoscopy Drape has the same technological and design characteristics as the predicate device.

PHYSICAL PROPERTIES
Property	Test Standard	Comparison to Predicate	Submission Section
Weight	ASTM D3776	Identical	18
Grab Tensile Strength	ASTM D5034	Identical	18
Water Impact	INDA IST 80.3	Identical	18
Water Hydrostatic	INDA IST 80.4	Identical	18
Surface WettingSpray	INDA IST 80.1(range 0-100)	Identical	18
Alcohol Repellency	INDA IST 80.6(range 0-10)	Identical	18
Flame Retardencyrated Class I, NormalFlammability	16 CFR Part 1610.4	Identical	18
BIOCOMPATIBILITY PROPERTIES
Property	Test Standard	Comparison to Predicate	Submission Section
Cytotoxicity (MEMElution)	ISO 10993-1:2003	Identical	15
Skin Irritation	ISO 10993-1:2003	Identical	15
Skin Sensitivity	ISO 10993-1:2003	Identical	15
AAMI LIQUID BARRIER CLASSIFICATION PROPERTIES
Level	Test Standard	Comparison to Predicate	Submission Section
2	AAMI PB 70:2003approved 23 October 2003as an American NationalStandard	Identical	18

Non-Clinical Performance (Bench Testing): Non-clinical performance (bench) testing of the ENDODRAPETM Upper Endoscopy Drape consisted of Physical, Mechanical, Liquid Barrier Penetration and Biocompatibility, in accordance with applicable industry recognized test methods. The ENDODRAPE™ Upper Endoscopy Drape were found to be acceptable for its intended use and identical to the predicate device.

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Vortek Surgical, LLC 510(k) Number K080341 ENDODRAPETM Upper Endoscopy Drape

Summary: The Vortek Surgical ENDODRAPE™ Upper Endoscopy Drape subject to this submission have the same intended use, non-clinical performance data, and technological characteristics as the legally marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas E. Szymczak President Vortek Surgical, LLC 1426 West 29th Street, Suite 300 Indianapolis, Indiana 46208

JUL 2 1 2008

Re: K080341

Trade/Device Name: ENDODRAPE™ Upper Endoscopy Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: August 20, 2007 Received: June 24, 2008

Dear Mr. Szymczak:

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 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. Szymczak

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu-Lin, Ph.D.

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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Vortek Surgical, LLC 510(k) Number K080341 ENDODRAPETM Upper Endoscopy Drape

Indications for Use

510(k) Number (if Known): K080341

Device Name: ENDODRAPE™ Upper Endoscopy Drape (Model # 69052)

Indications for Use: The intended use of the ENDODRAPE™ Upper Endoscopy Drape is to protect patients, staff and equipment from bodily secretions and to maintain a cleaner procedural site during non-sterile upper gastrointestinal endoscopic procedures. 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.

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)

Sheila M. Maughan, MD

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

510(k) Number:

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.