(164 days)
Not Found
No
The device description and intended use clearly define it as a physical, disposable drape for protection during endoscopic procedures. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No.
The ENDODRAPE™ Upper Endoscopy Drape is described as a single-use, disposable covering intended to protect patients, staff, and equipment from bodily secretions during non-sterile upper gastrointestinal endoscopic procedures, not to treat a disease or condition.
No
Explanation: The device is a drape used to protect patients, staff, and equipment from bodily secretions during non-sterile endoscopic procedures. Its function is to provide a barrier and maintain cleanliness, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device is a physical drape made of various materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect patients, staff and equipment from bodily secretions and to maintain a cleaner procedural site during non-sterile upper gastrointestinal endoscopic procedures." This describes a barrier device for physical protection and cleanliness, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a surgical drape made of common medical drape materials. It functions as a physical barrier.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect substances, or provide any diagnostic information.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to aid in diagnosis or monitoring. This device's function is purely protective and procedural.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KKX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper gastrointestinal
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)
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.
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.
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
§ 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.
0
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 Diagnostic
Procedure 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.
1
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 Wetting | |||
| Spray | INDA IST 80.1 | ||
| (range 0-100) | Identical | 18 | |
| Alcohol Repellency | INDA IST 80.6 | ||
| (range 0-10) | Identical | 18 | |
| Flame Retardency | |||
| rated Class I, Normal | |||
| Flammability | 16 CFR Part 1610.4 | Identical | 18 |
| BIOCOMPATIBILITY PROPERTIES | |||
| Property | Test Standard | Comparison to Predicate | Submission Section |
| Cytotoxicity (MEM | |||
| Elution) | 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 70:2003 | ||
| approved 23 October 2003 | |||
| as an American National | |||
| Standard | 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.
2
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.
3
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.
4
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
5
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: