(209 days)
Not Found
Not Found
No
The device description and intended use focus on a physical barrier and fluid collection system, with no mention of AI/ML technologies or data processing.
No.
The device is a surgical drape designed to protect clinical staff and maintain a cleaner procedural site during colonoscopies, rather than directly treating a medical condition or restoring a bodily function.
No
The device is described as a surgical drape used to protect clinical staff from patient secretions and maintain a cleaner procedural site during colonoscopy. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states it is a surgical drape composed of physical materials like polyethylene film and polypropylene components, including a fluid collection pouch and a ring. This indicates a physical, hardware-based medical device, 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 the clinical staff from patient secretions and to help maintain a cleaner procedural site" during colonoscopy. This is a physical barrier and fluid collection function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a surgical drape with a fluid collection pouch and components to secure around an endoscope. This is a physical device used during a medical procedure, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and protective.
N/A
Intended Use / Indications for Use
Use the ColoSHIELD during colonoscopy procedures to protect the clinical staff from patient secretions and to help maintain a cleaner procedural site.
Product codes
KKX
Device Description
The proposed surgical drape is composed of polyethylene film and polypropylene components. The drape is a blue polyethylene sheet with an acrylic copolymer adhesive. The drape has a fluid collection pouch. The middle of the drave has a polypropylene ring approximately 5.25" in diameter. It is used to hold in place a polypropylene plate that reduces the 6.25" diameter down to 1.70" in diameter. The polypropylene plate has a thermo-plastic elastomer (TPE) feature that is molded to the 1.70" polypropylene plate aperture with a 0.375" diameter fenestration that secures. around an endoscope. Attached to the bottom of the plate is a polyethylene reservoir. This reservoir may be used to contain a water-soluble lubricant to aid in the insertion of the scope during the procedure.
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
clinical staff
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
Summary of testing: The adhesive component of the drape was evaluated per the applicable section of ISO 10993-1 for skin contact devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3MTM Steri-Drape™ 1100
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 8 2002
510(k) Summary of Safety and Effectiveness
Manufacturer: Medical Concepts Development 2500 Ventura Drive Woodbury, MN 55125 Fax: 651-735-7197 Phone: 800-345-0644
Date prepared: 7/25/02
Contact:
Classification: Class II, Colo Shield Colonoscopy Drape Model E2000
Predicate Device: 3MTM Steri-Drape™ 1100
Device Description: The proposed surgical drape is composed of polyethylene film and polypropylene components. The drape is a blue polyethylene sheet with an acrylic copolymer adhesive. The drape has a fluid collection pouch. The middle of the drave has a polypropylene ring approximately 5.25" in diameter. It is used to hold in place a polypropylene plate that reduces the 6.25" diameter down to 1.70" in diameter. The polypropylene plate has a thermo-plastic elastomer (TPE) feature that is molded to the 1.70" polypropylene plate aperture with a 0.375" diameter fenestration that secures. around an endoscope. Attached to the bottom of the plate is a polyethylene reservoir. This reservoir may be used to contain a water-soluble lubricant to aid in the insertion of the scope during the procedure.
Intended use:
Use the ColoSHIELD during colonoscopy procedures to protect the clinical staff from patient secretions and to help maintain a cleaner procedural site.
Substantial Equivalence: The intended use is the same as the predicate device
Summary of testing:
The adhesive component of the drape was evaluated per the applicable section of ISO 10993-1 for skin contact devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eric Euteneuer Medical Concepts Development, Incorporated 2500 Ventura Drive Woodbury, Minnesota 55125-3927
Re: K020581
Trade/Device Name: ColoSHIELD Colonoscopy Drape Regulation Number: 878.4370 Regulation Name: Surgical Drapes and Drape Accessories Regulatory Class: II Product Code: KKX Dated: June 28, 2002 Received: July 1, 2002
Dear Mr. Euteneuer:
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.
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.
2
Page 2 – Mr. Euteneuer
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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
Timothy A. Ulatowski
Timothy A. Ulatowski 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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Pg 1 of 1
510(k) number (if known): K020581
Device name: ColoSHIELD Colonoscopy Drape
Indications for Use:
Use the ColoSHIELD during colonoscopy procedures to protect the clinical staff from patient secretions and to help maintain a cleaner procedural site.
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off) (Division Sign-Olli)
Division of Anesthesiology, General Hospital. Division Control, Dental Devices
510(k) Number: K020581