(209 days)
Use the ColoSHIELD during colonoscopy procedures to protect the clinical staff from patient secretions and to help maintain a cleaner procedural site.
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.
The provided text describes the 510(k) summary for the ColoSHIELD Colonoscopy Drape. It primarily focuses on the device's description, intended use, and its substantial equivalence to a predicate device.
However, the document does not contain information about acceptance criteria, detailed study results proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment methods, or any multi-reader multi-case (MRMC) or standalone algorithm performance studies.
The "Summary of testing" section only states: "The adhesive component of the drape was evaluated per the applicable section of ISO 10993-1 for skin contact devices." This is a very high-level statement indicating biocompatibility testing for the adhesive, not performance testing related to the drape's primary function of protecting staff and maintaining a clean site.
Therefore, I cannot provide the requested table and detailed information as the source text does not contain this specific data.
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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.
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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.
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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
§ 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.