(183 days)
K90210, K911039
Not Found
No
The device description and intended use clearly describe a physical surgical drape with no mention of software, data processing, or AI/ML capabilities.
No.
The Dynarex Towel Drape is intended for use as a patient covering during surgical procedures to isolate the operative site, and is not designed to treat or diagnose a disease or condition.
No
The device is described as a patient covering and barrier for surgical procedures, designed to isolate the operative site and collect fluids, not to diagnose medical conditions.
No
The device description clearly states it is composed of physical materials (nonwoven fabric or polyethylene film) and is a physical patient covering, not software.
Based on the provided information, the Dynarex Towel Drape is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "as a patient covering during General Surgical Procedures." This is a physical barrier function performed on the patient during a surgical procedure.
- Device Description: The description focuses on the physical properties of the drape (materials, imperviousness to fluids and microorganisms, adhesive, fluid collection pouches) and its sterilization. These are all related to its function as a physical barrier and protective covering.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Dynarex Towel Drape does not perform any such function. It does not interact with bodily specimens for diagnostic purposes.
Therefore, the Dynarex Towel Drape is a surgical accessory used in vivo (on the body) during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Dynarex Towel Drape is a device consisting of natural or synthetic materials intended to be used as a patient covering during General Surgical Procedures.
Product codes
KKX
Device Description
The Dynarex Towel Drape is composed of nonwoven fabric or polyethylene film and are of various conformations appropriate for General Surgical Procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluids and microorganisms, thus function to isolate the operative site from the surrounding area. Dynarex Towel Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The Dynarex Towel Drape will be subjected to a sterilizing dose of gamma radiation to achieve a Sterility Assurance Level (SAL) of 10-6. This towel drape is a single use, disposable provided in a sterile package. The method of sterilization and the method used to validate the sterilization process are in compliance with ANSI/AAMI 11139-1991.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DEKA Medical Surgical Drape - K90210, Invacare International Drape K911039
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
Dynarex Corporation (Pre-market Notification)
Page 14
KO12957
Appendix A (Summary of Safety And Effectiveness)
6 2002 MAR
Submitter:
John Gagliardi, President (contact person) MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039 513-573-0085 (Telephone and fax) or 513-573-0519 (Telephone and fax) JGAGL777@One.Net
Trade Name: Towel Drape
Common Name: Towel Drape
Classification Name: Surgical Towel Drape
Summary of Safety and Effectiveness:
The Dynarex Towel Drape is substantially equivalent in function The Dynarex Towel Drape Is substantially equivals in Invelec International Drape K911039
and intended use to the DEKA Medical Surgical Drape -- K90210, Invotes International and intended use to the DERA Medical Surgical Drape - RoobErry In Solor
and the 18" x 26" Towel Drape, manufactured for Dynarex Corporation (see example of labeling in Appendix D). These products are presently on the market.
Specifically:
Specifically.
the Dynarex Towel Drape is exactly similar in functional design, performs the the Dynarex Tower Drape is exactly of hiller in rainer presently distributed devices.
same functions and has the same intended use as these presently distributively same functions and has the same intended abo as those problems.
The packaging methods and packaging materials are exactly the same, respectively.
The Dynarex Towel Drape is composed of nonwoven fabric or polyethylene film and are of The Dynarex Towel Drape is composed of nomfordinations or procedures. These devices use nonvarious collingurations approphate for General Suring surgical procedures.
woven and film materials as a protective patient covering during surgest them, thus f woven and film materials as a procective pacific surgitive argust them, thus function These barrier materials are essentially impervious to anarex Towel Drapes may feature
to isolate the operative site from the surrounding area. Dynarefiya site Fluid to isolate the operative site from the surrounding around of the operative site. Fluid
tape adhesive to temporarily bind the drape to the peripher wound solid, and tape admesive to temporarily bind the drape for collection of operative wound solid and collection pouches are attached to the drupe for collected to a sterilizing dose of gamma
liquid effluents. The Dynarex Towel Drape will be subjected to a sterilizing dose of ilquid ematines. The Dynarex a Sterility Assurance Level (SAL) of 10-6.
This towel drape is a single use, disposable provided in a sterile prockage. The This tower drape is a shigic use, disposuble pro validate the sterilization process are in
method of sterilization and the method used to validate the study of the clubs method of Stemization and the method used to validation of Health Care Products-----------------------------------------------------------------------------------------------Compliance with ANSI/Arily 1991 1139 17 000. Requirements for Validation and Routho Corner Towel Drape is 10th This is assured through assurance level (SAL) intenthot is achieved with each lot of sterilized product.
1
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 caduceus, a symbol often associated with medicine and healthcare, with three diagonal lines representing the wings of a bird or the staff of Hermes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 6 2002
Dynarex Corporation C/O John Gagliardi Midwest Process Innovation 7736 Woodside Court Mainsville, Ohio 45039
Re: K012957
Trade/Device Name: Dynarex Towel Drape Regulation Number: 878.4370 Regulation Name: Towel Drape Regulatory Class: II Product Code: KKX Dated: January 28, 2002 Received: January 31, 2002
Dear Mr. Gagliardi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your secures some 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 interstate conmisered prior to may 20, 20, 20, 20, 20, 2011, 2017 10, 2019 10, 2019 10, 2019 Amendinone, or to avriles and Cosmetic Act (Act) that do not require approval of a premarket the Four I vou, Drag, and Sounday, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provise 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 (I MIT), it may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be round the 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
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
Tim Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Dynarex Corporation_Pre-market Notification
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Device Name: Dynarex Towel Drape KO12957
Indications for Use: The Dynarex Towel Drape is a device consisting of natural or synthetic materials intended to be used as a patient covering during General Surgical Procedures.
Clins S. Lin
("Tivision Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 8 100k) Number _