(140 days)
Not Found
No
The device description and intended use clearly describe a physical surgical drape made of fabric and film, with no mention of software, data processing, or any computational capabilities that would involve AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device creates a sterile field and provides an absorbent barrier during surgery, but it does not treat or diagnose a disease or condition.
No
The device, 3M Steri-Drape™ Surgical Fabric Drapes, is used to create a sterile field during surgical procedures, acting as a barrier. It does not perform any diagnostic function.
No
The device is a physical surgical drape made of fabric and film, 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 "create a sterile field for a surgical procedure" and are for "external use only." This describes a device used during a surgical procedure on the patient's body, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a physical barrier (drape) used to cover the patient during surgery. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Use in a laboratory setting
The device is clearly described as a surgical drape used to maintain a sterile field during a procedure.
N/A
Intended Use / Indications for Use
3M Steri-Drape™ Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only.
3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.
Product codes
KKX
Device Description
The Steri-Drape™ Fabric Drapes described in this submission are onepiece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through.
Steri-Drape™ Fabric Drapes are provided in various sizes and shapes to meet the surgeon's needs. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes.
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
In addition to performance testing in accordance with industry recognized test methods, these drapes were tested for biocompatibility using cytotoxicity, primary skin irritation tests, and sensitization testing. All testing indicated that the drapes described above were biocompatible and acceptable for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Steri-Drape™ fabric drapes
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 0 2003
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, seemingly a combination of letters and numbers. The sequence reads 'K031287'. The characters are written in a bold, somewhat uneven style, giving it a casual, handwritten appearance.
Steri-Drape™ Fabric Drape Summary of Safety and Effectiveness
General Information
Manufacturer:
Requlatory Contact:
3M Health Care 3M Center St. Paul, MN 55144-1000 (651) 733-1110
Scott Sardeson Sr. Regulatory Affairs Associate
Date:
Dietary Name:
Steri-Drape™ Fabric Surgical Drape Proprietary Name:
March 21, 2003
Common Name: Sterile and Non-Sterile Surgical Drape
Steri-Drape™ Fabric Surgical Drapes Predicate Device: (Class II, KKX)
Device Description
The Steri-Drape™ Fabric Drapes described in this submission are onepiece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through.
Steri-Drape™ Fabric Drapes are provided in various sizes and shapes to meet the surgeon's needs. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes.
Indication for Use
3M Steri-Drape™ Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only.
3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.
Substantial Equivalence
The Steri-Drape™ fabric drapes described in this submission are substantially equivalent to the currently marketed Steri-Drape™ fabric drapes. These drapes have the same intended use as the currently marketed Steri-Drape™ Fabric Drapes.
Description of Testing
In addition to performance testing in accordance with industry recognized test methods, these drapes were tested for biocompatibility using
1
cytotoxicity, primary skin irritation tests, and sensitization testing. All testing indicated that the drapes described above were biocompatible and acceptable for the intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three horizontal lines above two curved lines, resembling an abstract representation of the human form.
Public Health Service
SEP 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott S. Sardeson Senior Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 Street Paul, Minnesota 55144-1000
Re: K031287
Trade/Device Name: Steri- Drape Surgical Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 24, 2003 Received: July 28, 2003
Dear Mr. Sardeson:
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 vour 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. Sardeson
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 Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Russe
Susan Runner, DDS, MA Interim 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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510(k) Number (if known): K031287
Device Name: 3M Steri-Drape™ Surgical Fabric Drapes
Indications for Use:
3M Steri-Drape™ Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only.
3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.
Susabunne
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K031287
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)