(52 days)
To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room peronnel from the transfer of microorganisms, body fluids, and particulate material.
To be used as a protective patient covering, such as to isolate the site of suraical incision from microbial and other contamination.
To be used as an accessory to other surgical drapes; wiping, blotting, hand drying, etc.
Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable
I apologize, but the provided text from the FDA 510(k) notification for the "Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable" does not contain information about acceptance criteria or a study proving device performance as requested.
The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information is typically found in accompanying technical documentation or study reports, which are not part of this specific FDA letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 1998
Mr. Gary VanDriel President Medcom Laundry Services, Incorporated 517 North Link Lane, Unit D Fort Collins, Colorado 80524
Re : K981073 Trade Name: Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable Regulatory Class: II FYA/KKX Product Code: Dated: March 18, 1998 March 24, 1998 Received:
Dear Mr. VanDriel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can-be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. VanDriel
through 542 of the Act for devices under the Electronic enrough Badiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (K) PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
K981073 510 (K) NUMBER
med Com GOWN PACK / DRAPE PACK (Reusable) DEVICE NAME:
INDICATIONS FOR USE:
To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room peronnel from the transfer of microorganisms, body fluids, and particulate material.
Return to Medcom Laundry Services after use for reprocessing / recycling.
DEVICE NAME: DRAPE PACK
INDICATIONS FOR USE:
To be used as a protective patient covering, such as to isolate the site of suraical incision from microbial and other contamination.
Return to Medcom Laundry Services after use for reprocessing / recycling.
DEVICE NAME: TOWEL PACK
INDICATIONS FOR USE:
To be used as an accessory to other surgical drapes; wiping, blotting, hand drying, etc.
Return to Medcom Laundry Services after use for reprocessing / recycling.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
OR
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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescriptive Use (Per 21 CFR 801.109) Over-The-Counter Use
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§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.