(52 days)
Not Found
Not Found
No
The 510(k) summary describes reusable surgical gowns, drapes, and towels, which are physical barriers and do not involve software or data processing, let alone AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
Explanation: The device is intended to protect surgical patients and operating room personnel from microorganism transfer and other contaminants, and its stated uses are for covering, wiping, blotting, and hand drying, none of which are therapeutic in nature.
No
The device, a surgical gown/drape/towel pack, is intended to protect against the transfer of microorganisms and body fluids. Its function is protective, not diagnostic.
No
The device description clearly indicates physical products ("Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable") which are not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a protective barrier (gowns, drapes, towels) used during surgical procedures to prevent the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
- Device Description: The device is described as "Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable." These are all physical items used for protection and isolation.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic information about a patient's health status.
- No Mention of IVD-Related Terms: The description does not include any terms typically associated with IVDs, such as "assay," "reagent," "analyzer," "diagnostic test," etc.
In summary, the device's purpose is to provide physical protection and isolation in a surgical setting, which falls under the category of medical devices used for infection control and barrier protection, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
DEVICE NAME: med Com GOWN PACK / DRAPE PACK (Reusable)
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.
Product codes
FYA, KKX
Device Description
Not Found
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
operating room personnel
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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
- PAGE 7 -
(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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