(52 days)
Not Found
No
The device description and intended use clearly define the device as surgical gowns made of standard materials, with no mention of software, algorithms, or any technology related to AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical gown, which is intended to protect personnel and patients from transfer of microorganisms and fluids, not to treat a medical condition.
No
The device is a surgical gown, which is used for protection, not for diagnosing medical conditions.
No
The device description clearly states the device is comprised of physical material (Polypropylene Spunbond Meltblown Spunbond (SMS)) and is a physical garment, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate materials during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material composition and performance testing related to barrier properties (fluid resistance, flammability, etc.). There is no mention of analyzing samples from the body or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is classified as surgical attire, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The DeRoyal Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect both the operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate material.
DeRoyal Surgical Gowns are identified in 21 CFR, part 878.4040 as surgical attire to be worn by operating room personnel during surgical procedures to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The DeRoyal Surgical Gowns are comprised of Polypropylene Spunbond Meltblown Spunbond (SMS) material commonly used in the industry for these devices have been tested according to relevant performance standards (ISO 10993, AATCC 127, AATCC42, ASTM1671, 16 CFR 1610, ASTM 1342, ASTM D1424, ASTM D5034, NFPA Standards) to determine their equivalency to the predicate devices.
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 / operating room
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)
The DeRoyal Surgical Gowns are comprised of Polypropylene Spunbond Meltblown Spunbond (SMS) material commonly used in the industry for these devices have been tested according to relevant performance standards (ISO 10993, AATCC 127, AATCC42, ASTM1671, 16 CFR 1610, ASTM 1342, ASTM D1424, ASTM D5034, NFPA Standards) to determine their equivalency to the predicate devices.
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.
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
DeRoyal Industries, Inc.
DeRoyal Surgical Gowns
510(k) Summary
Summary of the Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Based
SUBMITTER INFORMATION:
| NAME: | DeRoyal Industries, Inc. | TELEPHONE: | (865) 362-6157 |
|---|---|---|---|
| ADDRESS: | 200 DeBusk Lane | CONTACT: | Sharon Cook |
| Powell, TN 37849 | DATE OF PREPARATION: | September 25, 2003 |
DEVICE NAMES
| Name: | Surgical Gowns |
|---|---|
| COMMON/USUAL NAME: | Surgical Gowns |
| CLASSIFICATION NAME: | FYA, Surgical Apparel |
| Class II device, per 878.4040 |
PREDICATE OR LEGALLY MARKETED DEVICES
PrimeLine primaGARD Surgical Gowns (K023117) Precept Ultraguard™ Surgical Gowns (no 510k available, Owner/Operator number 9038820)
DEVICE DESCRIPTION
The DeRoyal Surgical Gowns are comprised of Polypropylene Spunbond Meltblown Spunbond (SMS) material commonly used in the industry for these devices have been tested according to relevant performance standards (ISO 10993, AATCC 127, AATCC42, ASTM1671, 16 CFR 1610, ASTM 1342, ASTM D1424, ASTM D5034, NFPA Standards) to determine their equivalency to the predicate devices.
DEVICE INTENDED USE
The DeRoyal Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect both the operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate material.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICES
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Material | Spunbond Meltblown Spunbond | |
| (SMS) | Spunbond Meltblown Spunbond | |
| (SMS) | ||
| Color | Blue | Blue |
| Sizes | Various | Various |
| Sterility | Sterile and Non-Sterile | Sterile and Non-Sterile |
| Disposable | Yes | Yes |
| Package | Bulk, single put-ups or as a | |
| component in trays or kits | Bulk, single put ups or as a | |
| component in trays or kits |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Ms. Sharon Cook Regulatory Affairs Group Manager DeRoyal Industries, Incorporated 200 DeBusk Lane Powell, Tennessee 37849
Re: K033057
Trade/Device Name: DeRoyal Surgical Gowns, Sterile, Non-Sterile Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: September 25, 2003 Received: September 29, 2003
Dear Ms. Cook:
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 mav, 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.
2
Page 2 - Ms. Cook
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), v 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,
Sirser Q.unas
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k): K033057 Device Name: DeRoyal Surgical Gowns Starte, non-sterele
Intended Use: DeRoyal Surgical Gowns are identified in 21 CFR, part 878.4040 as surgical attire to be worn by operating room personnel during surgical procedures to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials.
Susanna F. Pasulu
sthesiology, General Hospital, I. Dental Devices
510(k) Number: K033057
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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