(52 days)
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.
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.
The provided document is a 510(k) premarket notification for DeRoyal Surgical Gowns. It states that the device is substantially equivalent to legally marketed predicate devices based on a comparison of technological characteristics and performance standards. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
This document is for a medical device (surgical gowns), which are evaluated based on material properties, performance standards, and comparison to legally marketed predicate devices, rather than a "study proving device meets acceptance criteria" in the context of an AI/ML device or a device requiring a clinical efficacy trial.
Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to a different type of device evaluation (e.g., diagnostic device, software as a medical device).
Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations for this type of query:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list specific "acceptance criteria" for performance values in a table format that are then compared to reported device performance. Instead, it states that the device materials "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."
The "device performance" is implicitly that it meets the requirements of these standards and is equivalent to the predicate devices. The specific numeric results of these tests are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliant with ISO 10993 (Biocompatibility) | Yes, tested compliant |
| Compliant with AATCC 127 (Water Resistance: Hydrostatic Pressure) | Yes, tested compliant |
| Compliant with AATCC 42 (Water Resistance: Impact Penetration) | Yes, tested compliant |
| Compliant with ASTM 1671 (Resistance to Penetration by Blood-Borne Pathogens) | Yes, tested compliant |
| Compliant with 16 CFR 1610 (Flammability) | Yes, tested compliant |
| Compliant with ASTM 1342 (Permeability of Air to Porous Materials) | Yes, tested compliant |
| Compliant with ASTM D1424 (Tear Strength of Woven Fabrics) | Yes, tested compliant |
| Compliant with ASTM D5034 (Breaking Strength and Elongation of Textile Fabrics) | Yes, tested compliant |
| Compliant with NFPA Standards (various protective clothing) | Yes, tested compliant |
| Equivalency to predicate devices (material, color, sizes, sterility, disposable, package) | Yes, claimed and accepted |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For material testing, sample sizes would depend on the specific ASTM, ISO, or AATCC standards, but these details are not disclosed in this 510(k) summary. The concept of "data provenance" (country, retrospective/prospective) is not applicable here as it relates to clinical data, not material performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable to the evaluation of surgical gown material properties. "Ground truth" in this context would be established by standardized laboratory testing methods, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for clinical trial data or expert review scenarios, not for material property testing according to established international standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI-assisted tool where human reader performance would be measured or improved.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance
Not applicable. Surgical gowns are physical medical devices, not algorithms.
7. Type of Ground Truth Used
The "ground truth" for the device's properties is established through standardized laboratory testing according to the listed international and national consensus standards (ISO, AATCC, ASTM, NFPA, 16 CFR).
8. Sample Size for the Training Set
Not applicable. Surgical gowns do not involve machine learning algorithms with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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 acomponent in trays or kits | Bulk, single put ups or as acomponent 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.
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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
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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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§ 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.