(202 days)
JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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.
JOYKEY Surgical Gowns (Sterile) are non-reinforced surgical Gowns manufactured from non-woven fabric. The surgical Gown is supplied sterile and for single use only.
The provided text describes a 510(k) premarket notification for JOYKEY Surgical Gowns (Sterile). This type of device is classified as medical apparel, which falls under general controls and performance standards rather than requiring a complex clinical study with AI components. Therefore, many of the requested categories in your query (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI improvement effect size, training set insights) are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Standard | Reported Device Performance (Conforms To) |
|---|---|
| ASTM F1670-03 | Barrier properties against blood and body fluids |
| ASTM D1424 | Physical specifications (related to tear resistance, flexibility) |
| ASTM D5034 | Physical specifications (related to tensile strength, elongation) |
| NFPA Standards | Flammability standards |
| ISO 10993 series | Biological standards (biocompatibility) |
| ISO 11137 | Gamma Sterilization standard |
Note: The specific performance values or thresholds for each standard are not detailed in the provided summary, only that the device conforms to them.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission refers to "bench testing" which implies laboratory tests on samples of the gown material rather than a clinical "test set" with patient data. The provenance of the test materials is not specified, but they are manufactured by JOYKEY INDUSTRYIAL LTD. in Hong Kong. The testing is retrospective in the sense that the results were generated prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth for surgical gowns is established by adherence to recognized national and international performance standards (e.g., ASTM, ISO, NFPA) through laboratory testing, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As ground truth is based on laboratory test results against established material standards, there is no need for an adjudication method as would be used in an imaging or diagnostic study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC study is not relevant for surgical gowns. This type of study is typically performed for AI-assisted diagnostic devices to evaluate the impact of the AI on human readers' performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device (surgical gown).
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is compliance with established national and international performance standards for physical characteristics, barrier properties, flammability, biocompatibility, and sterility. This is demonstrated through objective laboratory (bench) testing.
8. The Sample Size for the Training Set
Not applicable. There is no AI component in this device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI component or training set, this information is not relevant.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
MAR 1 4 2007
- JOYKEY INDUSTRYIAL LTD. 1 . Submitter's Name: Unit 7-8,23rd Floor, No. 1, Hung To Road, Kwun Tong, Address: KL . Hong Kong 852-2612-0951 Phone: Fax: 852-2615-9138 Ms. Ting-Yu Chang (President) Contact:
-
- Device Name Trade Name: JOYKEY Surgical Gowns(Sterile) Common Name: Sterile Surgical Gowns GOWN , SURGICAL Classification name:
- Classification: Class II 3.
- Predicate Device: 4.
- Device Description: 5.
JOYKEY Surgical Gowns (Sterile) are non-reinforced surgical Gowns manufactured from non-woven fabric. The surgical Gown is supplied sterile and for single use only.
Master & Frank Surgical Gowns (Sterile) (K012186)
marketed by Master & Frank Enterprise Co., Ltd.
- Intended Use: ్. JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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.
Section 4 - 510(k) Summary
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- "Performance Summary: In terms of Physical specification, The dev to ASTM F1670-03 Barrier properties against blood and body fluids & ASTM D1424 , ASTM D5034 & NFPA Flammability standards --- etc. The device also conforms to Biological standards of ISO 10993 series, Gamma Sterilization standard of ISO 11137.
Conclusions: 8.
The JOYKEY Surgical Gowns (Sterile) have identical intended use and technological characteristics as the Master & Frank Surgical Gowns (Sterile) (K012186). Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the JOYKEY Surgical Gowns (Sterile) are substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2007
Joykey Industryial, Limited C/O Ms. Jennifer Reich 2904 North Boldt Drive Flagstaff, Arizona 86001
Re: K062479
Trade/Device Name: JOYKEY Surgical Gowns (Sterile) Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: February 15, 2007 Received: February 20, 2007
Dear Ms. Reich:
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 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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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Page 2 -Ms. Reich
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely vours.
CaeG
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
510(k) Number (if known): _K 06 2479
Device Name: JOYKEY Surgical Gowns (Sterile) JOYKEY INDUSTRYIAL LTD.
Indications For Use:
JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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.
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)
Shula A. Murphy, MD
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V
§ 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.