(193 days)
Not Found
No
The device description and performance studies focus on material properties, sterilization, and barrier performance, with no mention of AI or ML.
No
The device is described as a protective patient covering to isolate a surgical incision site from contamination, and it references barrier properties against blood and body fluids. This indicates a protective, not therapeutic, function.
No
The device description indicates it is a surgical drape, used as a protective covering to isolate a surgical site from contamination, not to diagnose a condition.
No
The device description explicitly states it is manufactured from non-woven fabric, PE, and a reinforce layer, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination." This describes a physical barrier used during surgery, not a test performed on a sample from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description details the materials and configurations of a surgical drape, which is a physical product used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the JOYKEY Surgical Drapes (Sterile) are a medical device used in a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
JOYKEY Surgical Drapes (Sterile) are single use article intend to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Product codes
KKX
Device Description
JOYKEY Surgical Drapes (Sterile), are manufactured from non-woven fabric, PE & Reinforce layer. The Surgical Drapes include (3) basic configurations of SPLIT DRAPE, THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes are supplied sterile and for single use only.
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
Not Found
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)
In terms of physical specification, the device conforms 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
510(K) SUMMARY
. nis summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
MAR 0 5 2007
- JOYKEY INDUSTRYIAL LTD. Submitter's Name: 1. Address: Unit 7-8,230 Floor, No. 1, Hung To Road, Kwun Tong, KL , Hong Kong Phone: 852-2612-0951 Fax: 852-2615-9138 Ms. Ting-Yu Chang (President) Contact:
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- Device Name
JOYKEY Surgical Drapes (Sterile) Trade Name: Common Name: Sterile Surgical Drapes Classification name: Drape , SURGICAL
-
- Classification: Class II
- MASTER & FRANK SURGICAL DRAPES (STERILE) Predicate Device: 4. (K020393) marketed by Master & Frank Enterprise Co., Ltd.
-
- Device Description: JOYKEY Surgical Drapes (Sterile), are manufactured from non-woven fabric, PE & Reinforce layer. The Surgical Drapes include (3) basic configurations of SPLIT DRAPE, THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes are supplied sterile and for single use only.
-
- Intended Use: JOYKEY Surgical Drapes (Sterile) are single use article intend to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
1
- Performance Summary: In terms of physical specification, the device conforms 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 Drapes (Sterile) have the same intended use and similar technological characteristics as the MASTER & FRANK SURGICAL DRAPES (STERILE) (K020393). 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 Drapes (Sterile) are substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 5 2007
JOYKEY Industryial Limited C/O Ms. Jennifer Reich 2904 N. Boldt Drive Flagstaff, Arizona 86001
Re: K062480
Trade/Device Name: JOYKEY Surgical Drapes (Sterile) Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: February 12, 2007 Received: February 16, 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 vour 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.
3
Page 2 - Ms. Reich
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sytte Y. Michin Oms
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
4
Indications for Use
510(k) Number (if known): K062480
Device Name: JOYKEY Surgical Drapes (Sterile) JOYKEY INDUSTRYIAL LTD.
Indications For Use:
Prescription Use
(Part 21 CFR 801 Subpart D)
JOYKEY Surgical Drapes (Sterile) are single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
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)
Shule A. Murphy b
Page 1 of ﺪﺳ
(Dision sign-omm
Division of Anesthecology, General Hospital,
Infection Crintrol, Dental Devices
510(K) Number K042480