(65 days)
Not Found
Not Found
No
The device description and intended use clearly define the product as disposable surgical drapes, which are physical barriers and do not involve any computational or analytical functions. The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no information suggesting any software or data processing capabilities.
No
The device, disposable sterile drapes, is intended for patient protective covering and equipment protection, not for treating or diagnosing a medical condition.
No
The device, disposable sterile drapes, is used for protective covering during surgical procedures and to protect equipment from contamination. Its function is not to diagnose conditions or diseases.
No
The device description clearly outlines physical, disposable surgical drapes made of SMS material, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the drapes are for patient protective covering during surgical procedures and for covering equipment to prevent contamination. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the material, style, and sterility of surgical drapes. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Lack of Diagnostic Elements: The document does not mention any process of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely protective and preventative in a surgical setting.
N/A
Intended Use / Indications for Use
Disposable sterile drapes are intended for use for :
- patient protective covering used to isolate incision sites and protect . against contamination during surgical procedures.
- cover a variety of surgical and non-surgical equipment in various settings . throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures
Drapes provided as sterile and non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 1135.
Product codes
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
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)
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
§ 878.4370 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
Image /page/0/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three parallel lines that curve to form the body, wings, and tail. The logo is encircled by text, which is difficult to read due to the image quality. The overall design is simple and abstract, suggesting movement and freedom.
Pood and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO56-G609 Silver Spring, MD 20993-0002
Kunshan Jiehong Non Woven Product Company, Limited C/O Mr. Glen Feye President Accurate Consultants Incorporated i 340 West Pennsylvania Avenue San Diego, California 92103
SEP 2 9 2011
Re: K112136
Trade/Device Name: Surgical and Equipment Drape-Sterile and Non Sterile Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 20, 2011 Received: July 26, 2011
Dear Mr.Feve:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Mr. Feye
Enclosure
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 hmited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH²'s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.
Sincerely yours,
Th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use Statements Section 5:
Indications for Use
510(k) Number (if known): K | | 2136
Device Name: Surgical and Equipment Drape-Sterile and Non Sterile
Indications for Use:
Disposable sterile drapes are intended for use for :
- patient protective covering used to isolate incision sites and protect . against contamination during surgical procedures.
- cover a variety of surgical and non-surgical equipment in various settings . throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures
Drapes provided as sterile and non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 1135.
The following disposable surgical drape types and model numbers are included in this submission
| MATERIAL | DRAPE STYLE | STERILE | DRAPE TYPE | MODEL # |
|---|---|---|---|---|
| SMS | Non | |||
| Reinforced | Sterile | Top | JHSAD 150-240E | |
| Bottom | JHSAD 180-175E | |||
| Non Sterile | Top | JHSAD 150-240NS | ||
| Bottom | JHSAD 180-175NS |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR :
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Kunshan Jiehong NonWoven Product Corp. Ltd.
Section 510(k) Notification Surgical and Equipment Drapes Eliford F. Clario - Wille (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: