(418 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical properties, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is described as surgical instruments for cutting, grasping, dissecting, and coagulation of soft tissue, which are interventional actions rather than therapeutic in nature. Also, the description lacks any mention of treating or curing a disease or condition.
No
The device is described as an endoscopic surgical instrument intended for cutting, grasping, dissecting, and coagulation of soft tissue. These are surgical functions, not diagnostic ones. There is no mention of it being used to detect, monitor, or identify diseases or conditions.
No
The device description explicitly details physical components (handle, shaft, jaw) and mentions bench testing related to mechanical and electrical performance, indicating it is a hardware device.
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 instruments are for "cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures." This describes a surgical tool used on the patient's body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description details a physical surgical instrument with a handle, shaft, and jaw. This aligns with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
Endoscopic Surgical Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Endoscopic Surgical Instruments are disposable,single use,individually packaged devices that are composed of biocompatible materials. The instruments are 5mm in diameter as well as 330mm (or 420mm) in length.
The instruments consist of handle, shaft and dissector /grasper/scissor jaw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Evidence of safety and effectiveness was obtained from electrical safety testing and function bench testing as following:
Testing in accordance with IEC 60601-1
Testing in accordance with IEC 60601-1-2
Testing in accordance with IEC 60601-2-2
Function bench testing such as Transverse holding force, Longitudinal holding force, Ratchet holding force and Cutting efficacy, Thermal effects on Tissue.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
Qingdao Kingston Medical Devices Ltd. Wu Hanhua Quality Manager No. 5 Seoul Road Free Trade Zone Qingdao 266555 China
Re: K132771
Trade/Device Name: Endoscopic Surgical Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 17, 2014 Received: September 29, 2014
Dear Hanhua:
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.
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
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comply with all the Act's requirements, including, but not limited 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 contact the Division of Industry and Consumer Education 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.htm. 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.htm for the CDRH'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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
David Krause -S
- for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K132771
Device Name: Endoscopic Surgical Instruments
Indications for Use:
Endoscopic Surgical Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Qingdao Kingston Medical Devices Ltd. The logo features the word "Kingston" in a stylized, bold font, with the company name written in a smaller, simpler font underneath. To the right of the text is a graphic of a stylized crown or burst symbol. The logo is black and white.
510(k)Summary
510(k) Owner
Qingdao Kingston Medical Devices Ltd. No.5 Seoul Road, Free Trade Zone,Qingdao,China Phone:+86 0532-86769190 Fax:+86 0532-86767322
Contact Person
Wu Hanhua Quality Manager Email:Kingston-med1@hotmail.com
Date Prepared
September 17, 2014
Name of Device
Trade Name:Kingston Endoscopic Surgical Instruments Common Name: Endoscopic Surgical Instruments Classification Name:Electrosurgical,cutting&coagulation&accessories Product Code:GEI Regulation Number:21 CFR 878.4400 Class:Il
Device description
The Endoscopic Surgical Instruments are disposable,single use,individually packaged devices that are composed of biocompatible materials. The instruments are 5mm in diameter as well as 330mm (or 420mm) in length.
The instruments consist of handle, shaft and dissector /grasper/scissor jaw.
Intended use
The Endoscopic Surgical Instruments are intended for cutting, grasping,dissecting and coagulation of soft tissue in endoscopic surgical procedures.They are intended for single patient use.
Predicate Device
GENICON, Electrosurgical Instrumentation previously cleared under 510(k) K061417
Technological Characteristics
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Image /page/4/Picture/0 description: The image contains the logo for Qingdao Kingston Medical Devices Ltd. The logo features the word "Kingston" in a stylized, bold font, with the company name written in a smaller font underneath. To the right of the text is a graphic element that appears to be an abstract design, possibly representing a medical device or a symbol related to the company's field.
The technological characteristics are the same as or equivalent to the predicate device.
Performance Data
Evidence of safety and effectiveness was obtained from electrical safety testing and function bench testing as following:
Testing in accordance with IEC 60601-1
Testing in accordance with IEC 60601-1-2
Testing in accordance with IEC 60601-2-2
Function bench testing such as Transverse holding force,Longitudinal holding force,Ratchet holding force and Cutting efficacy,Thermal effects on Tissue.
Conclusion
Because the Endoscopic Surgical Instruments is composed of the same material,has the same design and dimensions,and is supplied sterile,it is as safe,as effective,and performs as well as the predicate device,we can conclude that the new device is substantially equivalent to the predicate device under the Federal Food,Drug,and Cosmetic Act.