(418 days)
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.
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.
The provided text is a 510(k) summary for the Kingston Endoscopic Surgical Instruments. This document focuses on demonstrating substantial equivalence to a predicate device based on material, design, dimensions, and sterilization, supported by electrical safety and functional bench testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.
Therefore, I cannot provide the requested information in the format specified because the document does not contain:
- A table of acceptance criteria and reported device performance related to a clinical outcome or diagnostic accuracy study. The performance data mentioned are for electrical safety and bench testing, not clinical effectiveness.
- Sample size used for a test set and data provenance related to clinical performance. Bench testing doesn't typically involve a "test set" in this context.
- Number of experts used to establish ground truth or their qualifications. Ground truth is not established for clinical outcomes in this document.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study information.
- Standalone (algorithm-only) performance information. This is a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical performance.
- Sample size for a training set. This is not an AI/ML device requiring training data.
- How ground truth for the training set was established.
The "Performance Data" section solely refers to:
- Electrical safety testing: In accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Function bench testing: Including Transverse holding force, Longitudinal holding force, Ratchet holding force, Cutting efficacy, and Thermal effects on Tissue.
These are engineering and safety tests, not clinical studies demonstrating performance against a specific clinical acceptance criterion. The conclusion of the 510(k) is about substantial equivalence, stating the device is "as safe, as effective, and performs as well as the predicate device" based on these engineering and design similarities and bench tests.
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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.
§ 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.