(239 days)
Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/ laparoscopic, general surgical procedures.
Endoscopic Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The device includes Disposable Endoscopic Surgical Instrument and Reusable Endoscopic Surgical Instrument. Both of the disposable and reusable endoscopic instruments are provided sterile when they're released. After used for the first time, Reusable Endoscopic Instrument needs to be sterilized by the end users. The instruments are 5mm in diameter as well as 340mm in length.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics that would typically be found in an Acceptance Criteria table. Instead, it refers to compliance with international standards and internal design control procedures.
However, based on the non-clinical testing performed, we can infer some performance aspects:
| Feature/Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Testing in accordance with IEC 60601-1 (device passed) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Testing in accordance with IEC 60601-1-2 (device passed) |
| Special Requirements for Electrosurgical Units | Compliance with IEC 60601-2-2 | Testing in accordance with IEC 60601-2-2 (device passed) |
| Endoscopic Equipment (Electrosurgical) | Compliance with IEC 60601-2-18 | Testing in accordance with IEC 60601-2-18 (device passed) |
| Appearance | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Basic Dimension | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Corrosion Resistance | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Transverse Holding Force | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Longitudinal Holding Force | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Ratchet Holding Force | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Cutting Efficacy | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Thermal Effects on Tissue | Acceptable thermal damage zone | The thermal effect has been performed on fresh pig's liver, kidney, and muscle tissue. The thermal damage zone is measured under magnification using histology after performing cauterizing. All testing results show the device meets internal specifications. |
| Biocompatibility | Compliance with ISO 10993 series | The device meets the applicable requirements of the FDA Blue Book Memorandum G95-11 entitled Use of International Standards ISO 10993-1:2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a risk management process, including ISO 10993-5, -7, -10, -11, -12. |
| Sterility (Reusable Instruments) | Sterility Assurance Level (SAL) of 10⁻⁶ | Both EO and Steam sterilization methods have been validated, and test reports show that the sterilization effect of the proposed device can achieve a SAL of 10⁻⁶. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes non-clinical laboratory testing (e.g., electrical safety, performance, biocompatibility). It does not involve a "test set" in the context of clinical data or AI model evaluation.
- Sample Size for performance tests: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with specified standards and characteristics. For the thermal effects on tissue, it involved "fresh pig's liver, kidney, and muscle tissue," but the number of samples is not quantified.
- Data Provenance: The tests were conducted in a laboratory setting as part of the device's design control and regulatory submission. The document doesn't specify the country of origin for the non-clinical test data itself, beyond the manufacturer being based in China. The study is a prospective evaluation of the device against predefined performance standards and characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is an electrosurgical instrument for cutting, dissecting, manipulating, and cauterizing tissues. There is no AI component or image analysis that would require expert adjudication to establish "ground truth" for a test set. The evaluation is based on objective measurements and compliance with technical standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of expert review or clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device (surgical instrument), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a manual surgical instrument that requires human operation. It does not have an autonomous algorithm component.
7. The Type of Ground Truth Used
The "ground truth" in this context is the objective, measurable performance of the physical device against established engineering standards and specifications. Examples include:
- Compliance with International Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ISO 10993 series.
- Physical and Functional Specifications: Appearance, basic dimension, corrosion resistance, various holding forces (transverse, longitudinal, ratchet), cutting efficacy.
- Biological Outcome: Thermal damage zone measured via histology on tissue samples, sterility assurance level (SAL).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI model, there is no training set or associated ground truth establishment process.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 13, 2018
Hunan Handlike Minimally Invasive Surgery Co., Ltd % Ms. Elly Xu Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, Guangdong, P.R.China
Re: K171825
Trade/Device Name: Endoscopic Surgical Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 10, 2017 Received: December 18, 2017
Dear Ms. Xu:
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 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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -
53
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) K171825
Device Name Endoscopic Surgical Instrument
Indications for Use (Describe)
Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/ laparoscopic, general surgical procedures.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Product: Endoscopic Surgical Instruments
Version: A/0
VOL 005_510(k) Summary
This 510(K) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Submission Sponsor
| Applicant Name | Hunan Handlike Minimally Invasive Surgery Co.,Ltd |
|---|---|
| Address | A4, Lugu Yuyuan, #27, Wenxuan Rd, High-tech Zone,Changsha, Hunan, CHINA |
| Post Code | 410205 |
| Phone No. | 86-731-89727782 |
| Fax No. | 86-731-88830694 |
| Contact Person | Hanhan Hu |
| huhanhan@handlike.cn | |
| Date Prepared | 2018-2-10 |
2. Submission correspondent
Image /page/3/Picture/10 description: The image shows a company logo with the text "Name" and "Address" above it. The logo is green and features a stylized animal head with wings. Below the logo, there are four Chinese characters, which translate to "Zhuo Yuan Tian Cheng."
Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District, Shenzhen, Guangdong, P.R.China Post Code 518000 Phone No. 86-755-86069197 Contact Person Elly Xu; Field Fu
elly@cefda.com; cefda13485@163.com
3. Devices Identification
| Trade name | Endoscopic Surgical Instrument |
|---|---|
| Common name | Endoscopic Surgical Instrument |
| Model | Disposable Endoscopic Surgical Instrument |
| Reusable Endoscopic Surgical Instrument | |
| Classification | II |
| Classification name | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation number | 878.4400 |
| Product code | GEI |
| 510(k) review panel | General & Plastic Surgery |
| Performance standards | The performance and safety was evaluated in |
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K171825
| Hunan Handlike Minimally Invasive Surgery Co.,Ltd | VOL_005:001_510(K) Summary | |
|---|---|---|
| Product: Endoscopic Surgical Instruments | Version: A/0 | |
| accordance with Electrosurgical Device Guidanceof FDA. | ||
| Biocompatibility tests were done in conformancewith relevant requirements of ISO10993. |
4. Leqally Marketed Predicate Devices
| Trade Name | Endoscopic Surgical Instruments |
|---|---|
| Regulation number | 878.4400 |
| Regulation class | II |
| Regulation name | Electrosurgical, Cutting & Coagulation & Accessories |
| 510(k) Number | K132771 |
| Product Code | GEI |
| Manufacturer | Qingdao Kingston Medical Devices Ltd. |
| Trade Name | Endoscopic Surgical Instruments |
|---|---|
| Regulation number | 878.4400 |
| Regulation class | II |
| Regulation name | Electrosurgical, Cutting & Coagulation & Accessories |
| 510(k) Number | K102921 |
| Product Code | GEI |
| Manufacturer | BEMA GmbH & Co. KG |
5. Device Description
Endoscopic Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The device includes Disposable Endoscopic Surgical Instrument and Reusable Endoscopic Surgical Instrument. Both of the disposable and reusable endoscopic instruments are provided sterile when they're released. After used for the first time, Reusable Endoscopic Instrument needs to be sterilized by the end users. The instruments are 5mm in diameter as well as 340mm in length.
6. Indications for Use Statement
Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.
7. Substantial Equivalence Discussion
7.1 Comparison between Disposable Endoscopic Surgical Instrument and K132771
| Characteristic | Disposable EndoscopicSurgical Instrument | Endoscopic SurgicalInstrument | Comments |
|---|---|---|---|
| Indication for | Disposable Endoscopic | The Endoscopic Surgical | Same |
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Hunan Handlike Minimally Invasive Surgery Co.,Ltd
Product: Endoscopic Surgical Instruments
VOL_005:001_510(K) Summary Version: A/0
| use/Intended use | Surgical is designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. | Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use. | Same | ||
|---|---|---|---|---|---|
| Operation mode | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. | |||
| Structure | Handle, shaft and dissector/grasper/scissor jaw | Handle, shaft and dissector/grasper/scissor jaw | |||
| Diameter | 5mm/34cm | 5mm/33cm (or 42cm) | Similar | ||
| Sterilization | EO | EO | Same | ||
| Single Use | Yes | Yes | Same | ||
| Biocompatibility | Comply withISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-11ISO 10993-12 | Comply withISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-11ISO 10993-12 | Same | ||
| Electric Safety, EMC andPerformance Test | IEC 60601-1,IEC 60601-1-2IEC 60601-2-2IEC 60601-2-18 | IEC 60601-1,IEC 60601-1-2IEC 60601-2-2 | Same |
7.2 Comparison between Reusable Endoscopic Surgical Instrument and K102921
| Characteristic | Reusable EndoscopicSurgical Instrument | Endoscopic MonopolarInstruments andAccessories | Comments |
|---|---|---|---|
| Indication for use/Intended use | Reusable EndoscopicSurgical is designed to cut,dissect, manipulate and/or | Endoscopic MonopolarInstruments andAccessories are used in | Same |
| cauterize various tissues | laparoscopic and other | ||
| during | minimally invasive | ||
| endoscopic/laparoscopic, | procedures for cutting, | ||
| general surgical | dissection, fixation and | ||
| procedures. | taking of biopsy samples, | ||
| depending on the design | |||
| of the tip. They are also | |||
| intended to control | |||
| bleeding by use of | |||
| monopolar high-frequency | |||
| electrical current. | |||
| Devices are either | Devices are either | ||
| monopolar endoscopic | monopolar endoscopic | ||
| instruments for tissue | instruments for tissue | ||
| manipulation and | manipulation and | ||
| Operation mode | cutting/coagulation, or | cutting/coagulation, or | Same |
| non-powered endoscopic | non-powered endoscopic | ||
| instruments for tissue | instruments for tissue | ||
| manipulation dissection, | manipulation dissection, | ||
| and cutting. | and cutting. | ||
| Handle, shaft and | |||
| Structure | dissector/grasper/scissor | Handle, shaft and tip | Same |
| jaw | |||
| Assembly type, | Two and Three-piece | Similar, see | |
| Design | Tip-detachable type | modular system, | Note 1 |
| Single-piece instrument | |||
| Diameter | 5mm/34cm | Unknown | See Note 2 |
| Sterilization | EO and Steam | Steam | See Note 3 |
| Comply with | Comply with | ||
| Biocompatibility | ISO 10993-5 | ISO 10993-5 | |
| ISO 10993-7 | ISO 10993-7 | Same | |
| ISO 10993-10 | ISO 10993-10 | ||
| ISO 10993-11 | ISO 10993-11 | ||
| ISO 10993-12 | ISO 10993-12 | ||
| IEC 60601-1 | IEC 60601-1 | ||
| Electric Safety,EMC and | IEC 60601-1-2 | Same | |
| IEC 60601-2-2 | IEC 60601-1-2 | ||
| Performance Test | IEC 60601-2-18 | IEC 60601-2-2 |
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Hunan Handlike Minimally Invasive Surgery Co.,Ltd
Product: Endoscopic Surgical Instruments
VOL_005:001_510(K) Summary Version: A/0
Note 1: The Assembly type and Tip-detachable type is similar with Two-piece modular system. Both the subject device and the predicate device can be detached into two pieces.
Note 2: The diameter of Reusable Endoscopic Surgical Instrument is similar to Page 4 of 5
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| Hunan Handlike Minimally Invasive Surgery Co.,Ltd | VOL_005:001_510(K) Summary |
|---|---|
| Product: Endoscopic Surgical Instruments | Version: A/0 |
Endoscopic Surgical Instrument (K132711).
Note 3: The reusable endoscopic instruments are provided sterile when they're released from the manufacture. After used for the first time, Reusable Endoscopic Instrument needs to be steam sterilized by the end users. Both the steam sterilization have been validated, and the test reports show that the sterilization effect of the proposed device can achieve a Sterility Assurance Level (SAL) of 10°.
8. Non-clinical Testing
Evidence of safety and effectiveness was obtained from electrical safety testing and performance 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
Testing in accordance with IEC 60601-2-18
Moreover, other performance testing of Endoscopic Surgical Instruments were conducted included appearance, basic dimension, corrosion resistance, transverse holding force, longitudinal holding force, ratchet holding force, cutting efficacy and thermal effects on tissue. The thermal effect have been performed on the fresh pig's liver, kidney and muscle tissue. And the thermal damage zone is measured under magnification using histology after performing cauterizing. All the testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures.
Biocompatibility testing of the Endoscopic Surgical Instrument confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-11 entitled Use of International Standards ISO 10993-1:2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a risk management process. All testings above were conducted per Electrosurgical Device Guidance of FDA.
9. Clinical Testing
Substantial equivalence does not depend on clinical test data.
10. Conclusions
Based on device comparison information and non-clinical testing, the differences between Endoscopic Surgical Instrument and predicate devices will be not raise any new issues of safety and effectiveness, Endoscopic Surgical Instrument is substantially equivalent to legally marketed predicate devices.
§ 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.