(239 days)
Not Found
No
The description focuses on the mechanical and electrical functions of surgical instruments and does not mention any AI/ML capabilities or related data processing.
Yes.
The device is designed to cut, dissect, manipulate, and cauterize tissues during surgical procedures, which are actions intended to treat or alleviate a condition.
No
Explanation: The device is described as an endoscopic surgical instrument used to cut, dissect, manipulate, and/or cauterize tissues. Its intended use is for surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it includes both disposable and reusable physical instruments (5mm in diameter, 340mm in length) and details performance testing related to physical properties like dimension, corrosion resistance, holding force, cutting efficacy, and thermal effects on tissue. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut, dissect, manipulate and/or cauterize various tissues during endoscopic/ laparoscopic, general surgical procedures." This describes a surgical instrument used directly on the patient's body.
- Device Description: The description details a physical instrument (5mm diameter, 340mm length) used for surgical procedures.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Performance Studies: The performance studies focus on the physical and electrical performance of the instrument during surgical use (cutting efficacy, thermal effects on tissue, biocompatibility, electrical safety). They do not involve analyzing patient samples for diagnostic purposes.
Therefore, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/ laparoscopic, general surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various tissues
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)
Non-clinical Testing:
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.
Clinical Testing:
Substantial equivalence does not depend on clinical test data.
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.
0
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);
1
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
2
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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3
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 |
4
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 Guidance | ||
| of FDA. | ||
| Biocompatibility tests were done in conformance | ||
| with 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 Endoscopic
Surgical Instrument | Endoscopic Surgical
Instrument | Comments |
|----------------|----------------------------------------------|-----------------------------------|----------|
| Indication for | Disposable Endoscopic | The Endoscopic Surgical | Same |
5
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 with | ||||
| ISO 10993-5 | |||||
| ISO 10993-7 | |||||
| ISO 10993-10 | |||||
| ISO 10993-11 | |||||
| ISO 10993-12 | Comply with | ||||
| ISO 10993-5 | |||||
| ISO 10993-7 | |||||
| ISO 10993-10 | |||||
| ISO 10993-11 | |||||
| ISO 10993-12 | Same | ||||
| Electric Safety, EMC and | |||||
| Performance Test | IEC 60601-1, | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-2-2 | |||||
| IEC 60601-2-18 | IEC 60601-1, | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-2-2 | Same |
7.2 Comparison between Reusable Endoscopic Surgical Instrument and K102921
| Characteristic | Reusable Endoscopic
Surgical Instrument | Endoscopic Monopolar
Instruments and
Accessories | Comments |
|-------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------|
| Indication for use/
Intended use | Reusable Endoscopic
Surgical is designed to cut,
dissect, manipulate and/or | Endoscopic Monopolar
Instruments and
Accessories 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 | |
6
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
7
| 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.