(184 days)
This instrument has been designed to be used with endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
The subject device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cut, coagulate and stop bleeding in the digestive tract by using high-frequency current.
The disposable Hot Biopsy Forceps consists of an insertion part and a handle part. The insertion part includes a jaw assembly and a spring tube; the handle part includes a handle, a finger ring, a conductive column, a rotating sleeve, a locking sleeve, and a sheath tube.
The subject device has 7 specifications. The differences among these models are the jaws type, Jaw O.D, and Working Length.
The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The materials used for construction of Disposable Hot Biopsy Forceps are typical for this type of medical device. Materials of Jaw and spring tube is stainless steel SUS304, the Sheath tube is made of HDPE, the Locking sleeve, Rotating sleeve and handle are made of ABS. The conductive column is made of H62.
Based on the provided text, the device in question is a "Disposable Hot Biopsy Forceps" and it is a Class II medical device. The document describes several non-clinical tests conducted to evaluate its performance and functionality against specific acceptance criteria.
However, it's crucial to note that the provided text explicitly states: "No clinical study is included in this submission." This means that the device's acceptance criteria and proven performance are based solely on non-clinical (bench) testing, not on human-in-the-loop (MRMC) or standalone (algorithm only) clinical performance studies.
Therefore, for the following points, I can only provide information based on the non-clinical test data presented. Information related to clinical studies, human expert involvement, or AI performance will be marked as "Not Applicable" or "Not Provided" as per the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds for each test item in a clear "acceptance criteria" column. Instead, the "Description" column implies the criteria (e.g., "smooth rotation and without interference" for rotation performance). The reported performance is generally stated as "has been verified" or "fulfilled." For "Conduction resistance," a numerical acceptance criterion and result are provided.
| Test Item | Acceptance Criteria (Implied from Description) | Reported Device Performance |
|---|---|---|
| Appearance | Integrity, cleanliness, and hygiene | Confirmed |
| Dimension | Complied with company's requirements | Confirmed |
| Rotation performance | Smooth rotation and without interference | Verified (smooth rotation confirmed) |
| Pushability Testing | Ease and smoothness of advancement through endoscope working channel | Verified |
| Actuation Testing | Functional, proper opening/closing for effective tissue sampling | Verified |
| Hemostatic Performance Testing | Ability to achieve hemostasis effectively after tissue sampling | Verified |
| Compatibility testing with endoscopes | Free insertion into corresponding endoscope orifice, no distortion or resistance | Verified (can be freely inserted without distortion or resistance) |
| Conduction resistance | $\le 30 \Omega$ | Confirmed to be $\le 30 \Omega$ |
| Sterility | Sterile (Sterilized by ethylene oxide) | Confirmed to be sterile |
| EO residue | $\le 10 \mu g/g$ | Confirmed to be $\le 10 \mu g/g$ |
| Biocompatibility | Fulfilled ISO 10993 criteria (non-toxic and biocompatible) | Verified |
| Sterilization and shelf life | Sterility Assurance Level (SAL) of 10⁻⁶ and 3-year shelf life | Successfully tested according to ISO 11135 and ASTM 1980, 3-year shelf life. |
| Electromagnetic Compatibility and Electrical Safety | Conform to IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2017 | Performed in accordance with standards |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., how many forceps were tested for pushability). It broadly states "Bench testing was performed."
- Sample Size: Not explicitly stated for individual tests. The phrasing "the subject device has been subjected to compliance testing" implies a sufficient number of units were tested to demonstrate compliance.
- Data Provenance: This is non-clinical bench test data, not patient data. The tests were performed in a lab setting by the manufacturer, Beijing ZKSK Technology Co., Ltd. (China). The document does not specify whether the data is retrospective or prospective, as this distinction typically applies to clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. These are non-clinical bench tests; ground truth is established by objective measurements against engineering specifications and industry standards, not by human expert interpretation of medical images or conditions.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As these are non-clinical, objective bench tests, there is no need for expert adjudication. The results are based on direct measurement or observation against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No. The device is a physical medical instrument (forceps), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance evaluation is for the physical device itself.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the non-clinical tests is based on engineering specifications, industry standards (e.g., ISO, IEC), and predefined functional requirements. For example, the criterion for "Conduction resistance" ($\le 30 \Omega$) is an engineering specification. Biocompatibility is assessed against ISO 10993 standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI model. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this is not an AI model requiring a training set. The design and validation of the device rely on established engineering principles and compliance with relevant medical device standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
December 14, 2023
Beijing ZKSK Technology Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K231721
Trade/Device Name: Disposable Hot Biopsy Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KGE Dated: October 21, 2023 Received: November 13, 2023
Dear Boyle Wang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231721
Device Name Disposable Hot Biopsy Forceps
Indications for Use (Describe)
This instrument has been designed to be used with endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K231721
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Beijing ZKSK Technology Co., Ltd |
|---|---|
| Address: | Building 9, 6 & No.6 Yuan Hengye North 7th Street, YongleEconomic Development Zone, Tongzhou District,Beijing 101105,China |
| Tel: | +86 -13811778090 |
| Contact: | Ma Li |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
2.0 Device Information
| Trade name: | Disposable Hot Biopsy Forceps |
|---|---|
| Common name: | Forceps, Biopsy, Electric |
3.0 Classification
| Production code: | KGE |
|---|---|
| Regulation number: | 21 CFR 876.4300 |
| Regulation name: | Endoscopic electrosurgical unit and accessories |
| Classification: | Class II |
|---|---|
| Panel: | Gastroenterology/Urology |
4.0 Predicate Device Information
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| Manufacturer: | OLYMPUS MEDICAL SYSTEMS CORP. |
|---|---|
| Trade/Device Name: | Electrosurgical Hemostatic Forceps Series |
| 510(k) number: | K062517 |
5.0 Device Description
The subject device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cut, coagulate and stop bleeding in the digestive tract by using high-frequency current.
The disposable Hot Biopsy Forceps consists of an insertion part and a handle part. The insertion part includes a jaw assembly and a spring tube; the handle part includes a handle, a finger ring, a conductive column, a rotating sleeve, a locking sleeve, and a sheath tube.
The subject device has 7 specifications. The differences among these models are the jaws type, Jaw O.D, and Working Length.
The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The materials used for construction of Disposable Hot Biopsy Forceps are typical for this type of medical device. Materials of Jaw and spring tube is stainless steel SUS304, the Sheath tube is made of HDPE, the Locking sleeve, Rotating sleeve and handle are made of ABS. The conductive column is made of H62.
6.0 Indication for Use Statement
This instrument has been designed to be used with endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
7.0 Summary of Non-Clinical Testing
Summary of non-clinical and performance testing- Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 10993-1, ISO 10993-7, ISO 11607-1, and Technical Requirements of "Disposable Hot Biopsy Forceps" provided by Beijing ZKSK Technology Co., Ltd. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
7.1 Sterilization and shelf life of Disposable Hot Biopsy Forceps is delivered sterile and have successfully been tested according to ISO 11135 and ASTM 1980. The label shelf life is 3 years.
7.2 Biocompatibility testing of Disposable Hot Biopsy Forceps has successfully been
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tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Disposable Hot Biopsy Forceps is non-toxic and biocompatible.
7.3 Performance testing - Bench: The performance of Disposable Hot Biopsy Forceps has been verified. Tests as described in table 1 have been completed.
| Test Item | Description |
|---|---|
| Appearance | To confirm that subject device is integrity and cleanlinessand hygiene. |
| Dimension | To confirm that the dimensions of the subject devicecomplied with the company's requirements. |
| Rotation performance | With smooth rotation and without interference. |
| Pushability Testing | To evaluate the ease and smoothness with which theforceps can be advanced or pushed through the workingchannel of an endoscope. |
| Actuation Testing | To evaluate the functionality and performance of theforceps' actuation mechanism. Actuation testing ensuresthat the forceps can be properly opened and closed,allowing for effective tissue sampling during endoscopicprocedures. |
| Hemostatic PerformanceTesting | To assess their ability to achieve hemostasis effectivelyafter tissue sampling during endoscopic procedures. |
| Compatibility testing withendoscopes | The hot biopsy forceps can be freely inserted into theorifice of the corresponding specification of theendoscope, without no sense of distortion or resistance. |
| Conduction resistance | The resistance between the hot biopsy forceps connectorand the forceps head assembly shall be $\le 30 \Omega$ . |
| Sterility | This device is sterilized by ethylene oxide. The deviceshall be sterile. |
| EO residue | EO residue shall be $\le 10 \mu g/g$ . |
| Table 1: Performance testing summary - Bench | |
|---|---|
| ---------------------------------------------- | -- |
7.4 Electromagnetic Compatibility and Electrical Safety: Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2017.
8.0 _Summary of Clinical Testing
No clinical study is included in this submission.
9.0 Technological Characteristic Comparison Table
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| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(k) No. | K231721 | K062517 |
| Product Code | KGE | KGE |
| Regulation No. | 21 CFR 876.4300 | 21 CFR 876.4300 |
| Class | II | II |
| IntendedUse/Indicationfor Use | This instrument has beendesigned to be used withendoscopes to collect tissue,cauterize, coagulate and performhemostasis using high-frequencycurrent within the digestive tract. | FD-1L/U-1 Hot Biopsy ForcepsThis instrument has beendesigned to be used with Olympusendoscopes to collect tissue,cauterize, coagulate and performhemostasis using high-frequencycurrent within the digestive tract.FD-410LR Single UseElectrosuraical HemostaticForcepsThis instrument has beendesigned to be used with Olympusendoscopes to cauterize,coagulate and perform hemostasisusing high-frequency currentwithin the digestive tract. |
| Minimal workingchannel | 2.8mm | 2.8mm |
| Sheath OD. | 2.4mm,1.8mm | 2.4mm,1.8mm |
| WorkingLength | 1600mm,1800mm,2000mm,2300mm | 1650mm, 1950mm and 2300mm |
| Jaws Type | Pointed type:Image: Pointed type jawsStandard type: | Image: Type A jawsImage: Type B jawsImage: Type C jaws |
| Image: Medical device | ||
| EnergyUsed/Delivered | Monopolar Radio FrequencyCurrent | Monopolar Radio FrequencyCurrent |
| RatedHigh-FrequencyVoltage | Cutting—1600Vp;Coagulation—2100Vp | COAG :2900Vp-p |
| Materials ofConstruction | Materials of Jaw and spring tubeis stainless steel SUS304, theSheath tube is made of HDPE,the Locking sleeve, Rotatingsleeve and handle are made ofABS. The conductive column ismade of H62. | Not publicly available |
| OpeningWidth | Pointed type:7mmStandard type:6mm | 5mm |
| Sterile | Ethylene Oxide, SAL: 10-6 | Ethylene Oxide, SAL: 10-6 |
| Shelf Life | 3 years | 3 years |
| Single Use | Single Use | Single Use |
| PerformanceComparisontesting | The test was conducted to the predicate device and current device tocompare their performance including device Rotation performance,Pushability Testing, Actuation Testing, Hemostatic Performance,Conduction resistance and Compatible endoscopes tests. | |
| Biocompatibility | Conform with ISO 10993 -1standards | Conform with(ISO10993-5,ISO10993-1,ISO10993-10,ISO10993-11) |
| ElectromagneticCompatibilityand ElectricalSafety | Conform with IEC60601-1 andIEC 60601-2-2. | Conform with IEC60601-1:2005+A1:2012 and IEC60601-2-2:2017 |
Table 2- Comparison of Technology Characteristics
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10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the
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proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K062517 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).