(184 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality for tissue collection, cauterization, and hemostasis, with no mention of AI or ML.
Yes
The device is described as harvesting tissue, cauterizing, coagulating, and performing hemostasis within the digestive tract, all of which are considered therapeutic actions.
No
The device is designed for therapeutic purposes (collecting tissue, cauterizing, coagulating, and performing hemostasis) rather than diagnosing conditions.
No
The device description clearly outlines physical components made of materials like stainless steel, HDPE, ABS, and H62, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect tissue, cauterize, coagulate, and perform hemostasis within the digestive tract using high-frequency current. This is a direct intervention on the patient's body.
- Device Description: The device is a physical instrument used with endoscopes for surgical procedures (cutting, coagulating, stopping bleeding).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue samples in a laboratory setting.
This device is clearly an electrosurgical instrument used for therapeutic and diagnostic (tissue collection) procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
KGE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract
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
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.
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.
Biocompatibility testing of Disposable Hot Biopsy Forceps has successfully been 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.
Performance testing - Bench: The performance of Disposable Hot Biopsy Forceps has been verified. Tests as described in table 1 have been completed.
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.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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).
2
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
3
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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4
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, Yongle |
| Economic 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, 200120 |
| China | |
| 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
5
| 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
6
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 cleanliness |
| and hygiene. | |
| Dimension | To confirm that the dimensions of the subject device |
| complied with the company's requirements. | |
| Rotation performance | With smooth rotation and without interference. |
| Pushability Testing | To evaluate the ease and smoothness with which the |
| forceps can be advanced or pushed through the working | |
| channel of an endoscope. | |
| Actuation Testing | To evaluate the functionality and performance of the |
| forceps' actuation mechanism. Actuation testing ensures | |
| that the forceps can be properly opened and closed, | |
| allowing for effective tissue sampling during endoscopic | |
| procedures. | |
| Hemostatic Performance | |
| Testing | To assess their ability to achieve hemostasis effectively |
| after tissue sampling during endoscopic procedures. | |
| Compatibility testing with | |
| endoscopes | The hot biopsy forceps can be freely inserted into the |
| orifice of the corresponding specification of the | |
| endoscope, without no sense of distortion or resistance. | |
| Conduction resistance | The resistance between the hot biopsy forceps connector |
| and the forceps head assembly shall be $\le 30 \Omega$ . | |
| Sterility | This device is sterilized by ethylene oxide. The device |
| shall 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
7
| 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 |
| Intended | ||
| Use/Indication | ||
| for Use | 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. | FD-1L/U-1 Hot Biopsy Forceps | |
| This instrument has been | ||
| designed to be used with Olympus | ||
| endoscopes to collect tissue, | ||
| cauterize, coagulate and perform | ||
| hemostasis using high-frequency | ||
| current within the digestive tract. | ||
| FD-410LR Single Use | ||
| Electrosuraical Hemostatic | ||
| Forceps | ||
| This instrument has been | ||
| designed to be used with Olympus | ||
| endoscopes to cauterize, | ||
| coagulate and perform hemostasis | ||
| using high-frequency current | ||
| within the digestive tract. | ||
| Minimal working | ||
| channel | 2.8mm | 2.8mm |
| Sheath OD. | 2.4mm,1.8mm | 2.4mm,1.8mm |
| Working | ||
| Length | 1600mm,1800mm,2000mm, | |
| 2300mm | 1650mm, 1950mm and 2300mm | |
| Jaws Type | Pointed type: | |
| Image: Pointed type jaws | ||
| Standard type: | Image: Type A jaws | |
| Image: Type B jaws | ||
| Image: Type C jaws | ||
| Image: Medical device | ||
| Energy | ||
| Used/Delivered | Monopolar Radio Frequency | |
| Current | Monopolar Radio Frequency | |
| Current | ||
| Rated | ||
| High-Frequency | ||
| Voltage | Cutting—1600Vp; | |
| Coagulation—2100Vp | COAG :2900Vp-p | |
| Materials of | ||
| Construction | 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. | Not publicly available | |
| Opening | ||
| Width | Pointed type:7mm | |
| Standard 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 |
| Performance | ||
| Comparison | ||
| testing | The test was conducted to the predicate device and current device to | |
| compare their performance including device Rotation performance, | ||
| Pushability Testing, Actuation Testing, Hemostatic Performance, | ||
| Conduction resistance and Compatible endoscopes tests. | ||
| Biocompatibility | Conform with ISO 10993 -1 | |
| standards | Conform with | |
| (ISO10993-5, | ||
| ISO10993-1, | ||
| ISO10993-10, | ||
| ISO10993-11) | ||
| Electromagnetic | ||
| Compatibility | ||
| and Electrical | ||
| Safety | Conform with IEC60601-1 and | |
| IEC 60601-2-2. | Conform with IEC | |
| 60601-1:2005+A1:2012 and IEC | ||
| 60601-2-2:2017 |
Table 2- Comparison of Technology Characteristics
8
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the
9
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.