(184 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality for tissue sampling and electrocoagulation, with no mention of AI or ML.
Yes
The device is used for histological sampling (biopsy) and electrocoagulation, which are medical procedures performed to treat or diagnose conditions within the body. Histological sampling involves removing tissue for diagnostic purposes, while electrocoagulation is a therapeutic procedure used to stop bleeding or destroy abnormal tissue.
No
Explanation: The device is described as being used for "histological sampling or electrocoagulation," which are procedures for obtaining tissue samples and controlling bleeding/destroying tissue, respectively. While histological sampling provides tissue for subsequent diagnostic analysis, the device itself is an instrument for obtaining the sample, not for analyzing or diagnosing with it. Therefore, it is a surgical/interventional device, not a diagnostic one.
No
The device description clearly outlines physical components such as a flexible wire cable, jaws, spring sheath, and handle, and describes its function through mechanical action and delivery of electrical current, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is used within the body (in the gastrointestinal and bronchial tracts) for histological sampling (taking tissue samples) and electrocoagulation (using electrical current to stop bleeding or remove tissue).
- Intended Use: The intended use clearly states it's for procedures performed during an endoscopy, not for analyzing samples in a lab.
While the device is used to obtain tissue for subsequent histological examination (which is an in vitro process), the device itself is a surgical/endoscopic instrument used in vivo.
N/A
Intended Use / Indications for Use
This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.
Product codes
KGE
Device Description
The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. It consists of a flexible wire cable and jaws which can be opened and closed by a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current for histological sampling or electrocoagulation with the jaws.
The main component of the proposed device is jaws, spring sheath and handle.
The proposed device has four (4) models, HBF55-11023180 and HBF55-11023230, HBF65-11023180 and HBF65-11023230. HBF65-11023180 and HBF65-11023230 are two new models added. The differences between the two new models and the two approved models (predicate device) are the color of Handle and the jaws. The news models are White-blue Handle and Alligator Forceps; the two approved models are Grey-blue Handle and oval forceps.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of $10^{-6}$ and placed in a sterility maintenance package to ensure a shelf life of 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal and bronchial tracts
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
Non clinical tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment, the non-clinical tests verify that the proposed device met all acceptance criteria and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM F88/F88M-15 Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ASTM F1929-15 Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration
ASTM F1140/F1140M-13 Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages
ASTM F1886/F1886M–16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
USP 40 - NF35:2017 Sterility Tests
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO 10993-1:2009 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11: 2006 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity USP 40 NF 35:2017 Pyrogen Test
ISO 11135 Second Edition 2014 Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and is stacked in two lines.
July 5, 2018
Micro-Tech (Nanjing) CO., Ltd. Becky Li Ouality and Regulatory Affairs Director NO. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China
Re: K180018
Trade/Device Name: Disposable Hot Biopsy Forceps Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KGE Dated: May 18, 2018 Received: May 21, 2018
Dear Becky Li:
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.
1
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); 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 comprehensive regulatory information about mediation-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,
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Disposable Hot Biopsy Forceps
Indications for Use (Describe)
This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the words "MICRO-TECH" to the right of the letters. Below the words "MICRO-TECH" are two Chinese characters. The logo is blue and white.
510K Summary
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K180018
1. Date of Preparation: 05/08/2018
-
- Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing 210032, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Quality and Regulatory Affairs Director Tel: +86-25-58646378 Fax: +86-25-58350006 Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Trade Name: Disposable Hot Biopsy Forceps Common Name: Forceps, Biopsy, Electric Classification Name: Endoscopic electrosurgical unit and accessories Classification: 2 Product Code: KGE Requlation Number: 876.4300 Review Panel: Gastroenterology/Urology
4. ldentification of Predicate Device
510(k) Number: K160625 Trade Name: Disposable Hot Biopsy Forceps Common Name: Forceps, Biopsy, Electric
5. Indications for Use
This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.
4
510K Summary
Device Description 6.
The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. It consists of a flexible wire cable and jaws which can be opened and closed by a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current for histological sampling or electrocoagulation with the jaws.
The main component of the proposed device is jaws, spring sheath and handle.
The proposed device has four (4) models, HBF55-11023180 and HBF55-11023230, HBF65-11023180 and HBF65-11023230. HBF65-11023180 and HBF65-11023230 are two new models added. The differences between the two new models and the two approved models (predicate device) are the color of Handle and the jaws. The news models are White-blue Handle and Alligator Forceps; the two approved models are Grey-blue Handle and oval forceps.
The proposed devices are 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.
7. Comparison of Technological Characteristics
The Disposable Hot Biopsy Forceps incorporates substantially equivalent device materials, design, configuration, manufacturing processes, sterilization process and intended use as those featured in.
| Item | Proposed Device
Disposable Hot Biopsy
Forceps | Predicate Device
Disposable Hot Biopsy
Forceps (K160625) | Comparison
to Predicate
Device |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Product Code | KGE | KGE | Same |
| Regulation No. | 876.4300 | 876.4300 | Same |
| Class | 2 | 2 | Same |
| Supplied Sterile | Yes | Yes | Same |
| Jaws Shape | Oval Jaws
Alligator Jaws | Oval Jaws | Similar |
| Outer Tube
Diameter | 2.3mm | 2.3mm | Same |
| Minimal Working
Channel | 2.8mm | 2.8mm | Same |
| Working Length | 1800mm, 2300mm | 1800mm, 2300mm | Same |
| Indications for Use | The device is intended to
be used for endoscopic
histological sampling or
electrocoagulation of
various tissues, within the | The device is intended to
be used for endoscopic
histological sampling or
electrocoagulation of
various tissues, within the | Same |
Comparison to predicate Device:
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Image /page/5/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue font on the left side of the image. To the right of the letters is the word "MICRO-TECH" in a similar blue font. Below the word "MICRO-TECH" are two Chinese characters.
| Item | Proposed Device
Disposable Hot Biopsy
Forceps | Predicate Device
Disposable Hot Biopsy
Forceps (K160625) | 510K Summary
Comparison
to Predicate
Device |
|------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | the gastrointestinal and
bronchial tracts, via the
operating channel of
endoscopic instruments. | gastrointestinal and
bronchial tracts, via the
operating channel of
endoscopic instruments. | |
| Configuration | Jaws, Spring Sheath,
High-Frequency, and
Handle | Jaws, Spring Sheath,
High-Frequency, and
Handle | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 | Same |
| Sterility | Sterility Assurance Level:
$10^{-6}$ . | Sterility Assurance Level:
$10^{-6}$ . | Same |
| Packaging | Single-use EO sterilized
pouch with one device per
pouch | Single-use EO sterilized
pouch with one device per
pouch | Same |
| Shelf Life | Three years | Four years | Different |
Compared to the predicate device, the proposed device is different from the predicate device in the following:
-
- Add two new models that the Jaws shape is Alligator;
-
- Change the color of spring tube from blue to Red and add mark;
-
- Change the packaging, delete the inner plate and add the Jaws protective cap and Fixed Tape.
- Shelf life Change 4)
8. Non-Clinical Test
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Non clinical tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment, the non-clinical tests verify that the proposed device met all acceptance criteria and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM F88/F88M-15 Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ASTM F1929-15 Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration
ASTM F1140/F1140M-13 Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages
ASTM F1886/F1886M–16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
6
Image /page/6/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the letters in blue and white. To the right of the letters is the text "MICRO-TECH" in blue, with a horizontal line underneath. Below the line is some Chinese text.
510K Summary
USP 40 - NF35:2017 Sterility Tests
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO 10993-1:2009 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11: 2006 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity USP 40 NF 35:2017 Pyrogen Test
ISO 11135 Second Edition 2014 Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Disposable Hot Biopsy Forceps has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Disposable Hot Biopsy Forceps cleared under K160625.