(202 days)
Not Found
No
The description focuses on mechanical and electrical properties for cauterization and coagulation, with no mention of AI or ML.
Yes
The device is used to cauterize, coagulate, or perform hemostasis within the digestive tract, actively treating a medical condition.
No
The device is used for therapeutic purposes (cauterizing, coagulating, hemostasis) and does not acquire or analyze data to inform a diagnosis.
No
The device description clearly outlines a physical medical device with mechanical and electrical components (jaw, sheath, electrical interface, handle) intended for use with an endoscope and an electrosurgical current generator. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract." This describes a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a mechanical and energy-based device used to clamp and apply electrical current to bleeding points. This is consistent with a surgical or interventional device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on treating bleeding within the digestive tract.
N/A
Intended Use / Indications for Use
These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
Product codes (comma separated list FDA assigned to the subject device)
KGE
Device Description
The proposed Ensure™ Single-Use Coagulation Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract. The proposed device is only for adult patients.
The Coagulation Forceps is a hemostasis device which combines both mechanical property and energy. It consists of a jaw, coated spring sheath, high frequency electrical interface and handle. The Coagulation Forceps can be advanced through an appropriate endoscope channel to reach targets and by pushing and pulling its Finger Ring of the handle, the forceps opens and closes. The bleeding point will be clamped with the Coagulation Forceps. At that point, high-frequency and high-voltage power will be delivered at the precise site of bleeding using an electrosurgical current generator so as to achieve hemostasis. 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 2 years.
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
adult patients
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)
The proposed device the Ensure™ Single-Use Coagulation Forceps meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process", ISO 11135 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".
The following bench tests were performed on the Ensure™ Single-Use Coagulation Forceps:
- Dimension Testing
- Rotatable Performance Testing
- Pushability Testing
- Actuation Testing
- The Removal of HF Plug Testing
- Electrode Contact Impedance Testing
- Hemostatic Performance Testing
- Tensile Strength Testing
The tests performed demonstrated that the proposed device and predicate device are substantially equivalent.
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Two-year aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test. Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16, 2016.
Electromagnetic compatibility, electric safety, and thermal safety had been confirmed according to the following standards:
IEC60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: Medical electrical equipment - general requirements for the basic safety and essential performance
IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
No animal study is included in this submission.
No clinical study is included in this submission.
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
§ 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 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 FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 15, 2021
Micro-Tech (Nanjing) Co., Ltd. Cecilia Sun RA Engineer No. 10 Gaoke Third Road Nanjing, Jiangsu Province 210032 CHINA
Re: K202438
Trade/Device Name: Ensure Single-Use Coagulation Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE Dated: February 9, 2021 Received: February 12, 2021
Dear Cecilia Sun:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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).
Sincerely,
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
2
Indications for Use
510(k) Number (if known) K202438
Device Name
Ensure(TM) Single-Use Coagulation Forceps
Indications for Use (Describe)
These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801 Subpart |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K202438 Page 1 of 6
Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks, giving them a bold and modern look. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
Section 5 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: _
1. Date of Preparation: 2020-05-27
-
- Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone,
Nanjing, Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Cecilia Sun
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Trade Name: Ensure™ Single-Use Coagulation Forceps
Common Name: Electrosurgical Hemostatic Forceps
Regulatory Information
Classification Name: Endoscopic electrosurgical unit and accessories Classification: 2 Product Code: KGE Regulation Number: 876.4300 Review Panel: Gastroenterology and urology
4
K202438 Page 2 of 6
Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks, giving them a bold and modern look. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
Section 5 510k summary
4. Identification of Predicate Device
510(k) Number: K062517
Product Name: Single-Use Electrosurgical Hemostatic Forceps Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
5. Indications for Use
These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
6. Device Description
The proposed Ensure™ Single-Use Coagulation Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract. The proposed device is only for adult patients.
The Coagulation Forceps is a hemostasis device which combines both mechanical property and energy. It consists of a jaw, coated spring sheath, high frequency electrical interface and handle. The Coagulation Forceps can be advanced through an appropriate endoscope channel to reach targets and by pushing and pulling its Finger Ring of the handle, the forceps opens and closes. The bleeding point will be clamped with the Coagulation Forceps. At that point, high-frequency and high-voltage power will be delivered at the precise site of bleeding using an electrosurgical current generator so as to achieve hemostasis. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 2 years.
7. Comparison of Technological Characteristics
The Ensure™ Single-Use Coagulation Forceps incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology,
5
K202438 Page 3 of 6
Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A small registered trademark symbol is located in the upper right corner of the logo.
Section 5 510k summary
sterilization process and intended use as those featured in the predicate device -
Single-Use Electrosurgical Hemostatic Forceps.
Comparison to predicate Devices:
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Item | Ensure™ Single-Use Coagulation | ||
| Forceps | Single-Use Electrosurgical | ||
| Hemostatic Forceps (K062517) | Remark | ||
| Product Code | KGE | KGE | Same |
| Regulation No. | 876.4300 | 876.4300 | Same |
| Class | 2 | 2 | Same |
| Supplied in | |||
| Sterile | Yes | Yes | Same |
| Main Material | 17-4ph, SUS303F, SUS304, HDPE, FEP | Stainless steel, Polyethylene | Similar |
| Configuration | Jaws, Tube, Plug, Slider | Forceps, Tube, Plug, Slider | Same |
| Working length | 1650mm and 2300mm. | 1650mm, 1950mm and 2300mm | Similar |
| Jaws Type | Image: Type A, Type B, Type C | Image: Type A, Type B, Type C | Same |
| Maximum | |||
| Diameter | ≤2.7 mm | ≤2.75 mm / ≤3.1 mm | Similar |
| Energy | |||
| Used/Delivered | Monopolar Radio Frequency Current. | Monopolar Radio Frequency | |
| Current. | Same | ||
| Rated | |||
| High-Frequency | |||
| Voltage | COAG: 2300 Vp (4600 Vp-p) | COAG: 2900 Vp (5800 Vp-p) | Different |
| Biological | |||
| Performance | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Same |
| Electrical Safety | |||
| and | |||
| Electromagnetic | |||
| Compatibility | Conform to: | ||
| IEC60601-1 | |||
| IEC 60601-1-2 | |||
| IEC 60601-2-2 | |||
| IEC 60601-2-18 | Conform to: | ||
| IEC60601-1 | |||
| IEC 60601-1-2 | |||
| IEC 60601-2-2 | |||
| IEC 60601-2-18 | Same | ||
| Indications for | These instruments have been designed | These instruments have been | Same |
| Section 5 510k summary | |||
| Item | Proposed Device | Predicate Device | Remark |
| Ensure™ Single-Use Coagulation | Single-Use Electrosurgical | ||
| Forceps | Hemostatic Forceps (K062517) | ||
| Use | to be used with endoscopes to cauterize | ||
| and coagulate or to perform hemostasis | |||
| using high-frequency current within the | |||
| digestive tract. | designed to be used with | ||
| Olympus endoscopes to | |||
| cauterize and coagulate or to | |||
| perform hemostasis using | |||
| high-frequency current within the | |||
| digestive tract. Do not use this | |||
| instrument for any purpose other | |||
| than its intended use | |||
| Single Use | Yes | Yes | 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 | Two years | Three years | Different |
| Sterilization | EO Sterilized, SAL:10-6 | EO Sterilized, SAL:10-6 | Same |
| Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | Same |
6
Image /page/6/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
8. Performance Data
The proposed device the Ensure™ Single-Use Coagulation Forceps meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process", ISO 11135 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals",
The following bench tests were performed on the Ensure™ Single-Use Coagulation Forceps
-
Dimension Testing
-
Rotatable Performance Testing
-
Pushability Testing
-
Actuation Testing
-
The Removal of HF Plug Testing
7
K202438 Page 5 of 6
Image /page/7/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A registered trademark symbol is located in the upper right corner of the logo.
Section 5 510k summary
- A Electrode Contact Impedance Testing
- A Hemostatic Performance Testing
-
Tensile Strength Testing
The tests performed demonstrated that the proposed device and predicate device are substantially equivalent.
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Two-year aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test. Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for
Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16,2016.
Electromagnetic compatibility, electric safety, and thermal safety had been confirmed according to the following standards:
IEC60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: Medical electrical equipment - general requirements for the basic safety and essential performance IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
8
Image /page/8/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are blocky and appear to be constructed from multiple layers, giving them a sense of depth. A small registered trademark symbol is located in the upper right corner of the logo. The logo is simple, bold, and easily recognizable.
Section 5 510k summary
disturbances - Requirements and tests
9. Animal Study
No animal study is included in this submission.
10. Clinical Study
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Ensure™ Single-Use Coagulation Forceps has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Single-Use Electrosurgical Hemostatic Forceps (K062517).