(182 days)
The Single Use Electrosurgical Knife has been designed to be used with flexible endoscopes to cut tissue using highfrequency current within the digestive tract.
The device is an endoscopic electrosurgical knife for Endoscopic Submucosal Dissection (ESD). The Single Use Electrosurgical Knife is used with flexible endoscopes to cut tissue using high-frequency current within the digestive tract.
It is recommended to use an ERBE VIO-200s electrosurgical unit to supply power to the device.
The provided text focuses on the 510(k) summary for the "Multi-Functional Electrosurgical Knife" and details why it is considered substantially equivalent to existing predicate devices. It does not describe a study that involves acceptance criteria for device performance based on AI/human reader comparison or ground truth established by experts in a diagnostic context. Instead, the performance data section outlines bench and electrical testing to ensure the device performs similarly to predicate devices and meets safety standards for an electrosurgical knife.
Therefore, many of the requested details, such as those related to AI effectiveness, human reader improvement, and expert-adjudicated ground truth, are not applicable to this submission as it doesn't describe such a study.
However, I can extract information related to the performance data and the general approach to demonstrating substantial equivalence for this medical device.
Here's a summary of the information available based on the provided text, addressing the points where information is present or clearly not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with reported numerical performance values in the format requested (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests conducted to demonstrate equivalence to predicate devices and conformance to standards. The "acceptance criteria" are implicitly that the proposed device performs "without significant difference" compared to predicate devices and meets established safety standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Cutting performance of digestive tract mucosa | Demonstrated no significant difference from predicate devices. |
| Biocompatibility | Demonstrated by passing cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and pyrogen testing. |
| Electrical performance | Demonstrated by testing and conformance to IEC 60601 series standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18). |
| Cutting performance of tissue | Demonstrated by testing; no significant difference from predicate devices. |
| Thermal damage performance of tissue | Demonstrated by testing; no significant difference from predicate devices. |
| Endoscope compatibility | Demonstrated by testing; compatible with endoscopes with a minimum working channel of Φ2.8mm and maximum length of 2300mm. |
| General durability | Demonstrated by testing. |
| Product appearance | Demonstrated by testing. |
| Operational flexibility | Demonstrated by testing. |
| Smoothness of movement | Demonstrated by testing. |
| Sterility Assurance Level (SAL) | Achieved SAL 10⁻⁶ via EO sterilization. |
| Shelf Life | 3 years. |
2. Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each bench test conducted.
- Data provenance is not explicitly mentioned in terms of country of origin, but the testing was conducted to support a submission to the U.S. FDA. The type of study is bench testing and conformance testing against standards, rather than a clinical trial or study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. The device is an electrosurgical knife, and its performance evaluation involves physical and electrical bench testing against established engineering and safety standards, and comparison to predicate devices, not interpretation of diagnostic images or data by human experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. As in point 3, the evaluation of an electrosurgical knife's performance is based on measurable physical and electrical properties, not on subjective expert consensus or adjudication of diagnostic cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable. The device is an electrosurgical knife, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers or AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation is based on established engineering and safety standards (e.g., IEC 60601 series) and the performance characteristics of legally marketed predicate devices. For biocompatibility, it's based on ISO 10993 standards. For tissue cutting and thermal damage, it's based on measurable physical effects demonstrated during bench testing.
8. The sample size for the training set:
- This question is not applicable. The device is a physical electrosurgical knife; it does not involve machine learning or a "training set" of data in the conventional sense.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
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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 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 21, 2022
Anrei Medical (Hangzhou) Co., Ltd. Huibing Yang Director, Regulatory Affairs No. 3 Ave 8. HEDA Hangzhou, Zhejiang 310018 CHINA
Re: K212999
Trade/Device Name: Multi-Functional Electrosurgical Knife Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: February 11, 2022 Received: February 17, 2022
Dear Huibing Yang:
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
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212999
Device Name Single Use Electrosurgical Knife
Indications for Use (Describe)
The Single Use Electrosurgical Knife has been designed to be used with flexible endoscopes to cut tissue using highfrequency current within the digestive tract.
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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510(k) Summary
Exhibit #8 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
1. Date of Preparation: 08/18/2021
2. Sponsor Identification
Anrei Medical (Hangzhou) Co., Ltd. No. 3, Ave 8, Hangzhou Economic Development Area, 310018 Hangzhou, P.R.China
Establishment Registration Number: 3006621103 Contact Person: Huibing Yang Contact Title: Director, Regulatory Affairs Tel: +86-571-8691333 ext. 8658 Fax: +86-571-87603502 Email: huibing.yang@anrei.com.cn
3. Identification of Proposed Device
Trade Name: Multi-Functional Electrosurgical Knife Common Name: Single Use Electrosurgical Knife (Model: EKM-417D, EKM-425D)
Regulatory Information Regulation Number: 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulation Class: II Product Code: KNS Product Code Name: Unit, Electrosurgical, Endoscopic (with or without accessories) Device Panel: Gastroenterology/Urology
Indication for Use Statement
The Single Use Electrosurgical Knife has been designed to be used with flexible endoscopes to cut tissue using high-frequency current within the digestive tract.
Device Description
The device is an endoscopic electrosurgical knife for Endoscopic Submucosal Dissection (ESD). The Single Use Electrosurgical Knife is used with flexible endoscopes to cut tissue using high-frequency current within the digestive tract.
It is recommended to use an ERBE VIO-200s electrosurgical unit to supply power to the device.
The list of compatible endoscopes is as below:
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510(k) Summary
| Model | Minimum endoscope working channel Φ(mm) | Maximum endoscope working length (mm) |
|---|---|---|
| EKM-417D | Φ2.8 | 2300 |
| EKM-425D | Φ2.8 | 2300 |
Identification of Predicate Devices 4.
Primary Predicate Device 510(k) Number: K171158 Product Name: Single Use Electrosurgical Knife Manufacturer: Olympus Medical Systems Corporation
Additional Predicate Device 1 510(k) Number: K092309 Product Name: Single Use Electrosurgical Knife Series Manufacturer: Olympus Medical Systems Corporation
Reference Device 2 510(k) Number: K083608 Product Name: ERBE Hybrid Knife Manufacturer: ERBE USA, Inc.
Technical Characteristics of the Device Compared to Predicate Device 5.
The Single Use Electrosurgical Knife and the predicate Olympus Single Use Electrosurgical Knife have identical intended use in the digestive tract. They are designed to be used with flexible endoscopes to cut tissue using high-frequency current within the digestive tract. The Single Use Electrosurgical Knife combines the two commonly used predicate Olympus DualKnife and ITKnife2 (K171158 and K092309), with two cutting heads that can move relative to each other and function independently without affecting each other. The O cutting knife diameter, maximum insertion portion diameter, minimum channel diameter and outer sheath tube material of the Single Use Electrosurgical Knife are different from that of the predicate Olympus Single Use Electrosurgical Knife (K171158 and K092309).
Additionally, the proposed device has similar intended use as additional reference Device 2 (ERBE HYBRID KNIFE, K083608) in cutting tissue using high-frequency current. Athough, there are minor differences in size/shape, bench testing of cutting performance has demonstrated that these differences do not affect the cutting performance.
| Item | ProposedDevice | PrimaryPredicateDeviceK171158 | AdditionalPredicateDevice1K092309 | ReferenceDevice2K083608 | Similarities andDifferences |
|---|---|---|---|---|---|
| Device name | Single UseElectrosurgicalKnife | Single UseElectrosurgicalKnife | Single UseElectrosurgicalKnife Series | ERBEHybridKnife | Identical |
| 510(k) Summary | |||||
| Product code | KNS | KNS | KNS | FQH and GEI | Proposed Device is identical to Primary Predicate Device 1& Additional Predicate Device2 and different to reference Device2 |
| Regulation number | 876.4300 | 876.4300 | 876.4300 | 880.5475 | Proposed Device is identical to Primary Predicate Device 1& Additional Predicate Device1 and different to Reference Device2 |
| Maximum insertion portion diameter | $≤$ 2.4mm | φ2.7mm | φ2.6mm | φ2.6mm | Similar. The Proposed Device and the predicate device are all suitable for φ2.8mm endoscope clamp channel. The difference does not affect the device compatibility with endoscope, refer to the bench testing. |
| Minimum channel diameter | φ2.8mm | φ2.8mm | φ2.8mm | φ2.8mm | Identical |
| Outer sheath tube material | HDPE | PTFE | PTFE | Unknown plastic | Similar; the proposed device and predicate consist of plastic outer sheaths. All materials meet the requirements of |
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6. Performance Data
510(k) Summary
Performance test was performed on the proposed device and predicate devices and the test result demonstrated that there was no significant difference between them. The test include following items:
A Cutting performance of digestive tract mucosa biocompatibility and
electrical performance.
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510(k) Summary
- Cutting performance of tissue >
-
Thermal damage performance of tissue
-
Endoscope compatibility
-
General durability
-
Product appearance
-
Operational flexibility
-
Smoothness of movement
Additional testing was provided to support conformance to the latest revision.
- IEC 60601-1:2005+A1:2012 Medical electric equipment Part 1: General requirements for A basic safety and essential performance
- A IEC 60601-1-2:2014 Medical electric equipment - Part 1-2: General requirements for basic safety and essential performance collateral standard: Electromagnetic Disturbances requirements and tests
-
IEC 60601-2-2:2017 Medical electric equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- A IEC 60601-2-18:2009 Medical electric equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
7. Biocompatibility
Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, EO sterilized device and in accordance with the GLP requirements: cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and pyrogen testing.
Sterilization and Shelf Life 8.
The Single Use Electrosurgical Knife is sterilized with EO to a sterility level of SAL 106. Shelf life: 3 years
9. Clinical Test Conclusion
No clinical evidence was required to support SE.
10. Substantially Equivalent (SE) Conclusion
Anrei Medical (Hangzhou) Co., Ltd has demonstrated that the proposed Single Use Electrosurgical Knife is substantially equivalent to the currently marketed Olympus predicate devices and can be safely and effectively used for its proposed indications.
§ 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).