(225 days)
The SureClip(TM) Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: (1) endoscopic marking, (2) hemostasis for (a) mucosal / sub-mucosal defects < 3cm, (b) bleeding ulcers, (c) polyps < 1.5cm in diameter, (d) diverticula in the colon, (3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively
The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
This document is a 510(k) premarket notification for a medical device, specifically a hemostasis clip. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for a novel AI or diagnostic system.
The "acceptance criteria" discussed in this document refer to various engineering and biological safety standards for the device itself, rather than performance metrics for an analytical or diagnostic function.
Based on the provided text, here's an analysis regarding your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of "acceptance criteria" in the sense of predefined performance metrics (e.g., sensitivity, specificity, accuracy) that an AI or diagnostic device would need to meet. Instead, it refers to performance standards for the physical device.
The study indicates that the SureClip™ Repositionable Hemostasis Clip met the requirements of several ISO standards and underwent specific bench tests. The compliance with these standards and the results of the bench tests are the "reported device performance" in this context.
| Acceptance Criteria (Standards/Tests) | Reported Device Performance |
|---|---|
| ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process" | The proposed device "meets the requirements" of this standard. This implies that the device's biocompatibility has been evaluated and found acceptable according to the standard. |
| ISO 11135 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices" | The proposed device "meets the requirements" of this standard. This indicates that the ethylene oxide sterilization process for the device has been developed, validated, and controlled according to the standard, ensuring sterility. |
| ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" | The proposed device "meets the requirements" of this standard. This suggests that the levels of ethylene oxide residuals on the device after sterilization are within acceptable limits as defined by the standard. |
| Bench Tests: | Results: |
| Dimensional verification | Performed, implying that the device dimensions conform to specifications. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies that the dimensions are comparable and acceptable. |
| Mechanical Integrity of Clip Assembly | Performed, implying the clip assembly maintains its structural integrity under specified conditions. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the mechanical integrity is comparable and acceptable. |
| Clamping Strength Testing | Performed, implying the clip can exert and maintain adequate clamping force. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the clamping strength is comparable and acceptable. However, specific values are not provided. |
| Tensile Strength Testing | Performed, implying the device components can withstand specified tensile forces. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the tensile strength is comparable and acceptable. |
| Release Force Testing | Performed, implying the clip can be released with an appropriate and controlled force. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the release force is comparable and acceptable. |
| Rotation Testing | Performed, implying the device can be rotated as intended in use. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the rotational capability and performance are comparable and acceptable. |
Important Note: This document does not concern an AI or diagnostic device. The "acceptance criteria" here are related to the safety and fundamental functionality of a physical medical instrument (a hemostasis clip), not to the diagnostic or predictive performance of an algorithm.
The remaining points (2-9) are not applicable to this document as they relate to studies for AI/diagnostic devices, which involve performance metrics like sensitivity, specificity, reader studies, and ground truth establishment. This 510(k) submission focuses on demonstrating substantial equivalence of a physical device through benchmark testing and compliance with recognized standards.
Specifically:
- 2. Sample sized used for the test set and the data provenance: Not applicable. This document is about a physical device, not an algorithm being tested on data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering specifications and test methodologies, not expert consensus on diagnostic data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical device, "ground truth" would be the device meeting its engineering design specifications and safety standards.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- 9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality Director No. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China
Re: K161463
Trade/Device Name: SureClip(TM) Repositionable Hemostasis Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: November 21, 2016 Received: November 28, 2016
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.
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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161463
Device Name
SureClip(TM) Repositionable Hemostasis Clip
Indications for Use (Describe)
The SureClip(TM) Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal / sub-mucosal defects < 3cm,
(b) bleeding ulcers,
(c) polyps < 1.5cm in diameter,
(d) diverticula in the colon,
(3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively
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 C)
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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. To the right of the letters is the text "MICRO-TECH" in a sans-serif font. Below the text "MICRO-TECH" is some text in a different language.
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: K161463
1. Date of Preparation: 2017-01-05
2. 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: Becky Li
Position: Quality Director
Tel: +86-25-58646378
Fax: +86-25-58744269
Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Trade Name: SureClip™ Repositionable Hemostasis Clip Common Name: Hemostasis Clipping Device
Regulatory Information
Classification Name: Hemostatic Metal Clip for the GI Tract Classification: 2 Product Code: PKL Regulation Number: 876.4400 Review Panel: Gastroenterology/Urology
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Image /page/4/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue, three-dimensional "MT" on the left, followed by the words "MICRO-TECH" in blue on the right. Below "MICRO-TECH" are two Chinese characters.
Intended Use Statement:
This device is intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract.
4. Identification of Predicate Device
510(k) Number: K152001
Product Name: Sterile Repositionable Hemostasis Clipping Device
5. Indications for Use
The SureClip™ Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
- (1) endoscopic marking,
- (2) hemostasis for
- (a) mucosal / sub-mucosal defects < 3cm,
- (b) bleeding ulcers,
- (c) polyps < 1.5cm in diameter,
- (d) diverticula in the colon,
- (3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively
6. Device Description
The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile,
single-use endoscopic clipping device, intended to be used for endoscopic marking,
hemostasis for mucosal/submucosal defects in digestive tract.
It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
7. Comparison of Technological Characteristics
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Image /page/5/Picture/1 description: The image contains the logo for Micro-Tech. The logo consists of a stylized blue "MT" monogram on the left, followed by the words "MICRO-TECH" in blue, with a line underneath. Below "MICRO-TECH" are two Chinese characters, also in blue.
The SureClip™ Repositionable Hemostasis Clip incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Micro-Tech (Nanjing) CO., Ltd. predicate devices.
Comparison to predicate Devices:
| Item | Proposed DeviceSureClip™ Repositionable Hemostasis Clip | Comparison toPredicateDevices |
|---|---|---|
| Product Code | PKL | Same |
| Regulation No. | 876.4400 | Same |
| Class | 2 | Same |
| Supplied Sterile | Yes | Same |
| Configuration | Delivery system and clip assembly | Same |
| Open width | 8mm, 11mm and 16mm | Similar |
| Minimal workingchannel | 2.8mm | Same |
| Working Length | 1650mm, 1950mm and 2350mm | Same |
| Indications for Use | The SureClip™ Repositionable HemostasisClip is indicated for endoscopic clipplacement within the gastrointestinal tract forthe purpose of:(1) endoscopic marking,(2) hemostasis for(a) mucosal / sub-mucosal defects < 3cm,(b) bleeding ulcers,(c) polyps < 1.5cm in diameter,(d) diverticula in the colon,(3) as a supplementary method, closure of GItract luminal perforations <20mm that can betreated conservatively | Same |
| Single Use | Yes | Same |
| Packaging | Single-use EO sterilized pouch with onedevice per pouch | Same |
| Shelf Life | Three years | Same |
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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 overlapping each other. To the right of the letters is the company name, "MICRO-TECH", in a simple sans-serif font. Below the company name are two Chinese characters.
8. Performance Data
The proposed device the SureClip™ Repositionable Hemostasis Clip 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 SureClip™ Repositionable
Hemostasis Clip,
| Dimensional verification | Mechanical Integrity of Clip Assembly |
|---|---|
| Clamping Strength Testing | Tensile Strength Testing |
| Release Force Testing | Rotation Testing |
The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent.
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 SureClip™ Repositionable Hemostasis Clip has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the Sterile Repositionable Hemostasis Clipping Device (K152001).
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.