(143 days)
The Sterile Repositionable Hemostasis Clipping Device 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 Gl tract luminal perforations <20mm that can be treated conservatively.
The proposed device Sterile Repositionable Hemostasis Clipping Device 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.
The provided text describes a 510(k) premarket notification for a medical device, the "Sterile Repositionable Hemostasis Clipping Device". This document is submitted to the FDA to demonstrate substantial equivalence to a predicate device, not typically to prove a device meets specific clinical performance acceptance criteria through a study with ground truth. Therefore, many of the requested categories for AI/algorithm performance studies are not directly applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct performance table in the typical sense of algorithm-based device performance (e.g., sensitivity, specificity). Instead, it lists bench tests performed to demonstrate equivalence to a predicate device. The general acceptance criterion is that the device "meets the requirements" of relevant ISO standards and that "the testing performed demonstrated that the proposed and predicate delivery systems are equivalent."
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Biological Evaluation | ISO 10993-1 (Evaluation and Testing) | Meets requirements |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Meets requirements | |
| Sterilization | ISO 11135-1 (Ethylene Oxide Sterilization) | Meets requirements |
| Bench Tests - Mechanical Integrity | Dimensional verification | Demonstrated equivalence to predicate delivery systems |
| Mechanical Integrity of Clip Assembly | Demonstrated equivalence to predicate delivery systems | |
| Clamping Strength Testing | Demonstrated equivalence to predicate delivery systems | |
| Tensile Strength Testing | Demonstrated equivalence to predicate delivery systems | |
| Release Force Testing | Demonstrated equivalence to predicate delivery systems | |
| Rotation Testing | Demonstrated equivalence to predicate delivery systems |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device for physical intervention, not an AI/algorithm-based diagnostic or prognostic device that uses a test set of data. The "tests" mentioned are bench tests on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device does not rely on expert-established ground truth for its performance evaluation in the context of this 510(k) submission.
4. Adjudication method 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
No. The document explicitly states: "No clinical study is included in this submission." This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical hemostasis clipping device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of AI/algorithm performance. For the bench tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device and the relevant ISO standards.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device.
9. How the ground truth for the training set was established
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
Micro-Tech (Nanjing) CO., Ltd. Becky Li Manager of Quality Department No. 10 Gaoke Third Road Nanjing, 210032 China
Re: K152001
Trade/Device Name: Sterile Repositionable Hemostasis Clipping Device Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated: November 10, 2015 Received: November 12, 2015
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 vours.
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Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152001
Device Name
Sterile Repositionable Hemostasis Clipping Device
Indications for Use (Describe)
The Sterile Repositionable Hemostasis Clipping Device 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 Gl tract luminal perforations <20mm that can be treated conservatively.
| 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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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: K152001
1. Date of Preparation: 12/08/2015
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: Manager of Quality Department
Tel: +86-25-58646378
Fax: +86-25-58744269
Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Trade Name: Sterile Repositionable Hemostasis Clipping Device
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
Intended Use Statement:
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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: K122660
Product Name: Resolution™ Hemomstasis Clipping Device
5. Indications for Use
The Sterile Repositionable Hemostasis Clipping Device 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 Sterile Repositionable Hemostasis Clipping Device 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
The Sterile Repositionable Hemostasis Clipping Device incorporates
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substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and
intended use as those featured in the Boston Scientific predicate devices.
Comparison to predicate Devices:
| Item | Proposed DeviceSterile Repositionable HemostasisClipping Device | Comparison toPredicateDevices |
|---|---|---|
| Product Code | PKL | Similar |
| Regulation No. | 876.4400 | Same |
| Class | 2 | Same |
| Supplied Sterile | Yes | Same |
| Configuration | Delivery system and clip assembly | Same |
| Open width | 11mm | Same |
| Minimal workingchannel | 2.8mm | Same |
| Working Length | 1650mm, 1950mm, 2350mm, 2700mm | Similar |
| Indications for Use | The Sterile Repositionable Hemostasis ClippingDevice 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 | Similar |
| Single Use | Yes | Same |
| Packaging | Single-use EO sterilized pouch with one deviceper pouch | Similar |
| Shelf Life | Three years | Same |
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8. Performance Data
The proposed device the Sterile Repositionable Hemostasis Clipping Device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing", ISO 11135-1 "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 Sterile Repositionable
Hemostasis Clipping Device:
| 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 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 Sterile Repositionable Hemostasis Clipping Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the Resolution™ Hemostasis Clipping Device (K122660) .
§ 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.