(265 days)
The The Haemostasis Clips are indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
- Endoscopic marking.
- Hemostasis for:
Mucosal/sub-mucosal defects <3cm;
Bleeding ulcers;
Arteries<2mm;
Polyps<1.5cm in diameter;
Diverticula in the colon;
Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. - Anchoring to affix jejunal feeding tubes to the wall of the small bowel;
- As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.
The Haemostasis Clips are sterile devices consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip part. The delivery system consists of a handle assembly and delivery catheter assembly. The delivery system is constructed using stainless steel and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2350mm working lengths. The clip part consists of a stainless steel tightening capsule, movable pin and clip arms. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.
The provided text describes the 510(k) premarket notification for the "Haemostasis Clips" device. It outlines non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria based on clinical outcomes or a multi-reader, multi-case study in the traditional sense of AI/software device evaluation.
The device is a medical instrument (Haemostasis Clips), not a software device or AI system, so many of the requested categories for AI/software evaluation (like MRMC studies, training set details, or ground truth establishment by experts for performance metrics) are not applicable. The evaluations are focused on the physical and performance characteristics of the clips themselves.
Here's a breakdown of the information that can be extracted and which requested points are not applicable in this context:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list numerical acceptance criteria for each test. Instead, it states that the tests were performed and the results "Pass" or "meet the requirement". For biocompatibility, specific outcomes like "Non-cytotoxic" are listed.
| Test | Reported Device Performance |
|---|---|
| Appearance | Pass |
| Size | Pass |
| Open and Close | Pass |
| Rotation property | Pass |
| Separation and clamping properties | Pass |
| Clip release force testing | Pass |
| Clip hardness | Pass |
| Corrosion | Pass |
| Connection strength before clip released | Pass |
| Breaking force of the delivery part | Pass |
| Clamping force maintenance | Pass |
| Chemical properties | Pass |
| In vitro cytotoxicity | Non-cytotoxic |
| Skin sensitization | Non-sensitive |
| Intracutaneous reactivity | Non-irritation |
| Acute systemic toxicity | Non-acute systemic toxicity |
| Pyrogen | Non-pyrogenic |
| Hemolysis test | Non Hemolysis reaction |
| Sub chronic toxicity | Non-Sub chronic toxicity |
| Implantation effect | Non-Implantation effect |
| Sterility Assurance Level (SAL) | 10⁻⁶ demonstrated |
| EO residuals | Meets requirements |
| Shelf-life | 3 years (based on accelerated aging) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for each of the bench or biocompatibility tests. It also does not mention data provenance as these are non-clinical (laboratory/bench) tests on manufactured devices, not data-driven studies from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. These are non-clinical, bench and biocompatibility tests for a physical medical device. "Ground truth" in the context of expert consensus on medical images or clinical outcomes is not relevant here. The "ground truth" for these tests are objective, measurable physical and chemical properties and biological reactions determined by standardized test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept relates to human expert review and consensus, which is not part of the non-clinical bench or biocompatibility testing described.
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. The device is a physical medical instrument (Haemostasis Clip), not an AI/software device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for these tests are the inherent physical, chemical, and biological properties measured against established standards (e.g., ISO standards, "Pass" criteria for physical performance).
8. The sample size for the training set
Not applicable. This information pertains to machine learning models, which are not relevant to this device.
9. How the ground truth for the training set was established
Not applicable. This information pertains to machine learning models, which are not relevant to this device.
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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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 2, 2025
Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. % Xiaoqing Xue Registration Engineer Sinow Medical AS Høyteknologisenteret Thormøhlens Gate 55 Bergen, 5008 Norway
Re: K241005
Trade/Device Name: Haemostasis Clips Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: December 4, 2024 Received: December 4, 2024
Dear Xiaoqing Xue:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Shanil P. Haugen -S
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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Indications for Use
Submission Number (if known)
K241005
Device Name
Haemostasis Clips
Indications for Use (Describe)
| The The Haemostasis Clips are indicated for endoscopic clip placement within the gastrointestinal |
|---|
| tract for the purpose of: |
| 1. Endoscopic marking. |
| 2. Hemostasis for: |
| Mucosal/sub-mucosal defects <3cm; |
| Bleeding ulcers; |
| Arteries<2mm; |
| Polyps<1.5cm in diameter; |
| Diverticula in the colon; |
| Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. |
| 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; |
| 4. As a supplementary method, closure for 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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510(K) Summary
1. Submitter
Submitter: Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. Address: 14th Industrial Building, Xiajiang Industrial Zone, Xiajiang, Ji'an, Jiangxi, China Telephone: +86 18170652161 Email: 602000274@gq.com Contact Person: Qin Xu Date Prepared: Apirl 12, 2024
2. Designated Submission Correspondent
Company: Sinow Medical AS Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway Contact Person: Xiaoqing Xue Telephone: +86 15161196032 Email: xue@bergemed.com
3. Subject Device
Trade name/common name: Haemostasis Clips Regulatory Class: II Regulation Number: 876.4400 Product Codes: PKL Classification Name: Hemorrhoidal ligator
4. Primary Predicate Device
Manufacturer: Hangzhou AGS MedTech CO., Ltd Trade name: Hemoclip 510(K) Number: K172727 Regulation Number: 21 CFR 876.4400 Product Codes: PKL Classification Panel: Gastroenterology/Urology Classification Name: Hemorrhoidal Ligator
5. Device Description
The Haemostasis Clips are sterile devices consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip part. The delivery system consists of a handle assembly and delivery catheter assembly. The delivery system is constructed using stainless steel and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2350mm working lengths.
The clip part consists of a stainless steel tightening capsule, movable pin and clip arms. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.
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Page 2 of 5 K241005
6. Intended Use/Indications for Use
The Haemostasis Clips are indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for
- Mucosal/sub-mucosal defects <3cm .
- Bleeding ulcers •
- Arteries<2mm •
- Polyps<1.5cm in diameter •
- . Diverticula in the colon
- Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection .
-
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.
7. Comparison of Technological Characteristics
| Attribute | Haemostasis Clips(Subject Device) | Hemoclip (Predicatedevice K172727) | Comment |
|---|---|---|---|
| RegulationNumber | 21 CFR 876.4400 | 21 CFR 876.4400 | Same |
| Regulation Name | Hemorrhoidal Ligator | Hemorrhoidal Ligator | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | PKL | PKL | Same |
| Indications forUse | The Haemostasis Clipsare indicated forendoscopic clip placementwithin the gastrointestinaltract for the purpose of:Endoscopic markingHemostasis for-Mucosal/sub-mucosaldefects <3cm-Bleeding ulcers-Arteries<2mm-Polyps<1.5cm in diameter-Diverticula in the colon-Prophylactic clipping toreduce the risk of delayedbleeding post lesionresection3.Anchoring to affix jejunalfeeding tubes to the wall ofthe small bowel4.As a supplementarymethod, closure for GI tractluminalperforations<20mm thatcan be treatedconservatively. | The disposable hemoclip isindicated for endoscopicclip placement within thegastrointestinal tract for thepurpose of:1.Endoscopic marking2.Hemostasis for-Mucosal/sub-mucosaldefects <3cm-Bleeding ulcers-Arteries<2mm-Polyps<1.5cm in diameter-Diverticula in the colon-Prophylactic clipping toreduce the risk of delayedbleeding post lesionresection3.Anchoring to affix jejunalfeeding tubes to the wall ofthe small bowel4.As a supplementarymethod, closure for GI tractluminal perforations<20mmthat can be treatedconservatively. | Same |
| Principle ofOperation | Endoscopic accessory usedto deliver metal clips to theGI tract. | Endoscopic accessory usedto deliver metal clips to theGI tract. | Same |
| RepositionableClip? | Yes | Yes and No (depending onmodel) | Same |
| MinimumEndoscopicWorking Channel | 2.8mm | 2.8mm | Same |
| Working length | 1650mm, 1950mm and2350mm | 1650mm, 1950mm and2350mm | Same |
| Outer tubediameter | 2.6mm | 2.6mm | Same |
| Clip openingwidth | 10mm, 12mm and 15mm | 9mm, 11mm, 13mm | Different1 |
| Single use only | Yes | Yes | Same |
| Sterilization | EO | EO | Same |
| Clip material | Stainless Steel (SUS 631and SUS303 ) | Stainless Steel (SUS 631) | Similar |
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Discussion of difference 1: The subject largest device clip opening width is not in the predicate device clip opening width dimension range. Although differences exist between clip opening width, the subject device have the same design, materials and intended performance between different specifications, only increased width. Furthermore, the largest clip opening width model is selected as representative sample to conduct bench performance testing and the test result showed to meet the requirement. Therefore, we considered that this difference does not raise new questions of safety or effectiveness.
8. Non-Clinical Testing
8.1. Performance Testing-Bench
Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. has performed the following non-clinical laboratory testing to determine substantial equivalence.
| Test | Result |
|---|---|
| Appearance | Pass |
| Size | Pass |
| Open and Close | Pass |
| Rotation property | Pass |
| Separation and clamping properties | Pass |
| Clip release force testing | Pass |
| Clip hardness | Pass |
| Corrosion | Pass |
| Connection strength before clip released | Pass |
| Breaking force of the delivery part | Pass |
| Clamping force maintenance | Pass |
| Chemical properties | Pass |
The above bench tests were performed on Haemostasis Clips: Appearance, Size, Chemical properties, Physical properties including Open and Close, Rotation property, Separation and clamping properties, Clip release force testing, Clip hardness, Corrosion resistance, Connection strength before clip released, Breaking force of the delivery part and Clamping force maintenance. The results of all testing meet the requirement.
8.2. Biocompatibility testing
The contact classification for the Haemostasis Clips of the subject device is a surface contact device that directly contact with the mucosal membrane (with the duration time 24h~30d). The
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biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and in accordance with FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff. The results of biocompatibility testing included in the table below demonstrate that the device meets biological safety requirements per ISO 10993-1 for mucosal membrane contact device.
| Test | Standard | Result |
|---|---|---|
| In vitro cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Skin sensitization | ISO 10993-10 | Non-sensitive |
| Intracutaneous reactivity | ISO 10993-10 | Non- irritation |
| Acute systemic toxicity | ISO 10993-11 | Non-acute systemic toxicity |
| Pyrogen | ISO 10993-11 | Non-pyrogenic |
| Hemolysis test | ISO 10993-4 | Non Hemolysis reaction |
| Sub chronic toxicity | ISO 10993-11 | Non-Sub chronic toxicity |
| Implantation effect | ISO 10993-6 | Non-Implantation effect |
8.3. Sterilization and shelf-life testing
The subject device is sterilized using Ethylene Oxide. The sterilization has been performed in accordance with the principles of ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. A sterility assurance level (SAL) of 10th has been demonstrated. The device meets EO residuals per ISO 10993-7.
A shelf-life of 3 years has been established based on accelerated aging testing.
9. Conclusion
The subject and predicate device share the same indications and technological characteristics. The subject device has the identical intended use as the predicate device. The subject device and predicate devices are substantially equivalent with only minor differences do not raise new questions of safety or effectiveness. The nonclinical performance data submitted in the documents demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device. Based on the information provided in this premarket notification, Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. has demonstrated that the proposed device Haemostasis Clips are substantially equivalent to Hangzhou AGS MedTech CO., Ltd's currently marketed Hemoclip, K172727.
§ 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.