(265 days)
Not Found
No
The summary describes a mechanical endoscopic clipping device and its physical properties and performance testing. There is no mention of software, algorithms, image processing, or any other indicators of AI/ML technology.
Yes
The device is used for therapeutic purposes such as hemostasis for bleeding, prophylactic clipping, and closure of GI tract luminal perforations, which are direct treatments or interventions for medical conditions.
No.
The device is used for therapeutic purposes like hemostasis, closing perforations, and anchoring, not for diagnosing conditions.
No
The device description clearly outlines physical components made of stainless steel and polyester, including a delivery system and a clip part, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Haemostasis Clips are physical devices used within the gastrointestinal tract for mechanical purposes: marking, hemostasis (stopping bleeding), anchoring, and closing perforations. They do not analyze samples or provide diagnostic information based on biological markers.
- Intended Use: The intended use clearly describes procedures performed directly on the patient's tissue, not on samples outside the body.
- Device Description: The description details the physical components and how they are used to manipulate tissue, not to perform laboratory tests.
Therefore, the Haemostasis Clips fall under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
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
§ 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.
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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 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."
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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