(165 days)
No
The device description and performance studies focus on mechanical properties and functionality, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes.
The device is used for hemostasis (stopping bleeding), which is a therapeutic intervention. It also aids in closing luminal perforations and anchoring feeding tubes, all of which are therapeutic actions.
No
Explanation: The device is used for therapeutic purposes such as hemostasis, marking, anchoring, and closure of perforations within the gastrointestinal tract. It does not perform any diagnostic function like detecting or identifying a medical condition.
No
The device description clearly details physical components (clip made of stainless steel, delivery system, spring tube) and bench testing related to mechanical properties (separating force, clamping force, etc.), 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 Diagnostic devices are used to examine specimens 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 Disposable Hemostatic Clips are used within the gastrointestinal tract for therapeutic and procedural purposes (hemostasis, marking, anchoring, closure). They are not used to analyze samples taken from the body.
- Intended Use: The stated intended uses are all related to direct intervention and manipulation within the GI tract, not laboratory analysis of specimens.
Therefore, the Disposable Hemostatic Clips fall under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Disposable Hemostatic Clips is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
1.Endoscopic marking
2. 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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2024
Zhejiang Soudon Medical Technology Co.,Ltd % Nick Wang RA Specialist Shanghai Vanhe Consulting Co., Ltd 2F, Building No.1, 3938 Hugingping Road, Oingpu District Shanghai. 201703 China
Re: K232450
Trade/Device Name: Disposable Hemostatic Clips Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: August 11, 2023 Received: August 14, 2023
Dear Nick Wang:
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" (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).
1
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 QS 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.
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).
Sincerely,
Sivakami Venkatachalam -S
for
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
2
Indications for Use
Submission Number (if known)
Device Name
Disposable Hemostatic Clips
Indications for Use (Describe)
Disposable Hemostatic Clips is 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."
3
Image /page/3/Picture/0 description: The image is a logo for Soudon Medical. The logo is blue and features a stylized design with the words "soudon medical" written in a sans-serif font below the design. The design itself appears to be a stylized representation of a medical device or symbol, with a flame-like element at the top.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Submitter
| Submitted by: | Zhejiang Soudon Medical Technology Co.,Ltd
Address:Room 302-1, Building 4, No.1 Nangonghe Road,
Donghu Street, Linping District, Hangzhou 311100 Zhejiang,
China |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Nick Wang
RA Specialist
Shanghai Vanhe Consulting Co., Ltd
Address: 2F, Building No.1, 3938 Huqingping Road, Qingpu
District, Shanghai, China.
Phone: 0086-13585860297
Email: vanheconsulting@126.com |
| Date
Prepared: | Jan 24, 2024 |
Device
| Device Name: | Disposable Hemostatic Clips |
|---|---|
| Classification Name: | Hemorrhoidal Ligator |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal Ligator |
| Product Code: | PKL |
Predicate Device
| Device Name: | Hemoclip, K172727 |
|---|---|
| Manufacturer: | Hangzhou AGS MedTech CO., Ltd |
| Classification Name: | Hemorrhoidal Ligator |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal Ligator |
| Product Code: | PKL |
Reference device
| Device Name: | Single Use Rotatable and Repositionable Hemoclip,
K201771 |
|---------------|--------------------------------------------------------------|
| Manufacturer: | Anrei Medical (Hangzhou) Co., Ltd |
4
Image /page/4/Picture/1 description: The image is a logo for Soudon Medical. The logo is blue and features a stylized design with the words "soudon medical" written in lowercase letters below the design. The design consists of two horizontal bars with a shape above them that resembles flames.
| Classification Name: | Hemorrhoidal Ligator |
|---|---|
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal Ligator |
| Product Code: | PKL |
2. Device Description
The Disposable Hemostatic Clips consist of one pre-loaded clip and delivery system for single patient use only. It is provided in sterile.
The clip is made of stainless steel with good superelasticity performance. The clip is pre-loaded in end of the Spring tube part through its deformation and it is deployed from the delivery system during use.The clip is 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.
The device is available in four clip opening widths, which are 9mm, 11mm, 13mm and 16mm, and the device effective length is available in 1650mm, 1950mm and 2300mm.
3. Indication for Use:
The Disposable Hemostatic Clips is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for:
- Mucosal/sub-mucosal defects