(267 days)
Not Found
No
The device description and performance studies focus on mechanical properties and functionality, with no mention of AI or ML.
Yes
The device is used for hemostasis, which is a therapeutic intervention to stop bleeding, and for anchoring feeding tubes and closing perforations, which are also therapeutic acts.
No
The device is primarily used for therapeutic and procedural purposes within the gastrointestinal tract, such as hemostasis, marking, anchoring, and closure, rather than for diagnosing conditions.
No
The device description clearly outlines physical components (Release part, Clip part, Clip, Frap Tube, Spring End, Plastic Coated Spring Tube / Spring Tube, Handle) and mentions sterilization and single-use, indicating it is a physical medical device, not software-only.
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 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 Hemoclip is a mechanical device used within the gastrointestinal tract during endoscopic procedures. It physically interacts with tissue for purposes like marking, hemostasis, anchoring, and closure.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the body. Its function is entirely procedural and mechanical.
Therefore, the Hemoclip falls under the category of a surgical or procedural device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Hemoclip is 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
March 3, 2022
Hangzhou AGS MedTech Co., Ltd. Yanping Fu, RA Supervisor Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 CHINA
Re: K211787 Trade/Device Name: Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: January 26, 2022 Received: February 2, 2022
Dear Yanping Fu:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
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
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K211787
Device Name
Hemoclip
Indications for Use (Describe)
The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
-
- Endoscopic marking,
-
- 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."
FORM FDA 3881 (6/20)
Page 1 of 1
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Image /page/3/Picture/0 description: The image contains a logo with a blue and green circular design on the left, and the text "AGS MEDTECH" in English and Chinese on the right. The circular design consists of three blue curved shapes that converge towards the center, with a green triangle in the middle. The text "AGS MEDTECH" is written in a simple, sans-serif font, and the Chinese characters below it are in a traditional style.
510(k) Summary
We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.
5.1 Submitter
| Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, NO.597 Kangxin Road Yuhang
District, Hangzhou, Zhejiang 311106 China |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping Fu
Phone: 0086-15958493282
Fax: 0086-0571-87671225
Email: fuyp@bioags.com |
| Date Prepared: | Jun,1,2021 |
5.2 Proposed Device
| Trade Name: | / |
|---|---|
| Device Name: | Hemoclip |
| Common Name: | Endoscope Clipping Device |
| Regulation class: | Class II |
| Regulation Number: | 876.4400 |
| Regulation Description: | Hemorrhoidal ligator. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | PKL |
| Product Code Name: | Hemostatic Metal Clip For The Gi Tract |
5.3 Predicate Device
| Trade Name: | / |
|---|---|
| Device Name: | Hemoclip |
| Common Name: | Endoscope Clipping Device |
| 510(k) Number: | K172727 |
| Regulation class: | Class II |
| Regulation Number: | 876.4400 |
| Regulation Description: | Hemorrhoidal ligator. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | PKL |
| Product Code Name: | Hemostatic Metal Clip For The Gi Tract |
5.4 Device Description
Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube . Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube
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Image /page/4/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a blue circular design with a green triangle in the center. To the right of the circular design is the text "AGS MEDTECH" in English, followed by the same name in Chinese characters.
K211787 Page 2 of 5
and Handle. EO Sterilization and use for single use only.
For 510 family, the grooves on the frap tube allow the released clip could be removed by snare loops. If the clip has been deployed, but its position is not satisfactory, or it affects the field of vision, we can remove it.
5.5 Indication for use statement
The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
-
- Endoscopic marking,
-
- Hemostasis for:
- Mucosal/sub-mucosal defects