(288 days)
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML or data processing.
Yes
The device is used for hemostasis, anchoring, and closure within the digestive tract, which are therapeutic interventions aimed at treating medical conditions or supporting bodily functions.
No
The Hemoclip is indicated for therapeutic purposes such as hemostasis, marking, anchoring, and closure of perforations within the digestive tract, not for diagnosing conditions.
No
The device description clearly outlines physical components like "Release part," "Clip part," "Spring End," "Handle part," 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.
- Hemoclip's Intended Use: The Hemoclip is used within the digestive tract for mechanical purposes: marking, hemostasis (stopping bleeding), anchoring, and closing perforations. It does not analyze biological specimens outside the body.
- Device Description: The description focuses on the mechanical components and how the clip is applied and released. There is no mention of reagents, assays, or any components used for analyzing biological samples.
The Hemoclip is a therapeutic and procedural device used directly on tissue within the body, not an IVD.
N/A
Intended Use / Indications for Use
The Hemoclip is indicated for endoscopic clip placement within the digestive 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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
July 12, 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: K213143
Trade/Device Name: Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: May 27, 2022 Received: June 6, 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
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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 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 (OS) 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,
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
510(k) Number (if known) K213143
Device Name Hemoclip
Indications for Use (Describe)
The Hemoclip is indicated for endoscopic clip placement within the digestive 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."
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Image /page/3/Picture/1 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The Chinese characters are likely the translation of the company name.
510(k) Summary Hemoclip
510(k) Summary (K213143)
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, 311106 Hangzhou, Zhejiang, 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: | July. 21, 2021 |
5.2 Proposed Device
| Trade Name: | Hemoclip |
|---|---|
| Device Name: | Hemoclip |
| Common Name: | Hemoclip |
| 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 and Reference Device
5.3.1Predicate Device
| Trade Name: | Hemoclip |
|---|---|
| Device Name: | Hemoclip |
| Common Name: | Hemoclip |
| 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 |
| 5.3.2 Reference Device | |
| Trade Name: | Single Use Reloadable Clip Applicator, |
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Image /page/4/Picture/1 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes intertwined, forming a triangular space in the center filled with green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it.
510(k) Summary Hemoclip
| Clip, Long Clip, Short Clip, Super Short Clip | |
|---|---|
| Device Name: | Single Use Reloadable Clip Applicator, |
| Clip, Long Clip, Short Clip, Super Short Clip | |
| Common Name: | Endoscopic Clipping Device |
| 510(k) Number: | K183590 |
| 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 |
| Trade Name: | Lockado™ Repositionable Hemostasis Clip |
|---|---|
| Device Name: | Lockado™ Repositionable Hemostasis Clip |
| Common Name: | Endoscopic Clipping Device |
| 510(k) Number: | K202333 |
| 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, Spring hose near clip end, Connect end, Plastic Coated Spring Tube / Spring Tube and Handle part. EO Sterilization and use for single use only. For our proposed Hemoclip, the release part could connect and release the clips repeatedly.
We include 5 series for this submission, 55501series, 55502 series, 55504 series and 55505 series. 55501 series and 55502 series are models consist of release part and clip part, and the release part and clip part are already combined, no additional separate clips include, 55501series and 55502 series are reloadable, the release part could connect and release clips repeatedly. 55503 series are models only consist of separate clip part, and the release part of 55501, 55502, 55503 and 55504 series can connect with the separate clip (55503 series) repeatedly. 55504 and 55505 series are models consist of one preloaded Hemoclip (consist of release part and clip part, and the release part and clip part are already combined) and additional separate clips, 55504 series and 55505 series are reloadable, the release part can connect separate clips and release clips repeatedly.
5.5 Indication for use statement
The Hemoclip is indicated for endoscopic clip placement within the digestive tract for the purpose of:
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Image /page/5/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a blue and green circular design on the left, with the text "AGS MEDTECH" and "安杰思医学" to the right of the design. The circular design appears to be made up of three curved shapes, with the blue shapes on the outside and the green shape in the center.
510(k) Summary Hemoclip
-
- Endoscopic marking,
-
- Hemostasis for:
- Mucosal/sub-mucosal defects