(217 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. It also aids in closing perforations and anchoring feeding tubes, all of which are direct treatments or supporting functions for treatment within the gastrointestinal tract.
No
The device is a therapeutic device used for endoscopic clip placement and closure within the gastrointestinal tract, not for diagnosing conditions.
No
The device description clearly outlines physical components made of stainless steel, polyester, and Cobalt Chrome, indicating it is a hardware 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The Hemoclip is a device used inside the body (in vivo) during endoscopic procedures. Its purpose is to physically interact with tissues within the gastrointestinal tract for various therapeutic and marking purposes.
- Intended Use: The intended uses listed (endoscopic marking, hemostasis, anchoring feeding tubes, closing perforations) are all direct interventions on the patient's anatomy, not diagnostic tests performed on samples.
- Device Description: The description details a mechanical device with a delivery system and a clip, designed for physical manipulation within the body. There is no mention of reagents, assays, or analysis of biological samples.
Therefore, the Hemoclip falls under the category of a surgical or therapeutic 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 16, 2018
Hangzhou AGS MedTech CO., Ltd % Ethan Liu RA Specialist Shanghai Thinkwell Consulting Co., Ltd. Xinling Rd., 211/6F Shanghai, 201100 China
Re: K172727 Trade/Device Name: Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: March 5, 2018 Received: March 8, 2018
Dear Ethan Liu:
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. 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.
1
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/0 description: The image contains a logo with a circular design on the left and text on the right. The circular design features three curved shapes in blue and green, arranged in a triangular pattern. To the right of the logo, the text "AGS MEDTECH" is written in a sans-serif font, with smaller text below it in Chinese characters. The text and logo are aligned horizontally, creating a balanced composition.
K172727 Page 1 of 4
510(k)Summarv
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | Hangzhou AGS MedTech CO., Ltd.
Building 6, Kangxin Road No.597, Qianjiang Economic
Development Area, Hangzhou, Zhejiang, 311106, China |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | Active; Awaiting Assignment Of Registration Number |
| Owner/Operator Number: | 10052959 |
| Contact Person: | Ethan Liu
Phone:0086-15216699240
Fax: 0086-21-60732022
Email:xtdeepwater@126.com |
| Date Prepared: | Jan 18, 2017 |
5.2 Proposed Device
| Trade Name: | Hemoclip |
|---|---|
| Common Name: | Endoscope Clipping Device |
| Classification: | Class II |
| Regulation Number | 876.4400 |
| Classification Name: | Hemorrhoidal ligator |
| Product Code Description: | Hemostatic Metal Clip For The Gi Tract |
| Product Code: | PKL |
5.3 Predicate Device
K122660 - Resolution™ Hemostasis Clipping Device(Primary) K161463- SureClip(TM) Repositionable Hemostasis Clip(Secondary)
5.4 Device Description
The Hemoclip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and delivery catheter. 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 2300mm working lengths.
The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. 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
4
Section 5 510(k) Summary Hemoclip
included with this device.
5.5 Indication for Use:
The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
- Endoscopic marking 1.
- Hemostasis for 2.
- Mucosal/sub-mucosal defects