(209 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 indicated for hemostasis, treatment of luminal perforations, and anchoring feeding tubes, all of which are considered therapeutic interventions.
No
The device description and intended use indicate that the Disposable Hemoclip is an endoscopic clip for therapeutic purposes (hemostasis, anchoring, closure) and marking, not for diagnosis.
No
The device description clearly outlines physical components like a clip made of stainless steel, a spring tube, a handle, and a delivery catheter, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the gastrointestinal tract for physical interventions like marking, hemostasis, anchoring, and closure. These are all therapeutic or procedural actions performed directly on the patient's tissue.
- Device Description: The device description details a mechanical clip and delivery system designed for physical manipulation within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnostic purposes.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used on the body for treatment and procedural support.
N/A
Intended Use / Indications for Use
The Disposable 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 shows 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.
July 31, 2023
Yangzhou Fartley Medical Instrument Technology Co., Ltd. % Ethan Liu RA Speciialist Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, Shanghai 201100 China
Re: K230004 Trade/Device Name: Disposable Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: June 29, 2023 Received: June 30, 2023
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. 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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 -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230004
Device Name Disposable Hemoclip
The Disposable 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: 06/30/2023 See PRA Statement below.
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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.
5.1 Submitter
| Submitted by: | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
|---|---|
| Address:Beizhou Road, Lidian Town, Guangling District, | |
| Yangzhou 225106 Jiangsu, China | |
| Contact | |
| Person: | Ethan Liu |
| RA Specialist | |
| Shanghai Thinkwell Consulting Co., Ltd | |
| Address: Room 211/6F, Xinling Road, Minhang Districtt, | |
| Shanghai, China. | |
| Phone: 0086-15216699240 | |
| Email: xtdeepwater@126.com | |
| Date | |
| Prepared: | June 26, 2023 |
5.2 Device
| Device Name: | Disposable Hemoclip |
|---|---|
| Classification Name: | Hemostatic Metal Clip For The Gi Tract |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal ligator |
| Product Code: | PKL |
5.3 Predicate Device
| Device Name: | Hemoclip
K172727 |
|----------------------|----------------------------------------|
| Manufacturer: | Hangzhou AGS MedTech Co., Ltd. |
| Classification Name: | Hemostatic Metal Clip For The Gi Tract |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal ligator |
| Product Code: | PKL |
5.4 Device Description
The Disposable Hemoclip consists of one pre-loaded clip and delivery system for single patient use only. Disposable Hemoclip is provided in sterile.
The clip is made of stainless steel with good superelasticity performance. The clip is
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Image /page/4/Picture/0 description: The image shows the brand logo for "ARTLEY UNIQUE 4 ENDOSCOPY". The word "ARTLEY" is in a stylized, bold, blue font, with a yellow streak extending from the top right of the "Y". Below "ARTLEY" is the phrase "UNIQUE 4 ENDOSCOPY", also in blue, but in a smaller, less bold font. The logo appears to be for a company that specializes in endoscopy equipment.
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 many 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.
The delivery system consists of a handle and delivery catheter. The delivery system will allow for the device to rotate at the distal end.
5.5 Indication for Use:
The Disposable Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for:
- Mucosal/sub-mucosal defects