(209 days)
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 < 3cm
• Bleeding ulcers
• Arteries<2mm
• Polyps<1.5cm in diameter
• Diverticula in the colon - Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- As a supplementary method, closure for GI tract luminal perforations <20mm that can be treated conservatively.
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 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.
The provided text describes a 510(k) premarket notification for a medical device, the Disposable Hemoclip. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a detailed clinical study demonstrating improved patient outcomes or diagnostic accuracy.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria for software or AI-driven diagnostic devices.
Specifically, the document states:
- "No Clinical Study is included in this submission." This means there is no study that evaluates the device's performance in a clinical setting against specific metrics like sensitivity, specificity, or reader improvement with AI assistance.
- The "acceptance criteria" listed for the device relate to non-clinical performance data (e.g., appearance, size, hardness, open/close performance, rotation performance, releasing force, clipping force, peeling force, connection firmness, dimensional verification, and MR safety testing), and compliance with ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7). These are engineering and material specifications, not performance metrics for diagnostic accuracy or clinical effectiveness in the way an AI/software device would have acceptance criteria.
- The device being discussed is a physical medical instrument (a disposable hemoclip), not a software or AI device. Hence, there are no concepts like "ground truth for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," or "training/test set sample sizes" in the context of an AI/diagnostic algorithm.
In summary, this document is not relevant for describing the acceptance criteria and study proving a device meets those criteria for an AI/software-driven diagnostic device. It details a substantial equivalence claim for a physical medical instrument.
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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 < 3cm
- . Bleeding ulcers
- Arteries<2mm
- Polyps<1.5cm in diameter
- Diverticula in the colon
-
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- As a supplementary method, closure for GI tract luminal perforations <20mm that can be treated conservatively.
Type of Use (Select one or both, as applicable)
| X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 | |
| ContactPerson: | Ethan LiuRA Specialist |
| Shanghai Thinkwell Consulting Co., Ltd | |
| Address: Room 211/6F, Xinling Road, Minhang Districtt,Shanghai, China. | |
| Phone: 0086-15216699240 | |
| Email: xtdeepwater@126.com | |
| DatePrepared: | 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: | HemoclipK172727 |
|---|---|
| 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 <3cm ●
- Bleeding ulcers
- Arteries<2mm
- Polyps<1.5cm in diameter
- Diverticula in the colon ●
-
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel
-
- As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.
5.6 Comparison of Technological Characteristics
The Disposable Hemoclip has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Hangzhou AGS MedTech Co., Ltd.'s Hemoclip, K172727. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | DisposableHemoclip(Proposed Device) | HemoclipK172727 | Discussion |
|---|---|---|---|
| Indicationfor Use | The Disposable Hemoclip isindicated for endoscopic clipplacement within thegastrointestinal tract for thepurpose of:1. Endoscopic marking2. Hemostasis for: | The hemoclip is indicatedfor endoscopic clipplacement within thegastrointestinal tract for thepurpose of:1. Endoscopic marking2. Hemostasis for: | Same |
| • Mucosal/sub-mucosal defects <3cm• Bleeding ulcers• Arteries<2mm• Polyps < 1.5cm in | • Mucosal/sub-mucosal defects <3cm• Bleeding ulcers• Arteries<2mm• Polyps < 1.5cm in | ||
| Item | DisposableHemoclip(Proposed Device) | HemoclipK172727 | Discussion |
| diameter● Diverticula in the colon3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel4. As a supplementary method, closure for GI tract luminal perforations <20mm that can be treated conservatively. | diameter● Diverticula in the colon3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel4. As a supplementary method, closure for GI tract luminal perforations <20mm that can be treated conservatively. | ||
| Principle ofOperation | Endoscopic accessory used to deliver metal clips to the GI tract. | Endoscopic accessory used to deliver metal clips to the GI tract. | Same |
| MinimumEndoscopicWorkingChannel | 2.8mm | 2.8mm | Same |
| WorkingLength | 1600mm, 1800mm, 2300mm, 2700mm | 1650mm, 1950mm, 2350mm | Similar |
| ClipOpeningWidth | 9mm,12mm, 16mm | 9mm,11mm, 13mm | Similar |
| Outer TubeDiameter | 2.5mm | 2.6mm | Similar |
| SAL | 10-6 | 10-6 | Same |
| Sterilization Method | EO Sterilization | EO Sterilization | Same |
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5.7 Non-clinical Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" .
The following bench tests were performed on Disposable Hemoclip: Appearance, Size,
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Image /page/6/Picture/0 description: The image shows the logo for "ARTLEY UNIQUE ENDOSCOPY". The word "ARTLEY" is in large, bold, blue font, with a yellow accent on the "Y". Below "ARTLEY" is the phrase "UNIQUE ENDOSCOPY", in a smaller, blue font. The logo appears to be for a medical device company specializing in endoscopes.
Hardness, Surface Roughness, Open and close performance, Rotation performance, Releasing force, Clipping force, Peeling force, Connection firmness, Dimensional Verification and MR Safety Testing. The results of all testing were passing.
5.8 Clinical Test Data
No Clinical Study is included in this submission.
5.9 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Disposable Hemoclip is substantially equivalent to predicate device Hangzhou AGS MedTech Co., Ltd.'s currently marketed Hemoclip K172727 in terms of safety and effectiveness.
§ 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.