(197 days)
No reference devices were used in this submission.
No
The document describes a purely mechanical device for endoscopic clip placement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for hemostasis, closure of GI tract lumenal perforations, and anchoring of feeding tubes, all of which are therapeutic interventions.
No
The device is used for therapeutic procedures like endoscopic clip placement, hemostasis, anchoring, and closure of perforations, not for diagnosing conditions.
No
The device description clearly outlines a physical, sterile, single-use device consisting of a metal clip and a delivery system, indicating it is a hardware medical 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 for therapeutic and procedural interventions within the gastrointestinal tract (clip placement for hemostasis, marking, closure, anchoring). This is a direct treatment or procedural action on the patient's body.
- Device Description: The description details a mechanical device (metal clip and introducer) designed for physical manipulation of tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information for diagnosis. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
This device falls under the category of a surgical or procedural device used for direct intervention in the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of GI tract lumenal perforations less than 20mm that can be treated conservatively.
Product codes
PKL
Device Description
The Single Use Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis and endoscopic marking in the gastrointestinal tract. The device is provided sterile (EO).
The large clip opening design meets various clinical treatment demands. It can be opened and closed repeatedly and can achieve repositioning. The 360 rotatable design is convenient for clinical use. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal (GI) tract, small bowel, colon.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- A Appearance;
- A Clip Releasing Force
- A Open and Close;
-
Clamping Strength;
- A Tensile Strength;
-
Separation Force;
- A Rotation property;
-
Matching with Endoscope;
-
Removability Performance;
- A Hemoclip assembly mechanical integrity;
- A EO residual;
-
Sterility;
- A Package performance (Appearance, Sealing strength, Dye penetration);
-
Biocompatibility was tested by the third GLP laboratory following ISO 10993-1:2018,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 12, 2024
Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory affairs manager No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, Zhejiang 311121 China
Re: K234124
Trade/Device Name: Single Use Hemoclips Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: December 28, 2023 Received: June 12, 2024
Dear Zearou Yang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Sivakami Venkatachalam - S
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
Submission Number (if known)
K234124
Device Name
Single Use Hemoclips
Indications for Use (Describe)
The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of Gl tract lumenal perforations less than 20mm that can be treated conservatively.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
3
Image /page/3/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a stylized font, with the "P" in green and the rest of the letters in blue. Above the "P" is a green circle connected to two blue circles by lines, resembling a molecular structure. To the right of the word is the registered trademark symbol.
Hangzhou City, 311121 Zhejiang, P. R. China.
510(k) Summary
Date prepared: 2024-07-12
| 1. Manufacturer[21 CFR 807.92 (a) (1)] | |
|---|---|
| Name | Promisemed Hangzhou Meditech Co., Ltd. |
| Address | No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China. |
| Contact Person | Zearou Yang |
| Phone | +86 571 88772985 |
| Fax | +86 571 88772985 |
| zearou.yang@promisemed.ca | |
| 2. Device [21 CFR 807.92 (a) (2)] | |
| Name | Single Use Hemoclips |
| Common Name | Single Use Hemoclips |
| Classification Name | Hemorrhoidal ligator |
| Regulation Number | 876.4400 |
| Class | Class II |
| Product Code | PKL |
| 3. Legally Marketed Predicate Device[21 CFR 807.92 (a) (3)] | |
| Predicate Name | Hemoclip |
| 510(k) Number | K211787 |
| Product Code | PKL |
| Reference Devices | No reference devices were used in this submission. |
| 4. Device Description [21 CFR 807.92 (a) (4)] | |
| The Single Use Hemoclip is a sterile, single use device that consists of metal clip that detaches from the |
introducer to maintain approximation of tissue to achieve hemostasis and endoscopic marking in the gastrointestinal tract. The device is provided sterile (EO).
4
R)
Hangzhou City, 311121 Zhejiang, P. R. China.
The large clip opening design meets various clinical treatment demands. It can be opened and closed repeatedly and can achieve repositioning. The 360 rotatable design is convenient for clinical use. lt consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
Indication for use [21 CFR 807.92 (a) (5)] 5.
The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix ieiunal feeding tubes to the wall of the small bowel. Closure of GI tract lumenal perforations less than 20mm that can be treated conservatively.
Indications for Use Comparison [21 CFR 807.92 (a) (5)] 6.
The subject device and predicate device indications for use statements are similar. See Section 7 below.
7. Comparison of Technological Characteristic [21 CFR 807.92 (g) (6)]
Compared with the predicate device, the subject device is identical in mechanism of action, materials, dimension, sterilization method and biocompatibility. The subject device has the same performance specifications except for working length. Through performance bench testing, the subject device and the predicate device demonstrated to be substantially equivalent. At a high level, the subject and predicate devices are based on the following same technological elements:
| Specification | Subject Device | Predicate Device(K211787) | Discussion of
difference |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Single Use Hemoclips | Hemoclip | |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Hangzhou AGS MedTech
Co., Ltd. | |
| Device Class | Class II | Class II | No difference |
| Product Code | PKL | PKL | No difference |
| Regulation number | 21 CFR 876.4400 | 21 CFR 876.4400 | No difference |
| Prescription/over-
the-counter use | Prescription | Prescription | No difference |
| Indications for Use | The device is used for
endoscopic clip placement
within the gastrointestinal(GI)
tract for the purpose of
endoscopic marking,
hemostasis for
mucosal/submucosal defects
less than 3cm, bleeding ulcers,
arteries less than 2mm, polyps
less than 1.5cm in diameter
and diverticula in the colon.
Anchoring to affix jejunal
feeding tubes to the wall of | The Hemoclip is indicated for
endoscopic clip placement
within the gastrointestinal
tract for the purpose of:
- Endoscopic marking;
- Hemostasis for
• Mucosal / sub-mucosal
defects , 2017 | ISO 10993-3:2014,
ISO 10993-5:2009,
ISO 10993-6:2016,
ISO 10993-10:2010,
ISO 10993-11:2017 | The biocompatibility
testing for subject
device has been
tested in accordance
with the ISO 10993-
1: 2018, and results
are qualified. |
5
6
Image /page/6/Picture/1 description: The image shows the logo for "Promisemed". The word "Promise" is in green, and the word "med" is in blue. There is a graphic above the word "Promise" that is also in green and blue. There is a registered trademark symbol to the right of the word "med".
No. 1388 Cangxing Street, Canggian Community, Yuhang District, Hanazhou City 311121 Zheiiana P R China
Promisemed Hangzhou Meditech Co., Ltd.
Nonclinical test [21 CFR 807.92 (b) (1)] 8.
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- A Appearance;
- A Clip Releasing Force
- A Open and Close;
-
Clamping Strength;
- A Tensile Strength;
-
Separation Force;
- A Rotation property;
-
Matching with Endoscope;
-
Removability Performance;
- A Hemoclip assembly mechanical integrity;
- A EO residual;
-
Sterility;
- A Package performance (Appearance, Sealing strength, Dye penetration);
-
Biocompatibility was tested by the third GLP laboratory following ISO 10993-1:2018,
9. Clinical test [21 CFR 807.92 (b) (2)]
No clinical test is included in this submission.
10. Conclusion [21 CFR 807.92 (b) (3)]
Based on the information provided within this 510(k) submission, the subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.