(277 days)
Not Found
No
The summary describes a mechanical clipping device and its intended uses, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is used for endoscopic clip placement for purposes such as hemostasis (stopping bleeding) in the gastrointestinal tract, which directly treats a medical condition.
No
The device is indicated for endoscopic clip placement for purposes such as endoscopic marking, hemostasis, and closure of GI tract luminal perforations, all of which are therapeutic or interventional actions, not diagnostic.
No
The device description explicitly states it consists of a delivery system and clip assembly, which are physical hardware components. The performance studies also focus on bench tests of mechanical properties.
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 actions like marking, hemostasis, and closure of perforations. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a physical clipping device and delivery system, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the body to diagnose, monitor, or screen for diseases or conditions. This device operates directly on the body for therapeutic and procedural purposes.
N/A
Intended Use / Indications for Use
The Single Use Hemoclip Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) 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.
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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 27, 2022
Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long, RA Manager 301B, No.22, XinYan Road Yuhang District, Hangzhou, Zhejiang 311100 CHINA
Re: K212669
Trade/Device Name: Single Use Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: April 21, 2022 Received: April 28, 2022
Dear Lucius Long:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
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
510(k) Number (if known) K212669
Device Name Single Use Hemoclip
Indications for Use (Describe)
The Single Use Hemoclip Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
(1) endoscopic marking,
- (2) hemostasis for
(a) 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/0 description: The image shows the logo for Zhejiang Chuangxiang Medical Technology Co., LTD. The logo includes a stylized hexagon shape with green and blue gradients. To the right of the shape is the company name in both Chinese characters and the English word "MEDNOVA".
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Section 5 510(k) Summary( 21CFR 807.92)
1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
Address: Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District, Hangzhou City, Zhejiang Province,311100,P.R. China
Contact person: Lucius.Long Telephone: 86-571-89167088-8680 Fax: 86-571-89167086
- Date of Submission
09-Aug- 2021
3. Device
Name of the device: Single Use Hemoclip Classification name: Hemorrhoidal ligator Regulation class: 2 Regulation number:876.4400 Panel: Gastroenterology/Urology Product code: PKL
4. Predicate device
510(k) Number: K172762, Product Name: Single Use Hemoclip
510(k) Number: K202333 Product Name: Lockado™ Repositionable Hemostasis Clip 5. Device description
The proposed device Single Use Hemoclip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
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Image /page/4/Picture/0 description: The image contains the logo for MEDNOVA. The logo consists of a hexagon shape on the left, with a gradient from blue to green. To the right of the hexagon is the text "MEDNOVA" in a combination of blue and green colors. Above the text "MEDNOVA" are four Chinese characters in blue.
dical Technology Co.,LTD. K212669 Zheiia
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6.Indication for use
The Single Use Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
- (1) endoscopic marking,
- (2) hemostasis for
- (a) mucosal / sub-mucosal defects