(112 days)
Not Found
No
The summary describes a mechanical endoscopic clipping device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for hemostasis for various conditions and closure of GI tract luminal perforations, which are therapeutic interventions.
No
The device is described as an endoscopic clipping device used for therapeutic purposes like hemostasis and closure of perforations within the GI tract, and also for endoscopic marking. It does not perform any diagnostic function.
No
The device description clearly states it is a sterile, single-use endoscopic clipping device consisting of a delivery system and a clip, which are physical hardware components.
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 examine specimens taken from the body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an endoscopic clipping device used within the Gastrointestinal (GI) tract for purposes like marking, hemostasis, and closure of perforations. It is a tool used directly on the patient's internal tissues.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the patient.
Therefore, this device falls under the category of a surgical or therapeutic device used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) Hemostasis for: Mucosal/sub-mucosal defects Pyrogen Test.
Dimension test was performed on the proposed device and the test result demonstrated that the device can meet its design specification requirement.
Performance test was performed on both the proposed device and predicate device and the test result demonstrated that there was no significant difference between them, the test include following items: Mechanical Integrity of Clip Assembly, Clamping Strength Testing, Tensile Strength Testing, Release Force Testing, Rotation Testing, Repositionability.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
October 19, 2020
Anrei Medical (Hangzhou) Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K201771
Trade/Device Name: Single Use Rotatable and Repositionable Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: September 16, 2020 Received: September 17, 2020
Dear Diana Hong:
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
1
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-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 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,
For
Shani 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) K201771
Device Name
Single Use Rotatable and Repositionable Hemoclip
Indications for Use (Describe) Single Use Rotatable and Repositionable Hemocip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) 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: 06/30/2020 See PRA Statement below.
3
Exhibit #8 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K201771
-
- Date of Preparation: 09/07/2020
-
- Sponsor Identification
Anrei Medical (Hangzhou) Co., Ltd
No.3 Ave. 8, Hangzhou Economic Development Area, Hangzhou, People's Republic of China
Establishment Registration Number: 3006621103
Contact Person: Huibing Yang Position: RA Director Tel: +86-571-86913333 Fax: +86-571-87603502 Email: huibing.yang@aanrui.com.cn
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
Identification of Proposed Device 4.
510(k) Summary
Trade Name: Single Use Rotatable and Repositionable Hemoclip Common Name: Hemorrhoidal ligator
Regulatory Information
Classification Name: Hemorrhoidal ligator Classification: II; Product Code: PKL; Regulation Number: 21CFR 876.4400 Review Panel: Gastroenterology/Urology;
Indication for Use Statement:
Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:
-
- Endoscopic marking,
-
- Hemostasis for: Mucosal/sub-mucosal defects
-
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
-
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
-
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
-
USP 42 NF 37 Pyrogen Test
Dimension test was performed on the proposed device and the test result demonstrated that the device can meet its design specification requirement.
Performance test was performed on both the proposed device and predicate device and the test result demonstrated that there was no significant difference between them, the test include following items
Mechanical Integrity of Clip Assembly Clamping Strength Testing Tensile Strength Testing Release Force Testing Rotation Testing Repositionability
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
6
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device 1 K161463 | Predicate Device 2 K152001 |
|---|---|---|---|
| Product Code | PKL | PKL | PKL |
| Regulation Number | 21CFR 876.4400 | 21CFR 876.4400 | 21CFR 876.4400 |
| Indication for Use | Single Use Rotatable and | ||
| Repositionable Hemoclip is indicated | |||
| for clip placement within the | |||
| Gastrointestinal (GI) tract for the | |||
| purpose of: |
- Endoscopic marking,
- Hemostasis for:
Mucosal/sub-mucosal defects