(306 days)
Not Found
No
The device is a mechanical ligating clip and applier, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device, a ligating clip, is used to close off tubular structures or vessels during surgery, which is a surgical tool/accessory used in a procedure rather than directly treating a condition itself.
No
The device description and intended use clearly state that the Mirus™ Ligating Clip is used for ligating (tying off) tubular structures or vessels during surgery, which is a therapeutic rather than a diagnostic function. It does not mention any role in detection, diagnosis, or monitoring of medical conditions.
No
The device description clearly states that the Mirus™ Ligating clip is a sterile, single-use, implantable device made of titanium, and the Mirus™ Ligating Clip applier is a multiuse non-sterile stainless steel device. These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "sterile, single use, implantable device made of implant grade titanium" and an "applier." These are surgical instruments and implants used during surgery.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such testing on samples.
The device is a surgical tool used for ligation during open surgery, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Mirus™ Ligating clip is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with size of the clip.
Mirus™ Ligating Clip applier is intended to apply ligating clips on tubular structures or vessels wherever a metal ligating clip is indicated.
Product codes (comma separated list FDA assigned to the subject device)
FZP, GAG
Device Description
Mirus™ Ligating clip are sterile, single use, implantable device made of implant grade titanium (ISO 5832-2 / ASTM F 67). The clips are available in various sizes with 6 clips packed in a single plastic cartridge.
Mirus™ Ligating clips are supplied with multiuse non sterile stainless steel Mirus™ Ligating Clip applier, allows the end user to ligate a wide range of vessels and tissue structures using the ligating clips
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tubular structures or vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open general surgery procedures
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)
Mirus™ Ligating Clip was subjected to the performance testing. The safety and effectiveness of Mirus™ Ligating Clip has been evaluated for the following performance and safety requirements.
-
- Dimension compliance
-
- Shape
-
- Radial pull off force
-
- Axial Pull off force
-
- Leakage
-
- Applier Performance
-
- Biocompatibility
- a. In Vitro Cytotoxicity Study
- b. Skin Sensitization Study
- c. Intracutaneous Reactivity Test
- d. Acute Systemic Toxicity Study
- e. Sub Acute Systemic Toxicity
- f. Intramuscular Implantation Test
- g. Bacterial Reverse Mutation Test
- h. In Vitro Hemolysis Test
- i. Material Mediated Pyrogen Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): ID the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 23, 2020
M/s. Meril Endo Surgery Private Limited Umesh Sharma General Manager - Ouality Assurance/Regulatory Affairs Third Floor , E1-E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi, 396191 In
Re: K200166
Trade/Device Name: Mirus Ligating Clip, Mirus Ligating Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Ligating clip Regulatory Class: Class II Product Code: FZP Dated: October 14, 2020 Received: October 20, 2020
Dear Umesh Sharma:
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
1
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 (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 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,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200166
Device Name Mirus™ Ligating Clip
Indications for Use (Describe)
The Mirus™ Ligating clip is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with size of the clip.
Mirus™ Ligating Clip applier is intended to apply ligating clips on tubular structures or vessels wherever a metal ligating clip is indicated.
Type of Use (Select one or both, as applicable)
| V Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for Meril Endo Surgery. The logo features the word "Meril" in a clean, sans-serif font, with a small yellow dot above the "i". Below the logo, the words "Endo Surgery" are written in a smaller, gray font. The background of the logo is a light blue color.
510(k) Summary
Submitter l.
M/s. Meril Endo Surgery Private Limited Third Floor, E1 – E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India.
Tel. No: +91-260-3052100 Extension: 3811, Fax: +91-260-3052125 Web site: www.merillife.com E-mail: umesh.sharma@merillife.com
Contact Person: Umesh Sharma Date Prepared: November 10tt, 2020
II. Device
| Trade Name | Mirus™ Ligating Clip & Clip Applier | |
|---|---|---|
| Panel | General and Plastic Surgery | |
| Common/ Usual Name | Ligating clip | Clip Applier |
| Classification Name | Clip Implantable | Manual surgical instrument for |
| general use | ||
| Regulation Number | 21 CFR 878.4300 | 21 CER 878.4800 |
| Classification | Class II | Class I |
| Product Code | FZP | GAG |
III. Predicate Device
K834267: Ligaclip™ Titanium Ligating Clip, Ethicon, Inc.(Primary Predicate Device) K982313: Horizon™ Titanium Clips, Weck Closure Systems
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Image /page/4/Picture/1 description: The image shows the logo for Meril Endo Surgery. The word "Meril" is in a large, sans-serif font, with the "i" dotted with an orange circle. The words "Endo Surgery" are in a smaller, sans-serif font below the word "Meril". The background is a light blue color.
IV. Device Description
Mirus™ Ligating clip are sterile, single use, implantable device made of implant grade titanium (ISO 5832-2 / ASTM F 67). The clips are available in various sizes with 6 clips packed in a single plastic cartridge.
Mirus™ Ligating clips are supplied with multiuse non sterile stainless steel Mirus™ Ligating Clip applier, allows the end user to ligate a wide range of vessels and tissue structures using the ligating clips
V. Intended Use
The Mirus™ Ligating clip is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with size of the clip.
Mirus™ Ligating Clip applier is intended to apply ligating clips on tubular structures or vessels wherever a metal ligating clip is indicated.
VI. Substantial Equivalence
The device design, material of construction, performance, packaging and intended uses are similar to the predicate device. Substantial equivalence is conducted based on the following parameters:
-
- Intended use
-
- Device Size
-
- Principle of Operation
-
- Single use
-
- Sterilisation method
-
- Packaging & Labelling
-
- Performance
5
Image /page/5/Picture/1 description: The image contains a logo for a company called "Meril Endo Surgery". The word "Meril" is in a large, sans-serif font and is white. Above the "i" in Meril are two small yellow dots. Below the logo is the text "Endo Surgery" in a smaller, sans-serif font and is gray.
VII. Performance Data
Mirus™ Ligating Clip was subjected to the performance testing. The safety and effectiveness of Mirus™ Ligating Clip has been evaluated for the following performance and safety requirements.
-
- Dimension compliance
-
- Shape
-
- Radial pull off force
-
- Axial Pull off force
-
- Leakage
-
- Applier Performance
-
- Biocompatibility
- a. In Vitro Cytotoxicity Study
- b. Skin Sensitization Study
- Intracutaneous Reactivity Test c.
- d. Acute Systemic Toxicity Study
- e. Sub Acute Systemic Toxicity
- f. Intramuscular Implantation Test
- Bacterial Reverse Mutation Test ರು.
- h. In Vitro Hemolysis Test
- Material Mediated Pyrogen Test i.
Conclusion VIII.
Mirus™ Ligating Clips are composed of implant grade Titanium. Also Mirus™ Ligating Clips have the same intended use and the same basic technology as that of the predicate devices. Meril's device is substantially equivalent to the predicate in term of material, features and design and it does not pose any new issues concerning safety and effectiveness.