(364 days)
Not Found
No
The device description and performance studies focus on mechanical aspects and standard biocompatibility/sterilization testing. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes.
The devices are used for surgical procedures like transection, resection, and creation of anastomoses, and for the treatment of hemorrhoidal disease, which aim to treat an illness or injury.
No
The Mirus™ Circular Stapler and other devices described are surgical staplers used for transection, resection, and creation of anastomoses, which are therapeutic functions, not diagnostic ones.
No
The device description clearly details physical, sterile, single-use surgical staplers made of materials like titanium, which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the devices as surgical staplers used for creating anastomoses, transection, resection, and treating hemorrhoidal disease. These are all surgical procedures performed directly on the patient's tissue.
- Device Description: The description details the mechanical function of the staplers (stapling and cutting tissue) and their components (staples, anvil, cartridge). This aligns with a surgical instrument, not a device used to test samples in vitro.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) outside of the body to provide information about a physiological state, health, or disease.
- Performance Studies: The performance studies focus on the mechanical function of the staplers (staple formation, pressure resistance, force to fire), biocompatibility with tissue, sterilization, packaging, and shelf life. These are typical evaluations for surgical devices, not IVDs which would involve analytical and clinical performance studies related to the diagnostic test itself.
In summary, the Mirus™ devices are surgical instruments used for mechanical manipulation of tissue during surgery, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
Mirus™ Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.
Mirus™ Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses.
Mirus™ Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
Mirus™ Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
1. The Mirus™ Circular Stapler
The Mirus™ Circular Stapler are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver double staggered concentric rows of staples on the outside of the cut line. The circular stapler is available in diameter of the staple line from 24mm, 25mm, 26mm, 29mm, 32mm or 34mm stapler. The device has a detachable anvil that allows the surgeon to place the anvil in the desired location. Mirus™ Circular Stapler is preloaded with Staples.
2. Mirus™ Linear Cutter and reload
Mirus™ Linear Cutter stapler and the Reload have two groups of staple lines in the target area, both of which are composed of a double row of titanium staples interlaced with each other and automatically cut the tissues between the two groups of staple lines when suturing. There are three suturing lengths of 60mm, 80mm and 100mm. The cartridge/ reload for Mirus™ Linear Cutter are supplied separately.
3. Mirus™ Hemorrhoidal Circular Stapler
Mirus™ Hemorrhoids Circular Stapler is a set of instruments that places a circular row of titanium staples (double staggered) while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired. The Mirus™ Hemorrhoid circular stapler is preloaded with staples.
4. Mirus™ Linear Stapler and reload
Mirus™ Linear Stapler places a double staggered row of titanium Staples. They are available in 30mm, 45mm, 60mm and 90mm staple line length. The cartridge/ reload for Mirus™ Linear stapler are supplied separately
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Alimentary tract, gastrointestinal, gynecologic, thoracic, pediatric, anal canal, abdominal, anorectal, left atrial appendage
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)
Performance Tests: Simulated use testing was performed utilizing each device of the Mirus™ family of surgical staplers. The following testing demonstrated that subject devices substantially equivalent to the predicates: Visual Inspection, Dimensional Measurement, Open Staple Height, Closed Staple Height, Staple Formation Test, Staple Line Integrity and Staple Formation, Pressure Resistance Test, Force to fire.
Biocompatibility: The biocompatibility evaluation for Mirus™ Family of Surgical Staplers was conducted in accordance with FDA Biocompatibility Guidance Document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 2016 and International Standards ISO 10993-1 "Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process" as recognized by FDA. Tests performed: In vitro cytotoxicity test, Skin sensitization test, Intracutaneous reactivity test, Acute systemic toxicity test, Material mediated pyrogen test, Hemolysis test, Genotoxicity test, Subchronic systemic toxicity test, Intramuscular implantation test.
Sterilization: Mirus™ Family of Surgical Staplers are sterilized by Ethylene Oxide (EtO). The validation was as per ISO 11135 using the overkill (half-cycle approach) method in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7 requirements. The sterilization processes have demonstrated a sterility assurance level of 10-6.
Packaging & Shelf life: Packaging validation as per ISO 11607, Shelf life validation as per ICH Q1A (R2) & ISO 11607, Performance testing on aged sample (Stability testing), Transportation Study as per ASTM D 999 & ASTM D 5276.
Conclusion: Mirus™ family of surgical staplers is substantially equivalent to currently marketed devices and presents no substantial differences in design, intended use, function and technological characteristics to predicate device. The performance, biocompatibility, sterilization, packaging and shelf life study conducted on Mirus™ family of surgical staplers demonstrated its safety and performance as predicate device. Hence, Mirus™ family of surgical staplers will perform as intended in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterility assurance level of 10-6.
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): Identify 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
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2021
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 Gujarat, India
Re: K200320
Trade/Device Name: Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: January 2, 2021 Received: January 7, 2021
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/cdrl/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.
1
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-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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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
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
2
Indications for Use
510(k) Number (if known) K200320
Device Name
Mirus™ Circular Stapler, Mirus™ Linear Cutter and Reload, Mirus™ Hemorrhoidal Circular Stapler and Reload.
Indications for Use (Describe)
Mirus™ Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.
Mirus™ Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses.
Mirus™ Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
Mirus™ Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/1 description: The image shows the word "Meril" in a sans-serif font. The word is white and is set against a blue background. There is a yellow dot above the "i" in "Meril", which is slightly offset to the right.
l. Submitter
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, Fax: +91-260-3052125 Contact Person: Umesh Sharma E-mail: umesh.sharma@merillife.com Web site: www.merillife.com
Date Prepared: February 5th, 2021
II. Device
| Trade Name | Mirus™ Family of Surgical Staplers | |||
|---|---|---|---|---|
| • Mirus™ Circular Stapler | ||||
| • Mirus™ Linear Cutter and Reload | ||||
| • Mirus™ Hemorrhoidal Circular Stapler | ||||
| • Mirus™ Linear Stapler and Reload | ||||
| Panel | General and Plastic Surgery | |||
| Common/ Usual Name | Reload | Stapler | ||
| Classification Name | Implantable Staple | Stapler, surgical | ||
| Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4800 | ||
| Classification | Class II | Class I | ||
| Product Code | GDW | GAG |
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Image /page/4/Picture/1 description: The image shows the word "Meril" in white font against a blue background. The "i" in Meril has a yellow dot above it. The font is sans-serif and appears to be modern and clean. The overall design is simple and professional.
III. Predicate Device
| Subject device | Predicate device | ||
|---|---|---|---|
| Trade Name | Manufacturer | 510 (K) No. | |
| Mirus™ Circular Stapler | Single Use Circular Stapler | ||
| Mirus™ Linear Cutter and Reload | Single Patient Use Linear Cutter and Reload | Golden Stapler Surgical Co., Ltd. | K162707 |
| Mirus™ Hemorrhoidal Circular Stapler | Single Use Hemorrhoidal Circular Stapler | ||
| Mirus™ Linear Stapler and Reload | Single Patient Use Linear Stapler and Reload |
IV. Device Description
1. The Mirus™ Circular Stapler
The Mirus™ Circular Stapler are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver double staggered concentric rows of staples on the outside of the cut line. The circular stapler is available in diameter of the staple line from 24mm, 25mm, 26mm, 29mm, 32mm or 34mm stapler. The device has a detachable anvil that allows the surgeon to place the anvil in the desired location. Mirus™ Circular Stapler is preloaded with Staples.
2. Mirus™ Linear Cutter and reload
Mirus™ Linear Cutter stapler and the Reload have two groups of staple lines in the target area, both of which are composed of a double row of titanium staples interlaced with each other and automatically cut the tissues between the two groups of staple lines when suturing. There are three suturing lengths of 60mm, 80mm and 100mm. The cartridge/ reload for Mirus™ Linear Cutter are supplied separately.
5
3. Mirus™ Hemorrhoidal Circular Stapler
Mirus™ Hemorrhoids Circular Stapler is a set of instruments that places a circular row of titanium staples (double staggered) while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired. The Mirus™ Hemorrhoid circular stapler is preloaded with staples.
4. Mirus™ Linear Stapler and reload
Mirus™ Linear Stapler places a double staggered row of titanium Staples. They are available in 30mm, 45mm, 60mm and 90mm staple line length. The cartridge/ reload for Mirus™ Linear stapler are supplied separately
V. Intended Use
-
- Mirus™ Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses.
-
- Mirus™ Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses.
-
- Mirus™ Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
-
- Mirus™ Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures.
6
VI. Substantial Equivalence
The Mirus™ family of Surgical Staplers is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics. The Mirus™ family of Surgical Staplers operates on the same principle as predicate devices. The results demonstrated that the subject devices are as safe and as effective as the predicates.
-
- Intended Use
-
- Principle of Operation
-
- Product design
-
- Sterilization
-
- Packaging
-
- Safety Mechanism
-
- Biocompatibility
VII. Preclinical Data
The following performance data were provided in support of the substantial equivalence determination.
Performance Tests
Simulated use testing was performed utilizing each device of the Mirus™ family of surgical staplers. The following testing demonstrated that subject devices substantially equivalent to the predicates.
- . Visual Inspection
- . Dimensional Measurement
- Open Staple Height
- Closed Staple Height
- Staple Formation Test
- Staple Line Integrity and Staple Formation ●
- Pressure Resistance Test
- Force to fire ●
7
Biocompatibility
The biocompatibility evaluation for Mirus™ Family of Surgical Staplers was conducted in accordance with FDA Biocompatibility Guidance Document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 2016 and International Standards ISO 10993-1 "Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process" as recognized by FDA.
Based on attachment A (Table A.1) of the FDA guidance, following tests were identified and performed
- In vitro cytotoxicity test .
- Skin sensitization test .
- Intracutaneous reactivity test .
- . Acute systemic toxicity test
- Material mediated pyrogen test ●
- Hemolysis test .
- Genotoxicity test .
- Subchronic systemic toxicity test .
- . Intramuscular implantation test
Sterilisation
Mirus™ Family of Surgical Staplers are sterilized by Ethylene Oxide (EtO). The Ethylene oxide sterilization process is validated as per ISO 11135. The method used for ethylene oxide sterilization was overkill (half-cycle approach) method in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7 requirements.
The sterilization processes have demonstrated a sterility assurance level of 10-6
8
Packaging & Shelf life
The Following packaging and shelf life study was conducted to ensure package integrity throughout the shelf life.
- Packaging validation as per ISO 11607 .
- . Shelf life validation as per ICH Q1A (R2) & ISO 11607
- . Performance testing on aged sample (Stability testing).
- . Transportation Study as per ASTM D 999 & ASTM D 5276
Conclusion VIII.
Mirus™ family of surgical staplers is substantially equivalent to currently marketed devices and presents no substantial differences in design, intended use, function and technological characteristics to predicate device.
The performance, biocompatibility, sterilization, packaging and shelf life study conducted on Mirus™ family of surgical staplers demonstrated its safety and performance as predicate device.
Hence, Mirus™ family of surgical staplers will perform as intended in the specified use conditions.