(90 days)
No
The summary describes a mechanical surgical stapler and does not mention any AI or ML components or functionalities.
No.
The device is a surgical stapler used for cutting and stapling tissue, which is a surgical tool rather than a therapeutic device designed to treat a disease or condition through non-surgical means.
No
This device is described as a surgical stapler for transection and anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description clearly indicates a physical surgical stapler with mechanical components (staples, cutting mechanism) and various sizes and lengths, which are hardware elements.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "transection, and/or creation of anastomoses" in surgical procedures. This describes a device used on the patient's body during surgery, not a device used to test samples from the body in a lab setting.
- Device Description: The description details a surgical stapler that places staples and cuts tissue. This is a surgical instrument, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device described is a surgical instrument used for cutting and stapling tissue during various surgical procedures. This falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The device is intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
Product codes
GDW
Device Description
The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of Endoscopic Linear Cutting Staplers and Loading Units for Single Use are available in in five staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm, 4.1mm and 4.8mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
Indicated Patient Age Range
pediatric
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
-
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
-
USP 38-NF 33 Bacterial Endotoxins Tests
-
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
-
ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
-
USP 39-NF34:2016 Pyrogen Test
The tests provided in this submission include package integrity test, bacteria endotoxin test, biocompatibility test, shelf life test and performance test were performed on both proposed device and predicate device to determine substantial equivalence, the performance test include following items
-
Firing Force Test
-
Staple Formation Test
-
Staple Line Pressure Test
-
Staple Line Tensile Test
-
Hemostasis Evaluation Test
-
Close Staple Height Test
Biocompatibility tests included cytotoxicity, sensitization, intracutaneous irritation and pyrogenicity.
Shelf life testing which included package integrity and performance evaluations were performed.
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2018
Ezisurg (Suzhou) Medical Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 Cn
Re: K181620
Trade/Device Name: Endoscopic Linear Cutting Staplers and Loading Units for Single Use Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 7, 2018 Received: June 20, 2018
Dear Ms. 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. 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 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181620
Device Name
Endoscopic Linear Cutting Staplers and Loading Units for Single Use
Indications for Use (Describe)
The device is intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Tab #7 510(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: __K181620
-
- Date of Preparation: 04/16/2018
-
- Sponsor Identification
Ezisurg (Suzhou) Medical Co., Ltd.
Building 16, No.8 Jinfeng Rd., Suzhou National Hi-Tech District, Suzhou 215163 Jiangsu, China
Establishment Registration Number: Not yet registered.
Contact Person: Jingtian Ren Position: VP Quality& Registration Tel: 021-50456176-8026 Fax: 021-50676156 Email: renjingtian@ezisurg.com
-
- 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: 3609253199 Email: info@mid-link.net
4
Identification of Proposed Device 4.
Trade Name: Endoscopic Linear Cutting Staplers and Loading Units for Single Use Common Name: Stapler and Reload
Regulatory Information Classification Name: Staple, Implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General& Plastic Surgery
Classification Name: Stapler, Surgical; Classification: I Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4800 Review Panel: General & Plastic Surgery
Intended Use Statement:
The device is intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
Device Description
The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of Endoscopic Linear Cutting Staplers and Loading Units for Single Use are available in in five staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm, 4.1mm and 4.8mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.
5
ડ. Identification of Predicate Device
Predicate Device 1 510(k) Number: K111825 Product Name: Endo GIATM Staplers
Predicate Device 2 510(k) Number: K061156 Device Name: ENDOPATH Linear Cutters and Staplers
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
-
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
-
USP 38-NF 33 Bacterial Endotoxins Tests
-
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
-
ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
-
USP 39-NF34:2016 Pyrogen Test
The tests provided in this submission include package integrity test, bacteria endotoxin test, biocompatibility test, shelf life test and performance test were performed on both proposed device and predicate device to determine substantial equivalence, the performance test include following items
-
Firing Force Test
-
Staple Formation Test
-
Staple Line Pressure Test
-
Staple Line Tensile Test
-
Hemostasis Evaluation Test
-
Close Staple Height Test
Biocompatibility tests included cytotoxicity, sensitization, intracutaneous irritation and pyrogenicity.
6
Shelf life testing which included package integrity and performance evaluations were performed.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
7
Substantially Equivalent (SE) Comparison 8.
| Table 1 Comparison for Endoscopic Linear Cutting Staplers and Loading Units for Single Use | |||
|---|---|---|---|
| Item | Proposed Device | Predicate Device 1 | Predicate Device 2 |
| K111825 | K061156 | ||
| Product Code | GDW | GDW | GDW |
| Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4750 | 21 CFR 878.4750 |
| Intended Use | The device are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures. | The Endo GIATM Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. | The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. |
| Cutting Mechanism | Linear | Linear | Linear |
| Operation Principle | Manual | Manual | Manual |
| Safety Mechanism | Green button is used for preventing from mis-firing. | Green button is used for preventing from mis-firing. | Green button is used for preventing from mis-firing. |
| Suture Length | 30mm, 45mm, 60mm | 30mm, 45mm, 60mm | 60mm |
| Staple height | 2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.8mm | 2.0mm, 2.5mm, 3.5mm, 4.8mm | 2.5mm, 3.5mm, 3.8mm, 4.1mm |
| Closed staple form | Image: staple | Image: staple | Image: staple |
| Endotoxin Limit | 20 EU | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
Table 1 Comparison for Endoscopic Linear Cutting Staplers and Loading Units for Single Use
8
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion