(87 days)
No
The summary describes a mechanical surgical stapler and does not mention any AI or ML components or functionalities.
No
This device is a surgical stapler used for transection, resection, and creating anastomoses, which are surgical procedures, not a therapeutic treatment in itself. Its function is to facilitate surgery, not to treat a disease or condition therapeutically.
No
The device is described as a surgical stapler used for transection, resection, and/or creation of anastomoses, which are therapeutic rather than diagnostic functions.
No
The device description clearly describes a physical surgical stapler and loading units, which are hardware components, not software.
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, resection, and/or creation of anastomoses" in surgical procedures. This involves directly interacting with and modifying living tissue within the body.
- Device Description: The description details a surgical stapler that places staples and divides tissue. This is a surgical instrument used in vivo (within a living organism).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
The information provided consistently describes a surgical device used during procedures on patients, not a device used to test samples outside of the body.
N/A
Intended Use / Indications for Use
The easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
Product codes
GDW, GAG
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 260mm, 350mm and 440mm three lengths. The device is available in four five sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 13 times 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 10993-5:2009 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
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicitv
- USP 43-NF38:2020 Pyrogen Test
- USP 42-NF 37 Bacterial Endotoxins Tests
- ASTM F88/F88M-15 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
Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test. Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for less than 2.5mm staple height. Burst pressure, closed staple formation were evaluated in jugular vein test.
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
§ 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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 24, 2021
Ezisurg Medical Co., Ltd. % Diana Hong General Manager Mid-Linking Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K210909
Trade/Device Name: easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: March 18, 2021 Received: March 29, 2021
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. 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
2
Indications for Use
510(k) Number (if known) K210909
Device Name
easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
Indications for Use (Describe)
The easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical 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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3
Tab #6 510(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: K210909
-
- Date of Preparation: 06/22/2021
-
- Sponsor Identification
Ezisurg Medical Co., Ltd.
Rm. 103, Bldg. 2, No.1690 Cailun Rd., China (Shanghai) Pilot Free Trade Zone, 201203 Shanghai, China
Establishment Registration Number: Not registered yet
Contact Person: Jingtian Ren Position: Senior RA Engineer Tel: +86-21-50456176-8026 Fax: +86-21-50676156 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: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: easyEndoTM Lite Linear Cutting Stapler and Loading Unit 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
Indication for Use Statement:
The easyEndo™ Lite Linear Cutting Stapler and Loading Units for Single Use 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.
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 260mm, 350mm and 440mm three lengths. The device is available in four five sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 13 times in a single procedure.
- ર. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K172960 Product Name: easyEndo™ Universal Linear Cutting Stapler and Loading Units for Single Use
Predicate Device 2 510(k) Number: K080839 Product Name: ECHELON GRAY CARTRIDGE, MODEL ERC45M
5
6. Non-Clinical Test Conclusion
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 10993-5:2009 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
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicitv
-
USP 43-NF38:2020 Pyrogen Test
- USP 42-NF 37 Bacterial Endotoxins Tests >
-
ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
- A ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test. Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for less than 2.5mm staple height. Burst pressure, closed staple formation were evaluated in jugular vein test.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
6
Ref.:M10692020
8. Summary of Technological characteristics
| Item | Proposed Device | Predicate Device 1
K172960 | Predicate Device 2
K080839 | Remark |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | GDW&GAG | GDW&GAG | GDW | SE |
| Regulation Number | 21 CFR 878.4750&21CFR 878.4800 | 21 CFR 878.4750&21CFR 878.4800 | 21 CFR 878.4750 | SE |
| Intended Use | The easyEndo™ Lite Linear Cutting
Stapler and Loading Units for Single
Use 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 devices 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 Echelon Endoscopic Linear
Cutters, Staplers and Reloads are
intended for transection, resection,
and/or anastomoses. The instruments
have application in multiple open or
minimally invasive general,
gynecologic, urologic, thoracic, and
pediatric surgical procedures. They
can be used with staple line or tissue
buttressing materials. The instruments
may also be used for transection and
resection of liver parenchyma (hepatic
vasculature and biliary structures),
pancreas, kidney and spleen. | Similar |
| Main Configuration | Stapler
Knife
Staple | Stapler
Knife
Staple | Knife
Staple | Similar |
| Operate Principle | Manual | Manual | Manual | SE |
| Cutting mechanism | Linear | Linear | Linear | SE |
| Safety mechanism | Safety release for preventing from | Safety release for preventing from | Safety release for preventing from | SE |
| | mis-firing | mis-firing | mis-firing | |
| Suture Length | 45mm, 60mm | 45mm, 60mm | 45mm | Similar |
| Staple Height | 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm | 2.5mm, 3.5mm, 3.8mm, 4.1mm | 2.0mm | Similar |
| Row Number of Staples | 6 | 6 | 6 | SE |
| Closed Staple Form | Image: staple form | Image: staple form | Image: staple form | SE |
| Staple Material | Unalloyed Titanium | Unalloyed Titanium | Unalloyed Titanium | SE |
| Patient-contact material | Stainless steel (SUS304)
Stainless steel (SUS420, 20Cr13)
Stainless steel (17-4PH)
Stainless steel (SUS301)
Polyamide
Unalloyed Titanium | Unalloyed Titanium
Polyphthalamide + Glass Fiber Stainless
Steel | Unalloyed Titanium | Different |
| Sterilization | Irradiation Sterilization | Irradiation Sterilization | EO sterilization | Different |
| Endotoxin Limit | 20 EU | 20 EU | 20 EU | SE |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | SE |
Table 1 Comparison of Technology Characteristics
7
Similar-Indication for use
The indication for use for proposed device is different from proposed device does not have the indication for using with buttessing material or organ transection. However, the indication for use for proposed device can be covered by the predicate device 2. In addition, the indications for use for the proposed device is same as the predicate device 1. Therefore, is not considered to affect substantially equivalence.
Similar-Structure
The structure for the proposed device is different from the predicate device 2 is a cartridge. However, the structure for proposed device is same as the predicate device 1. Therefore, this difference is not considered to affect substantially equivalence. Similar-Suture length
8
The proposed device has the additional suture levice. However, this suture length specification can be overed by the predicate device 1. Therefore, this difference is not considered to affect substantially equivalence.
Similar- Staple Height
The staple height of the proposed device is different from the predicate device 2. However, the staple height of the proposed device (2.5mm~4.1mm) can be covered by the proposed stable height 2.0mm is same as predicate device 2. Therefore, this difference is not considered to affect substantially equivalence.
Different- Patient-contact material
The patient-contact material of the proposed device. However, the biocompatbility test has been performed on the material of the proposed device and the test result show that the proposed device will not affect adverse effect on the patient. Therefore, this difference is not considered to affect substantially equivalence.
Different-Sterilization
The sterlization method for the proposed device. However, the sterlization process has been validated per ISO 11137 and the validation result can demonstrate the sterilization which can maintain the declared sterilization assurance level, In addition, the irradiation sterilization method is also used for the 1. Therefore, this difference is not considered to affect substantially equivalence.
9
Substantially Equivalent (SE) Conclusion 9.
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K172960 and K080839.