(90 days)
Not Found
No
The summary describes a mechanical surgical stapler and does not mention any AI or ML components or functionalities.
No.
The device is described as a surgical instrument used for resection, transection, and creating anastomoses, which are functions related to cutting and joining tissues during surgery, not directly associated with applying a therapeutic effect.
No
Explanation: The device is a surgical stapler used for resection, transection, and creation of anastomoses, which are therapeutic actions, not diagnostic ones. It is described as a "cutting stapler" and "surgical instrument," indicating its role in physically altering tissue rather than identifying or characterizing a condition.
No
The device description explicitly states it is a "sterilized and disposable surgical instrument" that "places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line." This clearly describes a physical, hardware-based medical device, not a software-only one.
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 is for surgical procedures (resection, transection, and creation of anastomoses) in abdominal, gynecologic, and pediatric surgery. This involves direct interaction with the patient's body during a surgical procedure.
- Device Description: The device is described as a surgical instrument used to place staples and divide tissue. This is a mechanical function performed on living tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. The tests mentioned in the performance studies are related to the device's physical properties, sterility, and biocompatibility, not its ability to analyze biological samples.
IVD devices are used in vitro (outside the living body) to analyze samples. This device is used in vivo (within the living body) during surgery.
N/A
Intended Use / Indications for Use
The easyEndo® Linear Cutting Stapler and Loading Unit for Single Use have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The proposed devices, easyEndo® Linear Cutting Stapler and Loading Unit for Single Use, are sterilized and disposable surgical instruments, which have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The easyEndo® Linear Cutting Stapler may be reloaded and fired no more than 25 times in a single procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecologic and pediatric surgery
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:
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM 1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration.
USP 37-NF32:2014, Bacterial Endotoxins Test
USP 37-NF32 Pyrogen Test (USP Rabbit Test)
ISO 10993-5,2009/(R) 2014:Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
No clinical study is included in this submission.
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): 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2015
EziSurgMedical Company, Ltd. % Ms. Diana Hong Mid-Link Consulting Company, Ltd. P.O. Box 120-119 200120 Shanghai China
Re: K143129
Trade/Device Name: easyEndo® 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: October 29, 2014 Received: October 31, 2014
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
easyEndo® Linear Cutting Stapler and Loading Unit for Single Use
Indications for Use (Describe)
The easyEndo® Linear Cutting Stapler and Loading Unit for Single Use have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.
| Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
Type of Use (Select one or both, as applicable)
3
Tab #7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: ________
-
- Date of Preparation: 10/24/2014
-
- Sponsor Identification
EziSurg Medical Co., Ltd.
Room 312, Bldg. 2, No. 1690, Cailun Road Zhangjiang High-Tech Park Pudong, Shanghai, 201203, P.R. China
Establishment Registration Number: Not yet registered
Contact Person: Johnny Yan Position: System Submission Specialist Tel: 86-21-50456156 Fax: 86-21-50456176 Email: johnnyyan@ezisurg.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: easyEndo® Linear Cutting Stapler and Loading Unit for Single Use Common Name: Stapler Model: Stapler F12S, F12M, F12L Loading Unit FDU 45W, FDU 45B, FDU 45G, FDU 60B, FDU 60G
Regulatory Information
Classification Name: Staple, Implantable; Classification: II; Product Code: GDW; Regulation Number: 21 CFR 878.4750; Review Panel: General & Plastic Surgery;
Intended Use Statement:
The easyEndo® Linear Cutting Stapler and Loading Unit for Single Use have applications in abdominal, gynecologic and pediatric surgery for resection, and creation, and creation of anastomoses.
Device Description
The proposed devices, easyEndo® Linear Cutting Stapler and Loading Unit for Single Use, are sterilized and disposable surgical instruments, which have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The easyEndo® Linear Cutting Stapler may be reloaded and fired no more than 25 times in a single procedure.
5. Identification of Predicate Device
510(k) Number: K120258 Product Name: Endo GIA™ Universal Staplers with Duet TRS™ reloads
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:
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials. >
5
-
ASTM 1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration.
-
USP 37-NF32:2014, Bacterial Endotoxins Test
-
USP 37-NF32 Pyrogen Test (USP Rabbit Test)
-
ISO 10993-5,2009/(R) 2014:Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
-
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The easyEndo® Linear Cutting Stapler and | |
| Loading Unit for Single Use have | ||
| applications in abdominal, gynecologic and | ||
| pediatric surgery for resection, transection, | ||
| and creation of anastomoses. | Similar | |
| Cutting Mechanism | Linear | Same |
| Operation Principle | Manual | Same |
| Safety Machanism | Green button for preventing from mis-firing. | Same |
| Suture Length | 45,60 mm | Same |
| Closed Staples | ||
| Height | 1.0, 1.5, 2.0 mm | Same |
| Closed Staples | ||
| Form | Image: Staples Form | Same |
| Patient-contact | ||
| Material | Unalloyed Titanium conforms to ASTM F | |
| 67, Polyamide resin | Similar | |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |
| Endotoxin Limit | 20 EU per Product | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 1 Comparison of Technology Characteristics
9. 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.