(129 days)
Not Found
No
The device description and intended use focus on mechanical stapling and cutting mechanisms, with no mention of AI/ML, image processing, or data analysis.
Yes
The described devices are surgical staplers used for resection, transection, and creation of anastomoses, which are direct interventions designed to treat medical conditions (e.g., hemorrhoids, or facilitate surgical procedures for disease management).
No
These devices are surgical staplers used for cutting tissue and creating anastomoses during surgical procedures. They are interventional devices, not diagnostic ones.
No
The device description clearly details physical, disposable surgical staplers made of 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 descriptions clearly state the devices are used for surgical procedures involving tissue manipulation (stapling, cutting, resection, anastomosis creation) within the body. This is a therapeutic or surgical intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The descriptions detail mechanical devices that physically interact with tissue. They are not reagents, instruments, or systems designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information.
The devices described are surgical staplers and cutters used for joining or removing tissue during surgery. This falls under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Linear Stapler has application in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance and biliary structures.
The Disposable Linear Cutter Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids
Product codes
GDW, GAG
Device Description
The Disposable Linear Stapler places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 90mm staple line length for use in various applications. Two staple sizes (3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.
Disposable Circular stapler place a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. It is available in 20, 22, 24, 26, 29, 32mm six specifications. Two staple sizes (4.7mm and 5.6mm) are available to accommodate various tissue thicknesses.
Disposable Endoscopic Linear Cutter Stapler and Cartridge places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.
Disposable Linear Cutter Stapler Cartridge places a two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.5mm. It may be reloaded and fired up to 5 times for a total 6 firings in a single procedure.
Disposable Circular Stapler for Hemorrhoids is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The device is available in 34mm with 4.6mm staple.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, abdominal, gynecological, pediatric, thoracic, liver, biliary structures, hemorrhoids
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)
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 10993-7: 2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals
- 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; A
- ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, China 100102
Re: K161905
Trade/Device Name: Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: October 19, 2015 Received: October 24, 2015
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 vour 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
1
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 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/ResourcesforYou/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,
Jennifer R. Stevenson -A
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) K161905
Device Name
Disposable Linear Cutter Stapler Cartridge, Disposable Circular Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Stapler, Disposable Circular Stapler for Hemorrhoids
Indications for Use (Describe)
The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-toside anastomoses in both open and laparoscopic surgeries.
The Disposable Linear Stapler has application in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance and biliary structures.
The Disposable Linear Cutter Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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 hoth, as annlicable)
3
Exhibit #3 510(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: K161905
-
- Date of Preparation: 10/19/2016
-
- Sponsor Identification
Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. No.51 Shuishan Road, Zhonglou Economic Development Zone, Changzhou, 213023, China.
Establishment Registration Number: Not yet registered
Contact Person: Boping Ma Position: General Manager Tel: +86-519- 88830515 Fax: +86-519-86865852 Email: mbp129@126.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: 240-238-7587 Email: info@mid-link.net
4
- Identification of Proposed Device 4.
Trade Name: Disposable Linear Cutter Stapler and Stapler Cartridge Disposable Circular Stapler Disposable Endoscopic Linear Cutter Stapler and Cartridge Disposable Linear Stapler Disposable Circular Stapler for Hemorrhoids
Common Name: Stapler and Reload
Regulatory Information
Classification Name: Staple, Implantable Classification: II; Product Code: GDW Subsequent Product Code: GAG Regulation Number: 21CFR 878.4750 Review Panel: General& Plastic Surgery
Intended Use Statement:
The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Linear Stapler has application in the resection of tissue for abdominal. gynecological, pediatric and thoracic surgical procedures.
The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance and biliary structures.
The Disposable Linear Cutter Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
The Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids.
Device Description
The Disposable Linear Stapler places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 90mm staple line length for use in various applications. Two staple sizes
5
(3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.
Disposable Circular stapler place a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. It is available in 20, 22, 24, 26, 29, 32mm six specifications. Two staple sizes (4.7mm and 5.6mm) are available to accommodate various tissue thicknesses.
Disposable Endoscopic Linear Cutter Stapler and Cartridge places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.
Disposable Linear Cutter Stapler Cartridge places a two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.5mm. It may be reloaded and fired up to 5 times for a total 6 firings in a single procedure.
Disposable Circular Stapler for Hemorrhoids is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The device is available in 34mm with 4.6mm staple.
న్. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K131511 Product Name: Disposable Circular Stapler Disposable Linear Staplers and Reloads Disposable Hemorrhoidal Stapler Disposable Linear Cutter Staplers and Reloads
Predicate Device 2 510(k) Number: K120179 Product Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units
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:
- Non-Clinical Test Conclusion
-
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
-
ISO 10993-7: 2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals
-
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; A
-
ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device 1 |
|---|---|---|
| Product Code | GDW | K131511 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries. | Same |
| Cutting Mechanism | Circular Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Insurance is used for preventing from mis-firing | Same |
| Closed staple height | 2.0mm, 2.3mm | Similar |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact material | Unalloyed Titanium | |
| Acrylonitrile-Butadiene-Styrene | ||
| Stainless Steel | Similar | |
| Sterilization | EO Sterilization | Irradiation Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 1 Comparison of Technology Characteristics for Disposable Circular Stapler
8
| Item | Proposed Device | Predicate Device 2 |
|---|---|---|
| Product Code | GDW | K120719 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Disposable Endoscopic Linear | |
| Cutter Stapler and Cartridge has | ||
| applications in general, gynecologic, | ||
| pediatric and thoracic surgery for | ||
| resection, transection, and creation of | ||
| anastomoses. They may be used for | ||
| transection and resection of liver | ||
| substance and biliary structures. | Same | |
| Cutting Mechanism | Linear Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety button for preventing from | |
| mis-firing | Same | |
| Closed staple height | 1.0, 1.5, 1.8mm | similar |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact | ||
| material | Unalloyed Titanium | |
| Polycarbonate | ||
| Stainless Steel | Unknown | |
| Sterilization | EO Sterilization | Same |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 2 Comparison of Technology Characteristics for Disposable Endoscopic Linear Cutter Stapler and Cartridge
9
| Item | Proposed Device | Predicate Device 1 |
|---|---|---|
| Product Code | GDW | K131511 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Disposable Linear Stapler has application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. | Same |
| Cutting Mechanism | N.A. | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety release for preventing from mis-firing | Same |
| Closed staple height | 1.5mm, 2.0mm | similar |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact material | Unalloyed Titanium | SE |
| Polycarbonate | ||
| Stainless Steel | ||
| Sterilization | EO Sterilization | Irradiation Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 3 Comparison of Technology Characteristics for Disposable Linear Stapler
10
| Item | Proposed Device | Predicate Device 1 |
|---|---|---|
| Product Code | GDW | K131511 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Disposable Linear Cutter Stapler | |
| and Stapler Cartridge has application | ||
| in abdominal, gynecological, thoracic | ||
| and pediatric surgery transection, | ||
| resection and the creation of | ||
| anastomoses. | Same | |
| Cutting Mechanism | Linear Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety release for preventing from | |
| mis-firing | Same | |
| Closed staple height | 1.5mm, 1.7mm | similar |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact | ||
| material | Unalloyed Titanium | |
| Polycarbonate | ||
| Stainless Steel | Same | |
| Sterilization | EO Sterilization | Irradiation Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 4 Comparison of Technology Characteristics for Disposable Linear Cutter Stapler Cartridge
11
| Item | Proposed Device | Predicate Device 1 |
|---|---|---|
| Product Code | GDW | K131511 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids. | Same |
| Cutting Mechanism | Circular Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety release for preventing from mis-firing | Same |
| Closed staple height | 2.0mm | similar |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact material | Unalloyed Titanium | |
| Polycarbonate | ||
| Stainless Steel | Same | |
| Sterilization | EO Sterilization | Irradiation Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 5 Comparison of Technology Characteristics for Disposable Circular Stapler for Hemorrhoids
-
- 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