(289 days)
No
The device description and performance studies focus on mechanical function and tissue interaction, with no mention of AI/ML, image processing, or data-driven decision making.
No
This device is a surgical stapler used for joining or transecting tissues, not for treating a disease or condition for therapeutic benefit.
No
Explanation: The devices described are surgical staplers and cutters used for transection, resection, and creation of anastomoses in various surgical procedures. Their intended use is to perform physical actions on tissue (stapling, cutting), not to diagnose conditions.
No
The device description clearly details physical, mechanical surgical staplers and their components, not software.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed on the patient's body (in vivo), such as creating anastomoses, transecting tissue, and treating hemorrhoidal disease. IVDs are used to examine specimens from the body (in vitro), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
- Device Description: The device descriptions detail mechanical instruments that physically manipulate tissue within the body using staples and cutting mechanisms. This is consistent with surgical devices, not IVDs.
- Performance Studies: The performance studies involve testing the devices on animal tissue (porcine intestine and stomach) to evaluate their mechanical function and tissue interaction (pressure resistance, staple formation, force to fire, staple line integrity). This is typical testing for surgical staplers, not IVDs which would involve analytical performance testing on biological samples.
The devices described are surgical staplers and cutters used for internal surgical procedures.
N/A
Intended Use / Indications for Use
The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.
The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.
The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Single Use Hemorrhodial Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
The Single Patient Use Transverse Cutter and Reload is intended for transection and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.
Product codes
GDW, GAG
Device Description
The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.
Single Use Circular stapler places 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. The stapler are available in 21mm, 26mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.
Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in five staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm. 3.5mm. 3.8mm and 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.
Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.
Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.8mm, 4.2mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.
Single Use Hemorrhoidal Circular Stapler 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 stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, anal, gastrointestinal, gynecologic, thoracic, pediatric, abdominal, pancreas, skeletal muscle, urologic.
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 provided in this submission include:
Biocompatibility Test: Cytotoxicity Test (ISO 10993-5:2009), Skin Sensitization Test (ISO 10993-10:2010), Irritation Test (ISO 10993-10:2010).
Performance tests performed on both subject device and predicate device include: Pressure Resistance Test in tissue (porcine intestine), Closed Staple Height Test in tissue (porcine intestine), Staple Formation Test in tissue (porcine intestine), Force to Fire Stapler Test in tissue (porcine intestine), Staple Line Integrity and Staple Formation in thick tissue (porcine stomach).
The results show that there are no significant difference between proposed device and predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030411, K983536, K020779, K111825, K061156, K062869
Reference Device(s)
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 & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being in the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
Golden Stapler Surgical Co., Ltd. % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China
Re: K162707
Trade/Device Name: Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler And Reload, Single Patient Use Linear Cutter And Reload, Single Patient Use Endo Cutter And Reload, Single Patient Use Transverse Cutter And Reload
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: June 15, 2017 Received: June 19, 2017
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (21 CFR 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.
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) K162707
Device Name
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
Indications for Use (Describe)
The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.
The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.
The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Single Use Hemorrhodial Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
The Single Patient Use Transverse Cutter and Reload is intended for transection and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
S001
Exhibit #2 510(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: K162707
-
- Date of Preparation: 07/12/2017
-
- Sponsor Identification
Golden Stapler Surgical Co., Ltd.
Building 7A, Jiangsu Wujin Sci-Tech Pioneer Park, 256, Mid Mingxin Road, Hutang Town, Wujin District, Changzhou, Jiangsu Province, China
Establishment Registration Number: Not yet registered
Contact Person: Hao Chao Position: General Manager Tel: +86-519-85070751 Fax: +86-519-85070752 Email: Victor.chao@goldenstapler.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: Single Use Circular Stapler
Single Use Hemorrhoidal Circular Stapler Single Patient Use Linear Stapler and Reload Single Patient Use Linear Cutter and Reload Single Patient Use Endo Cutter and Reload Single Patient Use Transverse Cutter and Reload
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 Single Use Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses.
The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.
The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection of pancreas.
The Single Use Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
5
The Single Patient Use Transverse Cutter and Reload is intended for transection and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.
Device Description
The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.
Single Use Circular stapler places 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. The stapler are available in 21mm, 26mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.
Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in five staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm. 3.5mm. 3.8mm and 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.
Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.
Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.8mm, 4.2mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.
Single Use Hemorrhoidal Circular Stapler 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 stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.
Identification of Predicate Devices న్.
6
S001
Predicate Device 1 510(k) Number: K030411 Product Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories
Predicate Device 2 510(k) Number: K983536 Product Name: PROXIMATE® Curved and Straight Intraluminal Staplers
Predicate Device 3 510(k) Number: K020779 Product Name: ENDOPATH and PROXIMATE Linear Cutters and Staplers
Predicate Device 4 510(k) Number: K111825 Product Name: DST Series™ Staplers
Predicate Device 5 510(k) Number: K061156 Product Name: ENDOPATH Linear Cutters and Staplers
Predicate Device 6 510(k) Number: K062869 Product Name: CONTOUR™ Curved Cutter Stapler and Reloads
Identification of Reference Devices 6.
Reference Device 1 510(k) Number: K080839 Product Name: Echelon™ Gray Cartridge-45mm
Reference Device 2 510(k) Number: K112056 Product Name: Echelon Endoscopic Linear Cutter Reload, Black
-
- 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 provided in this submission include:
- Non-Clinical Test Conclusion
Biocompatibility Test
7
S001
| Cytotoxicity Test | ISO 10993-5:2009 |
|---|---|
| Skin Sensitization Test | ISO 10993-10:2010 |
| Irritation Test | ISO 10993-10:2010 |
Performance tests performed on both subject device and predicate device include
Pressure Resistance Test in tissue (porcine intestine) Closed Staple Height Test in tissue (porcine intestine) Staple Formation Test in tissue (porcine intestine) Force to Fire Stapler Test in tissue (porcine intestine) Staple Line Integrity and Staple Formation in thick tissue (porcine stomach)
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
8
Substantially Equivalent (SE) Comparison 9.
Table 1 Comparison of Technology Characteristics for Single Patient Use Transverse Cutter and Reload
| Item | Proposed Device | Predicate Device 6
K062869 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Product Code | GDW | Same |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Patient Use Transverse
Cutter and Reload is intended for
transection, resection and/or creation
of anastomoses. The instrument has
application in multiple open or
minimally invasive general
(gastrointestinal and skeletal muscle
stapling), gynecologic, urologic, and
thoracic surgical procedures. | Same |
| Cutting Mechanism | Curved Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Reset Knob is used for preventing
from mis-firing | Same |
| Closed staple height | 1.5mm, 2.0mm | Same |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact
material | Unalloyed Titanium
Polycarbonate
Stainless Steel | Unknown |
| Sterilization | Irradiation Sterilization | EO Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
9
S001
E2 510(k) Summary
| Item | Proposed Device | Predicate Device 2 |
|---|---|---|
| Product Code | GDW | K983536 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Use Circular Stapler has | |
| application throughout the alimentary | ||
| tract for end to end, end to side and | ||
| side to side anastomoses. | Same | |
| Cutting Mechanism | Circular Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Insurance is used for preventing from | |
| mis-firing | Same | |
| Closed staple height | 1.0~2.5mm | Same |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact | ||
| material | Unalloyed Titanium | |
| Polycarbonate | ||
| Stainless Steel | Unknown | |
| Sterilization | Irradiation Sterilization | EO Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 2 Comparison of Technology Characteristics for Single Use Circular Stapler
10
S001
| Item | Proposed Device | Predicate
Device 5
K061156 | Reference
Device 1
K080839 | Reference
Device 2
K112056 | Item | Proposed Device | Predicate Device 4 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Product Code | GDW | Same | Same | Same | | | K111825 |
| Regulation
Number | 21 CFR 878.4750 | Same | Same | Same | Product Code | GDW | Same |
| Intended Use | The Single Patient Use Endo Cutter
and Reload is intended for
transection, resection, and/or
creation of anastomoses. The
instrument has application in
multiple open or minimally invasive
general, gynecologic, urologic,
thoracic, and pediatric surgical
procedures. | Same | Same | Same | Regulation Number | 21 CFR 878.4750 | Same |
| Cutting
Mechanism | Linear Knife | Same | Same | Same | Intended Use | The Single Patient Use 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. They may be
used for transection and resection of
pancreas. | Same |
| Operation
Principle | Manual | Same | Same | Same | Cutting Mechanism | N.A. | Same |
| Safety
Mechanism | Green button for preventing from
mis-firing | Same | Same | Same | Operation Principle | Manual | Same |
| Closed staple
height | 0.75, 1.0, 1.5, 1.8, 2.2mm | 1.0, 1.5,
1.8, 2.0mm | 0.75mm | 2.3mm | Safety Mechanism | Safety release for preventing from
mis-firing | Same |
| Closed staple
form | Image: staple form | Image: staple form | Image: staple form | Image: staple form | Closed staple height | 1.0mm, 1.5mm, 2.0mm | Same |
| Patient-contact
material | Unalloyed Titanium
Acrylonitrile-Butadiene-Styrene
Stainless Steel | Unknown | Unknown | Unknown | Closed staple form | 00 | 00 |
| Sterilization | Irradiation Sterilization | EO
Sterilization | EO
Sterilization | EO
Sterilization | Patient-contact
material | Unalloyed Titanium
Polycarbonate
Stainless Steel | Unknown |
| Endotoxin
Limit | 20 EU | Same | Same | Same | Sterilization | Irradiation Sterilization | EO Sterilization |
| Labeling | Conforms with 21 CFR 801 | Same | Same | Same | Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same | | | | | |
Table 3 Comparison of Technology Characteristics for Single Patient Use Endo Cutter and Reload
11
E2 510(k) Summary
Table 4 Comparison of Technology Characteristics for Single Patient Use Linear Stapler and Reload
12
| Item | Proposed Device | Predicate Device 3
K020779 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Product Code | GDW | Same |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Patient Use Linear Cutter
and Reload have application in
gastrointestinal, gynecologic,
thoracic, and pediatric surgery for
transection, resection, and/or creation
of anastomoses and can be used with
staple line or tissue buttressing
materials, such as bovine
pericardium. | Same |
| Cutting Mechanism | Linear Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety release for preventing from
mis-firing | Same |
| Closed staple height | 1.0mm, 1.5mm, 1.8mm, 2.0mm | Same |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact
material | Unalloyed Titanium
Polycarbonate
Stainless Steel | Unknown |
| Sterilization | Irradiation Sterilization | EO Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 5 Comparison of Technology Characteristics for Single Patient Use Linear Cutter and Reload
13
S001
E2 510(k) Summary
| Item | Proposed Device | Predicate Device 1 |
|---|---|---|
| K030411 | ||
| Product Code | GDW | Same |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | Use | |
| Hemorrhoidal | ||
| The | ||
| Single | ||
| Stapler has application | ||
| Circular | ||
| throughout the anal canal to perform | ||
| surgical treatment of hemorrhoidal | ||
| disease. | Same | |
| Cutting Mechanism | Circular Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety release for preventing from | |
| mis-firing | Same | |
| Closed staple height | 0.8~2.0mm | Same |
| Closed staple form | B | 儿 |
| Patient-contact | Unalloyed Titanium | |
| material | Polycarbonate | Unknown |
| Stainless Steel | ||
| Sterilization | Irradiation Sterilization | EO Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 6 Comparison of Technology Characteristics for Single Use Hemorrhoidal Circular Stapler
10. Substantially Equivalent (SE) Conclusion
Biocompatibility testing was performed on the proposed devices; including cytotoxicity, skin sensitization and irritation tests. The test results demonstrate that the device does not introduce any biocompatibility concerns. The proposed device is sterilized by radiation, a different method than the predicate, and sterility was established per ISO ISO11137. Therefore, testing demonstrates that the difference in patient contact material and sterilization method will not affect substantial equivalence.
The performance tests include pressure resistance test which is intended evaluate integrity of staple line, force to fire a stapler test which is intended to evaluate the force to fire a stapler, staple formation test which is intended to evaluate stapler formation characteristics, and closed staple height test which is intended evaluate whether the closed staple height can meet pre-defined criteria. The test results for both proposed device and predicate device was analyzed by statistical methods to ensure the sample size was appropriate to detect a meaningful difference between testing groups. The results show that there are no significant difference between proposed device and predicate device. Based on the comparison and performance test result analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.