(38 days)
Not Found
No
The device description and performance studies focus on mechanical aspects of surgical staplers and do not mention any AI or ML components.
No.
The devices described are surgical staplers and cutters used for creating anastomoses, resecting, or transecting tissues, which are considered surgical tools rather than devices that provide therapy for a condition.
No
Explanation: The device, as described, is a surgical instrument (stapler) designed for creating anastomoses, resection, or transection of tissue. Its primary function is to perform a surgical procedure, not to diagnose a condition.
No
The device description clearly details physical surgical instruments (staplers) and their components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes surgical procedures involving the creation of anastomoses, resection, transection, and treatment of hemorrhoids. These are all direct surgical interventions on the body.
- Device Description: The device description details surgical staplers and their function in physically joining or cutting 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 compatibility testing.
The device is a surgical instrument used during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Disposable Circular Stapler have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Linear Staplers and Reloads have application in the resection of transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Disposable Hemorrhoidal Staple have application for general surgical treatment of hemorrhoids.
The Disposable Endoscopic Linear Cutter Staplers and Reloads have applications in general, gynecologic, pediatic and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynesological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
The Disposable Curved Cutter Stapler is intended for transection, and/or creation of In answere of the instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
6.1 Disposable Circular Stapler
The proposed device, Disposable Circular Stapler is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
It places a double staggered, circular row of titanium staples upon activation, which was actieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created.
The staple is available in two specifications which are 4.8 mm and 5.2 mm to be used per different thickness of the tissue.
6.2 Disposable Linear Staplers and Reloads
The proposed device, Disposable Linear Staplers and Reloads is a sterilized and disposable surgical instrument intended to be used in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
It places a double staggered row of titanium staples and is available in 30 mm, 45 mm, 60mm and 94 mm staple line length for use in various applications. Four staple sizes (3.8mm ,4.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings.
The Disposable Linear Staplers and reloads have two configurations: (1) DLS serials are Disposable I he Disposable Linear Business and (2) DLR serials are reloads for Disposable Linear Staplers. Each of them has various specifications.
6.3 Disposable Hemorrhoidal Stapler
The proposed device, Disposable Hemorrhoidal Stapier is a sterilized and disposable surgical The "proposed" Corner and surgical treatment of hemorrhoids.
It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately It is a set of insultions and photo a knowlar knife blade resects the excess of compressed mucosa. The aller the formation of supres, and them. Sets are commonly used in the procedures for prolapsed and Hemorrhoids. They are also used for sets are ochanced , and circular or semicircular stapling of anorectic tissue is required.
6.4 Disposable Endoscopic Linear Cutter Staplers and Reloads
The proposed device, Disposable Endoscopic Linear Cutter Staplers and Reloads is a sterilized and I ile proposed unstrument, which has applications in abdominal, gynecologic, pediatic and thoracic surgery for resection, and creation of anastomoses. They may be used for thoracter bargery 200 on of liver substance, hepatic vasculature and biliary structures.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The size of the staples is decided by selecting 3.5 mm, or 4.8 mm reload. The Endoscopic Linear Cutter can be adapted for all of the reload sizes available.
The Disposable Endoscopic Linear Cutter Staplers and Reloads have two configurations: (1) DEC The Disposable Endoscopic Linear Cutter Staplers and Reloads, and (2) DER serials are sellas for Disposable Endoscopic Linear Cutter Staplers. Each of them has various specifications. Detail specifications are presented in Section 4.5 Model Description.
6.5 Disposable Linear Cutter Staplers and Reloads
The proposed device, Disposable Linear Cutter Staplers and Reloads is a sterilized and disposable surgical instrument, which has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutter Staplers and Reloads are available in 55 between the two 20 mm and 100 mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 3.8 mm, 4.0mm, 4.5mm and 4.8 mm.
The Disposable Linear Cutter Staplers and Reloads has two configurations: (1) DLC serials is The Disposable Linear Cutter Staplers Disposable Linear Cutter Staplers with Reloads, and (2) DCR serials is Reloads for Disposable Linear Cutter Staplers. Each of them has various specifications.
6.6 Disposable Curved Cutter Stapler
The proposed device, Disposable Curved Cutter Stapler is a sterilized and disposable surgical instrument, which is mainly suitable for low rectal resection and anastomosis of tissues where manual anastomosis is difficult.
It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines.
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 surgical procedures, hemorrhoids, liver substance, hepatic vasculature, biliary structures, gastrointestinal, 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. These tests include:
Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Periormality Tisting, Mercums Tensile Strength of Staple Line Repair and Force Required to Fire Stapler
Endotoxin Limit
Package Integrity, including internal pressure test, dye penetration tests and seal strength test
Shelf Lift
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
page 1/11
JUL 5 2013
3-1
Section 3 510(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: _ K31511
-
- Date of Submission: 04/07/2013
-
- Sponsor Identification
Changzhou Sinolinks Medical Innovation Co., Ltd NO. 10 Ziwei Road, Zhonglou Zone, Changzhou, Jiangsu, 213023,China
Establishment Registration Number: 3008383115
Contact Person: Junchang Yue Position: Quality Department Manager Tel: +86-519-88021676 Fax: +86-519-88021698 Email: junchang.yue@gmail.com
Submission Correspondent 3.
Ms. Diana Hong& Mr. Lee Fu 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
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K131511 page 2/11
Project #: M0172013Aa
Proposed Device Identification 4.
Proposed Device Name: Disposable Circular Stapler
Disposable Linear Staplers and Reloads
Disposable Hemorrhoidal Stapler
Disposable Endoscopic Linear Cutter Staplers and Reloads
Disposable Linear Cutter Staplers and Reloads
Disposable Curved Cutter Stapler
Proposed Device Common Name: Staplers
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 Disposable Circular Stapler have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Linear Staplers and Reloads have application in the resection of transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Disposable Hemorrhoidal Staple have application for general surgical treatment of hemorrhoids.
The Disposable Endoscopic Linear Cutter Staplers and Reloads have applications in general, gynecologic, pediatic and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynesological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
The Disposable Curved Cutter Stapler is intended for transection, and/or creation of In answere of the instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
2
Project #: M0172013Aa
Predicate Device Identification 5.
510(k) Number: K120179
Product Name: REACHTM Surgical Staplers, including:
Circular Staplers with Staples,
Linear Staplers with Single Use Loading Units,
Procedure Sets for Prolapse and Hemorrhoids,
Endoscopic Linear Cutting Staplers with Single Use Loading Units,
Linear Cutting Staplers with Single Use Loading Units
Manufacturer: Reach Surgical, Inc.
510(k) Number: K091322
Predicate Device Name: CONTOURTH Curved Cutter Stapler and Reloads Manufacturer: Ethicon Endo-Surgery, LLC
Device Description 6.
6.1 Disposable Circular Stapler
The proposed device, Disposable Circular Stapler is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
It places a double staggered, circular row of titanium staples upon activation, which was actieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created.
The staple is available in two specifications which are 4.8 mm and 5.2 mm to be used per different thickness of the tissue.
6.2 Disposable Linear Staplers and Reloads
The proposed device, Disposable Linear Staplers and Reloads is a sterilized and disposable surgical instrument intended to be used in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
It places a double staggered row of titanium staples and is available in 30 mm, 45 mm, 60mm and 94 mm staple line length for use in various applications. Four staple sizes (3.8mm ,4.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings.
3
Project #: M0172013Aa
The Disposable Linear Staplers and reloads have two configurations: (1) DLS serials are Disposable I he Disposable Linear Business and (2) DLR serials are reloads for Disposable Linear Staplers. Each of them has various specifications.
6.3 Disposable Hemorrhoidal Stapler
The proposed device, Disposable Hemorrhoidal Stapier is a sterilized and disposable surgical The "proposed" Corner and surgical treatment of hemorrhoids.
It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately It is a set of insultions and photo a knowlar knife blade resects the excess of compressed mucosa. The aller the formation of supres, and them.
Sets are commonly used in the procedures for prolapsed and Hemorrhoids. They are also used for sets are ochanced , and circular or semicircular stapling of anorectic tissue is required.
6.4 Disposable Endoscopic Linear Cutter Staplers and Reloads
The proposed device, Disposable Endoscopic Linear Cutter Staplers and Reloads is a sterilized and I ile proposed unstrument, which has applications in abdominal, gynecologic, pediatic and thoracic surgery for resection, and creation of anastomoses. They may be used for thoracter bargery 200 on of liver substance, hepatic vasculature and biliary structures.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The size of the staples is decided by selecting 3.5 mm, or 4.8 mm reload. The Endoscopic Linear Cutter can be adapted for all of the reload sizes available.
The Disposable Endoscopic Linear Cutter Staplers and Reloads have two configurations: (1) DEC The Disposable Endoscopic Linear Cutter Staplers and Reloads, and (2) DER serials are sellas for Disposable Endoscopic Linear Cutter Staplers. Each of them has various specifications. Detail specifications are presented in Section 4.5 Model Description.
6.5 Disposable Linear Cutter Staplers and Reloads
The proposed device, Disposable Linear Cutter Staplers and Reloads is a sterilized and disposable surgical instrument, which has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutter Staplers and Reloads are available in 55 between the two 20 mm and 100 mm lengths. Reloads are available in four staple sizes to accommodate उन्द
4
Project #: M017
various tissue thicknesses: 3.8 mm, 4.0mm, 4.5mm and 4.8 mm.
The Disposable Linear Cutter Staplers and Reloads has two configurations: (1) DLC serials is The Disposable Linear Cutter Staplers
Disposable Linear Cutter Staplers with Reloads, and (2) DCR serials is Reloads for Disposable Linear Cutter Staplers. Each of them has various specifications.
6.6 Disposable Curved Cutter Stapler
The proposed device, Disposable Curved Cutter Stapler is a sterilized and disposable surgical instrument, which is mainly suitable for low rectal resection and anastomosis of tissues where manual anastomosis is difficult.
It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines.
7. 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. These tests include:
Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Periormality Tisting, Mercums Tensile Strength of Staple Line Repair and Force Required to Fire Stapler
Endotoxin Limit
Package Integrity, including internal pressure test, dye penetration tests and seal strength test Shelf Lift
Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
5
Project #: M0172013A
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The Disposable Circular Stapler have applications | |
| throughout the alimentary tract for the creation of | ||
| end-to-end, end-to-side and side-to-side anastomoses | ||
| in both open and laparoscopic surgeries. | Same | |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Circular Knife | Same |
| Safety Mechanism | Indicator for appropriate range of desired closed | |
| staple height. | ||
| Safety Release for preventing from mis-firing. | Same | |
| Outsider Diameter | 21, 23, 25, 27, 29, 31, 33 mm | Similar |
| Cutting Diameter | 12.4, 15, 17, 18.5, 20, 22.2, 24, mm | Similar |
| Number of Staples | 18, 20, 22, 24, 28, 30 | Similar |
| Closed Staples Height | 2.0, 2.2 mm | Similar |
| Closed Staples Form | Image: Two staples connected at the top | Same |
| Hardness (Circular | ||
| knife) | $\ge$ 380HV0.2 | Same |
| Pressure Resistance | ||
| after Suturing | $\ge$ 3.6kPa | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 3-1 Comparison of Disposable Circular Stapler
Difference in Outsider Diameter, Cutting Diameter, Number of Staples and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, Disposable Circular Stapler, is determined to be Substantially Equivalent (SE) to the predicate device, Circular Staplers with Staples (K120179), in respect of safety and effectiveness.
રેન્ડર્
6
Section 3 510 (k) Summary
Project #: MOI 72013Aa
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The Disposable Linear Staplers and Reloads have | |
| application in the resection or transection of tissue for | ||
| abdominal, gynecological, pediatric and thoracic | ||
| surgical procedures. | Same | |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety Release for preventing from mis-firing. | Same |
| Suture Line Length | 30, 45, 60, 94 mm | Similar |
| Number of Staples | 11, 15, 21, 33 | Same |
| Closed Staples Height | 1.5, 1.8 mm | Similar |
| Closed Staples Form | Image: Two staples connected at the top | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 3-2 Comparison of Disposable Linear Staplers and Reloads
Difference in Suture Line Length, Closed Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, Disposable Linear Staplers and Reloads, is determined to be Substantially Equivalent (SE) to the predicate device, Linear Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.
7
Section 3 510 (k) Summary
Project #: M0172013Aa
r
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The Disposable Hemorrhoidal Staple have | |
| application for general surgical treatment of | ||
| hemorrhoids. | Same | |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Circular Knife | Same |
| Safety Mechanism | Indicator for appropriate range of desired closed | |
| staple height. | ||
| Safety Release for preventing from mis-firing. | Same | |
| Outsider Diameter | 32, 34 mm | Same |
| Cutting Diameter | 23, 25 mm | Same |
| Number of Staples | 32 | Same |
| Closed Staples Height | 1.9 mm | Similar |
| Closed Staples Form | Image: [staples] | Same |
| Hardness (Circular | ||
| knife) | ≥380HV0.2 | Same |
| Pressure Resistance | ||
| after Suturing | >3.6kPa | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 3-3 Disposable Hemorrhoidal Stapler
Difference in Closed Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, Disposable Hemorhoidal Stapler, is determined to be Substantially Equivalent (SE) to the predicate device, Procedure Sets for Prolapse and Hemorrhoids (K120179), in respect of safety and effectiveness.
8
K131511
page 9/11
Section 3 510 (k) Summary
Project #: M0172013AB
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The Disposable Endoscopic Linear Cutter Staplers | |
| and Reloads have 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, hepatic vasculature and biliary | ||
| structures. | Same | |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Linear | Same |
| Safety Mechanism | Green button for preventing from mis-firing. | Same |
| Suture Length | 30, 45, 60 mm | Same |
| Cutting Length | 26, 41, 58 mm | Similar |
| Closed Staples Height | 1.5, 1.9 mm | Similar |
| Closed Staples Form | Same | |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 3-4 Disposable Endoscopic Linear Cutter Staplers and Reloads
Difference in Cutting Length, Closed Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, Disposable Endoscopic Linear Cutter Staplers and Reloads, is determined to be The propose 2011.05, Days to the predicate device, Endoscopic Linear Cutting Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.
9
K131511
page 10/11
Section 3 510 (k) Summary
Project #: M0172013Aa
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The Disposable Linear Cutter Staplers and Reloads | |
| have application in abdominal, gynecological, | ||
| thoracic and pediatric surgery transection, resection, | ||
| and the creation of anastomoses. | Same | |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Linear | Same |
| Safety Mechanism | Safety Release for preventing from mis-firing. | Same |
| Suture Length | 56, 76, 81, 101 mm | Similar |
| Cutting Length | 55, 75, 80, 100 mm | Similar |
| Number of Staples | 32, 38, 42, 52 | Similar |
| Closed Staples Height | 1.5, 1.8 mm | Similar |
| Closed Staples Form | Image: Two circles connected by a line | Same |
| Knife Hardness | $≥$ 380HV0.2 | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 3-5 Disposable Linear Cutter Staplers and Reloads
Difference in Suture Length, Cutting Length, Number of Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is between the proposed and proposed will not affectiveness and safety of the proposed device.
The proposed device, Disposable Linear Cutter Staplers and Reloads, is determined to be Substantially File proposed arries, Linear Cutting Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.
10
K131511
page 11/11
Section 3 510 (k) Summary
Project #: M0172013Aa
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The Disposable Curved Cutter Stapler 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), gynecologic, | ||
| urologic, and thoracic surgical procedures. | Same | |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Circular Knife | Same |
| Safety Mechanism | Safety Release for preventing from mis-firing. | Same |
| Cutting Diameter | 40 mm | Same |
| Row Number of | ||
| Staples | 4 | Same |
| Closed Staples Height | 1.9 mm | Similar |
| Closed Staples Form | Image: Staples Form | Same |
| Knife Hardness | ≥380HV0.2 | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
sable Curved Cutter Stapler 2 4 Dies
Difference in Closed Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, Disposable Curved Cutter Stapler, is determined to be Substantially Equivalent (SE) I he proposed device, Disposable OLI 100 Cutter Stapler and Reloads (K091322), in respect of safety and effectiveness.
11
Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
July 5, 2013 Changzhou Sinolinks Medical Innovation Co., Ltd. % Mid-Link Consulting Co., Ltd. Ms. Diana Hong P.O. Box 120-119 Shanghai, 200120, China
Re: K131511
Trade/Device Name: Disposable Circular Stapler, Disposable Curved Cutter Stapler Disposable Linear Staplers and Reloads, Disposable Hemorrhoidal Stapler, Disposable Endoscopic Linear Cutter Staplers and Reloads, Disposable Linear Cutter Staplers and Reloads
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW " Dated: May 21, 2013 Received: May 28, 2013
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
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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 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 go to http://www.fdg.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131511
Device Name: Disposable Circular Stapler / Disposable Linear Staplers and Reloads / Disposable Hemormoidal Stapler / Disposable Endoscopic Linear Cutter Staplers and Reloads / Disposable Linear Cutter Staplers and Reloads / Disposable Curved Cutter Stapler
Indications For Use:
The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Disposable Hemorrhoidal Staple has application for general surgical treatment of hemorrhoids.
The Disposable Endoscopic Linear Cutter Staplers and Reloads have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.
The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
The Disposable Curved Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131511