The LS Series Linear Stapler and Reloads have application or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The CLC Series Curved Linear Cutter and Reloads 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, and thoracic surgical procedures.
The LC Series Linear Cutter and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses.
The ELC Series Endoscopic Linear Cutter and Single Use Loading Unit have applications in general, abdominal, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.
The proposed device, LS Series Linear Stapler 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. It is available in 30 mm, 45 mm, 60 mm and 90 mm staple line length for use in various applications. Three staple sizes (2.5 mm, 3.5 mm, and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings. It has two configurations: (1) LS serials are staplers, and (2) LSC serials are Reloads. Each of them has various specifications.
The proposed device, CLC Series Curved Linear Cutter and Reloads are sterilized and disposable surgical instrument, which has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures. It 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. It is available in 37mm and 43mm lengths. Two staple sizes (3.8 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. It has two configurations: (1) CLC serials are staplers, and (2) CLCC serials are reloads. Each of them has various specifications.
The proposed device, LC Series Linear Cutter Stapler and Reloads are sterilized and disposable surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, 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. It is available in 60 mm, 80 mm and 100 mm lengths. Three staple sizes (3.8 mm, 4.2mm and 4.5 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings. It has two configurations: (1) LC serials are staplers, and (2) LCC serials are reloads. Each of them has various specifications.
The proposed device, ELC Series Endoscopic Linear Cutter and Single Use Loading Unit are sterilized and disposable-surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection 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. Five staple sizes (2.0mm, 2.5mm, 4.0mm, and 4.8mm) are available to accommodate various tissue thicknesses. Each cartridge could be reloaded no more than 7 times for total 8 firings. It can be adapted for all of the reload sizes available. It has two configurations: (1) ELC-G and ELC-T serials are staplers, and (2) MG and RG serials are cartridges. Each of them has various specifications.
The provided text describes a 510(k) premarket notification for several series of surgical staplers and reloads (LS Series Linear Stapler, CLC Series Curved Linear Cutter, LC Series Linear Cutter, and ELC Series Endoscopic Linear Cutter). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are tied to non-clinical testing performed to show substantial equivalence. The document summarizes performance testing and other evaluations rather than a clinical study with human patients or an AI algorithm's performance.
Here's an analysis based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense for each parameter, but rather compares the proposed device's characteristics and performance to that of a predicate device. The implicit acceptance criterion is that the proposed device must perform "the same" or "similarly" to the predicate device in aspects deemed critical for safety and effectiveness, and any differences must not affect safety and effectiveness.
The non-clinical tests conducted include:
- Performance Testing: Physical Specification, Closed Staple Height Dimensions, Pressure Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair, and Force Required to Fire Stapler.
- Endotoxin Limit
- Package Integrity: Dye penetration tests and seal strength test.
- Shelf Life
Here's a table combining the general performance parameters across the different proposed devices, with the understanding that "Same" implies meeting the implicit acceptance criteria of being equivalent to the predicate device. Where specific values are given for the Proposed Device and "Same" or "Similar" for the Predicate, it means the proposed device meets that value and is considered acceptable in comparison to the predicate.
Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Item | Implicit Acceptance Criteria (Compared to Predicate) | Proposed Device Performance |
|---|---|---|
| General | ||
| Product Code | Must be GDW | GDW |
| Regulation No. | Must be 21 CFR 878.4750 | 21 CFR 878.4750 |
| Class | Must be II | II |
| Intended Use | Must be equivalent to predicate's intended use | Stated as "Same" or equivalent |
| Operation Principle | Must be Manual | Manual |
| Closed Staple Form | Must be "staple form" (Image) | "Image: staple form" (Same) |
| Pressure Resistance after Suturing | $\geq$ 3.6 kPa | $\geq$ 3.6 kPa (Same) |
| Staple Material | Unalloyed Titanium conforms to ASTM F 67-06 | Unalloyed Titanium conforms to ASTM F 67-06 (Same) |
| Stapler Materials | Stainless Steel, Polycarbonate | Stainless Steel, Polycarbonate (Same) |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Irradiation Sterilized, SAL: 10-6 (Same) |
| Endotoxin Limit | 20 EU per Product | 20 EU per Product (Same) |
| Package | Tray with Tyvek Paper | Tray with Tyvek Paper (Same) |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 (Same) |
| Specific to LS Series Linear Stapler | ||
| Safety Mechanism | Safety Release for preventing mis-firing | Safety Release for preventing from mis-firing (Same) |
| Suture Line Length | Similar to predicate | 30, 45, 50, 60, 90 mm |
| Number of Staples | Similar to predicate | 13, 19, 21, 23, 25, 39 |
| Closed Staple Height | Similar to predicate | 1.0, 1.5, 2.0 mm |
| Specific to CLC Series Curved Linear Cutter | ||
| Cutting Mechanism | Curved Knife | Curved Knife (Same) |
| Safety Mechanism | Safety Release for preventing mis-firing | Safety Release for preventing from mis-firing (Same) |
| Cutting Line | Similar to predicate | 37, 43 mm |
| Row Number of Staple | 4 | 4 (Same) |
| Closed Staple Height | Similar to predicate | 1.5, 2.0 mm |
| Hardness (Circular knife) | $\cong$ 380HV0.2 | $\cong$ 380HV0.2 (Same) |
| Specific to LC Series Linear Cutter | ||
| Cutting Mechanism | Linear Knife | Linear Knife (Same) |
| Safety Mechanism | Safety Release for preventing mis-firing | Safety Release for preventing from mis-firing (Same) |
| Suture Length | Similar to predicate | 60, 80, 100 mm |
| Cutting Length | Similar to predicate | 54, 74, 94 mm |
| Number of Staple | Similar to predicate | 64, 84, 104 |
| Closed Staple Height | Similar to predicate | 1.5, 1.8, 2.0 mm |
| Hardness (Circular knife) | $\geq$ 380HV0.2 | $\geq$ 380HV0.2 (Same) |
| Specific to ELC Series Endoscopic Linear Cutter | ||
| Cutting Mechanism | Linear Knife | Linear Knife (Same) |
| Safety Mechanism | Green button for preventing mis-firing | Green button for preventing from mis-firing (Same) |
| Suture Length | Same as predicate | 30, 45, 60 mm |
| Cutting Length | Same as predicate | 26, 41, 56 mm |
| Closed Staple Height | Same as predicate | 0.75, 1.0, 1.5, 1.7, 2.0 mm |
| Hardness (Circular knife) | $\ge$ 380HV0.2 | $\ge$ 380HV0.2 (Same) |
The study that proves the device meets (or is substantially equivalent to) these criteria is the "Non-Clinical Test Conclusion" section, which states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
2. Sample size used for the test set and the data provenance
The document specifies "Non clinical tests were conducted," including "Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair and Force Required to Fire Stapler." It also mentions "Endotoxin Limit," "Package Integrity," and "Shelf Life" tests.
The exact sample sizes for these non-clinical tests are not explicitly stated in the provided text. The data provenance is also not explicitly detailed, but it would have been generated internally by the manufacturer, Touchstone International Medical Science Co., Ltd., likely from their manufacturing and testing facilities. These are generally prospective tests conducted on manufactured devices/lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a non-clinical device submission for surgical staples and cutters. The "ground truth" in this context is established by engineering specifications, material standards (e.g., ASTM F 67-06 for titanium), and performance measurements against those specifications and the predicate device's known performance. There were no human experts establishing a "ground truth" in a diagnostic or clinical sense. The evaluation of test results would be performed by engineers and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is a non-clinical device test for engineering specifications, there is no "adjudication method" involving multiple human readers as would be seen in clinical or image-based AI studies. The data would be analyzed against predetermined engineering specifications and comparison data from the predicate device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for surgical stapling devices, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device evaluation is based on:
- Engineering specifications and design requirements: For parameters like dimensions, materials, and mechanical properties.
- International/Industry Standards: Such as ASTM F 67-06 for titanium.
- Comparison to predicate device performance: The "Same" or "Similar" designations in the comparison tables imply that the predicate device's established performance serves as a benchmark for the proposed device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm, so there is no training set or ground truth establishment for one.
{0}------------------------------------------------
Premarket Notification 510(k) Submission
Section 3 510(k) Summary
Section 3 510(k) Summary
2 5 2014
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: _
Submission Date: 05/08/2014 1.
Sponsor Identification 2.
Touchstone International Medical Science Co., Ltd. 21 A Science Plaza, International Science Park, No.1355 Jinjihu Avenue, Suzhou, 215021 P.R.CHINA
Establishment Registration Number:
Contact Person: Jo.Qiao Position: Management Representative Tel: +86 512 62991985 Fax: +86 512 62991998 Email: tsmo@touchstone.hk
{1}------------------------------------------------
Page 2 of 10 K141367
Premarket Notification 510(k) Submission
- Proposed Device Identification
3.1 Proposed Device for LS Series
Proposed Device Name: LS Series Linear Stapler and Reloads 3.1.1
3.1.2 Proposed Device Common Name: Stapler
3.1.3 Regulatory Information Classification Name: staple, implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery
3.1.4 Intended Use Statement
The LS Series Linear Stapler and Reloads have application or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Device Description 3.1.5
The proposed device, LS Series Linear Stapler 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. It is available in 30 mm, 45 mm, 60 mm and 90 mm staple line length for use in various applications. Three staple sizes (2.5 mm, 3.5 mm, and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings.
It has two configurations: (1) LS serials are staplers, and (2) LSC serials are Reloads. Each of them has various specifications.
{2}------------------------------------------------
1/
Premarket Notification 510(k) Submission
3.2 Proposed Device for CLC Series
Proposed Device Name: CLC Series Curved Linear Cutter and Reloads 3.2.1
Proposed Device Common Name: Stapler 3.2.2
3.2.3 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 3.2.4
The CLC Series Curved Linear Cutter and Reloads 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, and thoracic surgical procedures.
3.2.5 Device Description
The proposed device, CLC Series Curved Linear Cutter and Reloads are sterilized and disposable surgical instrument, which has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures. It 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. It is available in 37mm and 43mm lengths. Two staple sizes (3.8 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.
It has two configurations: (1) CLC serials are staplers, and (2) CLCC serials are reloads. Each of them has various specifications.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the text 'K141367' in a simple, sans-serif font. The text is arranged horizontally, with each character clearly legible. The characters are uniformly sized and spaced, creating a balanced and easily readable sequence.
page 4 of 10
Premarket Notification 510(k) Submission
Proposed Device for LC Series 3.3
Proposed Device Name: LC Series Linear Cutter and Reloads 3.3.1
Proposed Device Common Name: Stapler 3.3.2
3.3.3 Regulatory Information Classification Name: staple, implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery
3.3.4 Intended Use Statement
The LC Series Linear Cutter and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses.
Device Description 3.3.5
The proposed device, LC Series Linear Cutter Stapler and Reloads are sterilized and disposable surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, 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. It is available in 60 mm, 80 mm and 100 mm lengths. Three staple sizes (3.8 mm, 4.2mm and 4.5 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings.
It has two configurations: (1) LC serials are staplers, and (2) LCC serials are reloads. Each of them has various specifications.
{4}------------------------------------------------
K141367
10 Paqe 5 of
Section 3 510(k) Summary
Premarket Notification 510(k) Submission
Proposed Device for ELC Series 3.4
Proposed Device Name: ELC Series Endoscopic Linear Cutter and Single Use Loading Unit 3.4.1
Proposed Device Common Name: Stapler 3.4.2
3.4.3 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 3.4.4
The ELC Series Endoscopic Linear Cutter and Single Use Loading Unit have applications in general, abdominal, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.
3.4.5 Device Description
The proposed device, ELC Series Endoscopic Linear Cutter and Single Use Loading Unit are sterilized and disposable-surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection 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. Five staple sizes (2.0mm, 2.5mm, 4.0mm, and 4.8mm) are available to accommodate various tissue thicknesses. Each cartridge could be reloaded no more than 7 times for total 8 firings. It can be adapted for all of the reload sizes available.
It has two configurations: (1) ELC-G and ELC-T serials are staplers, and (2) MG and RG serials are cartridges. Each of them has various specifications.
{5}------------------------------------------------
Premarket Notification 510(k) Submission
Section 3 510(k) Summary
- Predicate Device Identification 4.
Predicate Device for Disposable Linear Staplers and Reloads 4.1
510(k) Number: K131511
Product Name: Disposable Linear Staplers and Reloads
Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd.
Predicate Device for Disposable Curved Cutter Stapler 4.2
510(k) Number: K131511
Product Name: Disposable Curved Cutter Stapler
Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd.
Predicate Device for Disposable Linear Cutter Staplers and Reloads 4.3
510(k) Number: K131511
Product Name: Disposable Linear Cutter Staplers and Reloads
Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd.
Predicate Device for Endoscopic Linear Cutting Staplers with Single Use Loading Units 4.4 510(k) Number: K120179 Product Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units
Manufacturer: Reach Surgical, Inc.
Non-Clinical Test Conclusion 5.
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 Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair and Force Required to Fire Stapler.
Endotoxin Limit
Package Integrity, including dye penetration tests and seal strength test.
Shelf Life
Substantially Equivalent (SE) Conclusion રું.
The following table compares the device to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
{6}------------------------------------------------
page 7 of 10
Premarket Notification 510(k) Submission
Section 3 510(k) Summary
| Table 3-1 | LS Series Linear Stapler and Reloads | |
|---|---|---|
| Item | Proposed Device | PredicateDevice |
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The LS Series Linear Stapler and Reloads have application in theresection 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, 45,50, 60, 90 mm | Similar |
| Number of Staples | 13, 19, 21, 23, 25,39 | Similar |
| Closed Staple Height | 1.0, 1.5, 2.0 mm | Similar |
| Closed Staple Form | Image: staple form | 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 | Same |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Stanler and Reloads a creat T--L1
Difference in Suture Line Length, Number of Staples, Closed Staple Height. Between the proposed and the 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, LS Series Linear Stapler and Reloads, is determined to be Substantially Equivalent (SE) to the predicate device, Disposable Linear Staplers and Reloads (K131511), in respect of safety and effectiveness.
3- 7
{7}------------------------------------------------
く
Premarket Notification 510(k) Submission
| Table 3-2 CLC Series Curved Linear Cutter and Reloads | ||
|---|---|---|
| Item | Proposed Device | PredicateDevice |
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The CLC Series Curved Linear Cutter and Reloads 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 | Curved Knife | Same |
| Safety Mechanism | Safety Release for preventing from mis-firing. | Same |
| Cutting Line | 37, 43 mm | Similar |
| Row Number of Staple | 4 | Same |
| Closed Staple Height | 1.5, 2.0 mm | Similar |
| Closed Staple Form | Image: staple form | Same |
| Hardness (Circular knife) | $\cong$ 380HV0.2 | Same |
| Pressure Resistance after Suturing | $\geq$ 3.6kPa | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 106 | Same |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
2 CLC Series Curved Linear Cutter and Reloads Toble
Difference in Cutting Line, Closed Staples Height. 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, CLC Series Curved Linear Cutter and Reloads, is determined to be Substantially Equivalent (SE) to the predicate device, Disposable Curved Cutter Stapler(K131511), in respect of safety and effectiveness.
{8}------------------------------------------------
Premarket Notification 510(k) Submission
Section 3 510(k) Summary
| Table 3-3 LC Series Linear Cutter and Reloads | ||
|---|---|---|
| Item | Proposed Device | PredicateDevice |
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The LC Series Linear Cutter and Reloads have applications inabdominal, gynecologic, pediatric and thoracic surgery for resection,transection, and the creation of anastomoses. | Same |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Linear Knife | Same |
| Safety Mechanism | Safety Release for preventing from mis-firing. | Same |
| Suture Length | 60, 80, 100 mm | Similar |
| Cutting Length | 54, 74, 94 mm | Similar |
| Number of Staple | 64, 84, 104 | Similar |
| Closed Staple Height | 1.5, 1.8, 2.0 mm | Similar |
| Closed Staple Form | Image: staple form | Same |
| Hardness (Circular knife) | $≥380HV_{0.2}$ | 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 | Same |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
I inear Cutter and Reloads 1 0 0 ----
Difference in Suture Length , Cutting Length , Number of Staple, Closed Staple Height. 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, LC Series Linear Cutter and Reloads, is determined to be Substantially Equivalent (SE) to the predicate device, Disposable Linear Cutter Staplers and Reloads(K131511), in respect of safety and effectiveness.
{9}------------------------------------------------
.
가
| Item | Proposed Device | PredicateDevice |
|---|---|---|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The ELC Series Endoscopic Linear Cutter and Single Use LoadingUnit have applications in general, abdominal, gynecologic, pediatricand thoracic surgery for resection, transection, and creation ofanastomoses. They may be used for transection and resection of liversubstance, hepatic vasculature and biliary structures. | Same |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Linear Knife | Same |
| Safety Mechanism | Green button for preventing from mis-firing | Same |
| Suture Length | 30, 45, 60 mm | Same |
| Cutting Length | 26, 41, 56 mm | Same |
| Closed Staple Height | 0.75, 1.0, 1.5, 1.7, 2.0 mm | Same |
| Closed Staple Form | Image: staple form | Same |
| Hardness (Circular knife) | $\ge 380\text{HV}_{0.2}$ | Same |
| Pressure Resistance after Suturing | $\ge 3.6\text{kPa}$ | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Same |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
| Table 3-4 ELC Series Endoscopic Linear Cutter and Single Use Loading Unit | ||
|---|---|---|
The proposed device, ELC Series Endoscopic Linear Cutter and Single Use Loading Unit, is determined to be Substantially Equivalent (SE) to the predicate device, Endoscopic Linear Cutting Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.
3- 10
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a globe. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
Touchstone International Medical Science Company, Ltd Mr. Jo Qiao Management Representative 21A Science Plaza, International Science Park No. 1355 Jinjihu Avenue Suzhou, 215021 P.R. CHINA
Re: K141367
Trade/Device Name: LS Series Linear Stapler and Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: May 26, 2014 Received: May 28, 2014
Dear Mr. Qiao:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{11}------------------------------------------------
Page 2 - Jo. Qiao
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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{12}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
KI413b1
Device Name LS Series Linear Stapler and Reloads
Indications for Use (Describe)
The LS Series Linear Stapler and Reloads have application in transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
1 1 1 . 5. 5. 5. 5 5 5 5 3 . 3 . 3 . 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . *** FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/12/Picture/13 description: The image shows the name "Peter Hudson -S" in a simple, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and easy to read. The word "Peter" is followed by "Hudson" and then "-S".
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 Drug 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."
{13}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
| 510(k) Number (if known) |
|---|
| -------------------------- |
KI41367
Device Name
CLC Series Curved Linear Cutter and Reloads
Indications for Use (Describe)
The CLC Series Curved Linear Cutter and Reloads 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, urologic, and thoracic surgical procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
ることができる。 このため、 FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
$$\mathtt{Peter} = \mathtt{\mathtt{\mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}}} \mathtt{\mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}}} \mathtt{\mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt{\mathtt{\mathtt{\bullet}}}} \mathtt{\mathtt$$
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 suppestions for reducing this burden, to:
Department of Health and Human Services Food and Drug 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."
{14}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
KJ41367
Device Name LC Series Linear Cutter and Reloads
Indications for Use (Describe)
The LC Series Linear Cutter and Reloads have applications in abdominal, genecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ----------------... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
PeterFDAson-S
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 Drug 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."
{15}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
K14367
Device Name
ELC Series Endoscopic Linear Cutter and Single Use Loading Unit
Indications for Use (Describe)
The ELC Series Endoscopic Linear Cutter and Single Use Loading Unit have applications in general, abdominal, gynecologic, pediatic and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . ' . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Peter FDAudson-S
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 roview 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 Drug 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."
§ 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.