(63 days)
Not Found
No
The device description and performance studies focus on mechanical aspects and physical properties, with no mention of AI/ML or data processing for decision-making.
Yes.
The device is a surgical instrument used for transection, resection, and creation of anastomoses, which are therapeutic medical procedures.
No
Explanation: The device description states that the devices are "sterilized and disposable surgical instruments intended to be used in the resection of tissue" and for creating anastomoses, which are surgical procedures, not diagnostic ones.
No
The device description clearly outlines physical surgical instruments (staplers and reloads) made of titanium, with specific dimensions and mechanical functions. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for surgical procedures involving the transection, resection, and creation of anastomoses of tissue within the body. This is a surgical instrument used in vivo.
- Device Description: The description details a surgical stapler and its components, used to physically manipulate and join tissue during surgery.
- 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) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical instrument used for therapeutic purposes in vivo, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal, Gynecological, Pediatric, Thoracic (for LS, LC, ELC series)
Abdominal (gastrointestinal and skeletal muscle), Gynecologic, Urologic, Thoracic (for CLC series)
Liver substance, hepatic vasculature and biliary structures (for ELC series)
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 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
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
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 | Predicate |
| Device | ||
| 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 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, 45,50, 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 | Predicate |
| Device | ||
| 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 | Predicate |
| Device | ||
| 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 in | |
| abdominal, 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 | Predicate
Device |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 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 Loading
Unit have applications in general, abdominal, 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 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."