(133 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML, image processing, or data-driven decision making.
No
The devices described are surgical staplers used for mechanical wound closure and tissue resection, which are procedural tools rather than devices that provide therapy for a condition.
No
The provided text describes various types of surgical staplers used for transection, resection, and creation of anastomoses in different surgical procedures. These devices are used for treatment and repair, not for diagnosing conditions.
No
The device description clearly outlines physical, mechanical staplers and their components (staples, knives, handles), indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided text, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed on the patient's body (in vivo), such as creating anastomoses, resecting tissue, and occluding structures. IVDs are used to examine specimens from the body (in vitro) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device descriptions detail mechanical staplers and cutting instruments used during surgery. This aligns with surgical devices, not diagnostic tests performed on samples.
- Performance Studies: The performance studies focus on mechanical properties and tissue interaction (bench tests on swine tissue), which are relevant to surgical devices. IVD performance studies would typically involve evaluating the accuracy and reliability of measurements or analyses performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The devices described are surgical instruments used for mechanical manipulation of tissue during procedures.
N/A
Intended Use / Indications for Use
The Disposable End-to-end Anastomosis Circular Stapler has applications throughout the alimentary tract for the creation of end-to end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
The Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and for transection and resection and resection of pancreas.
The Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection and creation of anastomosis. The stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection of pancreas.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
Disposable End-to-end Anastomosis Circular Stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm and 31mm three specifications. The staple size is 4.8 mm.
Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit places two, triple-staggered rows of progressive or equal titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in staple sizes 2mm-3mm, 3mm-4mm, 2.5mm, 4.0mm. 4.8mm to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.
Linear Cutting Stapler and Single Use Loading Unit places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 7 times for a total 8 firings in a single procedure.
Disposable Hemorrhoidal Circular Stapler is a set of instrument that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler is available in 33mm one specification. The staple size is 4.5mm. It cannot be reloaded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, abdominal, gynecologic, pediatric, thoracic, liver, hepatic vasculature, biliary structures, pancreas, left atrial appendage, anal canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Open and laparoscopic surgeries.
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
Bench test was conducted on swine stomach and intestine tissue for both proposed device and predicate device to determine substantially equivalence. The bench tests include following tests
- Pressure Resistance Test
- Closed Staple Height Test
- Staple Formation Test
- Force Required to Fire Stapler Test
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
- ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- USP 38-NF 33 Bacterial Endotoxins Tests
- ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials; A
- ISO 11137-2: 2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
- ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- ASTM F88/F88-09 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Bench test was conducted on swine stomach and intestine tissue for both proposed device and predicate device to determine substantially equivalence. The bench tests include following tests:
- Pressure Resistance Test
- Closed Staple Height Test
- Staple Formation Test
- Force Required to Fire Stapler Test
No clinical study is included in this submission.
Key Results: Based on the comparison and analysis, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
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.
K062850, K111825, K051301, K061156
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
Chongqing Qmi Surgical Co., Ltd % Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K162947
Trade/Device Name: Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler And Single Use Loading Unit; Linear Cutting Stapler And Single Use Loading Unit: Disposal Hemorrhoidal Circular Stapler
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 24, 2017 Received: January 30, 2017
Dear Ms. Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA mav 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 of medical device
1
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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162947
Device Name
Disposable End-to-end Anastomosis Circular Stapler, Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit, Linear Cutting Stapler and Single Use Loading Unit, Disposable Hemorrhoidal Circular Stapler
Indications for Use (Describe)
The Disposable End-to-end Anastomosis Circular Stapler has applications throughout the alimentary tract for the creation of end-to end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
The Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and for transection and resection and resection of pancreas.
The Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection and creation of anastomosis. The stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection of pancreas.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K162947
-
- Date of Preparation: 03/03/2017
-
- Sponsor Identification
CHONGQING QMI SURGICAL CO., LTD.
A Zone 1st floor, Yangliu Road No.2 North New Zone, Chongqing China
Establishment Registration Number: Not yet registered
Contact Person: Kang Li Position: General Manager Tel: +86-23-67300630 Fax: +86-23-63053502 Email: kang.li@qmimed.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Disposable End-to-end Anastomosis Circular Stapler
Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit Linear Cutting Stapler and Single Use Loading Unit Disposable Hemorrhoidal Circular Stapler Common Name: Stapler and Reload
Regulatory Information
Classification Name: Staple, Implantable Classification: II; Product Code: GDW Subsequent product code: GAG Regulation Number: 21CFR 878.4750 Review Panel: General & Plastic Surgery
Intended Use Statement:
The Disposable End-to-end Anastomosis Circular Stapler has applications throughout the alimentary tract for the creation of end-to end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
The Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecologic, pediatic and thoracic surgery for resection and creation of anastomosis. They may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection and creation of anastomosis. The stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Device Description
Disposable End-to-end Anastomosis Circular Stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go.
5
Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm and 31mm three specifications. The staple size is 4.8 mm.
Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit places two, triple-staggered rows of progressive or equal titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in staple sizes 2mm-3mm, 3mm-4mm, 2.5mm, 4.0mm. 4.8mm to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.
Linear Cutting Stapler and Single Use Loading Unit places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 7 times for a total 8 firings in a single procedure.
Disposable Hemorrhoidal Circular Stapler is a set of instrument that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler is available in 33mm one specification. The staple size is 4.5mm. It cannot be reloaded.
5. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K062850 Product Name: autosuture™ Circular EEATM surgical staplers
Predicate Device 2 510(k) Number: K111825 Product Name: Endo GIATM Staplers
Predicate Device 3 510(k) Number: K051301 Product Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories
Predicate Device 4 510(k) Number: K061156 Product Name: ENDOPATH Linear Cutters and Staplers
Non-Clinical Test Conclusion 6.
6
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
-
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- A USP 38-NF 33 Bacterial Endotoxins Tests
- ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials; A
-
ISO 11137-2: 2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
-
ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- A ASTM F88/F88-09 Standard test method for seal strength of flexible barrier materials.
-
ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Bench test was conducted on swine stomach and intestine tissue for both proposed device and predicate device to determine substantially equivalence. The bench tests include following tests
-
Pressure Resistance Test
-
Closed Staple Height Test
-
Staple Formation Test
-
Force Required to Fire Stapler Test
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device 1 | Item | Proposed Device | Predicate Device 2 | Predicate Device 4 |
|---|---|---|---|---|---|---|
| Product Code | GDW | K062850 | Product Code | GDW | K111825 | K061156 |
| Regulation Number | 21 CFR 878.4750 | Same | Regulation Number | 21 CFR 878.4750 | Same | Same |
| Intended Use | The Disposable End-to-end | |||||
| Anastomosis Circular Stapler has | ||||||
| applications throughout the | ||||||
| alimentary tract for the creation of | ||||||
| end-to end, side-to-side and | ||||||
| end-to-side anastomoses in both open | ||||||
| and laparoscopic surgeries, including | ||||||
| bariatric surgery. | Same | Intended Use | The Universal Endoscopic Linear Cutting Stapler | |||
| and Single Use Loading Unit has applications in | ||||||
| abdominal, gynecologic, pediatric and thoracic | ||||||
| surgery for resection, transection and creation of | ||||||
| anastomosis. They may be used for transection and | ||||||
| resection of liver substance, hepatic vasculature and | ||||||
| biliary structures and for transection and resection | ||||||
| of pancreas. | Same | The ENDOPATH Endocutter 60 Endoscopic | ||||
| Linear Cutter is intended for transection, | ||||||
| resection, and/or creation of anastomoses. | ||||||
| The instrument has application in multiple | ||||||
| open or minimally invasive general, | ||||||
| gynecologic, urologic, thoracic, and | ||||||
| pediatric surgical procedures. It can be used | ||||||
| with staple line or tissue buttressing | ||||||
| materials. | ||||||
| Cutting Mechanism | Circular Knife | Same | Cutting Mechanism | Linear Knife | Same | Same |
| Operation Principle | Manual | Same | Operation Principle | Manual | Same | Same |
| Safety Mechanism | Insurance is used for preventing from | |||||
| mis-firing | Same | Safety Mechanism | Green button is used for preventing from mis-firing | Same | Same | |
| Closed staple height | 2.0mm | Same | Closed staple height | 1.0, 1.5, 1.75, 2.0mm | ||
| 0.75 | 1.0, 1.5, 2.0mm | |||||
| 0.75 | 1.0, 1.5, 1.8mm | |||||
| Closed staple form | Image: staple form | Same | Closed staple form | Image: staple form | Same | Same |
| Sterilization | Irradiation Sterilization | EO Sterilization | Sterilization | Irradiation Sterilization | EO Sterilization | EO Sterilization |
| Endotoxin Limit | 20 EU | Same | Endotoxin Limit | 20 EU | Same | Same |
| Labeling | Conforms with 21 CFR 801 | Same | Labeling | Conforms with 21 CFR 801 | Same | Same |
Table 1 Comparison of Technology Characteristics for Disposable End-to-end Anastomosis Circular Stapler
8
Table 2 Comparison of Technology Characteristics for Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit
9
| Item | Proposed Device | Predicate Device 2 |
|---|---|---|
| Product Code | GDW | K111825 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Linear Cutting Stapler and | |
| Single Use Loading Unit has | ||
| applications in abdominal, | ||
| gynecological, pediatric and thoracic | ||
| surgical procedures for resection, | ||
| transection and creation of | ||
| anastomosis. The stapler may be used | ||
| for occlusion of the left atrial | ||
| appendage in open procedures. They | ||
| may be used for transection and | ||
| resection of pancreas. | Same | |
| Cutting Mechanism | Linear Knife | Same |
| Operation Principle | Manual | Same |
| Closed staple height | 1.5mm, 2.0mm | 1.0mm, 1.5mm, 2.0mm |
| Closed staple form | Image: staple form | Same |
| Sterilization | Irradiation Sterilization | EO Sterilization |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 3 Comparison of Technology Characteristics for Linear Cutting Stapler and Single Use Loading Unit
10
| Item | Proposed Device | Predicate Device 3 |
|---|---|---|
| Product Code | GDW | K051301 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. | Same |
| Cutting Mechanism | Circular Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Insurance is used for preventing from mis-firing | Same |
| Closed staple height | 2.0mm | Same |
| Closed staple form | Image: staple form | Same |
| Sterilization | EO Sterilization | Same |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |
Table 4 Comparison of Technology Characteristics for Disposable Hemorrhoidal Circular Stapler
- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.