(46 days)
The Disposable Circular Stapler has application throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses.
The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. After the deploying of the instrument, the circular knife blade inside the instrument can cut off excess tissue automatically to create a circular anastomosis. The instrument is fired by squeezing the trigger handle firmly as far as it will go. The size of the anastomosis site is determined by the diameter of the selected circular knife blade.
The provided 510(k) summary (K100723) describes the Changzhou Kangdi Medical Stapler Co., Ltd. Disposable Circular Stapler. However, it does not contain information related to acceptance criteria or a study proving that an AI-driven device meets such criteria.
The document describes a medical device, a surgical stapler, and its equivalence to a predicate device. The performance testing section focuses on biocompatibility, general device performance standards (for implanted titanium), and package integrity/shelf-life assessments. These are all related to the physical and functional aspects of the hardware device, not an AI or software component.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or AI-related effectiveness studies, as these details are not present in the given text.
In summary, the provided text describes a traditional hardware medical device and its predicate equivalence, not an AI-driven device.
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K100723 Page 1/6
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: October 17, 2009
APR 3 0 2010
- Company and Correspondent making the submission:
Name - Changzhou Kangdi Medical Stapler Co., Ltd.
Address - No.16, Kunlun Road, Xinbei Zone,
Changzhou Jiangsu, China 213022
Telephone — +86-519-85162780
Fax - +86-519-85139853
Contact - Fleming Jiang, Quality Manager
Email - jiangmingfang@kanghui-china.com
- Device :
Trade/proprietary name: Disposable Circular stapler
Common Name
Classification Name : Staple, implantable
Predicate Devices:
| Manufacturer | Device Name | 510(k) Number |
|---|---|---|
| Ethicon Endo-Surgery, Inc. | Endopath ILS EndoscopicCircular Stapler25mm, 29mm | K920752 |
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K100723 page 2/6
-
- Classifications Names & Citations :
21CFR 878.4750, GDW, Implantable Staple
- Classifications Names & Citations :
-
- Description :
- 4.1 General
The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. After the deploying of the instrument, the circular knife blade inside the instrument can cut off excess tissue automatically to create a circular anastomosis. The instrument is fired by squeezing the trigger handle firmly as far as it will go. The size of the anastomosis site is determined by the diameter of the selected circular knife blade.
-
- Indication for use :
The Disposable Circular Stapler has application throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses.
- Indication for use :
-
- Comparison with predicate device: Please see next page for the comparison table.
Page 23 of 155
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| Features & Description | Changzhou Kangdi Medical Stapler Co., Ltd Disposable Circular Stapler (DCS) 25.5mm, 28.5mm | Predicate |
|---|---|---|
| Name | Changzhou Kangdi Medical Stapler Co., Ltd Disposable Circular Stapler KYGW-25.5, KYGW-28.5 | Ethicon Endo-Surgery, Inc. Endopath ILS Endoscopic Circular Stapler 25mm, 29mm |
| Manufacturer of Record | Changzhou Kangdi Medical Stapler Co., Ltd | Ethicon Endo-Surgery, Inc. |
| Contract Manufacturer | Changzhou Kangdi Medical Stapler Co., Ltd | Ethicon Endo-Surgery, Inc |
| 510(k) Clearance Numbers | Subject of this Notification | K920752 |
| Intended use | Applications throughout the alimentary Tract for end-to-end, end-to-side and Side-to-side anastomoses. | Applications throughout the alimentary Tract for end-to-end, end-to-side and Side-to-side anastomoses. |
| Contraindications | Same, refer to labeling | Same, refer to labeling |
| FDA Class (System) | Class II | Class II |
| Sizes | 25.5mm, 28.5mm Circular Staplers | 25mm, 29mm Circular Staplers |
| Staple Shape | B-Shaped | B-Shaped |
| Features & Description | Changzhou Kangdi Medical Stapler Co.,LtdDisposable Circular Stapler25.5mm, 28.5mm | PredicateEthicon Endo-Surgery, Inc.Endopath ILS Endoscopic Circular Stapler25mm, 29mm |
| Closed Staple Height | 1.5mm-2.0mm | 1.0mm-2.5mm |
| Staple Material | ISO 5832-2: Implants for surgery - Metallicmaterials - Part 2: Unalloyed Titanium | ISO 5832-2: Implants for surgery - Metallicmaterials - Part 2: Unalloyed Titanium |
| Knife Material | Stainless steel | Stainless steel |
| Stapler Material | Polymeric materials, surgical grade stainless steelsand lubricants | Polymeric materials, surgical grade stainlesssteels, adhesives, and lubricants |
| Cutting Mechanism | Circular Knife | Circular Knife |
| DCS Internal Power | None | None |
| Power | Manually powered | Manually powered |
| Energy to bend Staple | 17.5 N | Similar |
| Software containing | No | No |
| Digital Information | None | None |
| How Supplied | Sterile-Single Patient Use | Sterile-Single Patient Use |
| Features & Description | Changzhou Kangdi Medical Stapler Co.,LtdDisposable Circular Stapler25.5mm, 28.5mm | PredicateEthicon Endo-Surgery, Inc.Endopath ILS Endoscopic Circular Stapler25mm, 29mm |
| Safety Mechanism | Contains indicators for appropriateRange for desired closed staple height,but can be deployed out of range | Contains indicators for appropriateRange for desired closed staple height,but can be deployed out of range |
| Staples per Clip | 20 for 25.5; 24 for 28.5 | 20 for 25mm; 24 for 29mm |
| Energy to Remove | 2.8-4.3 N | Same |
| Accuracy of B bend per clip | 100% | 100% |
| Insertion Mechanism | Rigid | Rigid |
| Method of Sterilization | Irradiation | Irradiation |
| Packaging | Blister Tray with Tyvek Lid | Blister Tray with Tyvek Lid |
.
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K100 723 page 3/6
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Page 25 of 155
K100723 po
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K100723 Asqe 5/6
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K100723 pag 6/6
-
- Performance Testing Section:
In order to establish substantial equivalence to the identified predicate device's) we performed the following tests: for biocompatibility we performed cytotoxicity, sensitization, irritation and acute systemic toxicity testing and the results of the testing provided evidence that the device was biocompatible. For assessment of device performance characteristics we assured that the device met all performance standards for implanted titanium and for package integrity and shelf life assessments following sterilization we assessed the results of the Tensile Seal Strength Test, Package Verification Test, Vacuum Leak Test, Impermeability Fusion Test, Agar Contact-Attack Test and Accelerated Aging Testing. The results of all of these tests provided evidence that the subject device was substantially equivalent to the predicate device.
- Performance Testing Section:
8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Changzhou Kangdi Medical Stapler Co., Ltd. concludes that , models KYGW-25.5 and KYGW-28.5 is substantially equivalent to predicate devices as described herein.
-
- Changzhou Kangdi Medical Stapler Co., Ltd. will update and include in a summary any other information deemed seasonably necessary by the FDA.
END
- Changzhou Kangdi Medical Stapler Co., Ltd. will update and include in a summary any other information deemed seasonably necessary by the FDA.
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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Changzhou Kangdi Medical Stapler Co., Ltd. % International Regulatory Consultants, LLC Mr. Charlie Mack 77325 Joyce Way Echo, Oregon, 97826
APR 30 2010
Re: K100723
Trade/Device Name: Disposable Circular Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 7, 2010 Received: March 15, 2010
Dear Mr. Mack:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Charlie Mack
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Indications for Use
510(k) Number (if known):
Device Name: Disposable Circular Stapler, Models KYGW-25..5 and KYGW-28.5
Indications for Use:
The Disposable Circular Stapler has application throughout the alimentary tract for endto-end, end-to-side and side-to-side anastomoses.
Prescription Use イ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krane for MXM
(Division Sign-Off)
Division
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100773
§ 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.