(102 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
No
The device aids in surgical procedures (anastomoses) by cutting and stapling tissue, which is a structural intervention, not a therapeutic treatment.
No
Explanation: The device description clearly states its function is to anastomose organs by firing staples and cutting tissue, which are surgical, not diagnostic, procedures. Its intended use is for "end-to-side and side-to-side anastomoses" in the alimentary tract, further confirming its therapeutic, not diagnostic, purpose.
No
The device description clearly describes a physical, mechanical stapler with titanium staples and circular blades, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating anastomoses (surgical connections) within the alimentary tract. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical stapler that physically cuts and staples tissue. It does not involve the examination of samples (like blood, urine, or tissue) outside of the body to diagnose a condition or monitor a patient's health status.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used for treatment.
N/A
Intended Use / Indications for Use
The Disposable Circular Stapler has application throughout the alimentary tract for end-to-side and side-to-side anastomoses.
Product codes
GDW, GAG
Device Description
The Disposable Circular Staplers, can anastomose organs by firing into the tissues of alimentary canal two staggered (interior and exterior) rings of titanium staples and cutting off inside tissue with the circular blades simultaneously. The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. The instrument is activated by squeezing the handles firmly as far as they will go. Immediately after staple formation, the knife blade resects the excess tissue, creating a circular anastomosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
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)
Performance testing included: Visual appearance, Dimensions, Sharpness, Operational Performance, Cutting Performance, Staple formation and closed staple height, Pressure resistance, Corrosion resistance, Packaging performance, Hardness, Firing Force, Energy Testing, and Sterility. Biocompatibility testing was performed. The modifications (new models with different staple sizes and a new adjusting nut shape) did not affect performance, sterility process, materials, or packaging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2017
Changzhou Kangdi Medical Stapler Co., Ltd. % Mr. Charlie Mack Principal Engineer IRC 2091 Oak Drive Lake Havasu City, Arizona 86406
Re: K172561
Trade/Device Name: Disposable Circular Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: October 29, 2017 Received: November 7, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
1000-1050.
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172561
Device Name Disposable Circular Stapler
Indications for Use (Describe)
The Disposable Circular Stapler has application throughout the alimentary tract for end-to-side and side-toside anastomoses.
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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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: November 2, 2017
Company making the submission:
Name - Changzhou Kangdi Medical Stapler Co., Ltd Address - No.16 Kunlun Road, XinBei Zone, Changzhou City, Jiangsu Province, China 213022 Telephone - 86-519-85162780 Fax - 86-519-85139853 Contact - Ms. Eve Zhou Email - charliemack@irc-us.com
Correspondent:
Name: Charles Mack Address: 2091 Oak Drive, Lake Havasu City, Arizona 86406 Telephone: 931-625-4938 Email: charliemack@irc-us.com
Device:
Trade/proprietary names:
| Disposable Circular Stapler | Model KYGWA- 23.5 / 25.5 / 28.5 / 31.5 /
33.5; Model KYGWB- 23.5 / 25.5 / 28.5 /
31.5 / 33.5; Model KYWC- 17.5 / 21.5 /
23.5 / 25.5 / 28.5 / 31.5 / 33.5 |
| ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Common Name: Implantable Staple Classification Name: Staple, implantable
Predicate Device:
This submission is a modification to the previously cleared Changzhou Kangdi Medical Stapler Co., Ltd Disposable Circular Stapler under 510(k) number K100723 with a decision date on
4
04/30/2010.
Classifications Names & Citations:
Classification of the device: Class II Panel: General and Plastic Surgery Product code: GDW, 21CFR878.4750
Description:
General
The Disposable Circular Staplers, can anastomose organs by firing into the tissues of alimentary canal two staggered (interior and exterior) rings of titanium staples and cutting off inside tissue with the circular blades simultaneously. The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. The instrument is activated by squeezing the handles firmly as far as they will go. Immediately after staple formation, the knife blade resects the excess tissue, creating a circular anastomosis.
Indications For Use
Disposable Circular Stapler:
The Disposable Circular Stapler has application throughout the alimentary tract for endto-end, end-to-side and side-to-side anastomoses.
Technical Characteristics:
The Disposable Circular stapler has not changed in basic design. The only difference in the current submitted device is there are new models, using different staple sizes. The KYGWG stapler has a new adjusting nut shape, which does not affect performance. Testing of the staples during insertion and extraction showed that there are no appreciable differences in the energy needed to insert or extract the staples.
5
Performance Test Summary:
The implanted staple is the same material as the predicate device and meets the Standard for Unalloyed Titanium for Surgical Implant Applications.
There is no FDA recognized performance standard for implanted staple and stabler. Therefore, the same testing submitted for the predicate was repeated. The testing was as follows:
-
- Visual appearance
-
- Dimensions
-
- Sharpness
-
- Operational Performance
-
- Cutting Performance
-
- Staple formation and closed staple height
-
- Pressure resistance
-
- Corrosion resistance
-
- Packaging performance
-
- Hardness
- 11.Firing Force
-
- Energy Testing
-
- Sterility
Biocompatibility testing was performed to ensure the stapler was
constructed of material which passes the Biological Evaluation of Medical Devices, parts 1,3,5,6, 10 and 11.
The modifications to the devices have not affected the sterility process, materials or packaging. For verifications, packaging and sterility verfication was completed per USP standards.
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 Disposable Circular Stapler, Models KYGWA/KYGWB/KYGWC are substantially equivalent to predicate devices as described herein.
END