(13 days)
No
The description focuses on mechanical function (stapling, resecting tissue) and does not mention any computational or learning capabilities.
No
The device is used to create anastomoses, which is a surgical procedure, but it does not directly treat a disease or condition itself. It's a surgical tool.
No
The device, a Disposable Circular Stapler, is used for creating anastomoses by placing staples and resecting tissue during surgical procedures. It does not collect or analyze data to inform a diagnosis.
No
The device description clearly describes a physical, mechanical stapler used for surgical procedures, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable Circular Stapler is a surgical instrument used during a procedure to create connections (anastomoses) within the alimentary tract. It physically manipulates tissue.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is mechanical.
Therefore, based on the provided information, the Disposable Circular Stapler is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Disposable Circular Stapler is intended to be used throughout the alimentary tract for the creation of end-to-end and end-to-side anastomosis.
Product codes
GDW
Device Description
The Disposable Circular Stapler places a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. It is applicable to end-to-end and end-to-side anastomosis. The proposed device is provided EO sterilized.
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 was conducted to validate and verify that the proposed device, Disposable Circular Stapler met all design specifications and was substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Chex™ Single Use Curved Intraluminal Circular Stapler as cleared in K090821.
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
MAR - 1 2010
.
:
510(k) Summary .
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date of Submission: | February 2, 2010 |
|---|---|
| Sponsor: | Changzhou Waston Medical Appliance Co.,Ltd |
| No.9, Wujin Rd, Wujin Hi-Tech Industry Zone | |
| Changzhou, Jiangsu, 213164, China | |
| Correspondent: | Ms. Diana Hong / Mr. Lee Fu |
| Shanghai Mid-Link Business Consulting Co., Ltd | |
| Suite 8D, No.19, Lane 999,Zhongshan Road (S-2),Shanghai, 200030, China | |
| Proposed Device | Disposable Circular Stapler WH-Y-25 / WH-Y-29 / WH-Y-32 |
| Classification: | Class II, GDW, 878.4750 |
| Predicate Device: | Chex™ Single Use Curved Intraluminal Circular Stapler as cleared in K090821. |
| Intended Use: | The Disposable Circular Stapler is intended to be used throughout the alimentary tract |
| for the creation of end-to-end and end-to-side anastomosis. | |
| Device Description: | The Disposable Circular Stapler places a circular, double staggered row of titanium |
| staples and resects the excess tissue, creating a circular anastomosis. The instrument | |
| is activated by squeezing the handle firmly as far as it will go. It is applicable to | |
| end-to-end and end-to-side anastomosis. The proposed device is provided EO | |
| sterilized. | |
| Testing Conclusion: | Performance testing was conducted to validate and verify that the proposed device, |
| Disposable Circular Stapler met all design specifications and was substantially | |
| equivalent to the predicate device. | |
| SE Conclusion: | The proposed device, Disposable Circular Stapler is claimed to be substantially |
| equivalent to the predicate device, ChexTM Single Use Curved Intraluminal Circular | |
| Stapler as cleared in K090821. |
1
: | "
. j
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered in the image. The font is a serif font, and the text is black.
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is relatively small compared to the eagle symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR - 1 2010
Changzhou Watson Medical Applicance Co., Ltd. % Shanghai Mid-Link Business Consulting Co., Ltd. Ms. Diana Hong Suite SD, No. 19, Lane 999 Zhongshan Road (S-2) Shanghai, 200003, China
Re: K100386
Trade/Device Name: Disposable Circular Stapler WH-Y-25/WH-Y-29/WH-Y-32 Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: February 11, 2010 Received: February 16, 2010
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 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
2
Page 2 - Ms. Diana Hong
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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Barbara Buemp
Mark N. Melkerson for
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
KIO0386
Device Name: Disposable Circular Stapler
Indications for Use:
The Disposable Circular Stapler is intended to be used throughout the alimentary tract for the creation of end-to-end and end-to-side anastomosis.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K100386 |
|---|---|
| --------------- | --------- |