(13 days)
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.
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.
The provided text is a 510(k) Summary for a medical device (Disposable Circular Stapler) and the FDA's response. It does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the way typically expected for an AI/CADe device. The "Testing Conclusion" section states: "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." However, it does not provide details about what those design specifications (acceptance criteria) were, nor does it describe the study that was conducted.
Therefore, most of the requested information cannot be extracted from the provided document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," but it does not list these specific design specifications (acceptance criteria) or the quantitative results of the device's performance against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. The document states "Performance testing was conducted," but it does not specify any test set size, data provenance, or the nature of the data (e.g., in-vitro, ex-vivo, in-vivo animal, or human clinical data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. There is no mention of ground truth establishment by experts for a test set, as this is not a study of diagnostic accuracy or similar performance for which expert consensus would typically be required. The device is a surgical stapler, and its performance evaluation would likely involve mechanical and functional testing, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. As there's no mention of a test set or expert involvement, adjudication methods are not applicable and not discussed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This is not an AI/CADe device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. This is a physical surgical device, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. The concept of "ground truth" as typically applied in AI/CADe studies (e.g., for diagnostic accuracy) does not directly apply to the performance testing of a mechanical surgical stapler. Its "ground truth" would likely be defined by engineering specifications, material properties, and functional tests (e.g., staple formation, burst pressure, tissue compression, leak tests). The document does not detail these.
8. The sample size for the training set:
- Cannot be provided. The device is a physical stapler, not a machine learning model, so there is no training set in the context of AI.
9. How the ground truth for the training set was established:
- Cannot be provided. As above, there is no training set for this type of device.
In summary: The provided document is a 510(k) summary for a physical surgical device. It states that performance testing was conducted to verify that the device met design specifications and was substantially equivalent to a predicate device. However, it does not provide the specific details of these design specifications (acceptance criteria) or the methodology, sample sizes, or results of the performance testing in the manner typically expected for a detailed study report of an AI/CADe device. The questions posed are primarily relevant to AI/CADe device evaluation, which is not what this document addresses.
{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.,LtdNo.9, Wujin Rd, Wujin Hi-Tech Industry ZoneChangzhou, Jiangsu, 213164, China |
| Correspondent: | Ms. Diana Hong / Mr. Lee FuShanghai Mid-Link Business Consulting Co., LtdSuite 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 tractfor the creation of end-to-end and end-to-side anastomosis. |
| Device Description: | The Disposable Circular Stapler places a circular, double staggered row of titaniumstaples and resects the excess tissue, creating a circular anastomosis. The instrumentis activated by squeezing the handle firmly as far as it will go. It is applicable toend-to-end and end-to-side anastomosis. The proposed device is provided EOsterilized. |
| Testing Conclusion: | Performance testing was conducted to validate and verify that the proposed device,Disposable Circular Stapler met all design specifications and was substantiallyequivalent to the predicate device. |
| SE Conclusion: | The proposed device, Disposable Circular Stapler is claimed to be substantiallyequivalent to the predicate device, ChexTM Single Use Curved Intraluminal CircularStapler 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 |
|---|---|
| --------------- | --------- |
§ 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.