(100 days)
Not Found
No
The device description and performance studies focus on mechanical function and material biocompatibility, with no mention of AI/ML or related concepts.
Yes
A therapeutic device is one that treats or intervenes in a disease or condition. This device, a linear stapler/cutter, is used in surgical procedures like resection, transection, and the creation of anastomosis, which directly treats or intervenes in a medical condition.
No
Explanation: The device is a surgical stapler/cutter used for transaction, resection, and anastomosis of tissues. Its intended use is to approximate internal tissues or cut them, not to diagnose a condition.
No
The device description clearly details physical components (staples, instrument sizes, adjustable staple height) and bench testing related to mechanical function (energy to deliver/remove staples), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes surgical procedures for transaction, resection, and creation of anastomosis of internal tissues. This is a direct surgical intervention on the body.
- Device Description: The device is a surgical stapler/cutter that physically manipulates tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
Disposable Linear Stapler:
The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues.
Disposable Linear Cutter:
The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
General
Disposable Linear Stapler
The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in a variety of sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness. The model number defines the staple line. For example, the 30 mm instruments create a 30-mm staple line, the 45 mm instruments create a 45-mm staple line, the 60 mm instruments create a 60-mm staple line and the 90 mm instruments create a 90-mm staple line.
Disposable Linear Cutter
The disposable linear cutter and the cartridge for disposable linear cutter have applications in abdominal gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, internal tissues, abdominal, gynecological, pediatric, thoracic
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)
Bench testing was performed to demonstrate the energy to deliver staples and also to remove staples was consistent with the predicate device.
Biocompatibility testing was performed to ensure the stapler and cutters were constructed of material which passes the ISO 10993 benchmarks. The devices successfully passed tests for ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11.
The modifications to the devices have not affected the sterility process, materials or packaging. For verifications, packaging and sterility verfications were completed.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2017
Changzhou Kangdi Medical Stapler Co. Ltd. % Mr. Charlie Mack Principal Engineer IRC 2091 Oak Drive Lake Havasu City, Arizona 86406
Re: K172538
Trade/Device Name: Disposable Linear Stapler, Disposable Linear Cutter Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: August 12, 2017 Received: August 22, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K172538
Device Name Disposable Linear Stapler Disposable Linear Cutter
Indications for Use (Describe) Disposable Linear Stapler:
The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues.
Disposable Linear Cutter:
The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
X 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: August 13, 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. EveZhou 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 Linear Stapler | KFD-30L, KFD-30H, KFD-45L, KFD-45H, KFD-60L, KFD-60H, KFD-90L, KFD-90H |
|---|---|
| KYFA-30L, KYFA-30H, KYFA-45L, KYFA-45H, KYFA-60L, KYFA-60H, KYFA-90L, KYFA-90H | |
| KYFB-30L, KYFB-30H, KYFB-45L, KYFB-45H, KYFB-60L, KYFB-60H, KYFB-90L, KYFB-90H | |
| Disposable Linear Cutter | KYQ-60L, KYQ-60H, KYQ-80L, KYQ-80H, KYQ-100L, KYQ-100H |
| KYQB-60L, KYQB-60H, KYQB-80L, KYQB-80H, KYQB-100L, KYQB-100H |
Common Name: Implantable Staple Classification Name: Staple, implantable
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Predicate Device:
This submission is a modification to the previously cleared Changzhou Kangdi Medical Stapler Co., Ltd Disposable Linear Cutter and Disposable Linear Stapler under 510(k) number K121474 with a decision date on 07/16/2012.
Classification
21 CFR 878.4750, Implantable staple, Class II, GDW
Description:
General
Disposable Linear Stapler
The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in a variety of sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness. The model number defines the staple line. For example, the 30 mm instruments create a 30-mm staple line, the 45 mm instruments create a 45-mm staple line, the 60 mm instruments create a 60-mm staple line and the 90 mm instruments create a 90-mm staple line.
Disposable Linear Cutter
The disposable linear cutter and the cartridge for disposable linear cutter have applications in abdominal gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
Indications For Use
Disposable Linear Stapler:
The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues.
Disposable Linear Cutter:
The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
5
Technical Characteristics:
The Disposable Linear cutter and Disposable Linear cutter have not changed in basic design. There is no change to the staples in material or structure. The only difference in the current submitted device is the firing knob and the handles. 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.
Test Summary:
In order to establish substantial equivalence to the identified predicate device. the following tests were performed:
Bench testing was performed to demonstrate the energy to deliver staples and also to remove staples was consistent with the predicate device.
Biocompatibility testing was performed to ensure the stapler and cutters were constructed of material which passes the ISO 10993 benchmarks. The devices successfully passed tests for ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11.
The modifications to the devices have not affected the sterility process, materials or packaging. For verifications, packaging and sterility verfications were completed.
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 Linear Stapler. Model KYFB and Disposable Linear Cutter, Model KYQII are substantially equivalent to predicate devices as described herein.
END