(89 days)
Not Found
No
The summary describes a mechanical surgical stapler and its reloads. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies are bench tests of mechanical properties.
No
The device is a surgical stapler used for cutting and stapling tissue during various surgical procedures, primarily for transection and creation of anastomoses. It is a surgical tool, not a device intended for direct therapeutic treatment of a disease or condition.
No
The device, the MicroCutter 5/80, is described as a stapler used for surgical procedures involving transection and anastomosis. Its function is to deploy staples and cut tissue, which are therapeutic actions, not diagnostic ones. There is no mention of it being used to gather information about a patient's health status or to identify a disease.
No
The device description clearly describes a physical stapler and staple cartridges made of stainless steel, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical stapler used for transecting and creating anastomoses in various tissues during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a mechanical stapling device that physically cuts and staples 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 compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The MicroCutter 5/80 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The size of the Dextera MicroCutter 5/80TM Blue Reload and Dextera MicroCutter 5/80™ Blue Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the Dextera MicroCutter 5/80™ White Reload and Dextera MicroCutter 5/80TM White Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.0mm. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The Dextera MicroCutter 5/80™ Reloads are deployed using the Dextera MicroCutter 5/80™ Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urologic, thoracic, and pediatric surgical procedures, small and large intestine, and the appendix.
Indicated Patient Age Range
pediatric
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, including staple forming and release, cartridge loading force, cartridge unloading force, cartridge boss strength, cartridge retention during and outside of deployment, dimensional inspection, leak/burst pressure testing, staple form height, and deployment force, was performed. Bench testing was conducted to verify the performance of the staple. The results demonstrated that the subject devices perform as intended and are substantially equivalent to the predicate devices.
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.
K132581, K140118, K140170, K151081
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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2016
Cardica, Inc. Mr. Greg Watson Vice President of Operations 900 Saginaw Drive Redwood City, California 94063
Re: K161137
Trade/Device Name: Dextera Microcutter 5/80™ Blue Reload, Dextera Microcutter 5/80™ Blue Curved Tip Reload, Dextera Microcutter 5/80TM White Reload, Dextera Microcutter 5/80TM White Curved Tip Reload Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: April 21, 2016 Received: April 22, 2016
Dear Mr. Watson:
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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 yours,
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)
Device Name
Dextera MicroCutter 5/80™ Blue Reload; Dextera MicroCutter 5/80™ Curved Tip Blue Reload; Dextera MicroCutter 5/80™ White Reload; Dextera MicroCutter 5/80™ Curved Tip White Reload
Indications for Use (Describe)
The MicroCutter 5/80 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
| 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 - Dextera MicroCutter 5/80™
A. Date Prepared
April 21, 2016
B. 510(k) Owner
Cardica, Inc. 900 Saginaw Drive Redwood City, California 94063 Phone: 650-364-9975 Fax: 650-364-3134
C. Contact Person
Greg Watson Vice President, Operations (650) 331-7163 (office) (949) 412-9808 (cell) watson@cardica.com
D. Device Information
Trade name: Dextera MicroCutter 5/80™ Blue Reload, Dextera MicroCutter 5/80™ Blue Curved Tip Reload, Dextera MicroCutter 5/80™ White Reload and Dextera MicroCutter 5/80TM White Curved Tip Reload
Common name: Staple
Classification Name: Implantable staple
Regulation Number: 21 CFR §878.4750
Product Code: GDW
E. Marketed Predicate Devices
MicroCutter XCHANGE® 30 Blue Cartridge MicroCutter XCHANGE® 30 Blue Curved Tip Cartridge MicroCutter XCHANGE® 30 White Cartridge MicroCutter XCHANGE® 30 White Curved Tip Cartridge (K132581, K140118, K140170 and K151081)
F. Device Description
The size of the Dextera MicroCutter 5/80TM Blue Reload and Dextera MicroCutter 5/80™ Blue Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the Dextera MicroCutter 5/80™ White Reload and Dextera MicroCutter 5/80TM White Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.0mm. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The Dextera MicroCutter 5/80™
4
Reloads are deployed using the Dextera MicroCutter 5/80™ Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.
G. Intended Use
The MicroCutter 5/80™ is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
H. Comparison to Predicate Device
The Dextera MicroCutter 5/80™ Blue Reload, Dextera MicroCutter 5/80TM Blue Curved Tip Reload, Dextera MicroCutter 5/80™ White Reload and Dextera MicroCutter 5/80™ White Curved Tip Reload have minor modifications in comparison to the legally marketed predicate devices. The primary design changes include two minor modifications to the Reloads. These modifications were done to minimize interference and provide a better fit with other Reload components, and to help ensure the Reload is secured within the Stapler. The modifications do not alter the fundamental scientific technology and or intended use of the devices.
I. Non-Clinical Performance Data
Bench testing, including staple forming and release, cartridge loading force, cartridge unloading force, cartridge boss strength, cartridge retention during and outside of deployment, dimensional inspection, leak/burst pressure testing, staple form height, and deployment force, was performed.
J. Conclusion
Bench testing was conducted to verify the performance of the staple. The results demonstrated that the subject devices perform as intended and are substantially equivalent to the predicate devices.