(89 days)
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.
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.
This document is a 510(k) premarket notification for a medical device, specifically surgical stapler reloads (Dextera MicroCutter 5/80™), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against acceptance criteria in the way a new, novel AI/software medical device might.
Therefore, the information requested to describe "the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software medical device is largely not present in this document.
However, I can extract the available relevant information and highlight what is missing based on your request.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of explicit acceptance criteria with corresponding performance metrics in a pass/fail format, as might be found for a software device. Instead, it lists types of bench tests performed.
| Acceptance Criteria (Implicit from Tests) | Reported Device Performance |
|---|---|
| Proper staple formation | "Bench testing, including staple forming and release, ... was performed." (Implied successful formation) |
| Secure staple release | "Bench testing, including staple forming and release, ... was performed." (Implied successful release) |
| Appropriate cartridge loading force | "cartridge loading force... was performed." (Implied within acceptable limits) |
| Appropriate cartridge unloading force | "cartridge unloading force... was performed." (Implied within acceptable limits) |
| Sufficient cartridge boss strength | "cartridge boss strength... was performed." (Implied sufficient strength) |
| Secure cartridge retention | "cartridge retention during and outside of deployment... was performed." (Implied secure retention) |
| Correct dimensions | "dimensional inspection... was performed." (Implied conformity to specifications) |
| Leak/burst pressure integrity | "leak/burst pressure testing... was performed." (Implied meeting pressure integrity requirements) |
| Correct staple form height | "staple form height... was performed." (Implied correct height) |
| Appropriate deployment force | "deployment force... was performed." (Implied within acceptable limits) |
| Overall performance | "The results demonstrated that the subject devices perform as intended and are substantially equivalent to the predicate devices." (General conclusion of meeting requirements) |
Missing Information: Specific quantitative acceptance criteria (e.g., "loading force must be X-Y Newtons") and the precise measured performance values are not provided.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only states "Bench testing... was performed." The number of reloads or test specimens used for each type of test is not detailed.
- Data Provenance: The testing was conducted by Cardica, Inc. (the device manufacturer) as part of their 510(k) submission. It's not relevant in this context to speak of "country of origin of the data" or "retrospective or prospective" as these terms typically apply to clinical studies involving human or animal subjects, or retrospective analysis of medical records for AI/software devices. For bench testing, it refers to internal laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device and study. The "ground truth" for mechanical integrity, staple formation, etc., is established directly by physical measurements and engineering standards, not by expert interpretation.
4. Adjudication method for the test set
This is not applicable to this type of device and study. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human reviewers (e.g., radiologists, pathologists) when establishing ground truth for complex interpretations, typically in AI/software device studies. Bench testing relies on objective measurements.
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
This is not applicable to this type of device and study. An MRMC study is relevant for AI-assisted diagnostic or therapeutic decision-making devices where human reader performance is a key metric. This medical device (surgical stapler reloads) is a surgical tool, not an AI/software diagnostic or assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI/software medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation in this 510(k) submission is based on:
- Engineering specifications and standards: For measurements like dimensions, forces, and heights.
- Physical properties and integrity: For tests like leak/burst pressure and staple formation.
- Comparison to predicate device performance: The ultimate conclusion is often that the new device performs "as intended" and is "substantially equivalent" to the predicate, implying it meets the same functional requirements.
8. The sample size for the training set
This is not applicable as this is not an AI/Software medical device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/Software medical device that uses a training set.
{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
{2}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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.
§ 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.