The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.

Device Description

The MicroCutter XCHANGE™ 30 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. The MicroCutter XCHANGE™ 30 Blue Staple Cartridge is available for deployment with the MicroCutter XCHANGE ™ 30 Stapler which delivers a blue staple (3.5mm) compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (MicroCutter XCHANGE™ 30 Blue Staple Cartridge) and describes its non-clinical performance data for demonstrating substantial equivalence to a predicate device. It is not a study proving the device meets clinical acceptance criteria or describing a comparative effectiveness study involving human readers and AI.

Here's an analysis of the provided information based on your request, highlighting what is present and what is missing because this document focuses on non-clinical data for a 510(k) submission:

1. Table of acceptance criteria and the reported device performance

The document provides a comparative table of technological characteristics between the predicate and subject devices and mentions various tests were conducted. However, it does not explicitly define acceptance criteria as a specific numeric or qualitative threshold for each test directly alongside reported performance data in a clear table format. It states that tests "met design specifications" or "passed."

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Reliability Testing	Meets design specification	Demonstrated device performance and strength meets design specification, post gamma sterilization, transit conditioning, environmental conditioning, and accelerated aging.
Bioburden Testing	Passed per ANSI/AAMI/ISO 11737-1	Passed in accordance with ANSI/AAMI/ISO 11737-1.
Shelf Life Testing	Passed per ASTM F 1980	Completed and passed in accordance with ASTM F 1980.
Biocompatibility Testing	Passed per ISO 10993-1	Completed and passed in accordance with ISO 10993-1 requirements.
Tissue Leak Pressure (Bench)	No statistical difference vs. predicate (p>0.05)	No statistical difference as compared to Covidien ENDO GIA Universal blue staple cartridge: p>0.05.
Other technological characteristics (e.g., staple material, size, deployment)	"No Change" compared to predicate	Subject device characteristics were "No Change" from predicate, implying they meet the predicate's established performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the "test sets" for the listed non-clinical tests. It refers to "design verification testing."

Sample Size: Not specified for individual tests.
Data Provenance: Not specified, but implied to be internal testing by Cardica, Inc. (Redwood City, California, USA). The tests are non-clinical bench tests.
Nature: The testing described is prospective, as it was conducted to verify a design modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this document. The tests described are non-clinical (mechanical, biological, physical) and do not involve human experts establishing ground truth for a diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. No adjudication method is described as the tests are non-clinical engineering and biological assessments.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical testing for a surgical stapler, not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This document describes the performance of a physical medical device (surgical stapler component), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" implicitly refers to engineering specifications, regulatory standards (e.g., ISO, ASTM, ANSI/AAMI), and established performance of the predicate device. For instance, 'Bioburden testing passed in accordance with ANSI/AAMI/ISO 11737-1' means the standard itself defines the acceptable reference. 'No statistical difference as compared to Covidien ENDO GIA Universal blue staple cartridge' means the predicate device's performance sets the benchmark.

8. The sample size for the training set

This information is not applicable. This document describes the testing of a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. As no AI algorithm or training set is involved, there is no "ground truth for the training set" to establish.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "cardica" in a stylized font. The word is positioned between two curved lines that resemble a stylized arrow or a design element. The font appears to be a sans-serif typeface, and the overall design has a clean and modern aesthetic.

K140118 Special 510(k) MicroCutter XCHANGETM 30

Attachment 1 510(k) Summary

510(k) Summary - MicroCutter XCHANGE™ 30 Blue Staple Cartridge

FEB 2 5 2014

Date Prepared A.

January 15, 2014

B. . Applicant Information

Cardica, Inc. 900 Saginaw Drive Redwood City, California 94063 Main: 650-364-9975 Fax: 650-364-3134

C. Contact Person

ﺮ

Vee Arya Senior QA/RA Manager

(650) 331-7152 direct (650) 644-7339 mobile (650) 331-7195 fax arya@cardica.com

Alternate Contact: Frederick Bauer Vice President of Operations

(650) 331-7163 direct (650) 331-7195 fax bauer@cardica.com

D. Establishment Registration Number

3004114958

E. Device Information

Device Class: Class II Common, Usual or Classification Name: Staple, Implantable Regulation Number: 21 CFR §878.4750 Product Code: GDW

r. Trade Name

MicroCutter XCHANGETM 30 Blue Cartridge

G. Legally Marketed Predicate Device(s) MicroCutter XCHANGETM 30 (K132581)

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "cardica" in a stylized font. The word is positioned between two curved lines, one above and one below. There is a small circle above and to the right of the letter "a".

K140118 Special 510(k) MicroCutter XCHANGETM 30

H. Device Description

l. Indications for Use

The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.

J. Comparison to Predicate Device

The subject MicroCutter XCHANGE™ 30 Blue Staple Cartridge (polyarylamide) is equivalent in its Indications for Use to the predicate MicroCutter XCHANGE™ 30 Blue staple cartridge (LCP) (K132581). The only modification is a change to the material used for the distal tip of the cartridge insert component from liquid crystal polymer (LCP) to polyarylamide supplied by a vendor. The implantable staple remains unchanged, and there are no other changes to design, operation or materials of the stapler or cartridge except the distal material and colorant of the cartridge insert component within the MicroCutter XCHANGETM 30 Blue Cartridge.

K. Technological Characteristics

The technological characteristics of the subject MicroCutter XCHANGE™ 30 Blue Staple Cartridge (polyarylamide) are substantially equivalent to the predicate device as demonstrated through verification testing as indicated in Section L "Non-clinical Performance Data" and table below.

The subject MicroCutter XCHANGE™ 30 Blue Staple Cartridge has similar features as compared to the predicate device as shown in table below:

Feature	PREDICATE DEVICEMicroCutter XCHANGE 30Blue Staple Cartridge (LCP)(K132581)	SUBJECT DEVICEMicroCutter XCHANGE 30Blue Staple Cartridge (IXEF)
Deployment Device
Deployment	Cartridge based deployment(up to 6 deployments per tool)for single patient use	No Change
Shaft Length	340mm	No Change
Transection Line Length	27mm	No Change
End-Effector Opening	2.4mm at tissue stop(proximal);11.7mm at distal opening	No Change
Shaft Rotation	360°	No Change
Articulation	160° (80° each direction)	No Change
Staple
Staple Material	Stainless steel (316L)	No Change
Unformed Staple height	3.22mm	No Change
Formed Staple Height	1.4mm (compatible with tissue thickness that can becompressed easily to 1.50mm)	No Change
Formed StapleConfiguration	D shaped	No Change
Feature	PREDICATE DEVICEMicroCutter XCHANGE 30Blue Staple Cartridge (LCP)(K132581)	SUBJECT DEVICEMicroCutter XCHANGE 30Blue Staple Cartridge (IXEF)
Staple Line Configuration	Two (2), double-staggeredrows	No Change
Staple Line Length	30mm	No Change
Number of Staples PerDeployment	50 (One row of 13 and onerow of 12 on either side oftransaction line)	No Change
MRI Compatibility	MR-Conditional	No Change
Biocompatibility
Material Biocompatibility(Delivery Device andStaple)	All components of theCardica MicroCutterXCHANGE 30 are comprisedof materials that were deemedacceptable in accordance withISO Standard 10993-1.	No Change
Staple CartridgeCartridge Insert	Liquid Crystal Polymer (LCP)and Stainless Steel	Polyarylamide replacing LCP isthe only change. Detailedinformation on the polyarylamidematerial was provided viareferencing to a Device MasterFile owned by the manufacturerof this material.
Staple Cartridge Packaging, Sterilization and Shelf Life
Packaging	Tyvek andNylon/LDPE/HDPEcoextrusion film Pouch	No Change
Sterilization	Gamma radiation	No Change
Sterility Assurance Level	10-6	No Change
Shelf Life	12 months	No Change
Performance
Tissue Leak Pressure(Bench)	No statistical difference ascompared to Covidien ENDOGIA Universal blue staplecartridge : p>0.05	No Change

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "cardica" in a stylized font. The word is written in lowercase letters. There are lines above and below the word, and a symbol after the word.

K140118 Special 510(k) Special 510(k)

MicroCutter XCHANGE™ 30

L. Non-Clinical Performance Data

This modification was verified through design verification testing. Bench testing was

ﺗ

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "cardica" in a stylized font. The word is positioned between two curved lines, one above and one below. There is a registered trademark symbol after the word.

conducted and the results demonstrated substantial equivalence to the predicate devices, and that the MicroCutter XCHANGE TM 30 Blue Staple Cartridge (polyarylamide) met design specifications. A summary of the design requirements evaluated were as follows:

Reliability testing was completed and demonstrated that device performance and . strength with the material change meets design specification, post gamma sterilization. transit conditioning, environmental conditioning, and accelerated aging.
. Bioburden testing was conducted and passed in accordance with ANSI/AAMI/ISO 11737-1 Sterilization of Medical Devices- Microbiological Methods Part I: Estimation of Population of Microorganisms on Products.
. Shelf life testing was completed and passed in accordance with ASTM F 1980.
Biocompatibility testing was completed and passed in accordance with ISO � 10993-1 requirements.

M. Clinical Performance

The modification was fully verified through design testing described in Section L above, and does not require a clinical study.

N. Conclusions

The subject MicroCutter XCHANGE™ 30 Blue Staple Cartridge ( polyarylamide has been carefully compared to a legally marketed device, MicroCutter XCHANGE™ 30 Blue Staple Cartridge (LCP), with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to verify the performance of the device and ensure the MicroCutter XCHANGE™ 30 Blue Staple Cartridge (polyarylamide) functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device for its intended use.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling a human figure with outstretched arms, composed of three curved lines. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2014

Cardica Incorporated Ms. Vee Arya Senior Quality Assurance/Regulatory Affairs Manager 900 Saginaw Drive Redwood City, California 94063

Re: K140118

Trade/Device Name: MicroCutter XCHANGE" 30 Blue Cartridge Regulation Number: 21 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 28, 2014 Received: January 29, 2014

Dear Ms. Arya:

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

{5}------------------------------------------------

Page 2 - Vee Arya

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) . K140118

Device Name

MicroCutter XCHANGE™ 30 Blue Cartridge

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/6/Picture/13 description: The image shows the name "David Krause -S" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct appearance. The name is written in all caps, with a dash separating the last name from the letter "S".

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 443-6746 EF

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

{7}------------------------------------------------

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."

Regulation Number and Section

§ 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.