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 White Cartridge is available for deployment with the MicroCutter XCHANGE ™ 30 Stapler and delivers a staple (2.8mm) compatible with tissue that can be compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MicroCutter XCHANGE™ 30 White Cartridge, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the MicroCutter XCHANGE™ 30 White Cartridge (K140170) positions the device as substantially equivalent to the predicate MicroCutter XCHANGE™ 30 Blue Cartridge (K132581). Therefore, the "acceptance criteria" are generally defined by demonstrating equivalence or non-inferiority to the predicate for critical performance parameters.

Feature / Acceptance Criteria	Reported Device Performance (MicroCutter XCHANGE™ 30 White Cartridge)	Notes / Comparison to Predicate
Staple Material	Stainless steel (316L)	Same as predicate device.
Staple Thickness	0.19mm	Same as predicate device.
Unformed Staple Height	1.82mm	Predicate: 1.83mm. Very similar.
Unformed Staple Primary Tine Length	1.81mm	Predicate: 3.43mm. This is a significant difference and a primary distinguishing feature of the White Cartridge.
Unformed Staple Secondary Tine Length	0.30mm	Predicate: 0.56mm. Another significant difference.
Formed Staple Height	1.16mm	Predicate: 1.4mm. Consistent with the intended use for thinner tissue.
Formed Staple Configuration	D shaped	Same as predicate device.
Intended tissue thickness compatibility	Compatible with tissue thickness that can be compressed easily to 1.00mm	Predicate: Compatible with tissue thickness that can be compressed easily to 1.50mm. This is a key functional difference and the ultimate purpose of the White Cartridge.
Staple Line Configuration	Two (2), double-staggered rows	Same as predicate device.
Staple Line Length	30mm	Same as predicate device.
Number of Staples Per Deployment	50 (One row of 13 and one row of 12 on either side of transaction line)	Same as predicate device.
MRI Compatibility	MR-Conditional	Same as predicate device.
Staple Cartridge Insert Material	Vectra A130 Liquid Crystal Polymer (LCP) with no colorant, and Stainless Steel	Predicate: Vectra A130 LCP with VG3010K20 Blue colorant, and Stainless Steel. Key physical change (colorant removal) and functional change (index ridge).
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Toxicity, Hemocompatibility)	Met acceptance criteria in accordance with ISO 10993-1.	Same as predicate device.
Packaging	Tyvek and Nylon/LDPE/HDPE coextrusion film Pouch	Same as predicate device.
Sterilization	Gamma radiation	Same as predicate device.
Sterility Assurance Level	10^-6	Same as predicate device.
Shelf Life	12 months	Same as predicate device.
Tissue Leak Pressure (Bench)	Non-inferior and substantially equivalent to the predicate Blue Staple Cartridge	Quantitative data not provided, but stated as meeting the criterion of non-inferiority/equivalence. This is a critical functional performance criterion for stapling devices.
Staple line pull-apart strength	11.5 +/- 1.2 lb.	Predicate: 8.2 +/- 0.9 lb. The subject device performed significantly better in this bench test, indicating improved strength for thinner tissue application. This meets or exceeds the implicit acceptance criterion of performing adequately for the intended tissue thickness.
Reliability	Demonstrated device performance and strength meets design specification post-gamma sterilization, transit conditioning, environmental conditioning, and accelerated aging.	Implies successful completion of various stress tests to ensure durability and functionality over time and use conditions.
Shelf Life Testing	Passed in accordance with ASTM F1980.	Confirms the stated 12-month shelf life.
Pre-clinical Evaluation (small intestinal anastomoses in juvenile pigs)	Demonstrated substantial equivalence to the predicate Blue Staple Cartridge.	This is an in-vivo evaluation of the device's functional performance in a relevant biological model. The acceptance criterion is substantial equivalence to the predicate.

Summary of Studies that Prove the Device Meets Acceptance Criteria:

The device's acceptance is primarily based on a combination of bench testing and a pre-clinical animal study, demonstrating substantial equivalence to the predicate device, especially in its adapted functionality for thinner tissues.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The document does not specify the exact sample sizes for each bench test (e.g., reliability, sterility, packaging, pull-apart strength). It typically involves a sufficient number of units to demonstrate statistical significance and consistency, but specific numbers are not disclosed in this summary.
- Animal Study: The document states a "chronic, pre-clinical evaluation of small intestinal anastomoses created in juvenile pigs." The number of animals used is not specified in the summary.
- Data Provenance: Not specified, but generally, such studies are conducted in a controlled laboratory or vivarium setting. It's prospective in nature for the tests conducted.
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)
- This device is a medical stapler, not an AI/imaging device requiring expert interpretation of results to establish ground truth in the same way. The "ground truth" for its performance is objective physical and biological measurements (e.g., staple height, pull-part strength, leak pressure, integrity of anastomoses).
- For the animal study, veterinarians and potentially veterinary pathologists would have been involved in assessing the anastomoses and animal health, serving as the "experts" in evaluating the biological outcomes. Their specific number and qualifications are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation or diagnostic studies where subjective expert opinion is harmonized. Here, the "ground truth" is based on direct measurements and observed biological outcomes.
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
- Not applicable. This device is a mechanical surgical instrument, not an AI-based diagnostic tool or an assist system for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. Its performance is evaluated through direct bench and animal testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Mechanical measurements (e.g., length, thickness), material properties, tensile strength (pull-apart), leak pressure. These are objective engineering and physical measurements.
- Animal Study: Biological outcomes, specifically the integrity and healing of "small intestinal anastomoses." This would involve macroscopic and potentially microscopic (pathology) evaluation of the surgical sites and animal health outcomes.
The sample size for the training set
- Not applicable. This is a traditional mechanical medical device, not a machine learning or AI-based system that requires a "training set." The design and manufacturing processes are refined through engineering, prototyping, and iterative testing, not through data-driven training algorithms.
How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of an AI/ML device. The "ground truth" for the device's design and engineering is established through established engineering principles, material science, and prior knowledge from predicate devices and surgical practice.

Summary

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

510(k) Summary - MicroCutter XCHANGE™ 30 White Cartridge (K140170)

FEB 1 9 2014

く

Date Prepared

January 22, 2014

B. Applicant Information

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

C. Contact Person

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

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

F. Trade Name

MicroCutter XCHANGETM 30 White Cartridge

G. Legally Marketed Predicate Device(s)

MicroCutter XCHANGETM 30 (K132581)

H. Device Description

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

510(k) Summary - MicroCutter XCHANGE™ 30 White Cartridge (K140170)

I. Indications for Use

J. Comparison to Predicate Device

The subject MicroCutter XCHANGE™ 30 White Cartridge is equivalent in its Indications for Use to the predicate MicroCutter XCHANGE™ 30 Blue Cartridge (K132581). The difference between the subject White Staple Cartridge and the predicate Blue Staple Cartridge are as follows:

1. Removal of the colorant from the plastic material used at the distal tip of the cartridge,
Decrease of primary and secondary staple tine length on the implant, and 2.
1. The proximal end of the subject MicroCutter XCHANGE™ 30 White Cartridge adds an index ridge feature so the Stapler can differentiate between the two Cartridges.

Technological Characteristics K.

The technological characteristics of the subject MicroCutter XCHANGE™ 30 White Cartridge are substantially equivalent to the predicate device as demonstrated through verification testing.

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

Feature	PREDICATE DEVICEMicroCutter XCHANGE 30Blue Cartridge (K132581)	SUBJECT DEVICEMicroCutter XCHANGE 30White Cartridge
Staple
Staple Material	Stainless steel (316L)	Same as predicate device
Staple Thickness	0.19mm	Same as predicate device
Unformed Staple height	1.83mm	1.82mm
Unformed Staple PrimaryTine Length	3.43mm	1.81mm
Unformed Staple SecondaryTine Length	0.56mm	0.30mm
Formed Staple Height	1.4mm (compatible withtissue thickness that can becompressed easily to 1.50mm)	1.16mm (compatible with tissuethickness that can be compressedeasily to 1.00mm)
Formed StapleConfiguration	D shaped	Same as predicate device
Feature	PREDICATE DEVICEMicroCutter XCHANGE 30Blue Cartridge (K132581)	SUBJECT DEVICEMicroCutter XCHANGE 30White Cartridge
Intended tissue thickness	Compatible with tissue thickness that can becompressed easily to 1.50mm	Compatible with tissue thickness that can be compressed easily to1.00mm
Staple Line Configuration	Two (2), double-staggeredrows	Same as predicate device
Staple Line Length	30mm	Same as predicate device
Number of Staples PerDeployment	50 (One row of 13 and onerow of 12 on either side oftransaction line)	Same as predicate device
MRI Compatibility	MR-Conditional	Same as predicate device
Staple CartridgeStaple CartridgeInsert	Vectra A130 Liquid CrystalPolymer (LCP) withVG3010K20 Blue colorant,and Stainless Steel	Vectra A130 Liquid CrystalPolymer (LCP) with no colorant,and Stainless Steel
BiocompatibilityMaterial Biocompatibility(Delivery Device, StapleCartridge and Staple)	All components of theCardica MicroCutterXCHANGE 30 are comprisedof materials that were deemedacceptable in accordance withISO Standard 10993-1.Biocompatibility: Cytotoxicity,Sensitization, Irritation, Toxicity,Hemocompatibility	Same as predicate device
Staple Cartridge Packaging, Sterilization and Shelf Life
Packaging	Tyvek andNylon/LDPE/HDPEcoextrusion film Pouch	Same as predicate device
Sterilization	Gamma radiation	Same as predicate device
Sterility Assurance Level	10-6	Same as predicate device
Shelf Life	12 months	Same as predicate device
Performance
Tissue Leak Pressure(Bench)	The subject White Staple Cartridge is non-inferior andsubstantially equivalent to the predicate Blue Staple Cartridge
Staple line pull-apart	8.2 +/- 0.9 lb.	11.5 +/- 1.2 lb.

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

510(k) Summary – MicroCutter XCHANGE™ 30 White Cartridge (K140170)

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

510(k) Summary - MicroCutter XCHANGE™ 30 White Cartridge (K140170) Non-Clinical Performance Data

This modification was verified through design verification testing. Bench and animal testing was conducted and the results demonstrated substantial equivalence to the predicate device, and the MicroCutter XCHANGE™ 30 White Cartridge met all design specifications. A summary of the design requirements evaluated were as follows:

Reliability testing was completed and demonstrated that device performance and . strength meets design specification, post gamma sterilization, transit conditioning, environmental conditioning, and accelerated aging.
Shelf life testing was completed and passed in accordance with ASTM F1980. ●
Biocompatibility testing was completed and passed in accordance with ISO . 10993-1 requirements.
A chronic, pre-clinical evaluation of small intestinal anastomoses created in . juvenile pigs by the white and blue staples, using the MicroCutter XCHANGE™ 30 Stapler, was performed and demonstrated substantial equivalence of the subject White Staple Cartridge to the predicate Blue Staple Cartridge.

M. Clinical Performance

There are no changes to the indications for use, so the subject White Staple Cartridge was fully verified and validated through design testing described in Section L above.

N. Conclusions

The subject MicroCutter XCHANGE™ 30 White Cartridge has been carefully compared to a legally marketed device, MicroCutter XCHANGE™ 30 Blue Cartridge, 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 White Cartridge functions as intended and meets all design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device for its intended use.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 19, 2014

Cardica, Inc. Vee Arya Senior OA/RA Manager 900 Saginaw Drive Redwood City, California 94063

Re: K140170

Trade/Device Name: MicroCutter XCHANGE™ 30 White Cartridge Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 22, 2014 Received: January 23, 2014

Dear Vee 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 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 yours,

David Krause -S

for Binita Ashar, MD, MBA, FACS 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

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

510(k) Number (if known) K140170

Device Name

MicroCutter XCHANGE™ 30 White 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 FOR FOR FOR FOR FOR FOR FOR USE ONLY BE FOR . . . . 1.32.35.25 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/6/Picture/13 description: The image shows the name "Jiyoung Deng -S" in a bold, sans-serif font. The first name, "Jiyoung," is written in a simple, clean style, while the last name, "Deng," has a more decorative, textured appearance. The "-S" is smaller and placed to the right of the last name.

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.