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.

Device Description

The MicroCutter XCHANGE™ 30 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 staple (blue; 3.5mm) is 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

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to predicate devices and meeting design specifications through various tests. The primary acceptance criterion highlighted in the provided text for clinical performance is non-inferiority related to adverse events.

Acceptance Criteria (Primary Clinical)	Reported Device Performance
Non-inferiority of composite related severe adverse event rate (composite of infection, leakage, bleeding, and strictures) compared to historical control in comparable open and laparoscopic procedures.	One (1) composite severe adverse event (composite of infection (non-dermal), leakage, bleeding, and strictures) related to the MicroCutter XCHANGE 30 System was reported in 153 patients (0.65%). The exact upper 95% confidence limit for this rate is 3.59%. The primary endpoint was met, indicating non-inferiority to the composite historical control.

Additional Performance Data (Non-Clinical/Bench Testing - not explicitly "acceptance criteria" but included to show general compliance)

Area of Performance	Reported Device Performance Summary (Met Design Specifications/Passed)
Integrity of Staple Line	Confirmed via dimensional analysis, visual inspection, and burst pressure testing.
Dimensional Tests	Confirmed attributes for shaft diameter, jaw aperture, clamp gap, articulation angle, and staple line length.
Ergonomics	Confirmed device ergonomics and usability for cartridge load/unload force, force to articulate, force to deploy, force to reset device, and torque required to rotate device.
Safety	Confirmed the strength of the deploy lockout safety mechanism.
Functionality	Confirmed device features for the clamp system, deployment system, and articulation.
Reliability	Demonstrated that device performance does not degrade within the indicated number of clinical deployments.
Packaging Validation	Passed in accordance with ASTM D4169.
Sterilization	Passed in accordance with ISO11137-2.
Bioburden	Passed in accordance with ANSI/AAMI/ISO 11737-1:1995.
Shelf Life	Passed in accordance with ASTM F1980.
Biocompatibility	Completed and passed in accordance with ISO 10993-1 requirements (Cytotoxicity, Intracutaneous Reactivity, Hemolysis, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogen, Coagulation, Thromboresistance).
Tissue Leak Pressure (Bench & Animal)	No statistical difference (p>0.05) compared to predicate (implied, as it states "No statistical difference p>0.05", but doesn't explicitly name the predicate in this line).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Test Set): 160 subjects were enrolled, and 423 deployments were performed. 153 patients were included in the primary endpoint calculation.
Data Provenance: The study was a "prospective, open label, multi-center study" meaning the data was collected specifically for this study in real-time or as events occurred. While the document does not explicitly state the country of origin, the FDA 510(k) submission context implies it would be relevant to US regulatory standards, and the manufacturer is based in Redwood City, California. The "MicroCutter European Trial I (METI)" mentioned under clinical performance suggests an international origin, but it specifically states "The Cardica MicroCutter in Surgical Stapling" for METI, and the results are cited as "Non-inferior to composite historical control." The main clinical study described appears to be for this specific submission and is referenced as "clinical study information" without explicit geographic limitation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical adverse events. The adverse event rate was compared to a "composite severe adverse event rate... derived from a comprehensive analysis of the medical literature," implying a benchmark from existing published data rather than a newly established expert consensus on the test set.

For the non-clinical and bench tests, it's reasonable to infer that qualified engineers and technicians performed the tests against established design specifications and industry standards, but specific expert qualifications for "ground truth" are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1) for the clinical adverse events. The events were "reported," and it states that "One (1) composite severe adverse event... related to the MicroCutter XCHANGE 30 System was reported." This suggests a direct reporting and classification of events rather than an independent adjudication process among multiple reviewers for the study itself, though standard clinical trial practices would involve physician assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The clinical study performed was a direct assessment of the device's performance against a historical control for adverse event rates, not a comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a surgical stapler, not an AI algorithm. Therefore, the concept of a "standalone algorithm only" performance study is not applicable. The performance studies evaluate the physical device's function.

7. Type of Ground Truth Used

Clinical Study: The "ground truth" for the clinical study's primary endpoint regarding adverse events was a composite historical control derived from a comprehensive analysis of the medical literature for comparable open and laparoscopic procedures.
Non-Clinical/Bench Testing: The ground truth for these tests would be based on established design specifications, industry standards (e.g., ASTM, ISO), and performance criteria for surgical staplers.

8. Sample Size for the Training Set

This product is a mechanical surgical stapler, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The design specifications and manufacturing processes are developed through engineering and material science principles.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" for this type of device. The "ground truth" for the device's design and manufacturing would be established through engineering design principles, material science, regulatory requirements, and established industry best practices for medical device development.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for "Cardica". The logo consists of a stylized, curved shape resembling an open bracket or a stylized letter "C" on the left side. To the right of this shape is the word "cardica" in a simple, sans-serif font, with a registered trademark symbol (®) next to it.

MicroCutter XCHANGE 30

JAN - 7 2014

510(k) Summary - Cardica MicroCutter XCHANGE™ 30

A. Date Prepared January 2, 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 XCHANGE™ 30

G. Legally Marketed Predicate Device(s)

Autosuture™ ENDO GIA™ Universal Stapler (K111825) Ethicon Proximate™ and Endopath™ Linear Staplers (K020779)

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MicroCutter XCHANGE 30

cardıca

H. Device Description

I. Indications for Use

J. Comparison to Predicate Device

The Cardica MicroCutter XCHANGE™ 30 is substantially equivalent in its Indications for Use to the Covidien Autosuture™ ENDO™ GIA Stapler (K111825) and Ethicon Proximate™ Linear Staplers (K020779) in regards to the predicates' use for the transection, resection, and/or creation of anastomoses in surgical procedures involving gastrointestinal tissue.

The Cardica MicroCutter XCHANGE™ 30 is substantially equivalent in design and performance specifications to the Covidien Autosuture™ ENDO™ GIA Universal Stapler trigger handle, shaft and end-effecter function (K111825) and the Ethicon Proximate™ Linear Cutters' and Staplers' staple cartridge (K020779).

K. Technological Characteristics

The Cardica MicroCutter XCHANGE™ 30 is a cartridge based stapling device with a 5mm diameter shaft, capable of unlimited rotation and articulation up to 160° (80° degrees in each direction) in 20° increments. Predicate devices are also cartridge based, offer varying amounts of shaft rotation (90° to unlimited rotation) and less articulation range (80° - 90° total compared to 160°).

The MicroCutter XCHANGE™ 30 Blue Cartridge delivers a 30mm staple line consisting of two double-staggered rows (4 rows total) of D-shaped staples constructed of medical grade 316L stainless steel. The outermost rows contain 12 staples each, while the inner rows contain 13 staples each, for a total of 50 staples. Predicate devices can be used with various cartridges to deliver titanium staples ranging from 30 - 90mm, consisting of either two, double-staggered rows (4 rows total) or two, triple staggered rows (6 rows total).

One of the primary differentiating factors in the design of the MicroCutter XCHANGE™ 30 staple is that the staples are medical grade 316L stainless steel, which is a higher strength material than titanium alloy used in other stapling products. Current B-shaped staples are formed by buckling the tines. The forces required to accomplish the buckling typically represent the peak forces during staple formation. The MicroCutter XCHANGE™ 30 uses a guided, rotating form. The motion through the tissue is similar to that of a curved needle.

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Image /page/2/Picture/1 description: The image shows the word "cardica" in a stylized font. The word is in black and has a registered trademark symbol after it. There is a curved line above and below the word, which gives the impression of a logo.

MicroCutter XCHANGE 30

The Cardica MicroCutter XCHANGE™ 30 has similar features as compared to the predicate devices as shown in table below:

Feature	MicroCutterXCHANGE 30	ENDO GIAUniversal(K111825)	PROXIMATELinear Cutters andStaplers (K020779)
Deployment Device
Deployment	Cartridge baseddeployment (up to 6deployments pertool) for singlepatient use	Cartridge baseddeployment (upto 25deployments pertool) for singlepatient use	Cartridge baseddeployment (up to 4-8 deployments pertool) for singlepatient use(excepting Access55)
Shaft Length	340mm	325mm	Not available
Transection LineLength	27mm	30mm	Up to 100mm(depending onCutter);Staplers do not cut(Staplers and Access55)
End-Effector Opening	5.3mm at tissue stop(proximal);16.7mm at distalopening	5.25mm at tissuestop (proximal);16.45mm atdistal opening	Adjustable paralleljaws (exceptingAccess 55)
Shaft Rotation	360°	Same as subjectdevice	90°; 30° shaft flex(Access 55 only)
Articulation	160° (80° eachdirection)	90° on theroticulator model(45° eachdirection)	80° (Access 55 only)
Staple
Staple Material	Stainless steel(316L)	Titanium	Titanium
Blue Unformed Stapleheight	3.22mm	3.50mm	3.50-3.85mm
Blue Formed StapleHeight	0.75mm (compatiblewith tissue thicknessthat can becompressed easily to1.50mm)	1.00mm(compatible withtissue thicknessthat can becompressedeasily to1.50mm)	1.00-1.50mm(compatible withtissue thickness thatcan be compressedeasily to 1.00-2.50mm)
Formed StapleConfiguration	D shaped	B shaped	B shaped
Staple Line	Two (2), double	Two (2), triple	Same as subject

Page 3 – K132581 Cardica Response

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MicroCutter XCHANGE 30

Feature	MicroCutterXCHANGE 30	ENDO GIAUniversal(K111825)	PROXIMATELinear Cutters andStaplers (K020779)
Configuration	staggered rows	staggered rows	device
Staple Line Length	30mm	30mm, 45mm,60mm	10 (Cutters only),30, 55 (Cutters andAccess 55), 60, 75(Cutters only) and90mm
Number of Staples PerDeployment	50 (One row of 13and one row of 12on either side oftransaction line)	48 (for the 30mmstaple line length)	58 and 74 (for the 30and 55mm stapleline)
MRI Compatibility	MR-Conditional	MR-Safe	Same as subjectdevice
Biocompatibility
MaterialBiocompatibility(Delivery Device andStaple)	All components ofthe CardicaMicroCutterXCHANGE 30 arecomprised ofmaterials that weredeemed acceptablein accordance withISO Standard10993-1.	Same as subjectdevice	Same as subjectdevice
Packaging, Sterilization and Shelf Life
Packaging	PTFE tray withTyvek lid	Thermoformedtray with Tyveklid	Thermoformed traywith Tyvek lid
SterilizationSterility AssuranceLevel	Gamma radiation$10^{-6}$	Ethylene OxideNot Available	Gamma radiationNot Available
Shelf Life	24 months	Not Available	Not Available
Performance
Tissue Leak Pressure(Bench)	No statistical difference p>0.05		Not Tested
Tissue Leak Pressure(Animal)	No statistical difference p>0.05		Not Tested
Clinical Performance(MicroCutter EuropeanTrial I (METI): TheCardica MicroCutter inSurgical Stapling)	Non-inferior tocomposite historicalcontrol	Not Applicable	Not Applicable

Image /page/3/Picture/5 description: The image shows the word "cardica" with a registered trademark symbol. The word is in a sans-serif font and is slightly italicized. To the left of the word is a stylized symbol that looks like a curved bracket or parenthesis.

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MicroCutter XCHANGE 30

L. Non-Clinical Performance Data

Bench and animal testing were conducted and the results demonstrated substantial equivalence to the predicate devices, and that the Cardica MicroCutter XCHANGE 30 met design specifications. A summary of the type of testing conducted is as follows:

Integrity of the staple line was confirmed via dimensional analysis of the staples, � visual inspection of the staple line, and through burst pressure testing of the staple line.
. Dimensional tests were conducted to confirm attributes for shaft diameter, jaw aperture, clamp gap, articulation angle, and staple line length.
. Ergonomics testing was conducted to confirm device ergonomics and usability for cartridge load/unload force, force to articulate, force to deploy, force reset . device, and torque require to rotate device.
Safety testing was completed to confirm the strength of the deploy lockout safety . mechanism to prevent advancement of the knife when a cartridge is not properly loaded into the device.
. Functionality testing was completed to confirm device features for the clamp system, deployment system, and articulation.
. Reliability testing was completed and demonstrated that device performance does not degrade when deploying within the indicated number of clinical deployments.
. Packaging Validation testing was completed and passed in accordance with ASTM D4169.
. Sterilization testing was completed and passed in accordance with ISO11137-2.
Bioburden testing was conducted and passed in accordance with . ANSI/AAMI/ISO 11737-1:1995 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 F1980.
0 Biocompatibility testing was completed in accordance with ISO 10993-1 requirements. The following tests were completed and passed:
- Cytotoxicity 해
- ISO Intracutaneous Reactivity
- Hemolysis (in vitro)
- 트 Sensitization
- l Acute Systemic Toxicity
- I Material Mediated Pyrogen (as required)
- 트 Coagulation (as required)
- Thromboresistance (as required)

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MicroCutter XCHANGE 30

M. Clinical Study Information

The MicroCutter XCHANGE™ 30 System was evaluated in a prospective, open label, multi-center study with an All-Comers enrollment of subjects requiring surgical stapling of the stomach and/or intestine. 160 subjects were enrolled and followed postoperatively for at least 30 days. 423 deployments were performed. The primary endpoint was statistical non-inferiority of composite related severe adverse event rate (composite of infection, leakage, bleeding, and strictures) in study subjects when compared to composite severe adverse event rate (composite of infection, leakage, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature with regards to the comparable open and laparoscopic procedure. One (1) composite severe adverse event (composite of infection (non-dermal), leakage, bleeding, and strictures) related to the MicroCutter XCHANGE 10 30 System was reported in a total of one hundred fifty three (153) patients (0.65%). The exact upper 95% confidence limit for this rate is 3.59%. Based on these results, the primary endpoint was met.

Additionally, there were 6 events reported for handsewn anastomoses and 6 events for other stapling devices in procedures in which the MicroCutter was used. These events do not factor into the calculation of the primary endpoint event rate for the MicroCutter. There is a procedural success rate of 91.5% (140/153) when the MicroCutter is used with other anastomoses modalities.

Stapler and Hand-sewn relatedSevere Adverse EventsCategories	Hand-sewnrelated	OtherStaplerrelated	MicroCutterrelated	Total N
Leakages	0	2	0	2
Bleedings	3	0	1	4
Infections	1	2	0	3
Strictures	0	1	0	1
Other Complications	2	1	0	3
Total	6	6	1	13

STAPLER AND HAND-SEWN ANASTOMOSIS RELATED PRIMARY ENDPOINT EVENTS

The following table depicts the tissue and number of deployments where the MicroCutter was used:

MicroCutter Tissue Use	All SitesN* (%)
Anastomose small intestine tostomach	1 (0.2)
Anastomosis of small intestine	25 (5.9)
Anastomosis of small intestine tocolon	13 (3.1)
Closure of enterotomy	5 (1.2)
Transection of appendix	57 (13.5)
Transection of colon	81 (19.1)
Transection of common bile duct	1 (0.2)

Page 6 - K 132581 Cardica Response

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MicroCutter XCHANGE 30

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

MicroCutter Tissue Use	All SitesN* (%)
Transection of duodenum	19 (4.5)
Transection ofMesocolon/Mesoappendix	6 (1.4)
Transection of ovary	1 (0.2)
Transection of small intestine	213 (50.4)
Vascular transection	1 (0.2)
Total	423

*N = number of deployments

The following table depicts procedures by clinical approach:

	TotalN* (%)
Observation	160 (N/A)
Open	70 (43.8)
Laparoscopic	75 (46.9)
Laparoscopicassisted	15 (9.4)
Converted	0 (0)

*N = number of observations

N. Conclusions

The MicroCutter XCHANGE™ 30 Stapler and Blue Cartridge have been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, clinical and non-clinical testing was conducted to validate the performance of the device and ensure the MicroCutter XCHANGE™ 30 Stapler and Blue Cartridge function as intended and meet design specifications. The comparison, clinical and non-clinical results demonstrate that the device is substantially equivalent to the predicate devices for its intended use.

Page 7 - K132581 Cardica Response

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 7. 2014

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

Re: K132581

Trade/Device Name: Cardica®MicroCutter XCHANGE™ 30 Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: November 21, 2013 Received: November 27, 2013

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 r ou may, merelors, manns 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 that I Dri has made a and regulations administered by other Federal agencies. You must of any I cottar statues and regairents, including, but not limited to: registration and listing (21

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Page 2 - Ms. Vee Arya

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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.

Binita S. Ashar -S. A 2014.01.07 16:32:32-05'00'

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132581

Device Name Cardica@MicroCutter XCHANGETM 30

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

2017 26 223 2

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)

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.