The MicroCutter XCHANGE® 30 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatic 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.

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 size of the White Cartridge staple is compatible with tissue that can be easily 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 Cardica MicroCutter XCHANGE® 30, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, for the tissue burst pressure tests, the acceptance is implied by demonstrating "no statistical difference" compared to the predicate device. For the animal studies, the acceptance is based on an "uncomplicated 5-week postoperative course" and "unremarkable" histological evaluation with "no demonstrable difference between the two groups."

Therefore, the table below reflects the reported performance relative to the predicate, rather than explicit numerical acceptance criteria.

Feature	Acceptance Criteria (Implied)	Reported Device Performance and Comparison to Predicate
Bench Testing
Tissue Burst Pressure (White Cartridge in Porcine Carotid Artery)	Substantially equivalent to predicate device (implied: no statistically significant difference in burst pressure performance compared to the Ethicon PROXIMATE Vascular Linear Cutter 55).	No statistical difference, p>0.05 when compared to the (primary) predicate device, Ethicon PROXIMATE Vascular Linear Cutter 55 (K020779). The document states "Not Available" for the secondary predicate, Ethicon ENDOPATH ETS-Flex45 Endoscopic Linear Cutters (K002398) for this test.
Tissue Burst Pressure (White Cartridge in Porcine Jugular Vein)	Substantially equivalent to predicate device (implied: no statistically significant difference in burst pressure performance compared to the Ethicon PROXIMATE Vascular Linear Cutter 55).	No statistical difference, p>0.05 when compared to the (primary) predicate device, Ethicon PROXIMATE Vascular Linear Cutter 55 (K020779). The document states "Not Available" for the secondary predicate, Ethicon ENDOPATH ETS-Flex45 Endoscopic Linear Cutters (K002398) for this test.
Chronic Animal Studies
Postoperative Course	Uncomplicated 5-week postoperative course, no signs of postoperative bleeding or infection, and unremarkable vascular/ureter stumps. Histological evaluation shows no demonstrable difference between subject and predicate device.	All animals had an uncomplicated 5-week postoperative course and were euthanized after a second terminal surgery. The vascular and ureter stumps were all unremarkable without any signs of postoperative bleeding or infection. The histologic evaluation was also unremarkable and showed no demonstrable difference between the two groups.
Endpoints	Met the defined study endpoints.	The endpoints of the studies were met.

2. Sample Size and Data Provenance for Test Set (Bench Testing & Animal Studies)

Bench Testing:
- Sample Size: Not explicitly stated in the provided text for the bench testing. The results are described generally as "Tissue Burst pressure testing was conducted."
- Data Provenance: Porcine carotid artery and porcine jugular vein were used, indicating animal tissue (ex vivo) for these specific tests. The country of origin is not specified, but it's likely a controlled laboratory environment. This is prospective data generation for the purpose of the 510(k).
Chronic Animal Studies:
- Sample Size: Not explicitly stated as a number of animals per group, but it involved two studies: "a study in which unilateral nephrectomies were performed and a study in which unilateral lobectomies were performed." "All animals" had an uncomplicated course, implying the sample size was sufficient for the study's conclusions.
- Data Provenance: The studies were "chronic animal studies," meaning conducted in vivo on live animals. The type of animal (e.g., porcine, canine) is not specified. The country of origin is not specified. This is prospective data generation.

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not Applicable. The described studies are performance tests (bench and animal), not diagnostic or image-based studies requiring human expert interpretation as ground truth. The "ground truth" (or outcome assessment) was based on direct physiological measurements (burst pressure), macroscopic observation (postoperative course, stump condition), and microscopic histological evaluation. These evaluations would typically be performed by trained technicians, veterinarians, and pathologists, but they are not "experts" in the context of establishing diagnostic ground truth from images or clinical data.

4. Adjudication Method for Test Set

Not Applicable. As mentioned above, the studies are performance tests and do not involve human interpretation or adjudication in the manner of, for example, multiple readers assessing medical images. Outcomes are based on objective measurements and pathological/histological findings.

5. MRMC Comparative Effectiveness Study

No. The provided document describes bench testing and chronic animal studies, not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers and AI assistance. The device is a surgical stapler, not an AI-powered diagnostic tool.

6. Standalone Performance (Algorithm Only)

No. The device is a surgical stapler. This concept primarily applies to AI/software as a medical device (SaMD) where an algorithm's performance is evaluated independently of human interaction.

7. Type of Ground Truth Used

Bench Testing: Direct physical measurements (e.g., burst pressure) under controlled laboratory conditions, and comparison to a legally marketed predicate device.
Chronic Animal Studies:
- Macroscopic observation: Postoperative course assessment (complications, bleeding, infection), visual inspection of vascular and ureter stumps.
- Microscopic evaluation: Histological assessment of tissue.
- Comparison of these outcomes between the subject device and the predicate device.

8. Sample Size for the Training Set

Not Applicable. This device is a mechanical surgical stapler. There is no AI or machine learning component that would require a "training set" in the conventional sense. The "development" or "training" of the device involves engineering design, material selection, and iterative physical testing, not data-driven algorithm training.

9. How Ground Truth for Training Set Was Established

Not Applicable. As there is no AI/ML component, there is no "training set" or ground truth for it. The design and validation relied on established engineering principles, material science, and pre-clinical testing against known performance benchmarks from predicate devices.

Summary

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

January 15, 2016

Cardica Incorporated % Ms. Cindy Domecus Domecus Consulting Services, LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K151081

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: December 14, 2015 Received: December 15, 2015

Dear Ms. Domecus:

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

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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) K151081

Device Name Cardica MicroCutter XCHANGE® 30

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)

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510(k) Summary - Cardica MicroCutter XCHANGE® 30

A. Date Prepared

January 12, 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

Cindy Domecus, R.A.C. (US & EU) Cardica Regulatory Consultant (650) 343-4813 (office) (650) 773-3445 (cell) (650) 343-7822 (fax) domecusconsulting@comcast.net

Alternate Contact: Sara Chen Senior Quality Systems Engineer & Regulatory Specialist

(650) 331-7117 direct (650) 331-7195 fax chen@cardica.com

D. Device Information

Trade name: MicroCutter XCHANGE® 30 White Cartridge and MicroCutter XCHANGE 30 White Curved Tip Cartridge

Common name: Staple

Classification Name: Implantable staple

Regulation Number: 21 CFR §878.4750

Product Code: GDW

E. Legally Marketed Predicate Devices Ethicon PROXIMATE Vascular Linear Cutter 55 (K020779) Ethicon ENDOPATH ETS-Flex45 Endoscopic Linear Cutters (K002398)

F. Device Description

The MicroCutter XCHANGE® 30 is a single patient use stapler that delivers two, double

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staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The size of the White Cartridge staple is compatible with tissue that can be easily compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

G. Intended Use

The MicroCutter XCHANGE® 30 is intended for transection and resection 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 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° in each direction) in 20° increments. The predicate devices are also cartridge based, offering shaft rotation of 360°. The primary predicate does not articulate (0°) and the secondary predicate is capable of articulation up to 70° (35° in each direction).

The Cardica MicroCutter XCHANGE® 30 delivers a 30mm staple line consisting of two double-staggered rows (4 rows total) of D-shaped staples constructed of 316L stainless steel. The outermost rows contain 12 staples each, while the inner rows contain 13 staples each, for a total of 50 staples. The primary predicate device delivers a 60mm staple line, consisting of two double-staggered rows (4 rows total) of B-shaped staples constructed of titanium. The secondary predicate device delivers a 45mm staple line, consisting of two triple-staggered rows (6 rows total) of B-shaped staples constructed of titanium.

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

Feature	MicroCutterXCHANGE® 30(K132581)	Ethicon PROXIMATEVascular Linear Cutter55 (K020779)(Primary Predicate)	Ethicon ENDOPATHETS-Flex45Endoscopic LinearCutters (K002398)(Secondary Predicate)
Deployment Device
Deployment	Cartridge baseddeployment (up to 6deployments per tool) forsingle patient use	Cartridge baseddeployment (up to 8deployments per tool) forsingle patient use	Cartridge baseddeployment for singlepatient use
Shaft Length	340 mm	78 mm	340 mm
Transection LineLength	27 mm	53 mm	41 mm
Feature	MicroCutterXCHANGE® 30(K132581)	Ethicon PROXIMATEVascular Linear Cutter55 (K020779)(Primary Predicate)	Ethicon ENDOPATHETS-Flex45Endoscopic Linear Cutters (K002398)(Secondary Predicate)
End-EffectorOpening	5.3mm at tissue stop(proximal);16.7mm at distal opening	Variable - two halvesseparate allowing end-effector to have as largeof an opening as userrequires	2.6mm at tissue stop(proximal); 12.3mm atdistal opening
Shaft Rotation	360°	Same as subject device	Same as subject device
Articulation	160° (80° each direction)	0° (no articulation)	70° (35° each direction)
Staple
Staple Material	Stainless steel (316L)	Titanium	Titanium
White UnformedStaple height	1.82 mm	2.5 mm	2.5 mm
White Formed StapleHeight	1.16 mm (compatible withtissue thickness that can becompressed easily to 1.0mm)	1.0 mm (compatible withtissue thickness that canbe compressed easily to1.00 mm)	1.0 mm (compatible withtissue thickness that canbe compressed easily to1.00 mm)
Formed StapleConfiguration	D shaped	B shaped	B shaped
Staple LineConfiguration	Two (2), double-staggeredrows	Two (2), double-staggered rows	Three (3), double-staggered rows
Staple Line Length	30 mm	55 mm	45 mm
Number of StaplesPer Deployment	50(One row of 13 and onerow of 12 on either side oftransection line)	56(for the 55 mm staple linelength)	66(one row of 11, one rowof 11, and one row of 11on either side oftransection line)
MRI Compatibility	MR-Conditional	Same as subject device	Same as subject device
Biocompatibility
MaterialBiocompatibility(Delivery Device andStaple)	All components of theCardica MicroCutterXCHANGE® 30 arecomprised of materials thatwere deemed acceptable inaccordance with ISOStandard 10993-1.	Same as subject device	Same as subject device
Packaging, Sterilization and Shelf Life
Packaging	Thermoformed tray withTyvek lid	Thermoformed tray withTyvek lid	Thermoformed tray withTyvek lid
Sterilization	Gamma radiation,	Gamma radiation,	Gamma radiation,
Sterility AssuranceLevel	$10^{-6}$	Not Available	Not Available
Shelf Life	24 months	Not Available	Not Available
Feature	MicroCutterXCHANGE® 30(K132581)	Ethicon PROXIMATEVascular Linear Cutter55 (K020779)(Primary Predicate)	Ethicon ENDOPATHETS-Flex45Endoscopic LinearCutters (K002398)(Secondary Predicate)
Performance
Tissue Burst PressureWhite in PorcineCarotid Artery(Bench)	No statistical difference, p>0.05		Not Available
Tissue Burst PressureWhite in PorcineJugular Vein (Bench)	No statistical difference, p>0.05		Not Available

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I. Non-Clinical Performance Data

Bench testing in the form of Tissue Burst pressure testing was conducted and the results demonstrated substantial equivalence to the predicate devices.

Cardica also performed two chronic animal studies for abdominal and intrathoracic vascular transections: a study in which unilateral nephrectomies were performed and a study in which unilateral lobectomies were performed. In these chronic animal studies, the Cardica subject staple was compared to the Ethicon predicate staple.

All animals had an uncomplicated 5-week postoperative course and were euthanized after a second terminal surgery. The vascular and ureter stumps were all unremarkable without any signs of postoperative bleeding or infection. The histologic evaluation was also unremarkable and showed no demonstrable difference between the two groups. The endpoints of the studies were met.

J. Conclusion

Bench testing and chronic animal studies were conducted to validate the performance of the staple. The results demonstrated that the subject device is substantially equivalent to the predicate devices.

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.