MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE

K132581 · Cardica, Inc. · GDW · Jan 7, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132581
• Device Name: MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
• Applicant: Cardica, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jan 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K132581 · Jan 7, 2014	MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE	Cardica, Inc.	Comprehensive analysis of medical literature (historical control data)	The sponsor used a composite historical control rate derived from medical literature to demonstrate non-inferiority of the device's severe adverse event rate compared to standard open and laparoscopic procedures.	Historical control; Literature review; Non-inferiority; Clinical performance

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
MicroCutter European Trial I (METI); Prospective, open label, multi-center study; Follow-up/Duration: At least 30 days postoperatively	Subjects requiring surgical stapling of the stomach and/or intestine; Sample Size: 160 subjects; Number of Sites: Multi-center	Composite historical control derived from medical literature	Statistical non-inferiority of composite related severe adverse event rate (infection, leakage, bleeding, and strictures)

Indications for Use

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 Story

MicroCutter XCHANGE 30 is a single-patient-use, cartridge-based surgical stapler. It delivers two double-staggered rows (4 rows total) of 316L stainless steel D-shaped staples while simultaneously transecting tissue. Features a 5mm diameter shaft with 360° rotation and 160° articulation. Operated by surgeons in open or minimally invasive procedures. Device uses a guided, rotating staple formation mechanism, mimicking curved needle motion. Output is a 30mm staple line. Benefits include high-strength stainless steel staples and enhanced articulation for surgical access. Device is MR-Conditional.

Clinical Evidence

Prospective, open-label, multi-center study (n=160) with 423 deployments. Primary endpoint: non-inferiority of composite severe adverse event rate (infection, leakage, bleeding, strictures) vs. historical literature control. One related severe adverse event reported (0.65%; 95% CI upper limit 3.59%). Primary endpoint met. Bench testing confirmed staple line integrity, burst pressure, and mechanical reliability.

Technological Characteristics

Cartridge-based stapler; 5mm shaft; 360° rotation; 160° articulation. Staples: 316L stainless steel, D-shaped, 30mm line length. Biocompatibility per ISO 10993-1. Sterilization: Gamma radiation (10^-6 SAL). Packaging: PTFE tray with Tyvek lid. Shelf life: 24 months. MR-Conditional.

Indications for Use

Indicated for patients undergoing open or minimally invasive surgical procedures requiring transection, resection, or creation of anastomoses in the small and large intestine, or transection of the appendix.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone]

### C. Contact Person

Vee Arya Senior QA/RA Manager

[phone] direct [phone] mobile [phone] fax [e-mail]

Alternate Contact: Frederick Bauer Vice President of Operations

[phone] direct [phone] fax [e-mail]

# 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

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.

### I. 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 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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MicroCutter XCHANGE 30

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

| Feature | MicroCutter<br>XCHANGE 30 | ENDO GIA<br>Universal<br>(K111825) | PROXIMATE<br>Linear Cutters and<br>Staplers (K020779) |
|--------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Deployment Device | | | |
| Deployment | Cartridge based<br>deployment (up to 6<br>deployments per<br>tool) for single<br>patient use | Cartridge based<br>deployment (up<br>to 25<br>deployments per<br>tool) for single<br>patient use | Cartridge based<br>deployment (up to 4-<br>8 deployments per<br>tool) for single<br>patient use<br>(excepting Access<br>55) |
| Shaft Length | 340mm | 325mm | Not available |
| Transection Line<br>Length | 27mm | 30mm | Up to 100mm<br>(depending on<br>Cutter);<br>Staplers do not cut<br>(Staplers and Access<br>55) |
| End-Effector Opening | 5.3mm at tissue stop<br>(proximal);<br>16.7mm at distal<br>opening | 5.25mm at tissue<br>stop (proximal);<br>16.45mm at<br>distal opening | Adjustable parallel<br>jaws (excepting<br>Access 55) |
| Shaft Rotation | 360° | Same as subject<br>device | 90°; 30° shaft flex<br>(Access 55 only) |
| Articulation | 160° (80° each<br>direction) | 90° on the<br>roticulator model<br>(45° each<br>direction) | 80° (Access 55 only) |
| Staple | | | |
| Staple Material | Stainless steel<br>(316L) | Titanium | Titanium |
| Blue Unformed Staple<br>height | 3.22mm | 3.50mm | 3.50-3.85mm |
| Blue Formed Staple<br>Height | 0.75mm (compatible<br>with tissue thickness<br>that can be<br>compressed easily to<br>1.50mm) | 1.00mm<br>(compatible with<br>tissue thickness<br>that can be<br>compressed<br>easily to<br>1.50mm) | 1.00-1.50mm<br>(compatible with<br>tissue thickness that<br>can be compressed<br>easily to 1.00-<br>2.50mm) |
| Formed Staple<br>Configuration | 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 | MicroCutter<br>XCHANGE 30 | ENDO GIA<br>Universal<br>(K111825) | PROXIMATE<br>Linear Cutters and<br>Staplers (K020779) |
|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------|
| Configuration | staggered rows | staggered rows | device |
| Staple Line Length | 30mm | 30mm, 45mm,<br>60mm | 10 (Cutters only),<br>30, 55 (Cutters and<br>Access 55), 60, 75<br>(Cutters only) and<br>90mm |
| Number of Staples Per<br>Deployment | 50 (One row of 13<br>and one row of 12<br>on either side of<br>transaction line) | 48 (for the 30mm<br>staple line length) | 58 and 74 (for the 30<br>and 55mm staple<br>line) |
| MRI Compatibility | MR-Conditional | MR-Safe | Same as subject<br>device |
| Biocompatibility | | | |
| Material<br>Biocompatibility<br>(Delivery Device and<br>Staple) | All components of<br>the Cardica<br>MicroCutter<br>XCHANGE 30 are<br>comprised of<br>materials that were<br>deemed acceptable<br>in accordance with<br>ISO Standard<br>10993-1. | Same as subject<br>device | Same as subject<br>device |
| Packaging, Sterilization and Shelf Life | | | |
| Packaging | PTFE tray with<br>Tyvek lid | Thermoformed<br>tray with Tyvek<br>lid | Thermoformed tray<br>with Tyvek lid |
| Sterilization<br>Sterility Assurance<br>Level | Gamma radiation<br>$10^{-6}$ | Ethylene Oxide<br>Not Available | Gamma radiation<br>Not Available |
| Shelf Life | 24 months | Not Available | Not Available |
| Performance | | | |
| Tissue Leak Pressure<br>(Bench) | No statistical difference p>0.05 | | Not Tested |
| Tissue Leak Pressure<br>(Animal) | No statistical difference p>0.05 | | Not Tested |
| Clinical Performance<br>(MicroCutter European<br>Trial I (METI): The<br>Cardica MicroCutter in<br>Surgical Stapling) | Non-inferior to<br>composite historical<br>control | Not Applicable | Not Applicable |

.

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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 related<br>Severe Adverse Events<br>Categories | Hand-<br>sewn<br>related | Other<br>Stapler<br>related | MicroCutter<br>related | 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 Sites<br>N* (%) |
|--------------------------------------------|---------------------|
| Anastomose small intestine to<br>stomach | 1 (0.2) |
| Anastomosis of small intestine | 25 (5.9) |
| Anastomosis of small intestine to<br>colon | 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 Sites<br>N* (%) |
|------------------------------------------|---------------------|
| Transection of duodenum | 19 (4.5) |
| Transection of<br>Mesocolon/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:

| | Total<br>N* (%) |
|--------------------------|-----------------|
| Observation | 160 (N/A) |
| Open | 70 (43.8) |
| Laparoscopic | 75 (46.9) |
| Laparoscopic<br>assisted | 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 [phone] or [phone] 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 [phone] or [phone] 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)