MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge

K151081 · Cardica, Inc. · GDW · Jan 15, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K151081
• Device Name: MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
• Applicant: Cardica, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jan 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

MicroCutter XCHANGE® 30 is a single-patient-use, cartridge-based surgical stapler; 5mm diameter shaft; 160° articulation; 360° rotation. Device delivers two double-staggered rows (4 rows total) of 316L stainless steel D-shaped staples while simultaneously transecting tissue. Used in open or minimally invasive urologic, thoracic, and pediatric surgeries; operated by surgeons. Provides 30mm staple line; 27mm transection length. Output is mechanical tissue closure and transection. Benefits include precise tissue management in confined spaces via articulation and rotation features.

Clinical Evidence

No human clinical data. Evidence includes bench testing (tissue burst pressure in porcine carotid artery and jugular vein) and two chronic animal studies (unilateral nephrectomies and lobectomies). Animal studies showed uncomplicated 5-week postoperative courses, no bleeding/infection, and unremarkable histology with no difference between subject and predicate groups. Bench testing showed no statistical difference (p>0.05) in burst pressure.

Technological Characteristics

Cartridge-based stapler; 5mm shaft; 316L stainless steel staples; D-shaped staple configuration; 30mm staple line; 160° articulation; 360° rotation. Biocompatibility per ISO 10993-1. Sterilization via gamma radiation (SAL 10^-6). Shelf life 24 months. Mechanical actuation.

Indications for Use

Indicated for patients undergoing open or minimally invasive urologic, thoracic, or pediatric surgical procedures requiring tissue transection, resection, or creation of anastomoses in the small and large intestine, and 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

• Ethicon PROXIMATE Vascular Linear Cutter 55 (K020779)
• Ethicon ENDOPATH ETS-Flex45 Endoscopic Linear Cutters (K002398)

Submission Summary (Full Text)

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

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

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

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 [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" (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 [phone] or [phone] 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

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

# Indications for Use

510(k) Number (if known) K151081

Device Name Cardica MicroCutter XCHANGE® 30

### Indications for Use (Describe)

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.

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

| <span style="text-decoration: underline;"><b> Prescription Use (Part 21 CFR 801 Subpart D) </b></span> |
|------------------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b> Over-The-Counter Use (21 CFR 801 Subpart C) </b></span> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 [e-mail]

"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."

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

# 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: [phone] Fax: [phone]

#### C. Contact Person

Cindy Domecus, R.A.C. (US & EU) Cardica Regulatory Consultant [phone] (office) [phone] (cell) [phone] (fax) [e-mail]

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

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

#### 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

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

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 | MicroCutter<br>XCHANGE® 30<br>(K132581) | Ethicon PROXIMATE<br>Vascular Linear Cutter<br>55 (K020779)<br>(Primary Predicate) | Ethicon ENDOPATH<br>ETS-Flex45<br>Endoscopic Linear<br>Cutters (K002398)<br>(Secondary Predicate) |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Deployment Device | | | |
| Deployment | Cartridge based<br>deployment (up to 6<br>deployments per tool) for<br>single patient use | Cartridge based<br>deployment (up to 8<br>deployments per tool) for<br>single patient use | Cartridge based<br>deployment for single<br>patient use |
| Shaft Length | 340 mm | 78 mm | 340 mm |
| Transection Line<br>Length | 27 mm | 53 mm | 41 mm |
| Feature | MicroCutter<br>XCHANGE® 30<br>(K132581) | Ethicon PROXIMATE<br>Vascular Linear Cutter<br>55 (K020779)<br>(Primary Predicate) | Ethicon ENDOPATH<br>ETS-Flex45<br>Endoscopic Linear Cutters (K002398)<br>(Secondary Predicate) |
| End-Effector<br>Opening | 5.3mm at tissue stop<br>(proximal);<br>16.7mm at distal opening | Variable - two halves<br>separate allowing end-<br>effector to have as large<br>of an opening as user<br>requires | 2.6mm at tissue stop<br>(proximal); 12.3mm at<br>distal 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 Unformed<br>Staple height | 1.82 mm | 2.5 mm | 2.5 mm |
| White Formed Staple<br>Height | 1.16 mm (compatible with<br>tissue thickness that can be<br>compressed easily to 1.0<br>mm) | 1.0 mm (compatible with<br>tissue thickness that can<br>be compressed easily to<br>1.00 mm) | 1.0 mm (compatible with<br>tissue thickness that can<br>be compressed easily to<br>1.00 mm) |
| Formed Staple<br>Configuration | D shaped | B shaped | B shaped |
| Staple Line<br>Configuration | Two (2), double-staggered<br>rows | Two (2), double-<br>staggered rows | Three (3), double-<br>staggered rows |
| Staple Line Length | 30 mm | 55 mm | 45 mm |
| Number of Staples<br>Per Deployment | 50<br>(One row of 13 and one<br>row of 12 on either side of<br>transection line) | 56<br>(for the 55 mm staple line<br>length) | 66<br>(one row of 11, one row<br>of 11, and one row of 11<br>on either side of<br>transection line) |
| MRI Compatibility | MR-Conditional | Same as subject device | Same as subject device |
| Biocompatibility | | | |
| Material<br>Biocompatibility<br>(Delivery Device and<br>Staple) | All components of the<br>Cardica MicroCutter<br>XCHANGE® 30 are<br>comprised of materials that<br>were deemed acceptable in<br>accordance with ISO<br>Standard 10993-1. | Same as subject device | Same as subject device |
| Packaging, Sterilization and Shelf Life | | | |
| Packaging | Thermoformed tray with<br>Tyvek lid | Thermoformed tray with<br>Tyvek lid | Thermoformed tray with<br>Tyvek lid |
| Sterilization | Gamma radiation, | Gamma radiation, | Gamma radiation, |
| Sterility Assurance<br>Level | $10^{-6}$ | Not Available | Not Available |
| Shelf Life | 24 months | Not Available | Not Available |
| Feature | MicroCutter<br>XCHANGE® 30<br>(K132581) | Ethicon PROXIMATE<br>Vascular Linear Cutter<br>55 (K020779)<br>(Primary Predicate) | Ethicon ENDOPATH<br>ETS-Flex45<br>Endoscopic Linear<br>Cutters (K002398)<br>(Secondary Predicate) |
| Performance | | | |
| Tissue Burst Pressure<br>White in Porcine<br>Carotid Artery<br>(Bench) | No statistical difference, p>0.05 | | Not Available |
| Tissue Burst Pressure<br>White in Porcine<br>Jugular Vein (Bench) | No statistical difference, p>0.05 | | Not Available |

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

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

#### 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.