MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE

K140170 · Cardica, Inc. · GDW · Feb 19, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140170
• Device Name: MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
• Applicant: Cardica, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Feb 19, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

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 White Cartridge is a single-patient-use surgical stapler component; used with MicroCutter XCHANGE™ 30 Stapler. Device delivers two double-staggered rows of 316L stainless steel staples while simultaneously transecting tissue. Input: manual operation by surgeon in open or minimally invasive procedures. Output: stapled and transected tissue (staple line ~30mm, transection ~27mm). Designed for tissue compressible to 1.0mm. Features index ridge for cartridge differentiation; no colorant in distal tip. Benefits: provides secure tissue closure and transection in gastrointestinal surgeries. Used in clinical/OR settings by surgeons.

Clinical Evidence

No human clinical data. Evidence consists of bench testing and a chronic pre-clinical evaluation in juvenile pigs. Bench testing verified staple line pull-apart strength (11.5 +/- 1.2 lb), tissue leak pressure, and reliability post-sterilization/aging. Animal study demonstrated substantial equivalence of anastomoses created with white staples versus blue staples.

Technological Characteristics

Materials: 316L stainless steel staples, Vectra A130 Liquid Crystal Polymer (LCP) cartridge. Dimensions: 30mm staple line, 27mm transection length. Energy: Manual. Connectivity: None. Sterilization: Gamma radiation (SAL 10^-6). Packaging: Tyvek and Nylon/LDPE/HDPE pouch. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for patients undergoing open or minimally invasive surgical procedures requiring transection, resection, or anastomosis of 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

• MicroCutter XCHANGE™ 30 (K132581)

Submission Summary (Full Text)

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

# FEB 1 9 2014

A.

く

## Date Prepared

January 22, 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 XCHANGETM 30 White Cartridge

### G. Legally Marketed Predicate Device(s)

MicroCutter XCHANGETM 30 (K132581)

### H. 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.

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

### I. 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.

### 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.
- 3. 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 DEVICE<br>MicroCutter XCHANGE 30<br>Blue Cartridge (K132581) | SUBJECT DEVICE<br>MicroCutter XCHANGE 30<br>White 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 Primary<br>Tine Length | 3.43mm | 1.81mm |
| Unformed Staple Secondary<br>Tine Length | 0.56mm | 0.30mm |
| Formed Staple Height | 1.4mm (compatible with<br>tissue thickness that can be<br>compressed easily to 1.50mm) | 1.16mm (compatible with tissue<br>thickness that can be compressed<br>easily to 1.00mm) |
| Formed Staple<br>Configuration | D shaped | Same as predicate device |
| Feature | PREDICATE DEVICE<br>MicroCutter XCHANGE 30<br>Blue Cartridge (K132581) | SUBJECT DEVICE<br>MicroCutter XCHANGE 30<br>White Cartridge |
| Intended tissue thickness | Compatible with tissue thickness that can be<br>compressed easily to 1.50mm | Compatible with tissue thickness that can be compressed easily to<br>1.00mm |
| Staple Line Configuration | Two (2), double-staggered<br>rows | Same as predicate device |
| Staple Line Length | 30mm | Same as predicate device |
| Number of Staples Per<br>Deployment | 50 (One row of 13 and one<br>row of 12 on either side of<br>transaction line) | Same as predicate device |
| MRI Compatibility | MR-Conditional | Same as predicate device |
| Staple Cartridge<br>Staple Cartridge<br>Insert | Vectra A130 Liquid Crystal<br>Polymer (LCP) with<br>VG3010K20 Blue colorant,<br>and Stainless Steel | Vectra A130 Liquid Crystal<br>Polymer (LCP) with no colorant,<br>and Stainless Steel |
| Biocompatibility<br>Material Biocompatibility<br>(Delivery Device, Staple<br>Cartridge and Staple) | All components of the<br>Cardica MicroCutter<br>XCHANGE 30 are comprised<br>of materials that were deemed<br>acceptable in accordance with<br>ISO Standard 10993-1.<br>Biocompatibility: Cytotoxicity,<br>Sensitization, Irritation, Toxicity,<br>Hemocompatibility | Same as predicate device |
| Staple Cartridge Packaging, Sterilization and Shelf Life | | |
| Packaging | Tyvek and<br>Nylon/LDPE/HDPE<br>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 |
| Performance | | |
| Tissue Leak Pressure<br>(Bench) | The subject White Staple Cartridge is non-inferior and<br>substantially equivalent to the predicate Blue Staple Cartridge | |
| Staple line pull-apart | 8.2 +/- 0.9 lb. | 11.5 +/- 1.2 lb. |

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

t

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## 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

L.

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.

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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

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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 [phone] or [phone] 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

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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: 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)

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)

> 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)

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