Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
K171561 · Dextera Surgical, Inc. · GDW · Aug 28, 2017 · General, Plastic Surgery
Device Facts
| Record ID | K171561 |
| Device Name | Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload |
| Applicant | Dextera Surgical, Inc. |
| Product Code | GDW · General, Plastic Surgery |
| Decision Date | Aug 28, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediativ 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. The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.
Device Story
The Dextera MicroCutter 30 Reloads are cartridge-based components used with the MicroCutter 5/80 Stapler. The system delivers two double-staggered rows of 316L stainless steel staples while simultaneously transecting tissue between the rows. Used in open or minimally invasive urologic, thoracic, pediatric, and intestinal surgeries. Operated by surgeons. The device provides mechanical tissue closure and transection, facilitating surgical procedures like anastomoses and organ resection. Benefits include reliable tissue approximation and vessel ligation during complex procedures.
Clinical Evidence
No clinical data. Evidence consists of non-clinical performance data, including functional tissue burst pressure testing on porcine veins and arteries, and previously submitted chronic animal studies (unilateral nephrectomies and lobectomies) comparing subject staples to predicate staples. Results showed no demonstrable differences in performance.
Technological Characteristics
Staples constructed of 316L stainless steel. Reloads provide two double-staggered rows of staples with a 28.0mm cut length and 30mm staple line. Staple sizes are specific to tissue compression thicknesses of 1.0mm (White) or 1.5mm (Blue). Mechanical actuation via the MicroCutter 5/80 Stapler. Single-patient use.
Indications for Use
Indicated for patients undergoing open or minimally invasive urologic, thoracic, pediatric, or intestinal surgical procedures requiring transection, resection, or anastomosis; also indicated for appendix transection and solid organ parenchymal dissection (veins 4-5mm, arteries 3-7mm). Contraindicated if tissue cannot be compressed to the specified staple thickness (1.0mm or 1.5mm).
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 ENDOPATH® ETS-Flex45 Endoscopic Articulating Linear Cutters and (Reloads) (K070887)
Reference Devices
- MicroCutter 30 Blue Reload, MicroCutter 30 Curved Tip Blue Reload, MicroCutter 30 White Reload and MicroCutter 30 Curved Tip White Reload used with the MicroCutter 5/80 Stapler (K151081 and K161137)
Related Devices
- K161137 — Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload · Cardica, Inc. · Jul 20, 2016
- K151081 — MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge · Cardica, Inc. · Jan 15, 2016
- K140170 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE · Cardica, Inc. · Feb 19, 2014
- K122781 — RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD · Covidien, Formerly US Surgical A Divison of Tyco H · Feb 5, 2013
- K132581 — MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE · Cardica, Inc. · Jan 7, 2014
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2017
Dextera Surgical, Inc. Ms. Pamela Segale Consulting VP, Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063
Re: K171561
Trade/Device Name: Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: May 27, 2017 Received: May 30, 2017
Dear Ms. Segale:
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
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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 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 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/Resourcesfor You/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 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 vours.
Binita S. Ashar -S
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) K171561
### Device Name
MicroCutter 30 Blue Reload, MicroCutter 30 Curved Tip Blue Reload, MicroCutter 30 Curved Tip White Reload, Dextera MicroCutter 5/80 Stapler
### Indications for Use (Describe)
The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediativ 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.
The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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### 510(k) Summary
#### Date Prepared A.
August 25, 2017
#### B. 510(k) Owner
Dextera Surgical Inc. 900 Saginaw Drive Redwood City, California 94063 Phone: 650-364-9975 Fax: 650-364-3134
#### C. Contact Person
Pamela Segale Consulting VP, Regulatory Affairs (650) 331-7131 (office) (650) 799-7162 (cell) psegale@dexterasurgical.com
#### D. Device Information
Trade name: MicroCutter 30 Blue Reload, MicroCutter 30 Curved Tip Blue Reload, MicroCutter 30 White Reload, and MicroCutter 30 Curved Tip White Reload
Common name: Staple Classification Name: Implantable staple Regulation Number: 21 CFR §878.4750 Product Code: GDW
#### E. Marketed Predicate Devices
Ethicon ENDOPATH® ETS-Flex45 Endoscopic Articulating Linear Cutters and (Reloads) (K070887)
## Reference Devices
MicroCutter 30 Blue Reload, MicroCutter 30 Curved Tip Blue Reload, MicroCutter 30 White Reload and MicroCutter 30 Curved Tip White Reload used with the MicroCutter 5/80 Stapler (K151081 and K161137)
#### F. Device Description
Each MicroCutter 30 Reload contains two double rows of 316L stainless steel staples. The size of the MicroCutter 30 Blue Reload and MicroCutter 30 Curved Tip Blue Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the MicroCutter30 White Reload and MicroCutter 30 Curved Tip White Reload staple is compatible with tissue that can be easily compressed to 1.0mm. If tissue cannot comfortably compress to the Maximum Tissue Thickness listed for each reload, or easily compresses to less than the Maximum Tissue Thickness listed for each reload, the tissue
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is contraindicated as it may be too thick or too thin for the selected staple size. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The MicroCutter 30 Reloads are deployed using the Dextera MicroCutter 5/80TM Stapler. The MicroCutter 5/80 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.
#### G. Indications for Use
The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Curved Tip White and Blue Reloads are 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.
The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.
#### H. Comparison to Predicate Device
A comparison of the subject devices to the predicate devices demonstrates that the devices have the same intended use, which is to transect, resect and create anastomoses in patients during surgery in a variety of surgical procedures including urologic, thoracic, pediatric, and intestinal surgery. Additionally, they have the same mechanism of action and similar technologies given both the subject and the predicate devices achieve their intended use by means of cartridge based metal staples that are delivered using stapling devices.
Chronic animal studies, previously submitted by Dextera Surgical (K151081), were conducted in which unilateral nephrectomies and unilateral lobectomies were performed comparing the Dextera Surgical subject staple and the predicate Ethicon staple. The endpoints of the studies were met with no demonstrable differences noted between the subject devices and the predicate devices. Non-clinical performance data was also previously submitted (K151081) in which the Dextera Surgical subject staple and the Ethicon predicate staple were compared during Tissue Burst Pressure testing in porcine arteries. The test data demonstrated the subject devices to be substantially equivalent to the predicate devices.
#### I. Performance Data
### Non-Clinical Performance Data
Functional performance testing was conducted using the subject staple and the predicate staple on porcine veins during Tissue Burst Pressure testing. The testing simulated transection of vessels as may be encountered during surgery on solid organs. The results demonstrated the subject devices to be substantially equivalent to the predicate devices.
#### J. Conclusion
The subject devices and the predicate devices have intended use and similar indications for use. Additionally, the subject devices and the predicate devices have the same mechanism of action and utilize similar technologies. Functional performance testing (Tissue Burst Pressure) was conducted with the results demonstrating the subject
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devices to be substantially equivalent to the predicate devices. Thus, based on the data and the comparison of the devices, the subject devices are substantially equivalent to the predicate devices.