(268 days)
No
The description focuses on the mechanical function of a surgical stapler and does not mention any AI/ML components or capabilities.
No.
The device is a surgical stapler used for transecting tissue and creating anastomoses, which are surgical procedures rather than therapeutic interventions.
No
The device description indicates it is a surgical stapler used for transecting tissue and creating anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a physical stapler made of stainless steel, which is a hardware component. The performance studies also involve bench testing and animal studies on physical tissue, further indicating it is not a software-only device.
Based on the provided information, the MicroCutter XCHANGE® 30 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes a surgical stapler used for transecting and creating anastomoses in various tissues within the body during surgical procedures. This is an in vivo application, meaning it's used on living tissue inside a patient.
- Device Description: The description details a surgical stapler that delivers staples and transects tissue. This aligns with a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue biopsies, etc.) in vitro (in a lab setting). There's no mention of reagents, assays, or diagnostic measurements.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The MicroCutter XCHANGE® 30 is a surgical tool used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
GDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small and large intestine, appendix, urologic, thoracic, and pediatric surgical procedures (implied anatomical sites for these procedures)
Indicated Patient Age Range
pediatic (sic)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing in the form of Tissue Burst pressure testing was conducted.
Two chronic animal studies:
- a study in which unilateral nephrectomies were performed (abdominal vascular transections)
- a study in which unilateral lobectomies were performed (intrathoracic vascular transections)
Sample size for animal studies: Not Specified (all animals had an uncomplicated 5-week postoperative course)
Key results: - Bench testing: "No statistical difference, p>0.05" in Tissue Burst Pressure for White in Porcine Carotid Artery and Porcine Jugular Vein compared to predicate.
- Chronic animal studies: "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."
Key Metrics
Not Found
Predicate Device(s)
Ethicon PROXIMATE Vascular Linear Cutter 55 (K020779), Ethicon ENDOPATH ETS-Flex45 Endoscopic Linear Cutters (K002398)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 (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
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 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
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
XCHANGE® 30
(K132581) | Ethicon PROXIMATE
Vascular Linear Cutter
55 (K020779)
(Primary Predicate) | Ethicon ENDOPATH
ETS-Flex45
Endoscopic Linear
Cutters (K002398)
(Secondary Predicate) |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Deployment Device | | | |
| Deployment | Cartridge based
deployment (up to 6
deployments per tool) for
single patient use | Cartridge based
deployment (up to 8
deployments per tool) for
single patient use | Cartridge based
deployment for single
patient use |
| Shaft Length | 340 mm | 78 mm | 340 mm |
| Transection Line
Length | 27 mm | 53 mm | 41 mm |
| Feature | MicroCutter
XCHANGE® 30
(K132581) | Ethicon PROXIMATE
Vascular Linear Cutter
55 (K020779)
(Primary Predicate) | Ethicon ENDOPATH
ETS-Flex45
Endoscopic Linear Cutters (K002398)
(Secondary Predicate) |
| End-Effector
Opening | 5.3mm at tissue stop
(proximal);
16.7mm at distal opening | Variable - two halves
separate allowing end-
effector to have as large
of an opening as user
requires | 2.6mm at tissue stop
(proximal); 12.3mm at
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
Staple height | 1.82 mm | 2.5 mm | 2.5 mm |
| White Formed Staple
Height | 1.16 mm (compatible with
tissue thickness that can be
compressed easily to 1.0
mm) | 1.0 mm (compatible with
tissue thickness that can
be compressed easily to
1.00 mm) | 1.0 mm (compatible with
tissue thickness that can
be compressed easily to
1.00 mm) |
| Formed Staple
Configuration | D shaped | B shaped | B shaped |
| Staple Line
Configuration | Two (2), double-staggered
rows | Two (2), double-
staggered rows | Three (3), double-
staggered rows |
| Staple Line Length | 30 mm | 55 mm | 45 mm |
| Number of Staples
Per Deployment | 50
(One row of 13 and one
row of 12 on either side of
transection line) | 56
(for the 55 mm staple line
length) | 66
(one row of 11, one row
of 11, and one row of 11
on either side of
transection line) |
| MRI Compatibility | MR-Conditional | Same as subject device | Same as subject device |
| Biocompatibility | | | |
| Material
Biocompatibility
(Delivery Device and
Staple) | All components of the
Cardica MicroCutter
XCHANGE® 30 are
comprised of materials that
were deemed acceptable in
accordance with ISO
Standard 10993-1. | Same as subject device | Same as subject device |
| Packaging, Sterilization and Shelf Life | | | |
| Packaging | Thermoformed tray with
Tyvek lid | Thermoformed tray with
Tyvek lid | Thermoformed tray with
Tyvek lid |
| Sterilization | Gamma radiation, | Gamma radiation, | Gamma radiation, |
| Sterility Assurance
Level | $10^{-6}$ | Not Available | Not Available |
| Shelf Life | 24 months | Not Available | Not Available |
| Feature | MicroCutter
XCHANGE® 30
(K132581) | Ethicon PROXIMATE
Vascular Linear Cutter
55 (K020779)
(Primary Predicate) | Ethicon ENDOPATH
ETS-Flex45
Endoscopic Linear
Cutters (K002398)
(Secondary Predicate) |
| Performance | | | |
| Tissue Burst Pressure
White in Porcine
Carotid Artery
(Bench) | No statistical difference, p>0.05 | | Not Available |
| Tissue Burst Pressure
White in Porcine
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.