(73 days)
Not Found
No
The summary describes a mechanical device for creating anastomoses using clips and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is used to create anastomoses, which is a surgical procedure for joining blood vessels, not to provide therapy itself.
No
The device is described as an "Anastomosis System" intended for creating anastomoses (surgical connections between blood vessels). Its function is therapeutic/surgical, not for diagnosing conditions or diseases.
No
The device description explicitly states it consists of an "Anastomosis Device and one Retractor Mount," which are physical hardware components used to deliver clips and create an anastomosis. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the creation of anastomoses (connections) in blood vessels and grafts during surgical procedures like coronary artery bypass grafting. This is a surgical device used in vivo (within the body).
- Device Description: The description details a system that delivers clips to physically connect blood vessels. This is a mechanical surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to perform procedures on the body itself.
N/A
Intended Use / Indications for Use
The Cardica® C-Port® xA Plus Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
Product codes
FZP
Device Description
The Cardica® C-Port® xA Plus Distal Anastomosis System delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). An array of metal clips creates a complete, end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood vessels and grafts, including use in coronary artery bypass grafting procedures.
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All the aforementioned modifications have been rigorously verified and validated using Cardica's Design Control process (Cardica procedures WD-0400 and 0401):
A Design Change Impact Analysis identified the system level ramifications of changes to materials and provided guidance and rationale for the selection of appropriate component and system level qualifications. A battery of tests and evaluations was performed to assess the impact of the component material changes identified above to ensure that these modifications do not alter the validity of in vitro and in vivo testing and other design validation activities previously performed on the predicate Cardica® C-Port® xA PLUS Distal Anastomosis System and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device.
Risk Management File review and Clinical Risk Benefit Analysis were conducted to ensure the continued safety and efficacy of the device. A detailed description of these changes is available in Section D, Summary of Design Controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
K101018
F. 510(k) Summary System Special 510{k) Premarket Notification Cardica C-Port® xA Hybrid PLUS Distal Anastomosis
April 9, 2010
JUN 2 5 2010
F. 510(k) Summary
| 510(k) Number | ||
|---|---|---|
| Date Prepared | April 9, 2010 | |
| Applicant | ||
| Information | Cardica, Inc. | |
| 900 Saginaw | ||
| Redwood City, California 94063 | ||
| Main: 650-364-9975 | ||
| Fax: 650-331-7195 | ||
| Contact Person | Matthew E. Chroust, Director of QA/RA | |
| Office: 650-331-7152 | ||
| Fax: 650-331-7195 | ||
| e-mail: chroust@cardica.com | ||
| Establishment | ||
| Registration Number | 3004114958 | |
| Device Information | Classification Name: | |
| Regulation Number: | ||
| Trade Name: | ||
| Common Name: | Clip, Implantable | |
| 21 CFR §878.4300 | ||
| Cardica® C-Port® xA PLUS Distal | ||
| Anastomosis System | ||
| Cardiovascular Surgical Instruments | ||
| Legally Marketed | ||
| Predicate Device(s) | Cardica® C-Port® xA PLUS Distal Anastomosis System | |
| (K090872) April 21, 2009 | ||
| Labeling and | ||
| Intended Use | The subject Cardica® C-Port® xA PLUS Distal Anastomosis | |
| System is intended for the creation of anastomoses in blood | ||
| vessels and grafts, including use in coronary artery bypass | ||
| grafting procedures. This is the same intended use as | ||
| previously cleared for the predicate C-Port® xA PLUS Distal | ||
| Anastomosis System (K090872). | ||
| Draft Instructions for Use can be found in Section E, Labeling, | ||
| of this submission. A redline showing the differences is also | ||
| provided for reference. | ||
| The Indications for Use statement can be found in Section H, | ||
| Indications for Use. | ||
| There is no change to the Product Label. | ||
| Device Description | The Cardica® C-Port® xA Plus Distal Anastomosis System | |
| delivers a series of clips that create an anastomosis between a | ||
| small target vessel (e.g. coronary artery) and conduit (e.g. | ||
| saphenous vein graft). An array of metal clips creates a | ||
| complete, end-to-side anastomosis that is functionally | ||
| equivalent to a hand-sutured interrupted stitch anastomosis. | ||
| The system consists of one Anastomosis Device and one | ||
| Retractor Mount | ||
| Indications for Use | The C-Port® xA Hybrid Plus Anastomosis System is is intended | |
| for use in the creation of anastomoses in blood vessels and | ||
| grafts, including use in coronary artery bypass grafting | ||
| procedures. The change in materials described above do not | ||
| impact the Indications for Use, therefore no changes will be | ||
| made to this labeling. |
C-Port xA Hybrid Distal Anastomosis System
1
F. 510(k) Summary System Special 510(k) Premarket Notification Cardica C-Port® xA Hybrid PLUS Distal Anastomosis
April 9, 2010
.
.
2
KI01018
Cardica C-Port® xA Hybrid PLUS Distal Anastomosis
April 9, 2010
| Comparison to
Predicate Device | The subject Cardica® C-Port® xA Plus Distal Anastomosis
System, is substantially equivalent to the predicate Cardica® C-
Port® xA PLUS Distal Anastomosis System, which was cleared
by FDA on April 21, 2009 (K090872) |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Like its predicate device, the subject C-Port® xA Plus
Distal Anastomosis System, is a sterile, single-use
device for creation of a reliably patent end-to-side
anastomosis between a conduit (graft vessel) and target
vessel. |
| 2. | Both products consist of sub-assemblies for stabilizing
and positioning the conduit for grafting and for creating
the anastomosis by deployment of an array of metal
clips. |
| 3. | Once the graft vessel has been loaded onto the device
and the device positioned against the target vessel, the
anastomosis between the graft and target vessel is
completed by pushing the actuation button. |
| | Modifications improving the reliability, manufacturability and
appearance of the predicate device included the following: |
| 1. | Knife Component material changes from Stainless Steel
to Nitinol for durability; |
| 2. | Heel Clip Component material changes from Stainless
Steel to Titanium To reduce the force required to clamp. |
| 3. | Cartridge Housing Component material changes with
the addition of pink and blue colorant for aesthetics; |
| 4. | A Cardica logo graphic is added to the Activation Knob
Component via pad printing for better market
recognition, and the material of the the Activation Knob
Component changes from glass-filled polycarbonate to
glass-filled nylon for durability. |
| 5. | The Anvil Base Component material changes from
machined type 416 Stainless steel to metal-injection
molded (MIM) 17-4 Stainless steel to improve
manufacturability. Adding Dicronite, a dry lubricant to
the Anvil Base Component's cable channels reduces
friction in the cable system. |
| 6. | Anvil Hinge Component material is changed, adding
carbon filling to the Victrex PEEK material for increased
dimensional stability. |
| Device Testing
Results and
Conclusion | All the aforementioned modifications have been rigorously
verified and validated using Cardica's Design Control process
(Cardica procedures WD-0400 and 0401):
A Design Change Impact Analysis identified the system level
ramifications of changes to materials and provided guidance
and rationale for the selection of appropriate component and
system level qualifications. A battery of tests and evaluations
was performed to assess the impact of the component material
changes identified above to ensure that these modifications do
not alter the validity of in vitro and in vivo testing and other
design validation activities previously performed on the
predicate Cardica® C-Port® xA PLUS Distal Anastomosis
System and its packaging to ensure substantial equivalence to
the predicate device, and to ensure the safety and
effectiveness of the device.
Risk Management File review and Clinical Risk Benefit
Analysis were conducted to ensure the continued safety and
efficacy of the device. A detailed description of these changes
is available in Section D, Summary of Design Controls. |
| Technological | See Device Description above |
| Characteristics | |
| Substantial
Equivalence
Summary | Both the subject Cardica® C-Port® xA PLUS Distal
Anastomosis System and its predicate have the same
Indications for Use and the same technological characteristics
as the predicate device C-Port xA PLUS (K090872). This
premarket notification has described the characteristics of the
modified device in sufficient detail to assure substantial
equivalence. |
| | The subject C-Port® xA PLUS Distal Anastomosis System has
the following similarities to those previously described and
cleared for the predicate device:
- same indicated use,
- same operating principle,
- same basic device design and size,
- same materials (with the exception of those changes
identified above), - same manufacturing processes,
- same packaging and sterilization materials,
- Instructions for Use are essentially identical, with the only
changes being the model name and the clarification in the
System Description of the Clip array construction being
Stainless Steel and Nitinol in the Subject C-Port xA PLUS,
where they had been Stainless Steel in the predicate. |
| Conclusions | In summary, the subject C-Port® xA PLUS Distal Anastomosis
System described in this submission is substantially equivalent
to the predicate device. This Special 510(k) for Device
Modification submission has demonstrated Substantial
Equivalence as defined and understood in the Federal Food
Drug and Cosmetic Act and various guidance documents. |
CARDICA, INC. CONFIDENTIAL & PROPRIETARY
.
Pg. 3 of 6
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. F. 510(k) Summary System Special 510(k) Premarket Notification
·
Cardica C-Port® xA Hybrid PLUS Distal Anastomosis
April 9, 2010
CARDICA, INC. CONFIDENTIAL & PROPRIETARY
Pg. 4 of 6
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Cardica C-Port® xA Hybrid PLUS Distal Anastomosis
April 9, 2010
CARDICA, INC. CONFIDENTIAL & PROPRIETARY
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100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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Cardica C-Port® xA Hybrid PLUS Distal Anastomosis
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April 9, 2010
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and the same of the same
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| issued by the Center for Devices and Radiological Health. |
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and the control control control controlled in the consideration
:
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CARDICA, INC. CONFIDENTIAL & PROPRIETARY
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
JUN 2 5 2010
Cardica, Inc. c/o Mr. Matthew E. Chroust Director, Quality & Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063
Re: K101018
Trade/Device Name: Cardica® xA™ PLUS Distal Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Clip, Implantable and Delivery System Regulatory Class: Class II Product Code: FZP Dated: May 27, 2010 Received: May 28, 2010
Dear Mr. Chroust:
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.
7
Page 2 - Mr. Matthew E. Chroust
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toase of action that I Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must corply 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 Of ice rated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic forth in the quarted 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 n you attp://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 note the 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 I ou may of Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Cardica C-Port® xA PLUS Distal Anastomosis System April 9, 2010
Indications for Use Statement
| 510(k) Number:
| (if known) | |
|---|---|
| Device Name: | Cardica® C-Port® xA Plus Distal Anastomosis System |
| Indications for Use: | The Cardica® C-Port® xA Plus Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. |
Prescription Use × (Part 21 CFR§801.109)
.
Over-The-Counter Use OR (Optional Format 1-2-96)
.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
·
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division/Sign-Off) |
|---|
| --------------------- |
CARDICA, INC. CONFIDENTIAL & PROPRIETDivision of Cardiovascular Devices
| 510(k) Number | K161018 Pg. 1 of 1 |
|---|---|
| --------------- | -------------------- |