(73 days)
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.
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
The provided text describes a Special 510(k) Premarket Notification for the Cardica® C-Port® xA Hybrid PLUS Distal Anastomosis System. This type of submission is for modifications to a legally marketed device that do not significantly alter its fundamental scientific technology or intended use. Therefore, the device is demonstrating substantial equivalence to its predicate device rather than undergoing extensive de novo clinical trials with acceptance criteria and a dedicated study design for proving performance against those criteria.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of acceptance criteria and the reported device performance:
Since this is a Special 510(k) for a modified device, the "acceptance criteria" primarily relate to demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the predicate device. The performance is assessed by confirming that the modified device remains substantially equivalent. No specific quantitative performance metrics (like sensitivity, specificity, or specific success rates) for a new device are presented as acceptance criteria for this submission.
The document states: "All the aforementioned modifications have been rigorously verified and validated using Cardica's Design Control process (Cardica procedures WD-0400 and 0401)... 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."
This indicates a process of verification and validation that confirmed the modified device still met the performance established by the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size for a "test set" in the context of a new performance study. The testing performed was related to verifying the impact of material changes on the modified device relative to the predicate. The provenance of the data is not specified beyond "Cardica's Design Control process." Given the nature of a Special 510(k) for material changes, this would likely involve a combination of in vitro and potentially in vivo testing, but not a large-scale clinical trial to establish new performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable and not provided. The submission focuses on substantial equivalence based on engineering and performance testing of the device itself and its components, not on evaluation by human experts using diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. As mentioned above, the evaluation is not based on human-expert assessment of "ground truth" to determine performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided. This device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the design validation activities mentioned, the "ground truth" would be established through engineering specifications, material properties, mechanical testing results (e.g., related to durability, force required to clamp, dimensional stability), and potentially animal in vivo models for anastomotic integrity, as was done for the predicate device. The document explicitly states: "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..." This implies relying on the established performance and safety profile of the predicate as the benchmark.
8. The sample size for the training set:
This information is not applicable and not provided. The device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. The device is not an AI algorithm that requires a training set.
Summary of the Study and Acceptance:
The submission K101018 for the Cardica® C-Port® xA Hybrid PLUS Distal Anastomosis System is a Special 510(k). This means it's a notification for changes to a device already cleared by the FDA (the predicate K090872). The "study" isn't a new clinical trial to establish performance de novo, but rather a Design Change Impact Analysis and a battery of verification and validation tests to ensure that modifications (primarily material changes) do not alter the safety or effectiveness of the device and that it remains substantially equivalent to its predicate.
The key acceptance criterion for this submission is substantial equivalence to the predicate device (K090872). This is evaluated by demonstrating that the modified device:
- Has the same intended use.
- Has the same operating principle.
- Has the same basic device design and size.
- Has primarily the same materials (with changes rigorously tested).
- Uses the same manufacturing processes.
- Uses the same packaging and sterilization materials.
- Has essentially identical Instructions for Use.
The study proving this involved:
- Design Change Impact Analysis: Identifying potential ramifications of the material changes.
- Verification and Validation Testing: A "battery of tests and evaluations" performed based on Cardica's Design Control process (WD-0400 and 0401) to assess the impact of the material changes. These tests were designed to confirm that the modifications did not invalidate prior in vitro and in vivo testing and design validation activities conducted for the predicate device.
- Risk Management File review and Clinical Risk Benefit Analysis: Conducted to ensure continued safety and efficacy.
No specific sample sizes for these tests are provided in the summary, nor is detailed information on the specific in vitro or in vivo tests performed. However, the FDA's clearance indicates they were satisfied that the evidence presented supported the claim of substantial equivalence.
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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 | |
| ApplicantInformation | Cardica, Inc.900 SaginawRedwood City, California 94063Main: 650-364-9975Fax: 650-331-7195 | |
| Contact Person | Matthew E. Chroust, Director of QA/RAOffice: 650-331-7152Fax: 650-331-7195e-mail: chroust@cardica.com | |
| EstablishmentRegistration Number | 3004114958 | |
| Device Information | Classification Name:Regulation Number:Trade Name:Common Name: | Clip, Implantable21 CFR §878.4300Cardica® C-Port® xA PLUS DistalAnastomosis SystemCardiovascular Surgical Instruments |
| Legally MarketedPredicate Device(s) | Cardica® C-Port® xA PLUS Distal Anastomosis System(K090872) April 21, 2009 | |
| Labeling andIntended Use | The subject Cardica® C-Port® xA PLUS Distal AnastomosisSystem is intended for the creation of anastomoses in bloodvessels and grafts, including use in coronary artery bypassgrafting procedures. This is the same intended use aspreviously cleared for the predicate C-Port® xA PLUS DistalAnastomosis System (K090872). | |
| Draft Instructions for Use can be found in Section E, Labeling,of this submission. A redline showing the differences is alsoprovided 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 Systemdelivers a series of clips that create an anastomosis between asmall target vessel (e.g. coronary artery) and conduit (e.g.saphenous vein graft). An array of metal clips creates acomplete, end-to-side anastomosis that is functionallyequivalent to a hand-sutured interrupted stitch anastomosis.The system consists of one Anastomosis Device and oneRetractor Mount | |
| Indications for Use | The C-Port® xA Hybrid Plus Anastomosis System is is intendedfor use in the creation of anastomoses in blood vessels andgrafts, including use in coronary artery bypass graftingprocedures. The change in materials described above do notimpact the Indications for Use, therefore no changes will bemade to this labeling. |
C-Port xA Hybrid Distal Anastomosis System
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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
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KI01018
Cardica C-Port® xA Hybrid PLUS Distal Anastomosis
April 9, 2010
| Comparison toPredicate Device | The subject Cardica® C-Port® xA Plus Distal AnastomosisSystem, is substantially equivalent to the predicate Cardica® C-Port® xA PLUS Distal Anastomosis System, which was clearedby FDA on April 21, 2009 (K090872) |
|---|---|
| 1. | Like its predicate device, the subject C-Port® xA PlusDistal Anastomosis System, is a sterile, single-usedevice for creation of a reliably patent end-to-sideanastomosis between a conduit (graft vessel) and targetvessel. |
| 2. | Both products consist of sub-assemblies for stabilizingand positioning the conduit for grafting and for creatingthe anastomosis by deployment of an array of metalclips. |
| 3. | Once the graft vessel has been loaded onto the deviceand the device positioned against the target vessel, theanastomosis between the graft and target vessel iscompleted by pushing the actuation button. |
| Modifications improving the reliability, manufacturability andappearance of the predicate device included the following: | |
| 1. | Knife Component material changes from Stainless Steelto Nitinol for durability; |
| 2. | Heel Clip Component material changes from StainlessSteel to Titanium To reduce the force required to clamp. |
| 3. | Cartridge Housing Component material changes withthe addition of pink and blue colorant for aesthetics; |
| 4. | A Cardica logo graphic is added to the Activation KnobComponent via pad printing for better marketrecognition, and the material of the the Activation KnobComponent changes from glass-filled polycarbonate toglass-filled nylon for durability. |
| 5. | The Anvil Base Component material changes frommachined type 416 Stainless steel to metal-injectionmolded (MIM) 17-4 Stainless steel to improvemanufacturability. Adding Dicronite, a dry lubricant tothe Anvil Base Component's cable channels reducesfriction in the cable system. |
| 6. | Anvil Hinge Component material is changed, addingcarbon filling to the Victrex PEEK material for increaseddimensional stability. |
| Device TestingResults andConclusion | All the aforementioned modifications have been rigorouslyverified and validated using Cardica's Design Control process(Cardica procedures WD-0400 and 0401):A Design Change Impact Analysis identified the system levelramifications of changes to materials and provided guidanceand rationale for the selection of appropriate component andsystem level qualifications. A battery of tests and evaluationswas performed to assess the impact of the component materialchanges identified above to ensure that these modifications donot alter the validity of in vitro and in vivo testing and otherdesign validation activities previously performed on thepredicate Cardica® C-Port® xA PLUS Distal AnastomosisSystem and its packaging to ensure substantial equivalence tothe predicate device, and to ensure the safety andeffectiveness of the device.Risk Management File review and Clinical Risk BenefitAnalysis were conducted to ensure the continued safety andefficacy of the device. A detailed description of these changesis available in Section D, Summary of Design Controls. |
| Technological | See Device Description above |
| Characteristics | |
| SubstantialEquivalenceSummary | Both the subject Cardica® C-Port® xA PLUS DistalAnastomosis System and its predicate have the sameIndications for Use and the same technological characteristicsas the predicate device C-Port xA PLUS (K090872). Thispremarket notification has described the characteristics of themodified device in sufficient detail to assure substantialequivalence. |
| The subject C-Port® xA PLUS Distal Anastomosis System hasthe following similarities to those previously described andcleared for the predicate device:1. same indicated use,2. same operating principle,3. same basic device design and size,4. same materials (with the exception of those changesidentified above),5. same manufacturing processes,6. same packaging and sterilization materials,7. Instructions for Use are essentially identical, with the onlychanges being the model name and the clarification in theSystem Description of the Clip array construction beingStainless 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 AnastomosisSystem described in this submission is substantially equivalentto the predicate device. This Special 510(k) for DeviceModification submission has demonstrated SubstantialEquivalence as defined and understood in the Federal FoodDrug and Cosmetic Act and various guidance documents. |
CARDICA, INC. CONFIDENTIAL & PROPRIETARY
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April 9, 2010
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Cardica C-Port® xA Hybrid PLUS Distal Anastomosis
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and the same of the same
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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.
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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
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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)
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Over-The-Counter Use OR (Optional Format 1-2-96)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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CARDICA, INC. CONFIDENTIAL & PROPRIETDivision of Cardiovascular Devices
| 510(k) Number | K161018 Pg. 1 of 1 |
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§ 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.