(422 days)
No
The summary describes a mechanical device for controlling blood flow using a balloon catheter and a controller. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device directly intervenes to control blood flow for medical procedures and monitoring, which aligns with the definition of a therapeutic device.
No
The device is primarily intended for therapeutic purposes (stopping or controlling blood flow) and blood pressure monitoring. While monitoring involves data collection, the core function described is interventional, not diagnostic for a medical condition.
No
The device description explicitly states the system includes a Balloon Occlusion Catheter, Controller, and Console, which are hardware components.
Based on the provided information, the preCARDIA device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "selectively stopping or controlling blood flow of the inferior and superior vena cava" and for "blood pressure monitoring." This is a therapeutic and monitoring function performed directly on the patient's circulatory system.
- Device Description: The device is a catheter with a balloon designed to be placed within blood vessels (IVC and SVC) to physically control blood flow. It also includes components for monitoring blood pressure. This is an invasive medical device used for intervention and monitoring within the body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The preCARDIA device does not perform any analysis on specimens in vitro.
The preCARDIA device is clearly an invasive medical device used for therapeutic and monitoring purposes within the patient's body, not for diagnostic testing of specimens outside the body.
N/A
Intended Use / Indications for Use
The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.
Product codes
MJN, DQY, DQO
Device Description
The preCARDIA System is for use in selectively stopping or controlling blood flow of the inferior and superior vena cava, in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring. The System includes a Balloon Occlusion Catheter (Catheter), Controller and Console. The Catheter has an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Inferior and superior vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians trained in endovascular techniques. Operating room or other appropriate care location.
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)
Bench Testing:
- Visual Inspection and Dimensional Verification
- System Verification
- System Interaction Testing
- User Validation Testing
- Air Leakage Testing
- . Liquid Leakage Testing
- Leakage - Tubing Set Testing
- Static Leakage of Occlusion Balloon with Tubing
- Thermistor Testing
- Thermodilution Impact Testing
- Occlusion Balloon Diameter to Filling Volume Test
- Robustness Test of Occlusion Balloon
- Torque and Kink Testing
- . Burst Pressure Testing
- Tensile and Peak Tensile Testing
- Crack Pressure Testing
- . Pressure Transducer Testing
- Luer-Compliance Testing
- Tensile Strength Testing
- . Connector Testing
- Inflation and Deflation Time Testing
- Bend/Kink Resistance Testing
- Radiopacity Testing
- . 1-hour Occlusion Testing
- . Guidewire Tracking Testing
- Packaging Validation
- Sterilization Validation
- Shelf Life
- Biocompatibility
- . Electrical Safety and EMC
- Software Verification and Validation
Animal study: An animal study to evaluate the performance of the preCARDIA Catheter in the intended anatomy was performed to demonstrate that the device meets applicable design and performance requirements and is therefore substantially equivalent to the predicate device.
Conclusions: Performance testing was completed and showed that the subject device, preCARDIA Occlusion System, met the acceptance criteria and demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 30, 2023
Abiomed Inc. Ken Ryder Sr. Director, Regulatory Affairs 22 Cherry Hill Drive Danvers, Massachusetts 01923
Re: K221294
Trade/Device Name: preCARDIA Occlusion System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: MJN, DQY, DQO Dated: May 31, 2023 Received: May 31, 2023
Dear Ken Ryder:
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 and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
The OHT2: Office of Cardiovascular Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings and Precautions section of the device's labeling:
-
- The safety and effectiveness of this device for use in the treatment of heart failure have not been established.
1
Furthermore, the indication for use "The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring" must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
| Sincerely, | |
|---|---|
| William C. | |
| for | Macfarland -S |
| Bram Zuckerman, M.D. | |
| Director | |
| OHT2: Office of Cardiovascular Devices | |
| Office of Product Evaluation and Quality | |
| Center for Devices and Radiological Health |
| Digitally signed by William C. Macfarland -S | |
|---|---|
| Date: 2023.06.30 10:50:45 -04'00' |
Enclosure
3
Indications for Use
510(k) Number (if known) K221294
Device Name preCARDIA Occlusion System
Indications for Use (Describe)
The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.
| 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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Image /page/4/Picture/0 description: The image shows a logo with four circles arranged in a square pattern. The top-left and bottom-left circles are blue, while the top-right and bottom-right circles are red. The bottom-right circle is incomplete, forming a 'C' shape. The logo has a clean and modern design.
preCARDIA Occlusion System 510(k) Summary
This summary is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807.92.
A. Application Information
| Date Prepared: | June 27, 2023 |
|---|---|
| Submitters Name & Address: | ABIOMED, Inc. |
| 22 Cherry Hill Drive | |
| Danvers, MA 01923 | |
| Contact Person: | J. Kenneth Ryder |
| Senior Director, Global Regulatory Affairs | |
| Ph: 978-646-1707 | |
| E-mail: kryder@abiomed.com |
B. Device Information
| Trade or Proprietary Name: | preCARDIA Occlusion System |
|---|---|
| Regulation Number: | 21 CFR 870.4450 |
| FDA Classification: | Class II |
| Product Code: | MJN, DQY, DQO |
| Regulation Description: | Vascular Clamp |
C. Predicate Device
The predicate device is the NEURESCUE Device (K210358) manufactured by Neurescue Aps. The QXMedical Occlusion Balloon Catheter (K183679) and the CoAxia FloControl Catheter (K090970) serve as reference devices.
The predicate and reference devices have not been subjected to any design-related recall.
D. Device Description:
The preCARDIA System is for use in selectively stopping or controlling blood flow of the inferior and superior vena cava, in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring. The System includes a Balloon Occlusion Catheter (Catheter), Controller and Console. The Catheter has
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Image /page/5/Picture/1 description: The image shows a logo consisting of four squares arranged in a 2x2 grid. The top-left and bottom-left squares are colored in blue, while the top-right and bottom-right squares are colored in red. The squares have a circular shape cut out from the center, creating a ring-like appearance. The trademark symbol is located at the top right of the logo.
an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.
E. Intended Use/Indications for Use:
The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.
F. Technological Characteristics Comparison of Subject and Predicate Devices
| Feature | Subject Device:
preCARDIA Device | Predicate:
Neurescue
Device | Reference
Device: CoAxia
FloControl
Catheter | Reference Device:
QX Medical
Occlusion Balloon
Catheter |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The preCARDIA device is
intended for use in
selectively stopping or
controlling blood flow of
the inferior and superior
vena cava in applications
including perioperative
procedures in patients
requiring emergency
control of hemorrhage, and
for blood pressure
monitoring. | The Neurescue
device is
intended for
temporary
occlusion of large
vessels and
blood pressure
monitoring
including patients
requiring
emergency
control of
hemorrhaging. | The CoAxia
FloControl
Catheter is
intended for use
in selectively
stopping or
controlling flow
in the peripheral
vasculature,
which includes
the descending
aorta. | The Occlusion
Balloon Catheter is
indicated for
temporary occlusion
of large vessels,
including the superior
vena cava, in
applications including
perioperative
occlusion and
emergency control of
hemorrhage. |
| General
System
Components | Occlusion Balloon
Catheter | Occlusion
Balloon Catheter | Occlusion
Balloon
Catheter | Occlusion Balloon
Catheter |
| Catheter
Lumen | 10 Fr | 7 Fr | 7 Fr | 8 and 10 Fr |
| Length | 63 and 65 cm working
lengths | 72 cm | 62 cm working
length | 90 cm shaft length |
| Occlusion
Balloon | 32 mm in diameter | 30 mm in
diameter | 32 mm in
diameter | 36 mm in diameter |
A technological characteristics comparison table is provided below.
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Image /page/6/Picture/0 description: The image shows a logo with a grid-like pattern. The logo consists of eight circles arranged in a 2x4 grid. The circles are colored in alternating shades of blue and red. The top-left and bottom-left circles are blue, while the top-right and bottom-right circles are red. A trademark symbol is located in the upper right corner of the logo.
| Feature | Subject Device:
preCARDIA Device | Predicate:
Neurescue
Device | Reference Device: CoAxia
FloControl
Catheter | Reference Device:
QX Medical
Occlusion Balloon
Catheter |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Balloon | Expandable Polyurethane
occlusion balloon and
expandable Polyurethane
distal floatation balloon | 2 expandable
Polyurethane
balloons
separated by 8
cm | Single
expandable
Polyurethane
Balloon | Single expandable
Polyurethane Balloon |
| Controller | Control unit that enables
mechanical inflation and
deflation of the occlusion
balloon as directed by the
user | Control unit that
enables
mechanical
inflation and
deflation of the
occlusion balloon
as directed by
the user | Manifold hub
that enables
manual inflation
and deflation of
the occlusion
balloon | Manifold hub that
enables manual
inflation and deflation
of the occlusion
balloon |
| Mechanism of
Action, General | Inserted manually using
standard techniques.
Indwelling (in vessel) after
insertion. Occlusion of
vessel occurs once
initiated by the physician. | Inserted
manually using
standard
techniques.
Indwelling (in
vessel) after
insertion.
Occlusion of
vessel occurs
once initiated by
the physician. | Inserted
manually using
standard
techniques.
Indwelling (in
vessel) after
insertion.
Occlusion of
vessel occurs
once initiated by
the physician. | Inserted manually
using standard
techniques.
Indwelling (in vessel)
after insertion.
Occlusion of vessel
occurs once initiated
by the physician. |
| Inflation
Cycling
Capabilities | Manual and Automatic | Manual | Manual | Manual |
| Marker Bands | 2 platinum-iridium marker
bands | 3 marker bands | 3 platinum-
iridium markers | 1 marker band |
The differences between the subject and the predicate devices in terms of technological characteristics do not raise new questions of safety or effectiveness.
G. Performance Testing
The following performance testing was conducted on the preCARDIA Occlusion System.
Bench Testing:
- Visual Inspection and Dimensional Verification ●
- System Verification
- System Interaction Testing ●
- User Validation Testing
- Air Leakage Testing
- . Liquid Leakage Testing
- Leakage - Tubing Set Testing
- Static Leakage of Occlusion Balloon with Tubing
- Thermistor Testing
- Thermodilution Impact Testing
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Image /page/7/Picture/0 description: The image shows a logo consisting of four rounded squares arranged in a 2x2 grid. The top-left and bottom-right squares are blue, while the top-right and bottom-left squares are red. A small "TM" symbol is located to the right of the top-right square, indicating a trademark.
- Occlusion Balloon Diameter to Filling Volume Test ●
- Robustness Test of Occlusion Balloon
- Torque and Kink Testing
- . Burst Pressure Testing
- Tensile and Peak Tensile Testing
- Crack Pressure Testing ●
- . Pressure Transducer Testing
- Luer-Compliance Testing
- Tensile Strength Testing
- . Connector Testing
- Inflation and Deflation Time Testing ●
- Bend/Kink Resistance Testing
- Radiopacity Testing
- . 1-hour Occlusion Testing
- . Guidewire Tracking Testing
- Packaging Validation
- Sterilization Validation ●
- Shelf Life
- Biocompatibility
- . Electrical Safety and EMC
- Software Verification and Validation ●
An animal study to evaluate the performance of the preCARDIA Catheter in the intended anatomy was performed to demonstrate that the device meets applicable design and performance requirements and is therefore substantially equivalent to the predicate device.
H. Conclusions
Performance testing was completed and showed that the subject device, preCARDIA Occlusion System, met the acceptance criteria and demonstrated substantial equivalence.