(28 days)
Not Found
No
The device description focuses on mechanical components and gravity-based blood flow, with no mention of AI/ML terms or functionalities.
No.
The device is described as a blood collection and storage device used during cardiopulmonary bypass procedures, and its function involves filtering and removing air from blood, not directly treating a disease or condition.
No
The device is described as a blood collection and storage device for use during cardiopulmonary bypass procedures, and its function relates to filtering and storing blood, not diagnosing conditions.
No
The device description clearly details a physical reservoir bag with inlet/outlet ports, a mesh filter, and an air purge feature, indicating it is a hardware device.
Based on the provided information, the CAPIOX® Flexible Venous Reservoir is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "blood collection and storage during cardiopulmonary bypass procedures." This is a device used in vivo (within the body's circulatory system during surgery) to manage blood flow and volume, not to perform diagnostic tests on blood samples in vitro (outside the body).
- Device Description: The description details its function in the extracorporeal circuit, managing blood flow, filtering air, and storing blood during surgery. This aligns with a medical device used for physiological support during a procedure, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components, detecting biomarkers, or providing any diagnostic information about the patient's condition. Its purpose is purely mechanical and supportive during the bypass procedure.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. The CAPIOX® Flexible Venous Reservoir does not perform this function.
N/A
Intended Use / Indications for Use
The Capiox Flexible Venous Reservoir is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit.
The device may be used for procedures lasting up to 6 hours.
Product codes (comma separated list FDA assigned to the subject device)
DTN
Device Description
The Capiox Flexible Venous Reservoir is used as a blood storage device during cardiopulmonary bypass procedures.
The reservoir bag is to be positioned at a level that is below patient (blood supply) level. When the bag is properly positioned, the blood that is drawn from the patient enters the reservoir via gravity into the blood inlet ports that are positioned at the base edge of the reservoir bag. As the patient's blood enters the device, it passes through a mesh filter that facilitates the removal of air from the blood. This removal of air via the mesh filter is accomplished when an air bolus makes contact with the mesh and is subsequently disintegrated. Additionally, there is an air purge feature at the upper region of the bag that allows for the collection and subsequent aspiration of air from the bag.
Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
APR 2 4 2007
CAPIOX® Flexible Venous Reservoir
Submitter Information: This premarket notification is submitted by:
Garry A. Courtney, MBA, RAC Terumo Cardiovascular Systems Regulatory Affairs Specialist Telephone: 1-800-283-7866, Ext. 7420
Date of Preparation: March 23, 2007
Device Names:
| Proprietary Name: | Capiox® Flexible Venous Reservoir |
|---|---|
| Common Name: | Blood Reservoir |
| Classification: | CPB Reservoirs (w/ filters) are classified as Class II devices. |
Predicate Device:
The Capiox Flexible Venous Reservoir is substantially equivalent in intended use, materials, design, performance, technology and principles of operation to the (unmodified/predicate) Capiox Flexible Venous Reservoir (K040023).
Intended Use:
The Capiox Flexible Venous Reservoir is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit.
The device may be used for procedures lasting up to 6 hours.
Principles of Operation and Technology:
The Capiox Flexible Venous Reservoir is used as a blood storage device during cardiopulmonary bypass procedures.
The reservoir bag is to be positioned at a level that is below patient (blood supply) level. When the bag is properly positioned, the blood that is drawn from the patient enters the reservoir via gravity into the blood inlet ports that are positioned at the base edge of the reservoir bag. As the patient's blood enters the device, it passes through a mesh filter that facilitates the removal of air from the blood. This removal of air via the mesh filter is accomplished when an air bolus makes contact with the mesh and is subsequently disintegrated. Additionally, there is an air purge feature at the upper region of the bag that allows for the collection and subsequent aspiration of air from the bag.
Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2007
Terumo Cardiovascular Systems Garry A. Courtney, Regulatory Manager 125 Blue Ball Rd. Elkton, MD 21921
Re: K070839
Trade/Device Name: Capiox Flexible Venous Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II Product Code: DTN Dated: March 23, 2007 Received: March 27, 2007
Dear Mr. Courtney:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Mr. Courtney
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
P. Lachner
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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Image /page/3/Picture/1 description: The image shows the logo for Terumo. The logo consists of a stylized letter "T" inside of a circle, followed by the word "TERUMO" in bold, sans-serif font. A small registration mark is present to the right of the "O" in "TERUMO".
Terumo Cardiovascular Systems Garry A. Courtney, MBA, RAC Office of Regulatory Management 125 Blue Ball Road Elkton, MD 21921 Telephone: (800) 283-7866 (x7420)
SECTION 4 Indications for Use
510(k) Number (if known): Unknown at time of Submission 4670839
CAPIOX® Flexible Venous Reservoirs Device Name:
Indications For Use:
The CAPIOX® Flexible Venous Reservoir is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit.
The device may be used in procedures lasting up to 6 hours.
Parry A. Courtney, MBA, RAC
3/23/2007
Cardiovascular Systems
Prescription Use -X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use -(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. lo. Lunes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K090839