(78 days)
Not Found
No
The description focuses on the physical components and function of a blood reservoir for extracorporeal circulation, with no mention of AI or ML technologies.
No.
The device is a reservoir that stores blood during extracorporeal circulation and facilitates the removal of particulate matter and air bubbles. It does not directly treat a disease or condition.
No
Explanation: The device is a reservoir for storing and filtering blood during extracorporeal circulation and autotransfusion. It does not perform any diagnosis of a patient's condition.
No
The device description clearly indicates it is a physical hardshell reservoir with filters and defoamers, used for storing blood during extracorporeal circulation. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in storing and filtering blood during extracorporeal circulation and for post-operative chest drainage and autotransfusion. These are procedures performed on the patient's blood outside the body, but the purpose is to return the blood to the patient, not to perform diagnostic testing on it.
- Device Description: The description focuses on the physical components and their role in handling and filtering blood. There is no mention of reagents, assays, or any process for analyzing the blood's composition or characteristics for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening
- Using reagents or calibrators
The device is a medical device used in surgical and post-operative procedures involving blood management, but its function is mechanical and supportive, not diagnostic.
N/A
Intended Use / Indications for Use
The CAPIOX SX Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
The CAPIOX SX Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.
The Hardshell Reservoir is also used with vacuum assisted venous return during cardiopulmonary bypass.
Product codes (comma separated list FDA assigned to the subject device)
DTN
Device Description
CAPIOX® SX hardshell reservoir has a rotatable venous blood inlet port to permit minimizing tubing lengths which could result in lower circuit priming volumes.
The Hardshell reservoir contains a defoamer and a screen filter in the venous blood inlet section. The defoamer resides in the upper part of the reservoir permitting blood to reside in the lower section of the reservoir while not in constant contact with the defoamer. The total capacity of the reservoir is 4,000 mL.
The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal of particulates/emboli from suctioned blood entering the reservoir.
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Proprietary Device Name: CAPIOX® SX Hardshell Reservoir
Classification Name: Cardiopulmonary bypass blood reservoir, defoamer, cardiotomy suction line filter
Reason for Submission:
Addition of the use of vacuum assisted venous drainage to the intended use of the hardshell reservoir.
Intended Use:
The CAPIOX SX Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
The CAPIOX SX Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.
The Hardshell Reservoir is also used with vacuum assisted venous return during cardiopulmonary bypass.
Description
CAPIOX® SX hardshell reservoir has a rotatable venous blood inlet port to permit minimizing tubing lengths which could result in lower circuit priming volumes.
The Hardshell reservoir contains a defoamer and a screen filter in the venous blood inlet section. The defoamer resides in the upper part of the reservoir permitting blood to reside in the lower section of the reservoir while not in constant contact with the defoamer. The total capacity of the reservoir is 4,000 mL.
The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal of particulates/emboli from suctioned blood entering the reservoir.
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- II Summary and Certification Summary of Safety and Effectiveness
Substantial Equivalence
The CAPIOX® SX Reservoir is substantially equivalent to the Baxter Bentley HSR4000 (K915573) and Bentley BMR Venous Reservoir (K971455) # as follows:
Intended use: same as described on previous page.
Design
These devices are constructed from a clear plastic casing containing filter and defoamer elements.
Technology and Principles of Operation
- Both devices utilize gravity and/or external vacuum (cardiotomy) for blood collection into the reservoir. Air removal is facilitated by defoamers and the tendency of air to rise through liquid. Particulate removal is facilitated by the blood flow pathway through filters contained in the reservoirs. Vacuum can be applied to the reservoirs to increase venous return.
The CAPIOX SX Hardshell Reservoir and the Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir are substantially equivalent in design, technology and principles of operation.
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II - Summary and Certification Summary of Safety and Effectiveness
Specifications
| Table 1 | ||
|---|---|---|
| Item | CAPIOX SX18/25 Reservoir | Bentley HSR Reservoir |
| Reservoir volume | ||
| Maximum | 4,000 mL | 4,500 mL |
| Minimum operating volume | 200 mL | 300 mL |
| Blood flow rate during | Cardiotomy inlet: 0.5-5LPM | 1-5 LPM |
| cardiopulmonary bypass | Venous flow: 0.5-7 LPM | 1-7 LPM |
| Cardiotomy Filtration | Greater than 90% efficiency | 80% efficiency for particles |
| Efficiency | for particles ≥20u | > 20u |
The specifications of the CAPIOX SX Hardshell Reservoir and the Baxter Bentley HSR4000 and are substantially equivalent.
In summary, the CAPIOX® SX Reservoir and the Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir are substantially equivalent in intended use, design and materials, technology/principles of operation, specifications and performance. Differences as described above do not raise new issues of safety or effectiveness.
Terumo's statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.
Additional Safety Information
·Pyrogen Testing
·Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 106.
· Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).
· Manufacturing control testing
· Blood contacting materials were tested in accordance with the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, " Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (External communicating devices/Circulating Blood/Limited contact duration).
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- II Summary and Certification Summary of Safety and Effectiveness
Date Prepared June 17, 1998
Prepared by: Sandi Hartka, Manager Regulatory Affairs
for: Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1998
Ms. Sandi Hartka Manager, Requlatory Affairs Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921
Re : K982223 CAPIOX® SX Harshell Reservoir Regulatory Class: II (two) Product Code: DTN Dated: June 22, 1998 - ------Received: June 24, 1998
Dear Ms. Hartka:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, qood 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 (Premarket Approval) , it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any
5
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, 2 Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance.at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahar Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 982223 510(k) Number (if known):
CAPIOX® SX Hardshell Reservoir Device Name:
Indications For Use:
The CAPIOX SX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement
The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.
Bee G. Campbell
(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices 510(k) Number_K 98222
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)