(47 days)
No
The device description and intended use focus on mechanical and material properties for gas exchange, filtration, and blood storage during cardiopulmonary bypass. There is no mention of AI or ML in the text.
Yes.
Explanation: The device is intended to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery, and it also facilitates air bubble removal and filtration of non-biologic particles. These functions directly address pathologies and restore normal physiological function, which aligns with the definition of a therapeutic device.
No
The device is an oxygenator and filter system used during cardiopulmonary bypass surgery. Its function is to exchange gases in the blood, filter particles and bubbles, and regulate blood temperature. It does not analyze or interpret physiological data to diagnose a condition.
No
The device description clearly outlines physical components like a hollow fiber oxygenator, arterial filter, heat exchanger, and hardshell reservoir, all made of various materials. This indicates a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Function: The Capiox FX device is used during cardiopulmonary bypass surgery to directly interact with the patient's blood outside the body but as part of a continuous circuit. Its primary functions are gas exchange (oxygenation and CO2 removal), blood filtration, temperature control, and blood storage.
- Intended Use: The intended use clearly describes its role in supporting a patient's physiological needs during surgery, not for diagnostic testing of specimens.
The device is a medical device used in a surgical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.
The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.
The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.
The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The Capiox FX device is a modification of the Capiox RX device that has an arterial filter integrated into the design. The design of the oxygenator device is such that it utilizes an integrated oxygenator/heat exchanger module that provides for gas transfer (blood oxygenation and carbon dioxide removal) and for blood temperature control. The RX Oxygenator/Arterial Filter device also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The filter contained within the oxygenator module is comprised of 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator fiber bundle. This design permits the oxygenation of blood and removal of carbon dioxide as blood passes through the fiber bundle and also facilitates blood filtration after the blood has been oxygenated. This filtration is designed to remove particulate matter and emboli prior to the blood's re-entry to the patient's body via mechanical entrapment. Air removal is accomplished by entrapment followed by permeation of the air into the hollow fibers of the oxygenator bundle - and subsequently is exhausted (along with carbon dioxide) via the gas outlet port. The materials used in the construction include polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.
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)
Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations: Gas Transfer, Effects on Blood Components (Hemolysis), Pressure Drop, Mechanical Integrity, Static Priming Volume, Heat Exchanger Performance, Filtration Efficiency, Air Handling, Tubing Connection Strength. Each of these tests is reported in detail in Section 18 of the submission. The Capiox FX Hollow Fiber Oxygenator/Arterial Filter exhibited performance that is deemed to be substantially equivalent to the performance of the predicate devices.
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.
K993772, K002238, K002026, K003371, K003604, K013526, K010443
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
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
0
TERUMO
JUL 16 2007
:
SECTION 5 510(k) Summary
:
Submitter Information
Device Names
18 18
Page
| Identification of Predicate Device | 18 |
|---|---|
| Intended Use | 18 |
| Principles of Operation and Technology | 19 |
| Design and Materials | 20 |
| Performance Evaluations | 20 |
| Substantial Equivalence Comparison | 21 |
| Substantial Equivalence Statement | 24 |
| Additional Safety Information | 25 |
| Conclusion for 510(k) Summary | 25 |
.
.
.
:
1
Submitter Information: This submission was prepared in May 2007 by: Garry A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Regulatory Management Terumo Corporation/Terumo Cardiovascular 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420
This submission was prepared for: Terumo Corporation (Ashitaka Factory) Manufacturer/Sterilizer 150 Maimaigi-cho Fujinomiya City, Shizuoka Pref. Japan 418-0015 Registration #9681834
Device Names/Classifications: Classification Name Common Name Proprietary Name Oxygenator Capiox® FX Hollow Cardiopulmonary Bypass Oxygenator (Code: DTZ) Fiber Oxygenator and Arterial Filter Heat Exchanger Cardiopulmonary Bypass Heat Exchanger (Code: DTR) Cardiopulmonary Bypass Arterial Filter Arterial Line Blood Filter (Code: DTM) Blood Reservoir Cardiopulmonary Bypass Blood Reservoir (Code DTN)
Predicate Device:
The device submitted in this 510(k) maintains characteristics that are substantially equivalent in intended use, design, technology/principles of operation, materials and specifications to the following devices:
- Terumo's Capiox® RX15 Oxygenator/Reservoir K051997. .
- Terumo's Capiox® RX25 Oxygenator/Reservoir K040210. .
- Terumo's Capiox® AF125X Arterial Filter K052205 .
Intended Use:
The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
2
The integrated arterial filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.
The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.
The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.
The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
Principles of Operation and Technology:
The Capiox FX Oxygenator utilizes micro-porous membrane technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A polypropylene fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion. Diffusion occurs as oxygen moves from the gas-phase into the blood-phase; and carbon dioxide moves from the blood-phase into the gas-phase. The carbon dioxide is subsequently exhausted via a gas outlet port.
The Capiox FX device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.
The Capiox FX device relies on external pump technology to allow for proper blood flow through the device. That is, after blood has been collected into a reservoir via gravity and/or vacuum assist, a pump (either roller or non-roller) will propel the blood into the oxygenator unit. The unit itself is not electro-mechanical in nature. Note: The external pump is responsible for facilitating blood flow through the extracorporeal circuit.
With respect to the filtration of arterial blood, the Capiox FX Oxygenator/Arterial Filter relies upon mechanical entrapment of particulates and emboli within the polyethylene terephthalate mesh as a means to remove those particulates from the blood. Air is removed from the blood
3
stream via diffusion of the air into the gas phase of the oxygenator (i.e., inside of the polypropylene fibers) - where it is expelled through a gas outlet port located at the base of the oxygenator module.
Design and Materials:
With respect to the design of the oxygenator, the design of the Capiox FX device is a modification of the Capiox RX device that has an arterial filter integrated into the design. The design of the oxygenator device is such that it utilizes an integrated oxygenator/heat exchanger module that provides for gas transfer (blood oxygenation and carbon dioxide removal) and for blood temperature control. The RX Oxygenator/Arterial Filter device also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. Note: The Hardshell Reservoirs have been previously cleared by FDA in K040210 and K051997.
With respect to the design of the Arterial Filter, the filter contained within the oxygenator module is comprised of 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator fiber bundle. This design permits the oxygenation of blood and removal of carbon dioxide as blood passes through the fiber bundle and also facilitates blood filtration after the blood has been oxygenated. This filtration is designed to remove particulate matter and emboli prior to the blood's re-entry to the patient's body via mechanical entrapment. Air removal is accomplished by entrapment followed by permeation of the air into the hollow fibers of the oxygenator bundle - and subsequently is exhausted (along with carbon dioxide) via the gas outlet port.
The materials that are used in the construction of the Capiox FX Hollow Fiber Oxygenator/Arterial Filter includes, but are not limited to, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.
Performance Evaluations:
Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:
- Gas Transfer .
- Effects on Blood Components (Hemolysis) .
- Pressure Drop .
- . Mechanical Integrity
- Static Priming Volume ●
- . Heat Exchanger Performance
- Filtration Efficiency .
- Air Handling .
- Tubing Connection Strength .
4
Substantial Equivalence Comparison:
The information presented in this section depicts a comparison between the subject of this 510(k) submission, the Capiox FX Oxygenator/Arterial Filter, and the predicate Capiox RX Oxygenator and Capiox Arterial Filter devices.
Comparison of Intended Use: .
The Capiox FX Hollow Fiber Oxygenator/Arterial Filter and the predicate Capiox RX devices are essentially equivalent in their intended uses:
The Capiox FX Hollow Fiber Oxygenator and the predicate Capiox RX Oxygenator devices each is comprised of the exact same oxygentor module and each is intended to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
The Capiox FX Hollow Fiber Oxygenator and the predicate Capiox RX Oxygenator devices each has identical integrated heat exchangers that are used to warm or cool blood and/or perfusion fluid as it flows through the device.
The Capiox FX Hollow Fiber Oxygenator and the predicate Capiox RX Oxygenator device each may be used with a (detachable) Hardshell Reservoir that is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. Each reservoir also contains filters that are used to facilitate the removal of air and particulate matter from incoming blood. Additionally, both devices may be used in vacuum-assisted venous drainage procedures - as well as post-operative chest drainage procedures.
The Capiox FX Oxygenator/Arter and the predicate Capiox AF125X Arterial Filter have identical intended uses. Both filters are intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through a cardiotomy bypass circuit.
Duration of Use: .
The Capiox FX Hollow Fiber Oxygenator/Arterial Filter and the predicate devices can be used in procedures lasting up to 6 hours.
Comparison of Labeling: .
Both the Capiox FX Hollow Fiber Oxygenator/Arterial Filter and the predicate Capiox devices are offered with adequate Instructions for Use and other product labeling as required by regulation. The Instructions for Use for the Capiox FX Hollow Fiber Oxygenator/Arterial Filter are presented in the Appendices of this submission; the Instructions for Use for the predicate Capiox devices are also presented in the Appendices of this submission.
The Reservoirs used with the FX Oxygenators are the exact same reservoirs that are used with the predicate RX Oxygenators and are already FDA cleared under a previous premarket notification (K051997). They are discussed in this submission because they are fully adaptable with the FX Oxygenator/Arterial Filter devices.
5
T TERUMO
Comparison of Principles of Operation & Technology: .
Both the Capiox FX Hollow Fiber Oxygenator and the predicate Capiox RX Oxygenator utilize the exact same technologies and principles of operation:
Each device utilizes micro-porous membrane technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A polypropylene fiber bundle provides a porous membrane surface to sufficiently allow the movement of gases through the walls of the hollow fibers via diffusion. Diffusion occurs as oxygen moves from the gas-phase into the blood-phase; and carbon dioxide moves from the blood-phase into the gas-phase. The carbon dioxide is subsequently exhausted via a gas outlet port.
The Capiox FX device and the predicate Capiox RX device each have integrated heat exchangers that are comprised of stainless steel. The stainless steel acts to provide a mechanism for the transfer of heat (generated from a temperature controlled external water bath) across the walls of the stainless steel to effect the necessary temperature change on the blood.
The Capiox FX device and the predicate Capiox RX device each rely on external pump technology to allow for proper operation. That is, after blood has been collected into a reservoir, a pump (either roller) will propel the blood into the oxygenator unit. The unit itself is not electro-mechanical in nature.
With respect to the filtration of arterial blood, the Capiox FX Oxygenator/Arterial Filter and the predicate Capiox AF125X each rely upon mechanical entrapment of particulates and emboli. However, there are differences in their respective mechanisms for air removal:
The predicate Capiox AF125X removes air from the extracorporeal circuit by forcing the bubbles to move towards an air purge that is located in the upper region of the filter. With such a design, as air migrates to the purge port, it is easily removed via the port. By contrast, the Capiox FX arterial filter removes air by permeation of air into the gas phase (i.e., inside of the polypropylene fibers) of the oxygenator where it is expelled through a gas outlet port located at the base of the oxygenator module. This difference in operation does not present any additional issues of safety and/or effectiveness - but merely represent a difference in the manner in which air is removed from the patient's blood.
The Capiox FX Hollow Fiber Oxygenator/ and the predicate device are substantially equivalent in operation and technology. The noted differences do not raise any new issues of safety and effectiveness.
Comparison of Design: .
With respect to the design of the oxygenator, the design of the Capiox FX Hollow Fiber Oxygenator has the exact same design as the predicate devices. In fact, the Capiox FX device is a modification of the Capiox RX device that has an arterial filter integrated into the design. The design of the oxygenator devices is exact in that they each utilize the same integrated oxygenator/heat exchanger module that provides for gas transfer (blood
6
T) TERUMO
oxygenation and carbon dioxide removal) and for blood temperature control. Each of the devices also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The reservoirs each provide for filtration of venous and cardiotomy blood as it enters the reservoir.
Noted difference in design between the Capiox FX device and the predicate Capiox RX devices:
The Capiox FX device has an integrated Arterial Filter that is enclosed within the oxygenator module of the device. In essence, the oxygenator and the integrated arterial filter are combined into a singular unit; whereas the Capiox RX device does not have an integrated Arterial Filter.
With respect to the design of the Arterial Filter, the filter contained within the oxygenator module is comprised of a 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator bundle. This design permits the oxygenation of blood and removal of Carbon Dioxide as blood passes through the fiber bundle - and also facilitates blood filtration after the blood has been oxygenated. This filtration is designed to remove particulate matter and emboli prior to the blood's re-entry to the patient's body via mechanical entrapment. Air removal is accomplished by entrapment followed by permeation of the air into the hollow fibers of the oxygenator bundle - and subsequently is exhausted (along with carbon dioxide) via the gas outlet port.
By contrast, the predicate Capiox AF125X filter is a unit that is not integrated into an oxygenator. but rather, is a separate device that may be included in the extracorporeal circuit. When included in an extracorporeal circuit, the predicate Capiox AF125X is positioned between the oxygenator and the patient - thereby effecting the same surgical benefits as the Capiox FX device that is the subject of this premarket notification application.
Terumo considers the design of the Capiox FX Hollow Fiber Oxygenator/Arterial Filter to be comparable and substantially equivalent to that of the predicate Capiox RX Oxygenator and Capiox Arterial Filter devices. The noted differences do not raise new issues of safety and effectiveness.
Comparison of Materials:
.
The Capiox FX Hollow Fiber Oxygenator/Arterial Filter and the predicate Capiox devices are manufactured from the exact same materials. The devices (both new and predicate) are comprised of polycarbonate, stainless steel (heat exchanger), polypropylene (gas transfer material), polyvinyl chloride, polyurethane (adhesives), polyethylene, polyester and other materials that are typically used in the manufacture of medical devices.
The Capiox FX devices and predicate devices contain polymethyl acrylate (PMEA). which is a biocompatible coating applied to the blood contacting surfaces of the devices. The PMEA coating is effective in reducing platelet adhesion to the device as blood circulates through the device during surgical procedures.
7
The safety and efficacy of PMEA is well recognized and is used on several other medical The sarely and entreasy cared by FDA.2 The use of PMEA on medical devices has been demonstrated as safe for use on medical devices and it's use is well documented in the medical community.
Terumo considers the Capiox FX device and the predicate devices to be comparable and substantially equivalent in materials of construction - especially since those materials are identical.
Comparison of Performance: .
The Capiox FX Hollow Fiber Oxygenator/Arterial Filter exhibited performance that is deemed to be substantially equivalent to the performance of the predicate devices. This determination is based upon the results of the following tests:
- Gas transfer testing. .
- Effects upon cellular blood components of the integral oxygenator/heat exchanger. .
- Pressure Drop Testing of the integral oxygenator/heat exchanger. .
- Mechanical Integrity of the integral oxygenator/heat exchanger. .
- Static Priming Volume of the integral oxygenator/heat exchanger. .
- Heat Exchanger performance evaluation (heat transfer). .
- Filtration Efficiency evaluations. ◆
- Air Handling testing. .
- Tubing Connection Strength .
Each of the above-indicated tests is reported in detail in Section 18 of this submission.
Conclusion:
In summary, Terumo deems the Capiox FX Hollow Fiber Oxygenator/Arterial Filter as substantially equivalent to the predicate Capiox RX Oxygenator and Capiox AF125X Arterial Filter device with respect to intended use, duration of use, design, materials, principles of operation, performance and specifications. It is further noted that any recognized differences do not raise any new issues of patient/user safety or product effectiveness.
Substantial Equivalence Statement:
The Capiox FX Hollow Fiber Oxygenator/Arterial Filter and the predicate devices are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance. Any noted differences between the subject device and the predicate devices do not raise new issues of safety and effectiveness.
2 Polymethoxyethyl acrylate is also used on X-Coated SX18/25 Oxygenators (K993772), Hardshell Reservoirs (K002238), CX*AF200X Arterial Filters (K002026), X-Coated Tubing (K003371), X-Coated Adapters (K003604), RX Hardshell Reservoirs (K013526), and X-Coated SX10 Oxygenators (K010443).
8
Additional Safety Information:
- Sterilization conditions have been validated in accordance with AAMI guidelines to provide . a Sterility Assurance Level (SAL) of 10th. Terumo further asserts that the ethylene oxide residues will not exceed the maximum residue limits at the time of product distribution.
- Terumo maintains biocompatibility studies as recommended in 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 Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.
- The polymer coating material that is applied to the blood-contacting surfaces of the device . was also evaluated in an in-vivo animal study. No adverse conditions were noted.
Conclusion:
In summary, the Capiox FX Hollow Fiber Oxygenator/Arter is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate oxygenator and reservoir devices identified in this application.
9
Public Health Service
Image /page/9/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA."
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 2007
Terumo Cardiovascular Systems Corp. c/o Mr. Garry A. Courtney Senior Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921
Re: K071494 ·
CAPIOX® FX Hollow Fiber Oxygenator with Integrated Arterial Filter Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: May 24, 2007 Received: May 30, 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 vour 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.
10
Page 2 - Mr. Garry A. 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
SECTION 4 Indications for Use
Unknown at time of Submission KO71494 510(k) Number (if known):
CAPIOX® FX Hollow Fiber Oxygenator with Integrated Arterial Filter Device Name:
Indications For Use:
The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.
The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.
The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.
The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
Prescription Use XX (Part 21 CFR 801 Subpart D) OROver-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)
(Division Sign-Off)
Division of Cardiovascula
510(k) Number K071494