(430 days)
The CAPIOX® 308 Hollow Fiber Oxygenator is used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool the blood or perfusion fluid flowing through the device. The device is intended for use during extracorporeal circulation for up to 6 hours. This device is for use with neonatal and pediatric patients.
CAPIOX® 308 Hollow Fiber Oxygenator (CAPIOX 308) contains an integrated heat exchanger. The CAPIOX 308 oxygenator is a membrane oxygenator consisting of microporous polypropylene hollow fibers. Blood flows internal to the hollow fibers while gases flow outside the fibers. The heat exchanger consists of stainless steel pipes with blood flowing inside the pipes and water flowing outside the pipes. A thermistor probe is located near the outlet port of the oxygenator which can be connected to accessory temperature monitoring equipment if desired.
The CAPIOX® 308 Hollow Fiber Oxygenator with integral heat exchanger is a new device that was found to be substantially equivalent to the Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger. The substantial equivalence was established based on intended use, design and materials, technology/principles of operation, specifications, and performance.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria (Specifications) and Reported Device Performance:
The acceptance criteria for the CAPIOX® 308 were established by demonstrating substantial equivalence to the predicate device, the Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger. The "acceptance criteria" are effectively the specifications of the predicate device that the new device needed to match or surpass for critical parameters to be considered substantially equivalent.
| Specification | Predicate Device (Avecor 0800 2A Oxygenator & Omnitherm Heat Exchanger) | CAPIOX® 308 Hollow Fiber Oxygenator |
|---|---|---|
| Effective surface area of oxygenator | 0.8 m² | 0.8 m² |
| Heat Exch. Max. water Pressure | 45 PSI | 42 PSI (Lower, which is typically acceptable if performance is equivalent) |
| Blood Flow Rate | 0-1.2 LPM (Liters Per Minute) | 0-0.8 LPM (Lower, but accepted due to specific intended use for neonatal and pediatric patients) |
| Static Priming Volume (Oxygenator and heat exchanger) | 148 mL | 95 mL (Lower, which is generally a benefit) |
| Dimensions (Oxygenator) | Height: 38.5 cm, Width: 8.0 cm, Weight: 530 g | Height: 24.0 cm, Width: 10.5 cm, Weight: 400 g |
| Dimensions (Heat Exchanger) | Height: 47.5 cm, Width: 6.5 cm, Weight: 230 g | Integrated (Dimensions listed under Oxygenator) |
Important Note: The document explicitly states: "Although some design dissimilarities exist, the performance s and and the the the there that these differences do not Although some design arsements that these differences do not testing results demonstrate that chose in the function and intended uses of the devices." This indicates that while some specifications varied, the overall functional performance was deemed equivalent. For instance, the lower blood flow rate for the CAPIOX® 308 is likely acceptable given its intended use for neonatal and pediatric patients, who require lower flow rates than adults. Similarly, a smaller priming volume is often an advantage.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" in the context of clinical trial data or patient samples. The "test results" refer to engineering and performance tests conducted to compare the CAPIOX® 308 with the predicate device. These tests would involve physical measurements and simulations, not patient data in the typical sense of a clinical trial.
- Sample Size: Not applicable in the context of human subjects or clinical data. The tests would involve multiple units of the device and the predicate device for various performance metrics. The exact number of units tested for each specific parameter (e.g., gas exchange, heat transfer, leak testing) is not provided in the summary.
- Data Provenance: The tests were likely conducted in a laboratory or manufacturing setting. The document does not specify the country of origin for the testing, but it was submitted by Terumo Medical Corporation, located in New Jersey, USA, and Elkton, Maryland, USA. The data would be considered prospective as it involves new testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The ground truth for this medical device submission is established through engineering specifications, direct comparative performance testing against a legally marketed predicate device, and compliance with recognized standards. There is no mention of expert consensus derived from reviewing diagnostic outputs or images.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study involving human interpretation of data where adjudication methods (like 2+1 for reaching consensus among experts) would be used. The "adjudication" in this context is the FDA's regulatory review process, which determined substantial equivalence based on the provided engineering and performance test data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., AI algorithms for medical imaging) to assess the impact of AI assistance on human reader performance. The CAPIOX® 308 is a therapeutic device (oxygenator with heat exchanger) used during cardiopulmonary bypass, not a diagnostic imaging tool.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Yes, the "performance" section implicitly refers to standalone performance studies. The document states, "The test results indicated the CAPIOX 308 performs in a substantially equivalent manner to the Avecor 0800 2A and Omnitherm Heat Exchanger." These tests were conducted on the device itself, measuring its physical and functional characteristics (e.g., gas exchange efficiency, heat transfer rate, priming volume, pressure resistance) without human intervention in its primary function during the test.
7. Type of Ground Truth Used:
The ground truth used for demonstrating substantial equivalence was a combination of:
- Engineering specifications and performance data of the legally marketed predicate device (Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger).
- Direct comparative performance testing of the CAPIOX® 308 against the predicate device to show that the new device's performance aligned with, or was acceptably different from, the predicate's performance.
- Compliance with recognized standards for medical device safety and biocompatibility (e.g., pyrogen testing, sterilization validation to SAL of 10⁻⁵, ethylene oxide residuals, 100% performance and leak testing, ISO-10993 for blood-contacting materials).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth established for one.
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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Proprietary Device Name: CAPIOX® 308 Hollow Fiber Oxygenator with integral heat exchanger
Classification Name:
Cardiopulmonary bypass oxygenator, heat exchanger .
Reason for Submission:
New device.
Intended Use:
The CAPIOX® 308 Hollow Fiber Oxygenator is used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass The integral heat exchanger is used to warm or cool surgery. the blood or perfusion fluid flowing through the device. The device is intended for use during extracorporeal circulation for up to 6 hours.
Description
CAPIOX® 308 Hollow Fiber Oxygenator (CAPIOX 308) contains an integrated heat exchanger. The CAPIOX 308 oxygenator is a membrane oxygenator consisting of microporous polypropylene hollow fibers. Blood flows internal to the hollow fibers while gases flow outside the fibers. The heat exchanger consists of stainless steel pipes with blood flowing inside the pipes and water flowing outside the pipes. A thermistor probe is located near the outlet port of the oxygenator which can be connected to accessory temperature monitoring equipment if desired.
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II - Summary and Certification Summary of Safety and Effectiveness
Substantial Equivalence
The CAPIOX® 308 Oxygenator with integrated heat exchanger is substantially equivalent to the Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger as follows:
Intended use: same
Design and Materials:
The CAPIOX 308 has an integrated heat exchanger while the Avecor 0800 2A oxygenator is designed to operate with the separate Avecor Omnitherm Heat Exchanger.
Gas exchange is accomplished through hollow polypropylene fibers in the CAPIOX 308. Blood flows through the fibers while gas flows on the outside the fibers.
The Avecor 0800 2A has a flat reinforced silicone rubber membrane envelope wound in a spiral coil around a polycarbonate spool. The entire unit is encased by a tightfitting silicone rubber sleever. The interior of the envelope is the qas compartment containing a spacer screen permitting gas flow.
The heat exchanger of the CAPIOX 308 uses straight stainless steel tubes as blood conduits with water flowing on the outside of the tubes.
The Avecor Omnitherm Heat Exchanger is a tube-in-shell design, and consists of thin-walled aluminum tubes containing aluminum rod inserts shaped in a "staircase" pattern to promote gentle mixing of the blood and to conduct heat from the tube walls into the bloodstream. The water and blood paths are separated at each end of the device by a pair of manifolds, between which is an air space which is open to the atmosphere through a hole in the shell of the heat exchanger. Water flows on the outside of the tubes.
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- II Summary and Certification Summary of Safety and Effectiveness
Although some design dissimilarities exist, the performance
s and and the the the there that these differences do not Although some design arsements that these differences do not testing results demonstrate that chose in the function and intended uses of the devices.
Technology_and_Principles_of_Operation
Both devices use membrane technology. The CAPIOX 308 uses
s membrane Both devices use membranc country.
hollow fibers while the Avecondanian is utilized to hollow fibers while the necessarism is utilized to plate. Some form of pumpilly to the heat exchanger transfer blood from the reber on the PCBPIOX 308) and from (separate for Avecon (Separato of the oxygenator component.
The technology and principles of operation for the CAPIOX
. The technology and principles or open of the provivalent.
308 and the Avecor 0800 2A are substantially equivalent.
| Speci | A-1 | ti | 1 | cations | ||
|---|---|---|---|---|---|---|
| ------- | ----- | ---- | --- | -- | -- | --------- |
| Table 1 | ||
|---|---|---|
| Effective surfacearea of oxygenator | 0.8 m2 | 0.8 m2 |
| Heat Exch. Max. waterPressure | 42 PSI | 45 PSI |
| Blood Flow Rate | 0-0.8 LPM | 0-1.2 LPM |
| Static Priming Volume(Oxygenator and heatexchanger) | 95 mL | 148 mL |
| Dimension | Height: 24.0 cmWidth: 10.5 cmWeight: 400 g | OxygenatorHeight: 38.5 cmWidth: 8.0 cmWeight: 530 gHeat ExchangerHeight: 47.5 cmWidth: 6.5 cmWeight: 230 g |
Table 1
These differences do not affect the substantial equivalence
s or the local leader and the case organization These differences do not arrood control of exchange for clinical use.
$$
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II - Summary and Certification Summary of Safety and Effectiveness
Performance
Comparison of the CAPIOX 308 with integrated heat exchanger and the Avecor 0800 2A and Omnitherm Heat Exchanger performance was conducted.
The test results indicated the CAPIOX 308 performs in a substantially equivalent manner to the Avecor 0800 2A and Omnitherm Heat Exchanger.
The CAPIOX 308 with integrated heat exchanger and the Avecor 0800 2A and Omnitherm Heat Exchanger 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
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· Pyrogen Testing
-
•Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 10-5.
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· 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).
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•Manufacturing control tests include 100% performance and leak testing.
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· 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 April 12, 1996 -
Sandi Hartka, M.A.S., R.A.C. Prepared by: Submissions Supervisor Regulatory Affairs
- Terumo Medical Corporation for : 2100 Cottontail Lane Somerset, NJ 08873
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes and a flowing tail. The logo is presented in black and white.
JUL - 7 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Sandi Hartka Manager Regulatory Affairs Regulatory Affairs Terumo Medical Corporation Regulatory Affairs Department 125 Blue Ball Road Elkton, Maryland 21921
Re: K961734
CAPIOX® 308 Oxygenator Hollow Fiber Oxygenator with Integrated Heat Exchanger Regulatory Class: III (Three) Product Code: DTZ Dated: April 6, 1997 Received: April 9, 1997
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 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 GME regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any 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.
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Page 2 - Ms. Sandi Hartka
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) Additionally, for questions on the promotion and 594-4648. advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.qov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| JAN-14-97 TUE 14:58 | L&RA-TMC/MD |
|---|---|
| --------------------- | ------------- |
| 870.4350 Oxygenatur | |
|---|---|
| 519 K # | K961734 |
| Device Name: | CAPIOXR 308 Hollow Fiber Oxygenator with integral heat exchanger |
|---|---|
| -------------- | ------------------------------------------------------------------ |
Indications For Usc:
The CAPIOX 308 Oxygenator is used to exchange gases between blood and a The CAPIDX 300 UXygenator 15 used to exchange needs of a patient during gaseous environment to sacrs inte integral heat exchanger is used to warm
cardiopulmonary bypass surgery. It in integral the device . This cardlopulmonary bypass Surgery. The firegran the device. . . . . . . . . . . . . . . . or cool the shood on perfaston-france on circulation for up to 6 hours.
device is for use during extracoporeal circulation nationts device is for use with neonatal and pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device OR Over-The-Counter Use ﺎ ﺍﻟﻤﺮﺍﺟﻊ (Optional Formal 1-7-96) Rev i sed
Concurrence of CDRH, Office of Device Evaluation (ODF)
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
-.005
§ 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.”