(52 days)
K 932252
Not Found
No
The description focuses on the physical components and mechanical function of the oxygenator and heat exchanger. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is intended to oxygenate blood, remove carbon dioxide, and temper blood during cardiopulmonary bypass procedures, which directly addresses a physiological condition.
No
This device is designed to perform a function (oxygenate blood, remove carbon dioxide, and temper blood) during cardiopulmonary bypass procedures, rather than to diagnose a condition or disease.
No
The device description clearly details a physical medical device (blood gas exchanger with integrated heat exchanger) made of materials like polypropylene and polyethylene fibers, intended for use in extracorporeal perfusion circuits. It is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures". This describes a device that interacts directly with blood outside the body to modify its properties for therapeutic purposes.
- Device Description: The description details a "blood gas exchanger with integrated heat exchanger" that works by passing blood through membranes to facilitate gas exchange and temperature regulation. This is a mechanical and physical process applied to blood.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Hollow Fibre Membrane Oxygenator does not involve any analysis or testing of blood to provide diagnostic information. It is a therapeutic device that modifies the blood itself.
Therefore, the Hollow Fibre Membrane Oxygenator HMO 1010 is a therapeutic medical device used in extracorporeal circulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hollow Fibre Membrane Oxygenator HMO 1010 is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 is a blood gas exchanger with integrated heat exchanger. In open heart surgery it is used in an extracorporeal perfusion circuit first to oxygenate blood and remove carbondioxide second to regulate the blood temperature during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The oxygenation system is principally based on microporous polypropylene hollow fiber membranes. The heat exchanger is made of thight polyethylene fibers. The QUADROX consists of two membrane compartments. In the first chamber of the oxygenator, sheets of heat exchanger fibers and sheets of microporous oxygenation fibers are arranged crosswise. In the second chamber only sheets of the oxygenation fibers are arranged.
Blood enters the housing via the inlet connector and is distributed into a pre-chamber. Then the blood streams through the membrane package. In the first section it is tempered and oxygenated. In the second part only oxygenation and removal of carbondioxide takes place.
Positioned and integrated at the top of the oxygenator is a de-airing membrane. This membrane is a hydrophobic membrane allowing only gaseous substances to pass through the membrane but fluids are held back. The de-airing membrane allows easier priming, deairing and elimination of air throughout the whole procedure. To prime the oxygenator the Luer cap has to be removed. It should be kept open during perfusion to eliminate air continuously.
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)
- In-vitro Bench Testing:
- Performance Tests
- Heat Exchanger Performance Factor
- Intearity testing of the product
- In-vivo Testing:
- Animal Testing has been performed.
- Clinical Studies:
- Clinical comparative studies
- Biocompatibility and Blood Cell Damage:
- Biocompatibility testing of the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 was performed in accordance with the FDA Blue Book Memorandum - #G95-1 and Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1, and in accordance with United States Pharmacopeia - XXIII.
- Based on the results of the biocompatibility testing performed, the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 was determined to be biocompatible and nontoxic and, therefore, safe for its intended use.
- Blood cell damage testing of the Quadrox HMO 1010 was performed.
- Sterility:
- Sterilization of the Hollow Fibre Membrane Oxygenator HMO 1010 has been validated to assure a sterility assurance level (SAL) of 10-6.
- EtO sterilized Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 are according to Federal Register, Vol. 43, No. 122 - Friday, June 23, 1978.
- EtO Residuals:
- Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 meets the limits for residual concentrations of ethylene oxide (
§ 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
SEP 2 0 1999 SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY
COMPANY NAME AND CONTACT PERSON
June 28, 1999
Jostra Medizintechnik AG Hechinger Straße 38 72145 Hirrlingen Germany
Kathy Johnson, Product Manager tel. (610)932-7365 fax (610)932-7366
DEVICE NAME
Hollow Fibre Membrane Oxygenator Quadrox HMO 1010
COMMON NAME
Oxygenator
CLASSIFICATION NAME
Cardiopulmonary bypass oxygenator (21 CFR - 870.4350)
PREDICATE DEVICE OR LEGALLY MARKETED DEVICE
Avecor Cardiovascular, Inc. - Affinity Hollow Fiber Oxygenator (K 932252)
DEVICE DESCRIPTION
The Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 is a blood gas exchanger with integrated heat exchanger. In open heart surgery it is used in an extracorporeal perfusion circuit first to oxygenate blood and remove carbondioxide second to regulate the blood temperature during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The oxygenation system is principally based on microporous polypropylene hollow fiber membranes. The heat exchanger is made of thight polyethylene fibers. The QUADROX consists of two membrane compartments. In the first chamber of the oxygenator, sheets of heat exchanger fibers and sheets of microporous oxygenation fibers are arranged crosswise. In the second chamber only sheets of the oxygenation fibers are arranged.
1
Blood enters the housing via the inlet connector and is distributed into a pre-chamber. Then the blood streams through the membrane package. In the first section it is tempered and oxygenated. In the second part only oxygenation and removal of carbondioxide takes place.
Positioned and integrated at the top of the oxygenator is a de-airing membrane. This membrane is a hydrophobic membrane allowing only gaseous substances to pass through the membrane but fluids are held back. The de-airing membrane allows easier priming, deairing and elimination of air throughout the whole procedure. To prime the oxygenator the Luer cap has to be removed. It should be kept open during perfusion to eliminate air continuously.
INTENDED USE
The Hollow Fibre Membrane Oxygenator HMO 1010 is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
| Name of the Product | Hollow Fibre Membrane
Oxygenator HMO 1010 (Jostra) | Affinity Hollow Fiber
Oxygenator (Avecor) |
|---------------------------------------|-------------------------------------------------------|----------------------------------------------|
| Parameter | | |
| 510(k) number | not assigned | K932252 |
| Specifications: | | |
| Membrane Type | Microporous Polypropylene Hollow
Fibre | Microporous Polypropylene
Hollow Fibers |
| Membrane Structure | Hollow fibre woven mats | unknown |
| Membrane surface area | $1.8 m^2$ | $2.5 m^2$ |
| Static priming volume | 250 ml | 270 ml |
| Blood flow path | Around the fibres | Around the fibres |
| Recommended blood flow rate | 0.5-7 liters/minute | 1-7 liters/minute |
| Maximal recommended gas
flow rate | 15 liters/minute | unknown |
| Maximum water side pressure | 14 psi | 30 psi |
| Material of heatexchanger | Polyethylene | Stainless steel |
| Surface area of the heat
exchanger | $0.60 m^2$ | unknown |
| Arterial outlet port | 3/8" | 3/8" |
| Venous inlet port | 3/8" | 3/8" |
| Arterial sample port | Luer-Port | Female Luer Port |
| Recirculation port | 1/4" | 1/4" |
| Gas inlet port | 1/4" | 1/4" |
| Gas outlet port | 1/4" | 3/8" non-barbed |
| Water ports | ½" Quick-Connect Fittings (Hansen) | ½" quick disconnects |
| Method of sterilization | Ethylene Oxide | unknown |
| Storage temperature | +15°C - +30°C (+59° -+86°F) | unknown |
| Use | Single-use device | Single-use device |
| Weight | 0.7 kg | unknown |
TECHNOLOGICAL CHARACTERISTICS
2
SUMMARY OF PERFORMANCE DATA
In-vitro Bench Testing:
In-vitro bench testing demonstrated that when compared to the predicate device (Affinity Hollow Fiber Oxygenator), the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 does not significantly affect safety and effectiveness and is substantially equivalent to the Affinity Hollow Fiber Oxygenator. The in-vitro bench testing included analysis of
- . Performance Tests
- Heat Exchanger Performance Factor .
- Intearity testing of the product .
In-vivo Testing:
- Animal Testing has been performed .
Clinical Studies:
- . Clinical comparative studies
Biocompatibility and Blood Cell Damage:
Biocompatibility testing of the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 was performed in accordance with the FDA Blue Book Memorandum - #G95-1 and Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1, and in accordance with United States Pharmacopeia - XXIII.
Based on the results of the biocompatibility testing performed, the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 was determined to be biocompatible and nontoxic and, therefore, safe for its intended use.
Blood cell damage testing of the Quadrox HMO 1010 was performed.
Sterility:
Sterilization of the Hollow Fibre Membrane Oxygenator HMO 1010 has been validated to assure a sterility assurance level (SAL) of 10-6
EtO sterilized Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 are according to Federal Register , Vol. 43, No. 122 - Friday, June 23, 1978.
3
EtO Residuals:
Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 meets the limits for residual concentrations of ethylene oxide (