(338 days)
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No
The description focuses on the physical components and performance characteristics of a hollow fiber oxygenator, with no mention of AI or ML.
Yes
The device is described as an oxygenator that oxygenates and removes carbon dioxide from blood and regulates blood temperature during cardiopulmonary bypass procedures, which are therapeutic interventions.
No
This device is an oxygenator used in cardiopulmonary bypass procedures, which is a therapeutic function (oxygenating and removing carbon dioxide from blood), not a diagnostic one.
No
The device description clearly states it is a hollow fiber oxygenator with an integral venous heat exchanger, a physical, single-use, disposable hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and regulate blood temperature during cardiopulmonary bypass procedures. This is a direct intervention on the patient's blood flow, not a test performed in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a hollow fiber oxygenator with a heat exchanger, designed to interact directly with blood flowing through it. This is consistent with a therapeutic device used during surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing blood samples, detecting biomarkers, or providing diagnostic information. The device's function is to modify the blood itself.
- Performance Studies: The performance studies focus on biocompatibility, gas transfer, heat exchange, and blood cell damage – all related to the device's function in supporting blood during bypass, not its ability to diagnose.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. The SAFE MAXI oxygenator is a therapeutic device used to support a patient's physiological function during a medical procedure.
N/A
Intended Use / Indications for Use
The SAFE MAXI hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
Product codes
DTZ, DTR
Device Description
SAFE MAXI is a hollow fiber oxygenator with an integral venous heat exchanger. The SAFE MAXI oxygenator is a single-use, disposable, sterile and non-pyrogenic device. The overall blood flow path is from bottom to top in the heat exchanger module and top to bottom in the gas exchange section. The inverted "U" shaped blood flow path optimizes the device's bubble trapping capabilities. Gas exchange occurs by diffusion across the porous hollow fiber membrane.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Biocompatibility and in-vitro testing was performed to demonstrate substantial equivalence to the predicate device.
- Biocompatibility Testing: In vitro Cytotoxicity Test (Elution Test), Test for Delayed Contact Hypersensitivity using the Guinea Pig Maximization Test (Sensitization), Intracutaneous Test in the Rabbit, Systemic Injection Test in the Mouse, Haemolysis Test (Haemocompatibility).
- In vitro Bench Testing: Performed according to the FDA's "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff" of November 13, 2000, with reference to ISO 7199:1996. Physical Characteristics tested included: Blood Pathway Integrity, Heat Exchanger Fluid Pathway Integrity, Gas Pathway Integrity, Blood Volume Capacity, Connectors. Performance Characteristics tested included: Oxygen Gas Transfer, Carbon Dioxide Gas Transfer, Blood Cell Damage, Blood Side Pressure Drop, Heat Exchanger Performance, Water Side Pressure Drop.
- In vivo Testing: Animal testing was performed.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
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AUG 1 4 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the SAFE MAXI OXYGENATOR as required by section 807.92(c).
Submitter's Information
Name: Address: Phone: Fax Contact person: Date of preparation:
Device name:
Trade Name: Common/Usual name: Classification name:
POLYSTAN A/S Walgerholm 8, 3500 Værløse, Denmark + 45 44 65 15 66 + 45 44 68 15 66 Dana Olsen, Regulatory Affairs May 27, 2002
SAFE MAXI hollow fiber oxygenator membrane oxygenator Cardiopulmonary bypass oxygenator (21 CFR - 870.4350)
Predicate Device Name(s):
Quadrox HMO 1010 HF Membrane Oxygenator - Jostra AG - 510(k) no. K992559.
Device Description
SAFE MAXI is a hollow fiber oxygenator with an integral venous heat exchanger. The SAFE MAXI oxygenator is a single-use, disposable, sterile and non-pyrogenic device. The overall blood flow path is from bottom to top in the heat exchanger module and top to bottom in the gas exchange section. The inverted "U" shaped blood flow path optimizes the device's bubble trapping capabilities. Gas exchange occurs by diffusion across the porous hollow fiber membrane.
Intended Use
The SAFE MAXI hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
Technological Characteristics Summary
When compared to the predicate device the SAFE MAXI oxygenator has some different technological characteristics, e.g. design.
In order to demonstrate that the SAFE MAXI oxygenator is substantially equivalent to the currently marketed Quadrox HMO 1010 HF Membrane Oxygenator (Jostra AG) biocompatibility and in-vitro testing was performed.
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- Biocompatibility Testing .
- o In vitro Cytotoxicity Test (Elution Test)
- Test for Delayed Contact Hypersensitivity using the Guinea Pig O Maximization Test (Sensitization)
- Intracutaneous Test in the Rabbit o
- Systemic Injection Test in the Mouse o
- Haemolysis Test (Haemocompatibility)
Based on the biocompatibility testing performed, the SAFE MAXI oxygenator was determined to be biocompatible and safe for its intended use.
- . In vitro Bench Testing
In vitro bench testing was performed according to the FDA's "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff" of November 13, 2000. Reference to the ISO 7199:1996 standard was made where appropriate.
Physical Characteristics
- Blood Pathway Integrity o
- Heat Exchanger Fluid Pathway Integrity o
- Gas Pathway Integrity o
- Blood Volume Capacity o
- Connectors o
Performance Characteristics
- Oxygen Gas Transfer o
- Carbon Dioxide Gas Transfer o
- Blood Cell Damage o
- Blood Side Pressure Drop o
- Heat Exchanger Performance O
- Water Side Pressure Drop O
- . In vivo Testing
- o Animal testing was performed
Conclusion:
The biocompatibility, performance, and function data demonstrated that the SAFE MAXI oxygenator is substantially equivalent to the predicate device Jostra Quadrox HMO 1010 HF Membrane Oxygenator.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2002
POLYSTAN A/S c/o Ms. Dana Olsen 8. Walgerholm DK-3500 Værløse - Denmark
Re: K013038
SAFE MAXI Hollow Fiber Oxygenator Regulation Number: 870.4350, 870.4240 Regulation Name: CPB Oxygenator, CPB Heat Exchanger Regulatory Class: Class II (two) Product Code: DTZ and DTR Dated: May 29, 2002 Received: May 31, 2002
Dear Ms. Olsen:
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Elisa D. Hayes Sr.
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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3 Indication for Use
Statement of Indication for Use
The SAFE MAXI – hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
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 Cardiovascular and Respiratory Devices | |
| 510(k) Number | K013038 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |