(30 days)
Not Found
No
The document describes a hollow fiber membrane oxygenator and its equivalence to a predicate device based on material changes. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to oxygenate and remove carbon dioxide from blood and to temper blood, which are therapeutic actions to support a patient during cardiopulmonary bypass.
No
Explanation: The device is an oxygenator used in cardiopulmonary bypass procedures, which is a therapeutic device that performs the function of lungs and heart, rather than diagnosing a condition.
No
The device description clearly identifies it as a physical medical device (Hollow Fiber Membrane Oxygenator) with specific hardware components (heat exchanger fiber). 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 "use in an extracorporeal perfusion circuit to 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 for therapeutic purposes (oxygenation, CO2 removal, temperature control).
- IVD Definition: In vitro diagnostics are devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease. This typically involves tests performed on samples like blood, urine, or tissue in a lab setting.
- Lack of Diagnostic Information: The description focuses on the device's function in modifying blood composition and temperature, not on analyzing blood to provide diagnostic information about a patient's condition.
Therefore, the Jostra Hollow Fiber Membrane Oxygenator Quadrox Safeline is a therapeutic medical device used in extracorporeal circulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hollow Fiber Membrane Oxygenator Quadrox Safeline 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.
The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbondioxide 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 Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane (instead of polyethylene) which reduces the risk of electrostatic discharge for the patient significantly.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro tests were performed to demonstrate that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 described in this submission is substantially equivalent to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 (K992559).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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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FEB 2 6 200
Special 510(k): Device Modification: Quadrox Safeline HMO 2030
510(k) SUMMARY
SUBMITTER:
Katrin Schwenkalenks Phone: +49 (7478) 921-151
Fax: + 49 (7478) 921-400
Hechinger Strasse 38 72145 Hirrlingen, Germany
January 24, 2003
Quadrox Safeline
Integral Heat Exchanger
Jostra AG.
DATE PREPARED:
CONTACT PERSON:
DEVICE TRADE NAME:
COMMON/USAUAL NAME
CLASSIFICATION NAME
PREDICATE DEVICE OR LEGALLY MARKETED DEVICE:
Jostra Hollow Fiber Membrane Oxygenator Quadrox Safeline HMO 1030
Cardiopulmonary Bypass Oxygenator
Cardiopulmonary Bypass Heat Exchanger
Jostra Hollow Fiber Membrane Oxygenator
Hollow Fiber Membrane Blood Oxygenator with
DEVICE DESCRIPTION/INDICATONS FOR USE
The Hollow Fiber Membrane Oxygenator Quadrox Safeline 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.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane (instead of polyethylene) which reduces the risk of electrostatic discharge for the patient significantly.
TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE
In-vitro tests were performed to demonstrate that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 described in this submission is substantially equivalent to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 (K992559).
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Jostra AG Ms. Katrin Schwenkglenks Regulatory Affairs Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K030264
Trade/Device Name: Quadrox Safeline Hollow Fiber Membrane Oxygenator HMO 2030 Regulation Number: 21 CFR 870.4350 Regulation Name: CARDIOPULMONARY BYPASS OXYGENATOR Regulatory Class: Class II Product Code: DTZ Dated: January 24, 2003 Received: January 27, 2003
Dear Ms. Schwenkglenks:
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.
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
2
Page 2 - Ms. Katrin Schwenkglenks
forth in the quality systems (OS) 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 (301) 594-4639, 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kirt Miller
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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Special 510(K): Device Modification Jostra AG – Safeline Quadrox Hollow Fiber Membrane Oxygenator
Page 1 of 1
510(k) Number (if known): K050864
Device Name: Jostra Safeline Quadrox Hollow Fiber Membrane Oxygenator
Indications for Use
The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbondioxide during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use Only
A. Catter
510(k) Number K02004