(30 days)
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 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.
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Change in the heat exchanger fiber material from polyethylene to polyurethane. | The Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane. |
| Risk Reduction | The new material (polyurethane) should significantly reduce the risk of electrostatic discharge for the patient. | The change in heat exchanger fiber material to polyurethane "reduces the risk of electrostatic discharge for the patient significantly." |
| Functional Equivalence | The device should be identical to the predicate device (Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030) in design, intended use, method of operation, components, packaging, and fundamental scientific technology, with the exception of the heat exchanger fiber material. | The Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the predicate device in design, intended use, method of operation, components, packaging, and fundamental scientific technology. |
| In-vitro Performance | In-vitro tests should demonstrate substantial equivalence to the predicate device. | In-vitro tests were performed to demonstrate substantial equivalence to the predicate device (K992559). |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set beyond mentioning "In-vitro tests were performed." The data provenance is also not specified; however, given that the manufacturer is based in Germany (Jostra AG, Hirrlingen, Germany) and the submission is to the US FDA, it can be inferred that the testing would have been conducted by the manufacturer, likely in Germany, to meet international standards for device evaluation. The data is retrospective in the sense that it's based on tests conducted on the modified device to compare against an existing predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns a device modification, focusing on material change and functional equivalence demonstrated through in-vitro tests, not diagnostic performance requiring expert interpretation of results. No expert adjudication of "ground truth" as typically understood in AI/imaging studies is relevant here.
4. Adjudication method for the test set
Not applicable. As this is not a study involving human interpretation of data for diagnostic purposes, no adjudication method was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This is not an MRMC comparative effectiveness study. This submission is for a modification to a medical device (oxygenator) and relies on in-vitro testing to show substantial equivalence to a predicate device, not on human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way. The "performance" of the device is evaluated in a standalone manner through in-vitro tests without human intervention in the device's operation or data interpretation during the test, beyond setting up the experiment and analyzing the results. The focus is on the device's physical and functional characteristics.
7. The type of ground truth used
The "ground truth" in this context is the predicate device's established performance and safety profile (Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030, K992559). The new device's performance is compared against the known and accepted performance of this predicate through physical and functional equivalence demonstrated by in-vitro testing. It's about demonstrating that the modified device performs effectively identically to the previously approved one, despite a material change.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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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).
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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
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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
§ 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.”