(78 days)
No
The description focuses on the physical components and function of an oxygenator and heat exchanger, with no mention of AI or ML.
Yes
The device is used for "extracorporeal oxygenation of and carbon dioxide removal from human blood," which directly treats a physiological condition (lack of oxygen and excess carbon dioxide in blood). Additionally, the mention of "heat exchanger" suggests it also helps maintain body temperature, another therapeutic function.
No
This device is an oxygenator used for extracorporeal circulation to oxygenate blood and remove carbon dioxide, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly details physical components like hollow fiber membranes, a heat exchanger, and a polycarbonate housing, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "extracorporeal oxygenation of and carbon dioxide removal from human blood." This describes a therapeutic procedure performed on the patient's blood outside the body, not a diagnostic test performed on a sample of blood or other bodily fluid to provide information about a patient's health status.
- Device Description: The description details a device that facilitates gas exchange and heat exchange with blood flowing through it. This aligns with a therapeutic device used during procedures like cardiopulmonary bypass.
- Lack of Diagnostic Language: The text does not mention any analysis of blood components, detection of biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to diagnose diseases, monitor conditions, or screen for health issues. This device's function is to modify the blood itself for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Medos Hilite 7000 & 7000 LT Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (7.0) liters per minute for periods of up to six (6.0) hours.
Product codes
DTZ
Device Description
The MEDOS HI LITE 7000 & 7000 L T Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 LT hollow fiber membrane consists of a Polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifyigal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
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)
The Medos Hilite 7000 & 7000 LT Oxygenator has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards. The following tests were performed due to the change in potting material:
- Blood Pathway Integrity
- Heat Exchanger Fluid Pathway Integrity
- Chemical analysis
- Macroplast CR 3502 / CR 4100, EO sterilized
- Hilite 7000, PUR Macroplast CR3505/CR4605
- Hilite 7000 LT, PUR Macroplast CR3505/CR4605
- Hilite 7000, PUR Macroplast CR3505/CR4100
- Evaluation of Biological Safety toxicology
- Macroplast CR 3502 / CR 4100, PUR posting material for hollow fibers of oxygenators
- Cytotoxicity, L 929-Proliferation
- Macroplast CR 3502 / CR 4100, EO sterilized
- Hemolysis (elution method)
- Macroplast CR 3502 / CR 4100, EO sterilized
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Pyrogen
- Hemocompatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K133261 page 1 of 3 Special 510(k) Submission Section 2, 510(k) Summary
SPECIAL 510(K) : 510(k) Summary For the Medos Medizintechnik AG Medos Hilite 7000 & 7000 LT Oxygenator
JAN - 9 2014
SUBMITTER/510(k) HOLDER: l.
Medos Medizintechnik AG Obere Steinfurt 8-10 5222 Stolberg, Germany Telephone: +49 7131 2706 150 Telefax: +49 7131 2706 250 Head of Requlatory Affairs: Heiko Frerichs Email: h.frerichs@medos-ag.com
CONTACT PERSON II.
Leann Christman Novalung, Inc. 3526 West Liberty Rd., Suite 100 Ann Arbor, MI 48103 Telephone: (734) 995-9089 ext. 232 Fax: (734) 995-0840 Email: leann.christman@Novalung.com
III. DEVICE NAME
Proprietary Trade Name: Medos Hilite 7000 & 7000 LT Oxygenator Common/Usual Name: Blood Oxygenator
IV. DEVICE CLASS:
Class II
V. CLASSIFICATION NAME AND CITATION:
Classification Name: Oxygenator, Cardiopulmonary Bypass Classification regulation: Sec. 870.4350
VI. PRODUCT CODES:
DTZ
VII. PREDICATE DEVICES
K088403, Medos Hilite 7000 & 7000 LT Oxygenator
VIII. PRODUCT DESCRIPTION
The MEDOS HI LITE 7000 & 7000 L T Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber
Medos Medizintechnik AG, Special 510(k) Medos Hilite 7000 & 7000 LT Oxygenator
Confidential Page 2-1
1
membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 LT hollow fiber membrane consists of a Polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifyigal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit,
IX. INDICATIONS OF USE
The Medos Hilite 7000 & 7000 LT Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (7.0) liters per minute for periods of up to six (6.0) hours.
X. TECHNOLOGICAL CHARACTERISITICS AND SUBSTANTIAL EQUIVALENCE
The Medos Hilite 7000 & 7000 LT Oxygenator are identical to the predicate device in terms of intended use, indications for use, levels of attachment, fundamental scientific technology, materials and surgical technique. Based on the information provided herein, the subject Medos Hilite 7000 & 7000 LT Oxygenator have been demonstrated to be substantially equivalent to the previously cleared Medos Hilite 7000 & 7000 LT Oxygenator (K088403). Please refer to the Table 9-1 for a comparison of the predicate and subject Medos Hilite 7000 & 7000 LT Oxygenator regarding substantial equivalence.
XI. PERFORMANCE TESTING -
The Medos Hilite 7000 & 7000 LT Oxygenator has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards. The following tests were performed due to the change in potting material:
- . Blood Pathway Integrity
- Heat Exchanger Fluid Pathway Integrity .
- Chemical analysis .
- Macroplast CR 3502 / CR 4100, EO sterilized 0
- Hilite 7000, PUR Macroplast CR3505/CR4605
- Hilite 7000 LT, PUR Macroplast CR3505/CR4605 O
- Hilite 7000, PUR Macroplast CR3505/CR4100 o
- Evaluation of Biological Safety toxicology .
2
- Macroplast CR 3502 / CR 4100, PUR posting material for hollow fibers of O oxygenators
- Cytotoxicity, L 929-Proliferation �
- o Macroplast CR 3502 / CR 4100, EO sterilized
- Hemolysis (elution method) .
- · Macroplast CR 3502 / CR 4100, EO sterilized
- . Cytotoxicity
- . Sensitization
- Intracutaneous Reactivity ●
- . Acute Systemic Toxicity
- Pyrogen .
- Hemocompatibility .
SUMMARY AND CONCLUSIONS XII.
Medos Medizintechnik AG makes the claim that the Medos Hilite 7000 & 7000 LT Oxygenator is substantially equivalent to the cited predicate in terms of intended use, indications for use, fundamental technology, design characteristics, generic materials of construction, and operational characteristics. As shown in Table 9-1 and the discussion above, the differences between the Medos Hilite 7000 & 7000 LT Oxygenator and cited predicate are minor and raise no new issues of safety or effectiveness. The Medos Hilite 7000 & 7000 LT Oxygenator meets design specifications.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2014
Medos Medizintechnik AG Leann Christman Novalung, Inc. 3526 West Liberty, Suite 100 Ann Arbor, Mich. 48103
Re: K133261
Trade/Device Name: Medos hilite 7000 & 7000LT Hollow Fiber Oxygenators Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: December 9, 2013 Received: December 11, 2013
Dear Ms. Christman:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Leann Christman
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
MDA
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known) K 133261
Device Name: Medos Hilite 7000 & 7000 LT Oxygenator
indications for use:
The MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1 .0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.
Prescription Device:
Federal Law (US) restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: Yes
OR
Over-The-Counter Use: No
MDA