(26 days)
Not Found
No
The summary describes a physical medical device (oxygenator and heat exchanger) with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for extracorporeal oxygenation and carbon dioxide removal from blood, which is a therapeutic intervention for patients requiring support for respiratory function.
No
The device is described as an oxygenator and heat exchanger used for extracorporeal oxygenation and carbon dioxide removal from blood. This is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "extracorporeal oxygenation of and carbon dioxide removal from human blood." This is a life support function performed outside the body, directly on the blood.
- Device Description: The description details a hollow fiber membrane oxygenator and heat exchanger, components used in extracorporeal circulation to modify the blood's gas content and temperature.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on a specimen. It directly interacts with and modifies the blood itself.
The device described is a medical device used in extracorporeal circulation procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 1000 & 800 LT are neonate, infant oxygenators intended for use at blood flow rates of 0.2 to 1.0 liters per minute for the HILITE 1000 and 0.2 to 0.8 liters per minute for tbe HILITE 800 LT for periods of up to six (6.0) hours.
Product codes
DTZ, DTR
Device Description
The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 infant hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 LT infant hollow fiber membrane consists of a polymetbylpentene plasma tight mat. The unique mat design increases tbe interaction between blood and gas, creating a highly efficient blood oxygenator. Tue 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 tbe inner lumen of the fibers and tberefore effects heat exchange while minimizing priming volume.
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
neonate, infant
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 1000 & 800 LT Infant Oxygenator have 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)
K090449, Medos Hilite Infant Oxygenator, Model 1000 & 800 LT Oxygenator
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
FEB 1 9 2014
SPECIAL 510(K) 510(k) Summary For the Medos Medizintechnik AG Medos Hilite 1000 & 800 LT Infant Oxygenator
l. SUBMITTER/510(k) HOLDER:
Medos Medizintechnik AG Obere Steinfurt 8-10 5222 Stolberg, Germany Telephone: +49 7131 2706 150 Telefax: +49 7131 2706 250 Head of Regulatory Affairs: Heiko Frerichs Email: h.frerichs@medos-ag.com FDA Registration: 3010223691
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 1000 & 800 LT Infant 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
PRODUCT CODES: VI.
DTZ
VII. PREDICATE DEVICES
K090449, Medos Hilite Infant Oxygenator, Model 1000 & 800 LT Oxygenator
PRODUCT DESCRIPTION VIII.
1
The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 infant hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 LT infant hollow fiber membrane consists of a polymetbylpentene plasma tight mat. The unique mat design increases tbe interaction between blood and gas, creating a highly efficient blood oxygenator. Tue 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 tbe inner lumen of the fibers and tberefore effects heat exchange while minimizing priming volume.
INDICATIONS OF USE IX.
The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 1000 & 800 LT are neonate, infant oxygenators intended for use at blood flow rates of 0.2 to 1.0 liters per minute for the HILITE 1000 and 0.2 to 0.8 liters per minute for tbe HILITE 800 LT for periods of up to six (6.0) hours.
TECHNOLOGICAL CHARACTERISITICS AND SUBSTANTIAL EQUIVALENCE X.
The Medos Hilite 1000 & 800 LT Infant 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 1000 & 800 LT Infant Oxygenator have been demonstrated to be substantially equivalent to the previously cleared Medos Hilite 1000 & 800 LT Infant Oxygenator (K090449). Please refer to the Table 9-1 for a comparison of the predicate and subject Medos Hilite 1000 & 800 LT Infant Oxygenator regarding substantial equivalence.
XI. PERFORMANCE TESTING
The 1000 & 800 LT Infant Oxygenator have 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 o
- O Hilite 7000, PUR Macroplast CR3505/CR4605
- Hilite 7000 LT, PUR Macroplast CR3505/CR4605 0
- Hilite 7000, PUR Macroplast CR3505/CR4100 0
- . Evaluation of Biological Safety - toxicology
2
- Macroplast CR 3502 / CR 4100, PUR posting material for hollow fibers of o oxygenators
- . Cytotoxicity, L 929-Proliferation
- Macroplast CR 3502 / CR 4100, EO sterilized o
- Hemolysis (elution method) .
- · Macroplast CR 3502 / CR 4100, EO sterilized
- Cytotoxicity .
- Sensitization .
- Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- . Pyrogen
- . Hemocompatibility
XII. SUMMARY AND CONCLUSIONS
Medos Medizintechnik AG makes the claim that the Medos Hilite 1000 & 800 LT Infant 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 1000 & 800 LT Infant Oxygenator and cited predicate are minor and raise no new issues of safety or effectiveness. The Medos Hilite 1000 & 800 LT Infant Oxygenator meets design specifications.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
February 19, 2014
Medos Medizintechnik AG c/o Leann Christman Novalung, Inc. 3526 West Liberty, Suite 100 Ann Arbor, Mich. 48103
Re: K140181
Trade/Device Name: Medos hilite 1000 & 800 LT Infant Oxygenators Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR Dated: January 22, 2014 Received: January 24, 2014
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, listing 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 misicading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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/ResourcesforYowIndustry/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 yours,
M. A. Hillerman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1
510(k) Number (if known) K 140181
Device Name: Medos Hilite 1000 & 800 LT Infant Oxygenator
indications for use:
The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators are 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 200 ml/min (0.2 liters/minute) to 1000ml/min (1.0 liters per minute) for the Hilite 1000 and 200 ml/min (0.2 liters/minute) to 800 ml/min (0.8 liters per minute) for the Hilite 800 LT 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 İF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: Yes
OR
Over-The-Counter Use: No
M.A. Lilleheman