(267 days)
Not Found
No
The description focuses on the physical components and function of a hollow fiber oxygenator and heat exchanger, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for extracorporeal circulation to oxygenate and remove carbon dioxide from human blood, which is a therapeutic intervention.
No
Explanation: The device is an oxygenator and heat exchanger used for extracorporeal blood oxygenation and carbon dioxide removal, which are therapeutic functions, not diagnostic.
No
The device description clearly outlines physical components like hollow fiber membranes, a heat exchanger, housing, tubing, and mentions blood flow driven by pumps, indicating it is a hardware device.
Based on the provided text, the MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "extracorporeal oxygenation of and carbon dioxide removal from human blood." This describes a process performed outside the body to treat the blood directly, not a test performed on a sample of blood or other biological material to provide diagnostic information.
- Device Description: The description details a device that physically interacts with blood flow (oxygenator, heat exchanger, tubing, pumps) to modify its composition (add oxygen, remove CO2, regulate temperature). This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components, detecting biomarkers, or providing any kind of diagnostic result.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MEDOS HILITE 7000 & 7000 LT Oxygenator does not fit this description.
N/A
Intended Use / 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.
Product codes
DTZ
Device Description
The MEDOS HILITE 7000 & 7000 LT 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 and coated with a proprietary coating. 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 centrifugal 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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
Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
1. Company making the submission:
| Name: | GISH Biomedical, Inc.
A member of the MEDOS group |
|------------|---------------------------------------------------------------------|
| Address: | 22942 Arroyo Vista
Rancho Santa Margarita, CA
92688-2600 |
| Telephone: | 949-635-6241 voice
949-635-6299 fax
janetp@gishbiomedical.com |
| Contact: | Janet Peets
Regulatory & Clinical Affairs |
2. Device:
Proprietary Name: MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator Common Name: Blood Oxygenator Classification Name: Oxygenator, Cardiopulmonary Bypass
3. Predicate Devices:
Vision Hollow Fiber Oxygenator, K961530, Manufactured by GISH Biomedical, Inc.
4. Classifications Names & Citations:
21 CFR 870.4350, Oxygenator, Cardiopulmonary Bypass, Class II, DTZ, Cardiovascular.
5. Description:
The MEDOS HILITE 7000 & 7000 LT 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 and coated with a proprietary coating. 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 centrifugal 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.
1
6. 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.
7. Contra-indications:
For oxygenators, no contra-indications have been noted.
8. Comparison:
The MEDOS HILITE 7000 & 7000 LT Oxygenator has the same device characteristics as the Predicate device.
9. Test Data:
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.
10. Literature Review:
A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safequards have been incorporated in the design of the MEDOS HILITE 7000 & 7000 LT Oxygenator.
11. Conclusions:
Based upon the testing and comparison to the predicate device the MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator has the same intended use, with similar technological characteristics. GISH Biomedical, Inc. a member of the MEDOS group, therefore posits that its device is equivalent in safety and effectiveness to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
MAY 1 5 2009
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Gish Biomedical, Inc. c/o Ms. Janet Peets Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688
Re: K082403
MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: May 1, 2009 Received: May 5, 2009
Dear Ms. Peets:
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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Page 2 - Ms. Janet Peets
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Donna Rivchine
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number K082403
・:.
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.
Prescription Use : Yes
OR
Over-The-Counter Use: No
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
er R. Vi Ames
Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices
510(k) Number K082403