(112 days)
None
No
The description focuses on the mechanical function of a blood reservoir and filter, with no mention of AI or ML capabilities.
No
The device is a reservoir for blood during cardiopulmonary bypass surgery, not a therapeutic device itself. Its function is to store, filter, and defoam blood, which assists in a therapeutic procedure but is not directly therapeutic.
No
This device is a Hardshell Venous Reservoir used during cardiopulmonary bypass surgery for collecting, storing, and filtering blood. Its function is to manage blood flow and prepare blood for return to the extracorporeal circuit, not to diagnose medical conditions or analyze patient data.
No
The device description clearly indicates a physical, disposable medical device made of polycarbonate with internal components like a defoamer filter cartridge. It is designed for collecting, storing, and filtering blood during cardiopulmonary bypass, which are physical processes.
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 during cardiopulmonary bypass surgery as a storage reservoir and filter for blood. This is a surgical procedure involving the patient's circulatory system, not an in vitro test performed on samples outside the body.
- Device Description: The description details a device designed for collecting, storing, and filtering blood during bypass. It describes physical components like a shell, defoamer, and filter, all related to handling blood within the extracorporeal circuit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. The device's function is purely mechanical and related to blood management during surgery.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The MVC 0730 is a neonate, infant reservoir intended for use in procedures at a maximum flow rate of 1.2 liters per minute for periods up to six hours (6.0) hours.
Product codes
DTN
Device Description
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 0730 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/4" venous inlet at the bottom section of the reservoir. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 1.2 lpm. The maximum cardiotomy flow rate is 0.9 lpm.
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
During cardiopulmonary bypass surgery
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
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CAPIOX® RX05 Hollow Fiber Oxygenator with Hardshell Reservoir, K022115
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
K09/062
MEDOS Medizintechnik AG
Traditional 510(k) Section 5, 510(k) Summary
Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
AUG 0 4 2009
Company making the submission: 1.
| Name: | GISH Biomedical, Inc. |
|---|---|
| A member of the MEDOS group | |
| Address: | 22942 Arroyo Vista |
| Rancho Santa Margarita, CA 92688-2600 | |
| Telephone: | 949-635-6200 voice |
| 949-635-6299 fax | |
| Contact: | janetp@gishbiomedical.com |
| Janet Peets | |
| Regulatory & Clinical Affairs |
2. Device:
| Proprietary Name: | MEDOS HILITE MVC 0730 Hardshell Venous Reservoir |
|---|---|
| Common Name: | Cardiopulmonary Blood Reservoir |
| Classification Name: | Extracorpeal Circuit Blood Defoamer |
| Cardiopulmonary Bypass Blood Reservoir |
3. Predicate Devices:
CAPIOX® RX05 Hollow Fiber Oxygenator with Hardshell Reservoir, K022115, manufactured by Terumo Cardiovascular Systems Corporation.
Classifications Names & Citations: 4.
21 CFR 870.4230, 21 CFR 870.4400, Extracorpeal circuit blood defoamers, Cardiopulmonary bypass blood reservoir. Cardiopulmonary Bypass, Class II, DTN, Cardiovascular.
5. Description:
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 0730 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/4" venous inlet at the bottom section of the reservoir. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 1.2 lpm. The maximum cardiotomy flow rate is 0.9 lpm.
1
6. Indications for use:
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The MVC 0730 is a neonate, infant reservoir intended for use in procedures at a maximum flow rate of 1.2 liters per minute for periods up to six hours (6.0) hours.
7. Contra-indications:
No contra-indications have been noted.
8. Comparison:
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has the same device characteristics as the predicate device.
9. Test Data:
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system 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 safeguards have been incorporated in the design of MEDOS HILITE MVC 0730 Hardshell Venous Reservoir.
11. Conclusions:
Based upon the testing and comparison to the predicate device, the MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has the same intended use, with similar technological characteristics. MEDOS Medizintechnik AG therefore posits that its device is equivalent in safety and effectiveness to predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 0 4 2009
GISH Biomedical, Inc. c/o Ms. Janet Peets Regulatory and Clinical Affairs 22942 Arroyo Vista Rancho Santa Margarita, CA 92688-2600 Lansing. MI 48917
K091062 Re:
Medos Hilite MVC 0730 Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: June 24, 2009 Received: June 25, 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.
3
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 (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 (240) 276-0120. Also, 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 (240) 276-3150 or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.
Sincerely yours,
ina R. bulmer.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MEDOS Medizintechnik AG
510(k) Number KL)91062
Device Name: MEDOS HILITE MVC 0730 Reservoir
Indications for use:
The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The MVC 0730 is a neonate, infant reservoir intended for use in procedures at a maximum flow rate of 1.2 liters per minute for periods up to six hours (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)
Dwna R. La Lune
ivision Sian-Off Division of Cardiovascular Devices
510(k) Number Ko 9 10 6 2
Section 4 510(k) Submission Page
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