(88 days)
Not Found
No
The summary describes a mechanical system for extracorporeal circulation with an automated air removal system based on ultrasonic sensing. There is no mention of AI or ML algorithms for data analysis, decision-making, or pattern recognition.
Yes
The device is used for extracorporeal gas exchange, circulatory support, and thermal regulation during surgical procedures, which are considered therapeutic interventions to maintain physiological function.
No
The device is described as a system for extracorporeal gas exchange, circulatory support, and thermal regulation during surgical procedures, which are therapeutic and supportive functions, not diagnostic ones.
No
The device description explicitly states the system consists of a "Controller" and a "Disposable Module," indicating hardware components beyond just software. The performance studies also mention testing on the "Active Air Removal Controller," further confirming the presence of hardware.
Based on the provided information, the Medtronic Resting Heart System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical procedures requiring extracorporeal gas exchange, circulatory support, and thermal regulation." This describes a device used on the patient's blood outside the body during surgery, not a device used to test samples of blood or other bodily fluids in vitro (in a lab setting).
- Device Description: The description details a system for cardiopulmonary bypass, involving components like a controller, disposable module, and a venous air removal device. This aligns with a surgical support system, not a diagnostic testing system.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The Medtronic Resting Heart System is a medical device used for extracorporeal support during surgery, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Medtronic Resting Heart System is intended for use in surgical procedures requiring extracorporeal gas exchange, circulatory support, and thermal regulation. This device is indicated for use in procedures requiring blood flow rate of 1 to 6 liters/min and lasting up to six hours. The system is indicated for use only with the Bio-Console.
Product codes (comma separated list FDA assigned to the subject device)
DTN, DTL
Device Description
The Medtronic Resting Heart System is a low prime volume alternative to existing Cardiopulmonary Bypass (CPB) perfusion circuit. The system is used for patient support during cardiopulmonary procedures lasting up to 6 hours. The System consists of the Medtronic Resting Heart System Controller for Active Air Removal and the Medtronic Resting Heart Disposable Module
The venous return portion of the CPB circuit is connected to a Venous Air Removal Device (VARD) that is equipped with an automated air removal system connected to the vent port on the device. The VARD is an AFFINITY Arterial Filter (38 micron) moved to the venous side of the circuit and equipped with ultrasonic crystals that sense the liquid level in the filter. The VARD replaces the Affinity™ Cardiotomy Venous Reservoir (CVR) or the Affinity™ Venous Reservoir Bag (VRB) that is normally used to remove air from the venous blood entering the CPB 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)
Performance data, such as, Air Handling capabilities, blood trauma, pressure drops have been provided in the 510(k) submission to show equivalence of the Medtronic Resting Heart System to a standard extracorporeal circuit. In addition comprehensive testing has been completed on the Active Air Removal Controller including performance and Software Verification and Validation.
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.
K935717, K891687, K953564, K012325
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
§ 870.4400 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
AUG 2 9 2003
Medtronic Resting Heart System 510(k) Submi
APPENDIX II
510(k) Summary
Medtronic Resting Heart System
(As required by 21CFR 807.92)
Submitter Information A.
| Submitter's Name: | Medtronic Perfusion Systems |
|---|---|
| Address: | 7611 Northland Drive N |
| Minneapolis, Minnesota 55428-1088 U.S.A. | |
| Telephone Number: | 763.391.9000 |
| Contact Person: | Preeti Jain |
| Date Submission Prepared: | May 30, 2003 |
B. Device Information
| Device Trade Name: | Medtronic Resting Heart System |
|---|---|
| Common or usual Name: | Cardiopulmonary Bypass Surgery Circuit with Active Air |
| Removal, Oxygenator, Centrifugal blood Pump, Arterial | |
| Filter, flow probe, tri-optic measurement cell, tubings and | |
| connectors, holding bag. | |
| Classification Name: | For the new/changed components: |
| Cardiopulmonary bypass blood reservoir, | |
| Cardiopulmonary bypass adaptors, fittings, manifold, | |
| For the unchanged components: | |
| Cardiopulmonary Bypass Oxygenator, | |
| Cardiopulmonary bypass heat exchanger, | |
| Cardiopulmonary Bypass blood pump (Non Roller type), | |
| Cardiopulmonary bypass arterial line blood filter, | |
| Cardiopulmonary bypass tubing, | |
| Cardiopulmonary bypass inline gas sensor, | |
| Cardiopulmonary bypass pump speed control |
1
Predicate Devices(For new/changed components):
| 1. AFFINITY® Venous Reservoir Bag (K935717) | |
|---|---|
| 2. Carmeda™ Coated Tubings and Connectors (K891687) | |
| 3. Medtronic Overpressure/Vacuum Relief Valve | |
| (K953564) | |
| 4. CardioVentions CORx System (K012325) | |
| Device Description: | The Medtronic Resting Heart System is a low prime |
| volume alternative to existing Cardiopulmonary Bypass | |
| (CPB) perfusion circuit. The system is used for patient | |
| support during cardiopulmonary procedures lasting up to 6 | |
| hours. The System consists of the Medtronic Resting Heart | |
| System Controller for Active Air Removal and the | |
| Medtronic Resting Heart Disposable Module | |
| The venous return portion of the CPB circuit is connected | |
| to a Venous Air Removal Device (VARD) that is equipped | |
| with an automated air removal system connected to the | |
| vent port on the device. The VARD is an AFFINITY | |
| Arterial Filter (38 micron) moved to the venous side of the | |
| circuit and equipped with ultrasonic crystals that sense the | |
| liquid level in the filter. The VARD replaces the Affinity™ | |
| Cardiotomy Venous Reservoir (CVR) or the Affinity™ | |
| Venous Reservoir Bag (VRB) that is normally used to | |
| remove air from the venous blood entering the CPB circuit. | |
| Indications for Use: | The Medtronic Resting Heart System is intended for use |
| in surgical procedures requiring extracorporeal gas | |
| exchange, circulatory support, and thermal regulation. This | |
| device is indicated for use in procedures requiring blood | |
| flow rate of 1 to 6 liters/min and lasting up to six hours. | |
| The system is indicated for use only with the Bio-Console |
C. Comparison of Required Technological Characteristics
Medtronic Resting Heart System is a system comprised of standard components of an extracorporeal circuit for use during cardiopulmonary bypass. The system has the same technological characteristics as a traditional circuit and the single components have the same technological characteristics as the predicate.
2
D. Performance Data
Performance data, such as, Air Handling capabilities, blood trauma, pressure drops have been provided in the 510(k) submission to show equivalence of the Medtronic Resting Heart System to a standard extracorporeal circuit. In addition comprehensive testing has been completed on the Active Air Removal Controller including performance and Software Verification and Validation.
Conclusion
Medtronic Resting Heart System is substantially equivalent to the noted predicate device based on the similarities of technological characteristics, indications for use and the results of performance comparative testing.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
AUG 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Ms. Preeti Jain 7611 Northland Drive Minneapolis, MN 55428
Re: K031700
Medtronic Resting Heart™ System Regulation Number: 21 CFR 870.4290, 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir and Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTN, DTL Dated: May 30, 2003 Received: June 2, 2003
Dear Ms. Jain:
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. Preeti Jain
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 Office of Compliance at (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Jhsa DAz fr
Bram D. Zuckerma Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Medtronic Resting Heart System 510(k) Submission
APPENDIX IV
Indications for Use Statement
| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | K031700 |
| Device Name: | Medtronic Resting Heart System |
Indications for Use:
ﻜ
Prescription Use (Per 21 CFR 801.109)
The Medtronic Resting Heart System is intended for use in surgical procedures requiring extracorporeal gas exchange, circulatory support, and thermal regulation. This device is indicated for use in procedures requiring blood flow rate of 1 to 6 liters/min and lasting up to six hours. The system is indicated for use only with the Bio-Console.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | [Signature] |
|---|---|
| [Signature] | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K031700 |
| Prescription Use
(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use
(Optional Format 1-2-96) | _ |
| ------------------------------------------ | --- | ---- | -------------------------------------------------- | --- |
|---|
N