(126 days)
The NovoSci ™ Ready System® is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
The NovoSci" Ready System® is a closed loop extracorporeal system providing circulatory, thermal and gas-exchange support for extracorporeal perfusion. The NovoSci" Ready System® is provided as a sterile system with a non-pyrogenic fluid pathway for single use only and is not to be re-sterilized by the user.
The provided text describes a 510(k) premarket notification for the NovoSci™ Ready System®, an extracorporeal system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new, innovative device. Therefore, much of the requested information regarding AI model performance, human reader studies, and detailed ground truth establishment is not applicable to this submission.
Here's a breakdown of the information that can be extracted and explanations for what cannot:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list "acceptance criteria" in the way one would for an AI algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Non-clinical testing) |
|---|---|
| Biocompatibility: Equivalent safety profile regarding interactions with biological systems. | "Biocompatibility...testing were performed to demonstrate equivalence." |
| In-vitro performance: Safe and effective operation in laboratory settings. | "in-vitro...testing were performed to demonstrate equivalence." |
| Performance testing (Mechanical/Functional): Meets functional requirements for extracorporeal circulation and gas exchange. | "performance testing were performed to demonstrate equivalence. These tests included: blood damage, reservoir pressure drop, minimum operating volume, micro air, vacuum pressure, flow rate vs. vacuum." |
| Duration of Use: Capable of supporting extracorporeal circulation and gas exchange for 6 hours or less. | "The NovoSci™ Ready System® is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less." (This is an indication for use, which implies performance within this timeframe.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the given text. Non-clinical testing typically involves bench-top tests, simulations, and material analyses rather than patient-derived "test sets" in the context of an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable/not provided. Ground truth establishment by experts is relevant for diagnostic AI devices where human interpretation is being benchmarked. For an extracorporeal circulation system, "ground truth" is typically defined by engineering specifications, validated test methods, and compliance with industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are used in studies involving human interpretation or agreement, typically for diagnostic accuracy studies of AI.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. The NovoSci™ Ready System® is a medical device for extracorporeal circulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. As explained above, this is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for non-clinical testing would involve:
- Engineering specifications and standards: Performance parameters like flow rate, pressure drop, and blood damage are compared against pre-defined, acceptable ranges established through engineering principles and regulatory guidelines for similar devices.
- Predicate device performance data: The NovoSci™ Ready System®'s performance is compared against the known, established performance of the legally marketed predicate devices (Jostra MECC System, V-bag, V-box). This acts as a de-facto "ground truth" for what constitutes safe and effective performance.
8. The sample size for the training set
This information is not applicable/not provided. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided. As not an AI device, there is no "training set" or ground truth established for it in that context.
{0}------------------------------------------------
510 (k) Premarket Notification: NovoSci ™ Ready System®
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92.
| Submitter: | NovoSci™ Corp2828 N. Crescent Ridge Dr.The Woodlands, Texas 77381 |
|---|---|
| Contact: | LeAnn LathamRegulatory Affairs ManagerPhone: 281-363-4949 ext. 234 |
| Device trade name: | NovoSci™ Ready System® |
| Common name: | Extracorporeal Circuit |
| Classification name: | Catheter, Cannula and Tubing, Vascular,Cardiopulmonary Bypass |
| Adaptor, Stopcock, Manifold, Fitting, CardiopulmonaryBypass | |
| Pump, Blood, Cardiopulmonary Bypass, Non-rollerType | |
| Filter, Blood, Cardiopulmonary Bypass, Arterial line | |
| Oxygenator, Cardiopulmonary Bypass | |
| Reservoir, Blood, Cardiopulmonary Bypass | |
| Classification:Panel:Product code:Regulation Number: | Class IIICardiovascular (CV)DWF, DTL, KFM, DTM, DTZ, DTN870.4360 |
| Predicate Device: | Jostra MECC SystemV-bag, V-box for vacuum assist. |
Device Description:
The NovoSci" Ready System® is a closed loop extracorporeal system providing circulatory, thermal and gas-exchange support for extracorporeal perfusion. The
{1}------------------------------------------------
NovoSci" Ready System® is provided as a sterile system with a non-pyrogenic fluid pathway for single use only and is not to be re-sterilized by the user.
Indications for Use:
The NovoSci™ Ready System® is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
Statement of Technological Characteristics Comparison:
The NovoSci" Ready System® is substantially equivalent to the predicate devices.
Non-clinical testing
Biocompatibility, in-vitro and performance testing were performed to demonstrate equivalence. These tests included: blood damage, reservoir pressure drop, minimum operating volume, micro air, vacuum pressure, flow rate vs. vacuum.
Conclusions:
These data support that the NovoSci™ Ready System® is substantially equivalent in safety and efficacy to the currently marketed Jostra MECC System and V-bag, Vac box
{2}------------------------------------------------
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
NovoSci™ Corp. c/o Ms. LeAnn Latham Regulatory Affairs Manager 2828 N. Crescent Ridge Drive The Woodlands, TX 77381
Re: K033270 NovoSci™ Ready System® Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type cardiopulmonary bypass blood pump Regulatory Class: Class III (three) Product Code: KFM Dated: December 18, 2003 Received: December 19, 2003
Dear Ms. Latham:
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. LeAnn Latham
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 and be obtained 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,
Dona R. Vachner
(gn Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number: K033270
Device Name: NovoSci™ Ready System®
Indications For Use:
The NovoSci ™ Ready System® is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K (33 ) + U
Page 1 of 1
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.