← Product Code [KFM](/productcode/KFM) · K033270 # NOVOSCI READY SYSTEM, MODEL RS-200 (K033270) _Novosci Corp. · KFM · Feb 13, 2004 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K033270 ## Device Facts - **Applicant:** Novosci Corp. - **Product Code:** [KFM](/productcode/KFM.md) - **Decision Date:** Feb 13, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4360 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## 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. ## Device Story The NovoSci Ready System is a closed-loop extracorporeal circuit providing circulatory, thermal, and gas-exchange support. It functions as a cardiopulmonary bypass system, managing blood flow and oxygenation during surgery. The system is intended for single-use in clinical surgical settings. It is operated by trained perfusionists or surgical staff. By providing temporary extracorporeal support, the device enables surgeons to perform complex procedures while maintaining patient perfusion and gas exchange. The system is provided sterile and non-pyrogenic. ## Clinical Evidence No clinical data. Equivalence demonstrated via non-clinical bench testing, including biocompatibility, blood damage, reservoir pressure drop, minimum operating volume, micro air, vacuum pressure, and flow rate vs. vacuum testing. ## Technological Characteristics Closed-loop extracorporeal circuit; includes blood pump, oxygenator, reservoir, tubing, and connectors. Sterile, single-use, non-pyrogenic fluid pathway. Designed for cardiopulmonary bypass. Mechanical/fluidic operation. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Jostra MECC System - V-bag - V-box for vacuum assist ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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™ Corp
2828 N. Crescent Ridge Dr.
The Woodlands, Texas 77381 | |------------------------------------------------------------------|------------------------------------------------------------------------------| | Contact: | LeAnn Latham
Regulatory Affairs Manager
Phone: 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, Cardiopulmonary
Bypass | | | Pump, Blood, Cardiopulmonary Bypass, Non-roller
Type | | | Filter, Blood, Cardiopulmonary Bypass, Arterial line | | | Oxygenator, Cardiopulmonary Bypass | | | Reservoir, Blood, Cardiopulmonary Bypass | | Classification:
Panel:
Product code:
Regulation Number: | Class III
Cardiovascular (CV)
DWF, DTL, KFM, DTM, DTZ, DTN
870.4360 | | Predicate Device: | Jostra MECC System
V-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 --- **Source:** [https://fda.innolitics.com/device/K033270](https://fda.innolitics.com/device/K033270) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com