(92 days)
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Not Found
No
The summary describes a treated tubing and connector system for cardiopulmonary bypass, focusing on material properties and blood compatibility. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is a component used in extracorporeal support during surgery. Its function is to connect other components and improve blood compatibility, not to directly treat a medical condition.
No
Explanation: The device description and intended use indicate that this product is tubing and connectors used in cardiopulmonary bypass circuits to improve blood compatibility during surgery requiring extracorporeal support. It is a component of a surgical system, not a device designed to diagnose a medical condition.
No
The device description clearly states it is tubing and connectors, which are physical hardware components. The "NovoCoat™ treatment" is applied to these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cardiopulmonary surgical procedures requiring extracorporeal support." This describes a device used during a surgical procedure to support the patient's physiological functions, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details tubing and connectors used to connect components of a cardiopulmonary bypass circuit. This is a system that circulates blood outside the body during surgery, which is a therapeutic and supportive function, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, tissue, or other samples to provide diagnostic information. The "blood compatibility" improvement is a functional characteristic related to the device's interaction with blood during circulation, not a diagnostic test.
IVD devices are typically used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to facilitate extracorporeal circulation during surgery, which is a direct intervention on the patient, not a diagnostic test.
N/A
Intended Use / Indications for Use
The NovoSci™ tubing and connectors with NovoCoat™ treatment are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.
Product codes
DWF, DTL
Device Description
The NovoSci ™ tubing and connectors treated with NovoCoat™ are sterile, single use only, disposable devices. They are used to connect cardiopulmonary bypass components used during surgery procedures requiring extracorporeal support. When used on devices for cardiopulmonary surgery, the NovoCoat™ treatment improves blood compatibility of non-biological surfaces in the extracorporeal circuit.
NovoSci™ tubing is polyvinyl chloride (PVC) tubing available in various sizes. The NovoSci™ connectors are polycarbonate in various configurations such as straight, reducing, "Y", with or without luer ports.
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
Non-clinical testing
Biocompatibility, in-vitro and performance testing were performed to demonstrate equivalence. These tests include: blood damage, bond strength, hardness, leak test, pump life.
Key Metrics
Not Found
Predicate Device(s)
NovoSci™ Duraflo treated tubing and connectors
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
JAN 1 6 2004
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 |
| Device trade name: | NovoSci™ Tubing and Connectors with NovoCoat™ |
| Common name: | Cardiopulmonary bypass tubing and connectors |
| Classification name: | Catheter, Cannula and Tubing, Vascular,
Cardiopulmonary Bypass
Adaptor, Stopcock, Manifold, Fitting, Cardiopumonary
Bypass |
| Classification:
Panel:
Product code:
Regulation Number: | Class II
Cardiovascular (CV)
DWF, DTL
870.4210, 870.4290 |
| Predicate Device: | NovoSci™ Duraflo treated tubing and connectors |
Device Description:
The NovoSci ™ tubing and connectors treated with NovoCoat™ are sterile, single use only, disposable devices. They are used to connect cardiopulmonary bypass components used during surgery procedures requiring extracorporeal support. When used on devices for cardiopulmonary surgery, the NovoCoat™ treatment improves blood compatibility of non-biological surfaces in the extracorporeal circuit.
NovoSci™ tubing is polyvinyl chloride (PVC) tubing available in various sizes. The NovoSci™ connectors are polycarbonate in various configurations such as straight, reducing, "Y", with or without luer ports.
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Pg 2 of 2
Indications for Use:
The NovoSci™ tubing and connectors with NovoCoat™ treatment are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.
Statement of Technological Characteristics Comparison:
The NovoSci™ NovoCoat™ treated tubing and connectors are substantially equivalent to the currently marketed NovoSci™ tubing and connectors with Durafio treatment.
Non-clinical testing
Biocompatibility, in-vitro and performance testing were performed to demonstrate equivalence. These tests include: blood damage, bond strength, hardness, leak test, pump life.
Conclusions:
This data supports that the NovoSci™ NovoCoat™ treated tubing and connectors are substantially equivalent in safety and efficacy to the currently marketed NovoSci 100 Duraflo treated tubing and connectors.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2004
NovoSci™ Corp. c/o Ms. LeAnn Latham 2828 N. Crescent Ridge Drive The Woodlands, TX 77381
Re: K033328
NovoSci™ Tubing and Connectors with NovoCoat™ Regulation Number: 21 CFR 870.4290 and 4210 Regulation Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTL and DWF Dated: October 15, 2003 Received: October 16, 2003
Dear Ms. Latham:
We have reviewed your Scction 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 adultcration.
If your device is classificd (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. 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. 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.
Sincerely Murs,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use
510(k) Number (if known) K033328
NovoSci™ tubing and connectors with NovoCoat™ Device Names: treatment
Indications for Use:
The NovoSci™ NovoCoat™ treated tubing and connectors are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) N
Dua Leenbe
X prescription