(92 days)
The NovoSci™ NovoCoat™ treated tubing and connectors are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.
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.
Acceptance Criteria and Study for NovoSci™ Tubing and Connectors with NovoCoat™
This 510(k) summary focuses on demonstrating that the NovoSci™ Tubing and Connectors with NovoCoat™ are substantially equivalent to the predicate device, NovoSci™ Duraflo treated tubing and connectors. The acceptance criteria and supporting study are therefore based on non-clinical performance and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (NovoSci™ NovoCoat™) | Based on Equivalence to Predicate |
|---|---|---|
| Biocompatibility | Demonstrated equivalence | Yes |
| In-vitro | Demonstrated equivalence | Yes |
| Blood Damage | Demonstrated equivalence | Yes |
| Bond Strength | Demonstrated equivalence | Yes |
| Hardness | Demonstrated equivalence | Yes |
| Leak Test | Demonstrated equivalence | Yes |
| Pump Life | Demonstrated equivalence | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test. However, it indicates that "Non-clinical testing" was performed. Given the nature of medical device testing (especially for substantial equivalence), it is assumed that appropriate, statistically valid sample sizes were used for each test to demonstrate equivalence to the predicate device.
The data provenance is not explicitly stated in terms of country of origin. The study is a non-clinical, in-vitro, bench-top testing assessment, therefore the concept of "retrospective or prospective" doesn't directly apply in the same way as a clinical trial. The testing was conducted to support the 510(k) submission, suggesting it was purpose-designed (prospective) to gather data for regulatory review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This section is not applicable to this 510(k) submission. The device is a medical accessory (tubing and connectors), and its performance assessment is based on objective, measurable physical and chemical properties through non-clinical testing rather than human interpretation of data where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical endpoints that require expert consensus, which is not the case for these non-clinical tests. The tests performed are objective measurements.
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 section is not applicable. This is a 510(k) submission for a physical medical device (tubing and connectors), not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. This submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance criteria in this submission is the established performance characteristics of the predicate device, NovoSci™ Duraflo treated tubing and connectors. The tests (biocompatibility, blood damage, bond strength, hardness, leak test, pump life) were designed to demonstrate that the new device performs equivalently to this well-established predicate. This would involve comparing quantitative or qualitative results of the new device against the known and accepted performance range/values of the predicate device.
8. The Sample Size for the Training Set
This section is not applicable as this is a non-AI medical device and does not involve a "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as point 8.
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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™ Corp2828 N. Crescent Ridge Dr.The Woodlands, Texas 77381 |
|---|---|
| Contact: | LeAnn LathamRegulatory Affairs ManagerPhone: 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 BypassAdaptor, Stopcock, Manifold, Fitting, CardiopumonaryBypass |
| Classification:Panel:Product code:Regulation Number: | Class IICardiovascular (CV)DWF, DTL870.4210, 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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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.
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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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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
§ 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.