(95 days)
The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a Novalung coated percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to < 6 hours.
The NovaPort® One Vascular Access cannula with Novalung coating are a wire reinforced, thin walled femoral cannula made of polyurethane. A cone without wire reinforcement allows clamping and serves as transition to a connector. The beveled tip is not a separate piece and is part of the whole cannula body. The NovaPort® one cannulas are inserted percutaneously into vessels. Insertion depth marks aid in positioning the cannula. They have a beveled tip that is made as part of the PVC body. The Cannula is intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriate sized cannula within the vessel for cardiopulmonary bypass. All surfaces of the NovaPort® One which come into contact with blood are protected with the Novalung Coating. This coating is a bioactive, stable, biocompatible and non-thrombogenic surface. This coating consists of high molecular weight heparin from pig mucosa bound covalently and ionically to immobilized polypeptides. NovaPort® one cannula is available in insertion lengths of 90 mm and with outer diameters of 13 F, 17 F, 19 F and 21 F. All are supplied sterile with Novalung coated, non-pyrogenic, and are single use.
The provided 510(k) summary for the Novalung® GmbH NovaPort® One Vascular Access device primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance criteria through a detailed clinical or standalone performance study as would be seen for AI/ML devices.
Here's an analysis based on the information provided, emphasizing what is present and what is absent from the request's specific questions regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a medical device (a vascular access cannula) and not an AI/ML diagnostic tool, there are no specific diagnostic "performance metrics" like sensitivity, specificity, or AUC. Instead, the acceptance is based on demonstrating equivalence to predicate devices across various attributes. The "acceptance criteria" here implicitly refer to meeting the expectations for functional and safety performance that allow for declaration of substantial equivalence.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary in 510(k)) |
|---|---|
| Intended Use | Identical to predicate devices |
| Indications for Use | Identical to predicate devices, limited to < 6 hours. Novalung coating indications same as Bioline coating (K102532) and Novalung sLA (K072362). |
| Fundamental Technology | Identical to predicate devices |
| Design Characteristics | Minor differences from predicate devices, raising no new safety/effectiveness issues. Wire-reinforced, thin-walled femoral cannula made of polyurethane, with Novalung coating. Beveled tip part of cannula body. |
| Generic Materials of Construction | Identical to predicate devices (polyurethane). Novalung coating made of high molecular weight heparin from pig mucosa bound to immobilized polypeptides. |
| Operational Characteristics | Identical to predicate devices |
| Pressure/Burst Resistance | Tested and found acceptable |
| Simulated Use | Tested and found acceptable |
| Kink Resistance | Tested and found acceptable |
| Tensile Strength | Tested and found acceptable |
| Flow Characteristics | Tested and found acceptable |
| Hemolysis | Tested and found acceptable |
| Biocompatibility | Tested and found acceptable |
| Coating Validation | Tested and found acceptable |
| Sterility | Supplied sterile |
| Non-pyrogenic | Supplied non-pyrogenic |
| Single Use | Designed for single use |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The NovaPort® One Vascular Access was subjected to numerous tests and comparisons to the predicate device: testing included pressure/burst, simulated use, kink resistance, tensile strength, flow characteristics, hemolysis, biocompatibility, and validation testing to coating."
- Sample Size: The specific sample sizes for these various engineering and bench tests are not provided in the 510(k) summary. These would typically be detailed in the full test reports submitted to the FDA, not in the summary.
- Data Provenance: The tests are described as "numerous tests," indicating they were likely benchtop/laboratory studies conducted by Novalung GmbH (likely in Germany, given the company's location) rather than human clinical trials. There is no mention of country of origin for any human data (as no human data appears to be used for acceptance) or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this 510(k) summary. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices where human expert interpretation is the gold standard for comparison (e.g., in AI/ML tasks). For this vascular access cannula, the "truth" is established through physical and material property testing, and comparison to the known performance of predicate devices. There's no mention of expert review panels for determining ground truth in the way described.
4. Adjudication Method for the Test Set
This question is not applicable for the reasons stated above. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human experts in diagnostic ground truth establishment, which isn't part of this device's acceptance testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices to assess how a device (often with AI assistance) impacts human reader performance. The NovaPort® One is a physical medical device (cannula), not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This concept is entirely specific to AI/ML or autonomous diagnostic algorithms. The acceptance testing for the NovaPort® One involves physical performance evaluations and material characterization, not algorithmic performance.
7. The Type of Ground Truth Used
For the NovaPort® One Vascular Access, the "ground truth" for its acceptance testing is based on:
- Engineering specifications and regulatory standards: For tests like pressure/burst, tensile strength, kink resistance, and flow characteristics.
- Established biocompatibility standards: For biocompatibility testing.
- Predicate device performance: The core of a 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device. This "ground truth" is therefore derived from the established safety and efficacy profiles of the predicate devices (Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit K052524 and One Piece Pediatric Arterial Cannula 7000 Models K024069).
8. The Sample Size for the Training Set
Not applicable. A "training set" refers to data used to train an AI/ML algorithm. This device is a physical medical instrument, not an AI/ML algorithm, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the NovaPort® One Vascular Access device.
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TRADITIONAL 510(K)
510(k) Summary
For the Novalung® GmbH NovaPort® One Vascular Access DEC - 6 2011
SUBMITTER/510(k) HOLDER: I.
Novalung® GmbH Zukunftspark 1 D-74076 Heilbronn, Germany Telephone: +49 7131 2706 - 0 Telefax: +49 7131 2706 - 299 FDA Establishment Registration Number: 3004569487
II. CONTACT PERSON
Leann Christman, MEd Telephone: (734) 995-9089 ext. 232 Fax: (734) 995-0840 Email: Ichristman@MC3Corp.com
III. DEVICE NAME
Proprietary Trade Name: NovaPort® One Vascular Access Common/Usual Name: Percutaneous Cannula and Introducer Set
DEVICE CLASS: IV.
Class II
CLASSIFICATION NAME: V.
Cardiopulmonary bypass vascular catheter, cannula, or tubing Classification regulation: Sec. 870.4210
PRODUCT CODES: VI.
DWF
VII. PREDICATE DEVICES
K052524, Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit K024069. One Piece Pediatric Arterial Cannula 7000 Models
PRODUCT DESCRIPTION VIII.
The NovaPort® One Vascular Access cannula with Novalung coating are a wire reinforced, thin walled femoral cannula made of polyurethane. A cone without wire reinforcement allows clamping and serves as transition to a connector. The beveled tip is not a separate piece and is part of the whole cannula body. The NovaPort® one cannulas are inserted percutaneously into
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vessels. Insertion depth marks aid in positioning the cannula. They have a beveled tip that is made as part of the PVC body.
The Cannula is intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriate sized cannula within the vessel for cardiopulmonary bypass.
All surfaces of the NovaPort® One which come into contact with blood are protected with the Novalung Coating. This coating is a bioactive, stable, biocompatible and non-thrombogenic surface. This coating consists of high molecular weight heparin from pig mucosa bound covalently and ionically to immobilized polypeptides.
NovaPort® one cannula is available in insertion lengths of 90 mm and with outer diameters of 13 F, 17 F, 19 F and 21 F. All are supplied sterile with Novalung coated, non-pyrogenic, and are single use.
IX. INDICATIONS OF USE
ﮯ ﻣﻌﻤ ﮨ
The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a Novalung coated percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to limited to < 6 hours.
TECHNOLOGICAL CHARACTERISITICS AND SUBSTANTIAL EQUIVALENCE X.
The NovaPort® One Vascular Access are identical to the predicate devices in terms of intended use, indications for use, levels of attachmental scientific technology, materials and surgical technique. Based on the information provided herein, the subject NovaPort® One Vascular Access have been demonstrated to be substantially equivalent to the previously cleared Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (K052524) and the One Piece Pediatric Arterial Cannula 7000 Models. Please refer to the Table 10-1 for a comparison of the predicates and subject Novaport regarding substantial equivalence.
Further on the indications for use of the Novalung coating of the Novaport One cannula with Novalung coating is the same as with the Bioline coating (K102532) and Novalung sLA (K072362).
PERFORMANCE TESTING XI.
The NovaPort® One Vascular Access was subjected to numerous tests and comparisons to the predicate device: testing included pressure/burst, simulated use, kink resistance, tensile strength, flow characteristics, hemolysis, biocompatibility, and validation testing to coating.
SUMMARY AND CONCLUSIONS XII.
Novalung GmbH makes the claim that the NovaPort® One Vascular Access is substantially equivalent to the cited predicates in terms of intended use, indications for use, fundamental technology, design characteristics, generic materials of construction, and operational characteristics. As shown in Table 10-1 and the discussion above, the differences between the NovaPort® One Vascular Access and cited predicates are minor and raise no new issues of
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safety or effectiveness. In addition, comparative testing included in this 510(k) premarket notification demonstrates that the NovaPort® One Vascular Access has performance substantially equivalent to Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (K052524) and the One Piece Pediatric Arterial Cannula 7000 Models (K024069). The Novaport One meets design specifications.
ﻬﻢ ﺷﻬﺪ ﺑﺎﻟﻘﺮﻥ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟ
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person embracing another person.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Novalung® GmbH c/o Ms. Leann Christman MC3, Inc. 3550 West Liberty, Suite 3 Ann Arbor, MI 48103
JAN 12 2012
K112565 Re:
NovaPort® One Vascular Access and Introducer Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DWF Dated: November 4, 2011 Received: November 8, 2011
Dear Ms. Christman:
This letter corrects our substantially equivalent letter of December 6, 2011
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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general anorols 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 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 Christman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
W
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): K112565
Device Name: NovaPort® One Vascular Access
Indications for Use:
The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to < 6 hours.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
.f.hilehem
(Division Sign-Off) Division of Cardiovascular Device
Page 1 of 1
510(k) Number K 112565
Novalung® GmbH, Traditional 510(k) NovaPort® One Vascular Access
· September 1, 2011
Confidential Page 4-1
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).