(155 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical dilator set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device, a "Protekt Venous Dilator Set," is used to prepare a vessel for the introduction of a large bore cannula, which is an interventional procedure rather than one that treats or cures a disease.
No
The device is a Venous Dilator Set, used to prepare a vessel for the introduction of a large bore cannula. Its purpose is to facilitate a medical procedure (cannulation) rather than to diagnose a condition or disease.
No
The device description clearly states it is comprised of physical vascular dilators made of radiopaque material, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in vessel cannulation" by physically dilating the vessel. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The description details physical dilators used to prepare a vessel for cannula insertion. It describes a mechanical action, not a diagnostic test performed on a sample in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on mechanical properties (tensile strength, deflection) and biocompatibility, which are relevant for a medical device used in a procedure, not for an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.
Product codes
DRE
Device Description
The Protek Venous Dilator Sets are comprised of vascular dilators with diameters of 14, 18, 22 and 26 Fr. outer diameter. There are two distinct kits, one intended for insertion of cannula smaller than 26 Fr. which includes the 14, 18, and 22 Fr. dilators and one intended for the insertion of cannula larger than 26 Fr. which also includes the 26 Fr. dilator. The Dilators are designed to accept a standard 0.038 inch guidewire. The Protek Venous Dilator Sets are intended as a single patient, single use, sterile device.
Each dilator consists of a tube with a hub. The dilators fit over a guidewire during insertion. The dilators are used to prepare the target vessel for the safe introduction of a large bore cannula. The dilator body is constructed from radiopaque material for visualization under nuoroscopy.
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
trained physician
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:
Test: Tensile Strength
Method: Pull test with objective acceptance criteria
Conclusion: All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application.
Test: Deflection Test
Method: Compliance measurement with side-by-side comparison to similar sized predicate devices
Conclusion: The Protek Venous Dilators are all more compliant than similarly sized predicate devices, as designed.
Test: Biocompatibility
Method: Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours
Conclusion: All tests passed.
Key Metrics
Not Found
Predicate Device(s)
Avalon Elite Vascular Access Kit (K081940)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three horizontal bars above them. The profiles and bars are all in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 06, 2017
CardiacAssist, Inc. Dr. Greg A. Johnson Vice President, Regulatory Affairs and Quality Assurance 240 Alpha Drive Pittsburgh, Pennsylvania 15238
Re: K162181
Trade/Device Name: Protek Venous Dilator Sets Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: December 6, 2016 Received: December 7, 2016
Dear Greg Johnson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 of medical devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
M.A. Hilleman
for 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) K162181
Device Name Protek Venous Dilator Sets
Indications for Use (Describe)
The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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് CardiacAssist, Inc.
Date: 8/3/2016
Applicant
CardiacAssist, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800
Contact person
Greg Johnson, PhD Title: Vice President of Regulatory Affairs and Quality Assurance Phone: 412-963-7770 x266 e-mail: gjohnson@tandemlife.com
Device
| Trade/Proprietary Name: | Protek Venous Dilator Sets |
|---|---|
| Common Name: | Vessel dilator for percutaneous catheterization |
| Classification Name: | Vessel dilator for percutaneous catheterization (21 CFR 870.1310) |
| Product Code DRE) |
Predicate Devices
Avalon Elite Vascular Access Kit (K081940)
Device Description
The Protek Venous Dilator Sets are comprised of vascular dilators with diameters of 14, 18, 22 and 26 Fr. outer diameter. There are two distinct kits, one intended for insertion of cannula smaller than 26 Fr. which includes the 14, 18, and 22 Fr. dilators and one intended for the insertion of cannula larger than 26 Fr. which also includes the 26 Fr. dilator. The Dilators are designed to accept a standard 0.038 inch guidewire. The Protek Venous Dilator Sets are intended as a single patient, single use, sterile device.
Each dilator consists of a tube with a hub. The dilators fit over a guidewire during insertion. The dilators are used to prepare the target vessel for the safe introduction of a large bore cannula. The dilator body is constructed from radiopaque material for visualization under nuoroscopy.
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Image /page/4/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo consists of a circular graphic with arrows pointing in different directions, followed by the text "CardiacAssist, Inc." The text is in a bold, sans-serif font and is colored blue. The logo is simple and professional, and it effectively communicates the company's name.
Intended Use
The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.
Comparison of Technological Characteristics
Technological differences between the Protek Venous Dilators and the predicate Avalon Elite Vascular Access Kit dilators are limited to the following differences:
- The Protek Venous dilators are approximately .35" (0.9 cm) longer than the predicate ● device.
- The venous dilators are tapered on the distal 1.3" of the dilator body. The predicate ● dilator includes a taper of similar length at the distal end but also includes a 1" straight section leading into the taper.
- The predicate device includes smaller and larger dilators than the Protek Venous ● Dilator Kits.
- The predicate device includes a kit with additional components such as a guidewire, ● mini scalpel, 10 cc syringe, and introducer needle not present with the Protek Venous Dilators.
- . The Protek Venous Dilators have a proximal hub which is not present on the predicate.
- The Protek Venous Dilators are more compliant than the predicate dilators.
Summary of Non-clinical Testing
Testing of the Protek Venous Dilator Sets included tensile strength, deflection (compliance) measurement, and biocompatibility.
| Test | Method | Conclusion |
|---|---|---|
| Tensile Strength | Pull test with objective | |
| acceptance criteria | All test articles met acceptance | |
| criteria. Mechanical integrity is | ||
| more than adequate for the intended | ||
| application. | ||
| Deflection Test | Compliance measurement with | |
| side-by-side comparison to | ||
| similar sized predicate devices | The Protek Venous Dilators are all | |
| more compliant than similarly sized | ||
| predicate devices, as designed. | ||
| Biocompatibility | Testing per ISO-10993 for an | |
| external communicating device | ||
| in contact with circulating | ||
| blood for limited duration less | ||
| than 24 hours | All tests passed. |
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Image /page/5/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo features a circular graphic to the left of the company name. The company name is written in a bold, sans-serif font. The color of the logo is a dark blue.
Conclusion
Testing of the Protek Venous Dilators demonstrated that tensile strength is sufficient for the intended use, that each individual dilator is more compliant (as designed) than a similarly sized predicate dilator, and that the dilators meet biocompatibility requirements for the intended use. The Protek Venous Dilator Sets are determined to be substantially equivalent to the predicate Avalon Elite Vascular Access Kit (K081940)