(23 days)
The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.
The Vascular Probe is a sterile, single use, disposable device with a polyurethane coated streamline bulb on each end of a flexible polycarbonate or polycarbonate-polyurethane shaft. The bulbs are of different size on each end of the Vascular Probe. An appropriately-sized bulb is inserted either proximally or distally through the arteriotomy to probe the interior of the vessel and may be used by the surgeon to retract the vascular wall.
The Vascular Probe is packaged in a double sterile barrier. The contents of the unopened, undamaged container are sterile.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Synovis Vascular Probe / Vascular Probe ES
Predicate Device: Synovis Life Technologies Inc. (previously doing business as Bio-Vascular, Inc.), Robicsek Probe/Retractor; 510(k) K910682
This submission focuses on a change in a component (new vinyl resin in the colorant of the polyurethane coating) of an already marketed device, rather than a completely new device. Therefore, the "study" described is primarily a series of verification and validation tests to ensure the new component does not negatively impact the pre-established safety and performance of the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Biocompatibility | Device continues to be biocompatible for its intended use. | "The testing performed on the Vascular Probes demonstrated the devices continue to be biocompatible and safe for their intended use." |
| Mechanical Strength | Probes continue to meet the current Vascular Probe finished device specifications for tensile strength. | "Tensile strength testing was conducted on the Vascular Probes manufactured with the new vinyl resin and concluded that the Probes continue to meet the current Vascular Probe finished device specifications." |
| Material Safety | Remain safe for its intended use with the new vinyl resin. | Implicitly covered by biocompatibility and tensile strength testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text does not specify the exact number of units or samples used for biocompatibility and tensile strength testing. It states "Testing conducted" and "Tensile strength testing was conducted on the Vascular Probes manufactured with the new vinyl resin."
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Synovis Surgical Innovations. Given it's a 510(k) submission for a component change, the data would be prospective for the specific tests, as they were conducted to evaluate the impact of the new resin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable (N/A). This submission is not a clinical study involving human assessment or interpretation for diagnostic accuracy. The "ground truth" for the tests performed (biocompatibility, tensile strength) is based on established scientific protocols and engineering standards, not expert clinical consensus on individual cases.
4. Adjudication Method for the Test Set
- Not applicable (N/A). As mentioned above, this is laboratory and bench testing, not a study requiring adjudication of clinical data or expert opinions. The results are objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was NOT done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Vascular Probe is an surgical instrument, not a diagnostic device of that nature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No, a standalone algorithm performance study was NOT done. This is relevant for AI/ML-driven diagnostic devices. The Vascular Probe is a physical surgical tool.
7. The Type of Ground Truth Used
- Laboratory Standard / Engineering Specification:
- For Biocompatibility: Conformance to ISO 10993-1 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process).
- For Tensile Strength: Conformance to "current Vascular Probe finished device specifications."
8. The Sample Size for the Training Set
- Not applicable (N/A). This device does not involve algorithms or machine learning that would require a "training set." The tests are designed to verify material properties and biological compatibility.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (N/A). See the answer to point 8.
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APR 2 4 2013
510(K) SUMMARY
Applicant (Manufacturer)
Synovis Surgical Innovations, a division of Synovis Life Technologies, Inc. 2575 University Ave. W. St. Paul, MN 55114-1024 U.S.A. Ph: (651) 796-7300 (Main) Fax: (651) 642-9018 (Main)
Contact (Manufacturer)
Stephani K. Ayala Regulatory Affairs Specialist Synovis Surgical Innovations, a division of Synovis Life Technologies, Inc. 2575 University Ave. W. St. Paul, MN 55114-1024 U.S.A. Ph: (651) 796-7339 (Direct) Fax: (651) 642-9018 (Main) E-mail: stephani ayala@baxter.com
Date Submission Prepared
03/26/2013
Device Trade Name
- · Vascular Probe
- · Vascular Probe ES
Common Name
Vessel Dilator, Surgical
Classification Name
- · Vessel Dilator, Surgical
- · 21 CFR §870.4475
- · Product Code: DWP
Predicate Device
Synovis Life Technologies Inc. (previously doing business as Bio-Vascular, Inc.), Robicsek Probe/Retractor; 510(k) K910682
Device Description
The Vascular Probe is a sterile, single use, disposable device with a polyurethane coated streamline bulb on each end of a flexible polycarbonate or polycarbonate-polyurethane shaft. The bulbs are of different size on each end of the Vascular Probe. An appropriately-sized bulb is inserted either proximally or distally through the arteriotomy to probe the interior of the vessel and may be used by the surgeon to retract the vascular wall.
The Vascular Probe is packaged in a double sterile barrier. The contents of the unopened, undamaged container are sterile.
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Statement of Intended Use
The Synovis Vascular Probe is intended for use during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.
Summary/Comparison of Technological Characteristics
The Vascular Probe is acting as its own predicate device, and is therefore substantially equivalent, having the same technological characteristics and indications for use.
A new vinyl resin utilized in the colorant of the polyurethane coating was identified for manufacturing the Vascular Probes and is the subject of this submission. The Vascular Probe is a blood contacting device. The length of time the Probe is in contact with the body is typically less than 15 minutes (i.e. transient use). Testing conducted to assure the Probe Tips, manufactured with the new vinyl resin, remain safe for its intended Biocompatibility and Tensile strength testing.
Biocompatibility testing was performed in accordance with ISO 10993-1 (Biological Evoluation of medical devices – Part 1: Evaluation and testing within a risk management process). The testing performed on the Vascular Probes demonstrated the devices continue to be biocompatible and safe for their intended use.
Tensile strength testing was conducted on the Vascular Probes manufactured with the new vinyl resin and concluded that the Probes continue to meet the current Vascular Probe finished device specifications.
Conclusion
The safety and performance of the Vascular Probes was evaluated through biocompatibility and bench testing. The bench testing results support the performance requirements for the Vascular Probes manufactured with the new vinyl resin. Biocompatibility testing was performed in accordance with ISO 10993-1 and demonstrated the Vascular Probes remain biocompatible.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2013
Synovis Life Technologies, Inc. c/o Stephani Avala 2575 University Ave. W. St. Paul, MN 55114 US
Re: K130896
Trade/Device Name: Vascular probe Regulation Number: 21 CFR 870.4475 Regulation Name: Vessel Dilator, Surgical Regulatory Class: Class II Product Code: DWP Received: April 1, 2013
Dear Stephani Avala:
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 mav 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 (reporting of medical
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Page 2 - Stephani Ayala
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.htmfor 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,
Matthew Gallillebrenner
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K130896
Device Name: Vascular Probe
Indications for Use:
: .
The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.
Prescription Use _ X Per 21 CFR 801.109
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew G퀘咖illebrenner
§ 870.4475 Surgical vessel dilator.
(a)
Identification. A surgical vessel dilator is a device used to enlarge or calibrate a vessel.(b)
Classification. Class II (performance standards).