(29 days)
The Auto-Fill® Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.
The Auto-Fill Syringe Kit contains disposable components that may be used to deliver dilute lidocaine solutions into subcutaneous tissues for the purposes of local anesthesia. The kit provides an extension tubing mechanism to conveniently refill a 12cc syringe from an IV bag eliminating the need for multiple reconnections to the solution container.
The kit contains the following items:
- 12cc Control Syringe .
- IV tubing with spike, dual check valve, and roller clamp .
- Extension line (various lengths ranging from 6" to 48") .
The provided text describes a 510(k) premarket notification for the "Auto-Fill® Syringe Kit". This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than performing de novo clinical studies with specific acceptance criteria that an AI/ML device would typically face.
Therefore, the information requested regarding acceptance criteria, study design for proving device performance, sample sizes, expert involvement, and ground truth establishment, which are standard for AI/ML device evaluation, is not applicable to this submission.
Here's why and what information is available:
- No AI/ML Device: The "Auto-Fill® Syringe Kit" is a physical medical device (syringe kit, tubing) used for delivering lidocaine. It is not an AI/ML device, and as such, the concepts of algorithms, training sets, test sets, ground truth established by experts, or MRMC studies do not apply.
- 510(k) Pathway: The 510(k) pathway for medical devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing indications for use, technological characteristics, and performance data.
What information can be extracted from the provided text, re-framed for clarity:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Design Requirements/Performance) | Reported Device Performance |
|---|---|
| Extension tubing static pressure capabilities | Met specified design and performance requirements |
| Extension tubing dynamic pressure capabilities | Met specified design and performance requirements |
| Biocompatibility of components | Demonstrated to be biocompatible through testing by original manufacturers |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "testing" mentioned is engineering performance testing (static and dynamic pressure, biocompatibility) rather than a clinical "test set" in the AI/ML context. Specific sample sizes for these engineering tests are not provided.
- Data Provenance: The engineering performance testing was conducted by the submitter (Vascular Solutions, Inc.) or "original manufacturers" for biocompatibility. There is no mention of country of origin or whether it was retrospective or prospective, as these are not relevant for this type of device and testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment for a test set by human experts is not a component of the engineering performance testing described for this device.
4. Adjudication method for the test set:
- Not applicable. There was no "test set" in the AI/ML sense requiring adjudication.
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:
- Not applicable. This is not an AI device, and no MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be the physical properties and functionality of the materials and assembled kit components meeting their design specifications.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, therefore no training set exists.
9. How the ground truth for the training set was established:
- Not applicable. No training set.
Summary of Clinical Testing:
- "No clinical evaluations of this product have been performed." This explicitly states that no human studies of the device (clinical trials) were conducted, as the 510(k) submission relied on substantial equivalence.
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Image /page/0/Picture/0 description: The image shows a logo for Vascular Solutions. The logo consists of the word "Vascular" in a bold, serif font, with the word "SOLUTIONS" in a smaller, sans-serif font underneath. Above the text is a graphic element that appears to be a series of squares that decrease in size as they ascend, creating a gradient effect. There is also some handwritten text in the upper right corner of the image.
463851(P.i 0.2)
JAN 26 2007
510(k) Summary
Vascular Solutions, Inc.
Minneapolis, MN 55369
6464 Sycamore Court
510(k) Number:_
Date Prepared December 27, 2006
Submitter Information
Submitter's Name/ Address:
Establishment Registration 2134812
Contact Person:
Patrice Stromberg Sr. Regulatory Affairs Associate (763) 656-4243 telephone (763) 656-4200 fax pstromberg@vascularsolutions.com
Device Information
Trade Name: Classification Name: Product Codes: Regulations:
Auto-Fill® Syringe Kit Piston Syringe; Intravascular Administration Set FMF, FPA Class II, 880.5860, 880.5440
Performance Standards
No performance standards applicable to this product have been developed under Section 514 of the Act.
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Predicate Device(s)
- Auto-Fill™ Syringe Kit marketed by Vascular Solutions, Inc. (K033721) �
- . IV Administration Set marketed by DeRoyal® (Codan USA) (pre-amendment device)
- Angiographic Control Syringe, marketed by DeRoyal, Inc. (CDI) (K920135) ◆
- L.O.N. Pressure Monitoring Lines, CPC Lines, Administration, marketed by . DeRoyal (CDI) (K853099)
- Multi-Ad Fluid Dispensing System, marketed by B. Braun Medical, K792227 .
Device Description
The Auto-Fill Syringe Kit contains disposable components that may be used to deliver dilute lidocaine solutions into subcutaneous tissues for the purposes of local anesthesia. The kit provides an extension tubing mechanism to conveniently refill a 12cc syringe from an IV bag eliminating the need for multiple reconnections to the solution container.
The kit contains the following items:
- 12cc Control Syringe .
- IV tubing with spike, dual check valve, and roller clamp .
- Extension line (various lengths ranging from 6" to 48") .
Intended Use/Indications for Use
The AutoFill® Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.
Summary of Non-Clinical Testing
Performance Testing: The static and dynamic pressure capabilities of the extension tubing for the Auto-Fill Syringe Kit were tested. The extension tubing met the specified design and performance requirements.
Biocompatibility Testing: The material in the components used to create the Auto-Fill Syringe Kit has been demonstrated to be biocompatible through biocompatibility testing performed by the original manufacturers.
Summary of Clinical Testing
No clinical evaluations of this product have been performed.
Statement of Equivalence
Through the data and information presented, Vascular Solutions considers the Auto-Fill® Syringe Kit to be substantially equivalent to the identified predicate devices based on a comparison of the indications for use and the technological characteristics of the supplied components.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patrice Stromberg Senior Regulatory Affairs Associate Vascular Solutions, Incorporated 6464 Sycamore Court North Minneapolis, Minnesota 55369
JAN 26 2007
Re: K063851
Trade/Device Name: Auto-Fill Syringe Kit, Model 7600 Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FPA Dated: December 27, 2006 Received: December 28, 2006
Dear Ms. Stromberg:
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, Or u 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.
If your device is classified (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 revire 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 Pegister.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
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Page 2 - Ms. Stromberg
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clues
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: Auto-Fill® Syringe Kit
Indications for Use:
The Auto-Fill® Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aina Bima
(Division Sign-Off) provision Olgh-Clif)
Division of Anesthesiology, General Hospital, and Cloin of Anesthesiology, Generiniestion Control, Dental Devices
510(k) Number:_ K463857
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).