(79 days)
Not Found
Not Found
No
The summary describes a mechanical syringe kit and administration set with a check valve. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes.
The device facilitates the introduction of lidocaine solutions into subcutaneous tissues for tumescent local anesthesia, which is a therapeutic intervention.
No
Explanation: The device is indicated for the "introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia," which describes a therapeutic or interventional function, not a diagnostic one. It administers a substance rather than detecting or identifying a condition.
No
The device description explicitly states it consists of physical components: a control syringe and fluid administration set with check valve. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of lidocaine solutions into subcutaneous tissues for tumescent local anesthesia. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device consists of a syringe and fluid administration set. These are tools for delivering a substance into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for the delivery of medication into the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA, FMF
Device Description
The Auto Fill Syringe Kit consists of a control syringe and fluid administration set with check valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been conducted to verify the integrity and strength of the bond used to attach the check valve to the tubing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Disposable Coronary Control Syringe marketed by Merit Medical Systems, Inc.; the Merit Administration Set marketed by Merit Medical Systems, Inc.; the KMI Repetitive Injection kit marketed by KMI Kolster Methods, Inc.; fluid administration set, marketed by Merit Medical Systems, Inc
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K033721
:
| FEB 1 3 2004 | |
|---|---|
| 510(K) SUMMARY | |
| Common/Usual Name: | Fluid Administration Set |
| Product Trade Name: | Auto Fill Syringe Kit |
| Classification Name: | Fluid Administration kit for use in General and Plastic |
| Surgery and in Dermatology | |
| 21 CFR 880.5440 (Product Code FPA) | |
| Manufacturer: | Vascular Solutions, Inc. |
| 6464 Sycamore Court | |
| Minneapolis, MN 55369 | |
| Establishment Registration: | 2134812 |
| Contact: | Sara L. Coon |
| Senior Regulatory Affairs Associate | |
| (763) 656-4300 phone | |
| (763) 656-4250 fax | |
| Performance Standards: | No performance standards have been developed under |
| section 514 for this device. | |
| Device Description: | The Auto Fill Syringe Kit consists of a control syringe and |
| fluid administration set with check valve. | |
| Intended Use: | The Auto-Fill™ Syringe Kit is indicated for the |
| introduction of dilute lidocaine solutions into subcutancous | |
| tissues for the purposes of tumescent local anesthesia. | |
| Summary of Non-Clinical Testing: | Testing has been conducted to verify the integrity and |
| strength of the bond used to attach the check valve to the | |
| tubing. | |
| Predicate Devices: | The Disposable Coronary Control Syringe marketed by |
| Merit Medical Systems, Inc .; the Merit Administration Set | |
| marketed by Merit Medical Systems, Inc.; the KMI | |
| Repetitive Injection kit marketed by KMI Kolster Methods, | |
| Inc .; fluid administration set, marketed by Merit Medical | |
| Systems, Inc | |
| Conclusions: | The Auto-Fill Syringe Kit is substantially equivalent to the |
| identified predicate devices based on a comparison of the | |
| indications for use and the components supplied and the | |
| technological characteristics of the supplied components. |
- Station Company of Children
.
1
Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sara L. Coon Senior Regulatory Affairs Specialist Vascular Solutions 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K033721
Trade/Device Name: Vascular Solutions Auto-Fili™ Syringe Kit Regulation Number: 880.5860, 880.5440 Regulation Name: Piston Syringe Intravascular Administration Set Regulatory Class: II Product Code: FMF, FPA Dated: November 25, 2003 Received: November 26, 2003
Dear Ms. Coon:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, and 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.
2
Page 2 - Ms. Coon
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 the labeling regulation, please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 http://www.fda.gov/cdrh.dsma/dsmamain.html.
Sincerely yours
Simon Runner
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
3
Indications for Use
510(k) Number (if known):
Device Name: Vascular Solutions 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 _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _
(21 CFR 807 Subpart C)
(IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Rumm
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control Dental Devices
510(k) Number: K033721
Page 1 of ____________________________________________________________________________________________________________________________________________________________________