(29 days)
Not Found
No
The device description and intended use describe a simple mechanical syringe with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
A therapeutic device is one that treats or mitigates a disease or condition. This device is used for injection, withdrawal, dispensing, measuring, and fluid transfer, which are not inherently therapeutic actions.
No
The device is described as an injection, withdrawal, dispenser, measuring, and fluid transfer device. Its intended uses do not include diagnosing a medical condition.
No
The device description clearly outlines physical components (calibrated hollow cylindrical body, movable plunger, tapered male connector) and its function involves the physical manipulation of fluids, indicating it is a hardware device.
Based on the provided information, the Acacia Piston Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "injection of fluids into, or withdrawal fluids from, the body." This describes a direct interaction with the human body, not the examination of specimens outside the body, which is the core function of an IVD.
- Device Description: The description details a mechanical device for handling fluids, not reagents, calibrators, or other components typically associated with IVD tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The device is a general-purpose syringe used for administering or collecting fluids directly from a patient. This falls under the category of medical devices used for patient care, not IVD devices used for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.
Product codes
FMF
Device Description
The Acacia Piston Syringe consists of a calibrated hollow cytincrical body and movable plunger. At the tip of the barrel is a tapered male connector, which can be in a luer lock, luer slip, oral lock, and oral slip configurations.
The Acacia Piston Syringe can also be used as a dispenser without the use of a plunger.
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
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
All necessary verification and validation testing has been performed for the Piston Syringe to assure substantial equivalence to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Baxa Piston Syringe (K951871), Becton Dickinson Safety Syringe (K872820), Sherwood Medical Piston Syringe (K811965), Terumo Hypodermic Syringe (K771205)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
5. 510(k) Summary of safety and effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Acacia, Inc. | |
|---|---|---|
| TRADE NAME: | Piston Syringe | |
| COMMON NAME: | Piston Syringe | |
| CLASSIFICATION NAME: | Piston Syringe | OCT 2 7 2005 |
| DEVICE CLASSIFICATION: | Class II | |
| PRODUCT CODE | FMF | |
| PREDICATE DEVICES: | Baxa Piston Syringe (K951871) | |
| Becton Dickinson Safety Syringe (K872820) | ||
| Sherwood Medical Piston Syringe (K811965) | ||
| Terumo Hypodermic Syringe (K771205) |
Substantially Equivalent To:
The Acacia Piston Syringe is substantially equivalent in intended use, principal of operation and technological characteristics to the Baxa Piston Syringe (K951871), Becton Dickinson Safety Syringe (K872820), Sherwood Medical Piston Syringe (K811965), and Terumo Hypodermic Syringe (K771205).
Description of the Device Subject to Premarket Notification:
The Acacia Piston Syringe consists of a calibrated hollow cytincrical body and movable plunger. At the tip of the barrel is a tapered male connector, which can be in a luer lock, luer slip, oral lock, and oral slip configurations.
The Acacia Piston Syringe can also be used as a dispenser without the use of a plunger.
Indications for Use:
The Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.
Technical Characteristics:
The Piston Syringe has similar physical and technical characteristics to the predicate devices.
Performance Data:
All necessary verification and validation testing has been performed for the Piston Syringe to assure substantial equivalence to the predicate devices.
Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Piston Syringe is determined by Acacia, Inc., to be substantially equivalent to the existing legally marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a wing-like shape, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Acacia, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services L.L.C. 1394 25th Street Northwest Buffalo, Minnesota 55313
OCT 2 7 2009
Re: K092986
Trade/Device Name: Acacia Piston Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 3, 2009 Received: October 14, 2009
Dear Mr. Job:
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.
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- Mr. Job
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Runne
Susan Runner, D.D.S., M.A. Acting 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
510(k) Number (if known):
Device Name: Acacia Piston Syringe
Indications for Use:
The Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.
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)
Cim 2(f)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1092486 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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