(130 days)
Not Found
No
The description focuses on the mechanical design of a safety syringe and makes no mention of AI or ML.
No
The device is used to inject or withdraw fluids and reduce sharps injuries, not to treat a medical condition or disease.
No
The device is described as a piston safety syringe used to inject or withdraw fluids, and its predicate devices are also syringes. There is no mention of it being used for diagnosis or generating diagnostic information.
No
The device description clearly states it is a "piston safety syringe" and utilizes "two syringes assembled in a plastic holder," indicating it is a physical hardware device.
Based on the provided information, the Procedur-SF device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, the body". This describes a device used on the body for therapeutic or diagnostic purposes, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description of a "piston safety syringe" used for injection and withdrawal of fluids from the body further reinforces that it's not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
The Procedur-SF device is clearly a medical device intended for direct use on a patient for fluid management.
N/A
Intended Use / Indications for Use
The Procedur-SF device is intended to be used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and potential for syringe reuse.
Product codes
MEG
Device Description
The Procedur-SF device is a piston safety syringe
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
JAN 2 1 2005
510(K) SUMMARY
| Sponsor: | Avanca Medical Devices, Inc.
800 Bradbury SE
Albuquerque, NM 87106 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical
Consultant to Avanca Medical Devices, Inc. |
| Contact Information: | Phone: 505.272.7000
FAX: 505.272.7000 |
| Classification Name: | Piston syringe, antistick |
| Common/Usual Name: | Syringe, safety syringe, injection syringe,
aspiration syringe and others |
| Proprietary Name: | Procedur-SF |
| Classification Number: | 21 CFR 880.5860/Procode ${90}$ FMF/ ${90}$ MEG |
| Substantial Equivalence: | Becton Dickinson Single Use Hypodermic
Syringes (K980987) and Retractable
Technologies, Inc. VanishPoint Safety Syringe
(K980069) |
| Device Description: | The Procedur-SF device is a piston safety
syringe |
| Intended Use: | The Procedur-SF device is intended to be used
to inject fluids into, or withdraw fluids from,
the body, while reducing the risk of sharps
injuries and potential for syringe reuse |
| Technological Characteristics: | The Procedur-SF device utilizes two syringes
assembled in a plastic holder. The syringe
plungers are connected by a pulley |
1
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines that appear to be emanating from a central point.
JAN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Avanca Medical Devices, Incorporated C/O Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road, NE #931 Albuquerque, New Mexico 87111
Re: K042487
Trade/Device Name: Procedur SF Safety Syringe Device Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 12, 2004 Received: December 27, 2004
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the referenced above and have acternines re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, or to that have been reclassified in accordance with the provisions of Amendinens, of to devroes mar na ris of the that do not require approval of a premarket the rederal I ood, Drug, and Ocenimay, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the First - 1110 Jisting of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is clubstired (200 as a dditional controls. Existing major regulations affecting (PMA), it may of subject to Sach adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
2
Page 2 - Mr. Ferguson
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualles of a base your device complies with other requirements mean that IDA has muce a doceminations administered by other Federal agencies. of the Act of ally I ederal statutes and rightenents, including, but not limited to: registration You must comply with an the Here Progations (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality sion 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) This letter will anon your be began mading of substantial equivalence of your device to a premarket notification. - The PDF mailis 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), If you desire specific at 110 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 may obtain 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/industry/support/index.html.
Sincerely yours,
Ching-Lin Liu, 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
3
Indications For Use
510(k) Number (If known): K042487
Device Name: Procedur-SF
Indications For Use:
The Procedur-SF device is used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Prescription Use __ ర్ల (Part 21 CFR 801 Subpart D) And/Or
Over-The- Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
from link
്സ്ision Sign-Off) (വിടിനെ ടിറ്റ്റ്-Off)
Division of Anesthesiology, General Hospital.
Division of Anesthesiology, General Devices Division of Antonion Control, Dental Devices
:10(k) Number:________________________________________________________________________________________________________________________________________________________________ Page 1 of 1