(124 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or related concepts.
No.
The device is described as a syringe used to inject and aspirate fluid from a balloon interventional device, which points to it being an accessory for a therapeutic procedure rather than a therapeutic device itself.
No
The device is described as a syringe used to inject and aspirate fluid, specifically for a balloon interventional device. This is a functional/therapeutic purpose, not a diagnostic one. There is no mention of it being used for detection, analysis, or diagnosis of a medical condition.
No
The device description explicitly states it consists of a "plastic syringe with a screw-type plunger and a locking mechanism," indicating it is a physical hardware device.
Based on the provided information, the Atrion Medical QL® Locking Syringe Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluid into and aspirate fluid from a balloon interventional device." This describes a device used directly on a patient (or a device being used on a patient) for a therapeutic or procedural purpose.
- Device Description: The description of a "plastic syringe with a screw-type plunger and a locking mechanism" aligns with a medical device used for fluid delivery or aspiration in a clinical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to gain information about a person's health. This device's function is directly related to a medical procedure involving a balloon interventional device.
N/A
Intended Use / Indications for Use
The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.
Product codes (comma separated list FDA assigned to the subject device)
MAV
Device Description
The Atrion Medical QL® Locking Syringe Device consists of a plastic syringe with a screw-type plunger and a locking mechanism.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The materials of the device which contact the solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use.
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.
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
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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K060643
p. 1 of 1
SECTION 5
Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel 256 586 1580 Fax 256 586 8529
JUL 1 2 2006
Image /page/0/Picture/4 description: The image shows the logo for Atrion Medical. The logo is in black and features a stylized "A" with a swoosh extending from the left side. The word "Atrion" is written in a bold, sans-serif font, with "Medical" written in a smaller font below and to the right of "Atrion". The logo is simple and modern.
SUMMARY OF SAFETY AND EFFECTIVENESS
July 7, 2006 Date of Preparation:
Atrion Medical QL® Locking Syringe Device Device Name:
Classification Name: Angiographic Injector and Syringe
Manufacturer: Atrion Medical Products, Inc. PO Box 564, 1426 Curt Francis Road Arab, AL 35016
Contact:
Mr. Dan Clark. Atrion Medical Products, Inc. 1426 Curt Francis Road Arab, AL 35016 Telephone: (256) 317-2220 Fax: (256) 586-8529 Email: dclark@atrionmedical.com
Predicates:
Atrion Medical Products, Inc. QL® Inflation Device, K032840. Merit Medical Systems, Inc. Viceroy™ Inflation device, K040138
Device Description:
The Atrion Medical QL® Locking Syringe Device consists of a plastic syringe with a screw-type plunger and a locking mechanism.
Intended Use: The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.
Technological Characteristics:
The Atrion Medical QL® Locking Syringe Device has a capacity of 25ml, while the predicate devices have a range of 10ml or 60ml, depending on the predicate. There are no other significant technological characteristics that distinquish the two devices, and no differences that should pose a risk to patient safety.
Testing:
The materials of the device which contact the solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2006
Atrion Medical Products, Inc. c/o Mr. Dan Clark Vice President 1426 Curt Francis Road Arab. AL 35016
Re: K060643
Atrion Medical QL® Locking Syringe Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: MAV Dated: June 9, 2006 Received: June 9, 2006
Dear Mr. Clark:
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 such 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.
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Page 2 - Mr. Dan Clark
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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
QSRN
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment for: Item 4
SECTION 4
Kobob43
INDICATIONS FOR USE
510(k) Number (if known): K060643
Device Name: Atrion Medical QL® Locking Syringe Device
Indications For Use: The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.
Prescription Use × (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)
Office of Device Evaluation (ODE) Concurrence) of CDRH,
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Numb
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