(332 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a simple syringe, with no mention of AI or ML capabilities.
No.
A therapeutic device is a medical device used to treat or cure a disease or condition. This device, a small volume syringe, is used to inject or withdraw fluids, which is a diagnostic or procedural function, not a therapeutic one.
No
The device description indicates it is a syringe used for injecting or withdrawing fluids, with no mention of analyzing or interpreting data for diagnostic purposes.
No
The device description clearly outlines physical components (barrel, plunger, stopper) made of materials like polycarbonate and rubber, and the performance studies focus on physical standards for syringes and needles. There is no mention of software as a component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the syringe is used to "inject fluids into, or withdraw fluids from, the body, ports and I.V. lines." This describes a device used for direct interaction with the human body, not for testing samples in vitro (outside the body).
- Device Description: The description details a standard syringe for fluid handling in a clinical setting. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes (identifying a disease or condition)
- Reagents or test kits
The device is a medical device used for administering or withdrawing fluids from a patient, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Small Volume Syringe is a 200 ul syringe used to inject fluids into, or withdraw fluids from, the body, ports and I.V. lines.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The syringe consists of three main parts: one barrel, one plunger and one stopper. The barrel is made from clear polycarbonate and is designed with printed graduation marks ranging up to 200 ul and a Luer-Lok end. The plunger is also made from clear Polycarbonate. The stopper is manufactured using grey or other dark colored non-latex based rubber. The printed graduation marks facilitate appropriate and accurate volume control for the dispensing and containment of fluid by manually application of pressure. The syringe is individually packaged in a flexible package with a peel-away cover that allows the syringe to remain sterile until opened.
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)
Safety tests on the Alcon Small Volume Syringe will demonstrate its compliance with applicable requirements of the following standards:
- ISO 7886, Sterile Hypodermic Syringes for Single Use .
- ISO 7864, Sterile Hypodermic Needles for Single Use .
- ISO 594, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and . Certain Other Medical Equipment
- . ISO 8537, Sterile, Single-Use Syringes, with or without Needle, for Insulin:
- . ANSI/AAMI/ISO 11137:2006, Sterilization of Healthcare Products -Requirements for Validation and Routine Control - Radiation Sterilization
The materials used in the manufacture of the Alcon Small Volume Syringe are the same materials used in the manufacture of other piston syringes currently marketed in the United States.
The Alcon Small Volume Syringe is provided sterile and is intended for single use only. The device will be sterilized by gamma irradiation using validated processes to provide a Sterility Assurance Level (SAL) of 10-6.
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
§ 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
510(k) Summary
AUG 2 3 2007
This summary document is being prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
Sean P. Griffin Manager, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134 Phone: (817) 551-8015 Fax: (817) 551-4630
Date Summary Prepared: August 1, 2007
Device Subject to this 510(k):
| Trade Name: | Alcon Small Volume Syringe |
|---|---|
| Common Name: | Piston Syringe |
| Classification Name: | Syringe, Piston (per 21 CFR 880.5860) |
1. Predicate Devices:
The legally marketed device to which we are claiming substantial equivalence is:
510(k) Number Device
K941562 BDTM 1mL Polycarbonate Syringe
2. Device Description:
The syringe consists of three main parts: one barrel, one plunger and one stopper. The barrel is made from clear polycarbonate and is designed with printed graduation marks ranging up to 200 ul and a Luer-Lok™ end. The plunger is also made from clear Polycarbonate. The stopper is manufactured using grey or other dark colored non-latex based rubber. The printed graduation marks facilitate appropriate and accurate volume control for the dispensing and containment of fluid by manually application of pressure. The syringe is individually
1
packaged in a flexible package with a peel-away cover that allows the syringe to remain sterile until opened.
3. Indications for Use:
The Small Volume Syringe is a 200 ul syringe used to inject fluids into, or withdraw fluids from, the body, ports and I.V. lines.
4. Brief Summary of Nonclinical Test and Results:
Safety tests on the Alcon Small Volume Syringe will demonstrate its compliance with applicable requirements of the following standards:
- ISO 7886, Sterile Hypodermic Syringes for Single Use .
- ISO 7864, Sterile Hypodermic Needles for Single Use .
- ISO 594, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and . Certain Other Medical Equipment
- . ISO 8537, Sterile, Single-Use Syringes, with or without Needle, for Insulin:
- . ANSI/AAMI/ISO 11137:2006, Sterilization of Healthcare Products -Requirements for Validation and Routine Control - Radiation Sterilization
The materials used in the manufacture of the Alcon Small Volume Syringe are the same materials used in the manufacture of other piston syringes currently marketed in the United States.
The Alcon Small Volume Syringe is provided sterile and is intended for single use only. The device will be sterilized by gamma irradiation using validated processes to provide a Sterility Assurance Level (SAL) of 10-6.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sean P. Griffin Manager, Regulatory Affairs Alcon Research, Limited 6201 South Freeway Fort Worth, Texas 76134
AUG 2 3 2007
Re: K062865
Trade/Device Name: Small Volume Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 9, 2007 Received: August 10, 2007
Dear Mr. Griffin:
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.
3
Page 2 - Mr. Griffin
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
4
Indications for Use
.
510(k) Number (if known): K062865
Device Name: Small Volume Syringe
Indications For Use:
The Small Volume Syringe is a 200 µl syringe used to inject fluids into, or withdraw fluids from, the body, ports and I.V. lines.
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)
| Division Sign-Off |
|---|
| Division of Anesthesiology, General Hospital, |
| Infection Control, Dental Devices |
| 510(k) Number: | K062865 |
|---|---|
| ---------------- | --------- |
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