(27 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of a syringe and do not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
Insulin syringes are delivery devices for medication, not therapeutic devices themselves. They do not treat or cure a condition; they merely facilitate the administration of a therapeutic substance (insulin).
No
Explanation: The device is an insulin syringe intended for subcutaneous injection of insulins, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (syringe barrel, plunger rod, needle/hub assembly) and mentions bench tests related to the performance of these physical components. It operates on the principle of a piston syringe, which is a mechanical function, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous injection of insulins." This describes a device used to administer a substance into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a syringe designed for injecting fluids. It doesn't mention any components or functions related to analyzing biological samples (like blood, urine, etc.).
- Lack of IVD Indicators: There is no mention of testing, analysis, diagnosis, or any other activities typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is clearly for administering a substance directly into the body.
N/A
Intended Use / Indications for Use
BD Insulin Syringes are intended for the subcutaneous injection of insulins
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The BD Insulin Syringes - Ultra-Fine™ and Ultra-Fine™ II are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Ultra-Fine™ Insulin Syringe has a 30g x 1/2" (12.7mm) needle and is available in 1cc (100 units), 1/2 cc (50 units), and 1/3 cc (30 units) sizes. The Ultra-Fine™ II 31g x 1/2" (8mm) needle and is available in 1cc (100 units), ½ cc (50 units), and 1/3 cc (30 units) sizes.
These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, non-pyrogenic and single use, disposable.
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)
Bench tests relating to the performance of the needle length were conducted. The tests performed included needle pull-out force, hub pull-off forces, needle angularity, needle break-off testing and dose accuracy. The results demonstrate that the BD Insulin Syringes performs equivalent to the predicate devices and is safe and effective when used as intended.
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
510K SUMMARY OF SAFETY AND EFFECTIVENESS
l . Submitted By:
John Schalago Manager, Regulatory Affairs
Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1883
201-847-5663 Phone: 201-848-0457 Fax:
2. Device Name:
BD Insulin Syringe - Ultra-Fine™ and Ultra-Fine™ II Trade Name:
Insulin Syringe Common Names:
Classification Name: Piston Syringe
3. Predicate Device:
BD Insulin Syringe - K941657 and K955235
Manufactured by: Becton Dickinson Consumer Healthcare
4. Device Description:
The BD Insulin Syringes - Ultra-Fine™ and Ultra-Fine™ II are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Ultra-Fine™ Insulin Syringe has a 30g x 1/2" (12.7mm) needle and is available in 1cc (100 units), 1/2 cc (50 units), and 1/3 cc (30 units) sizes. The Ultra-Fine™ II 31g x 1/2" (8mm) needle and is available in 1cc (100 units), ½ cc (50 units), and 1/3 cc (30 units) sizes.
These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, non-pyrogenic and single use, disposable.
Continued...
00001.6
1
510K Summary of Safety and Effectiveness (Continued)
5. Intended Use:
BD Insulin Syringes are intended for the subcutaneous injection of insulins
Technological Characteristics: 6.
The BD Ultra-Fine™ and Ultra-Fine™ II insulin syringes and the predicate devices have the identical technological characteristics and perform as piston syringes.
The only difference between the principal devices and the predicate device is the needle gauge.
7. Performance:
Bench tests relating to the performance of the needle length were conducted. The tests performed included needle pull-out force, hub pull-off forces, needle angularity, needle break-off testing and dose accuracy. The results demonstrate that the BD Insulin Syringes performs equivalent to the predicate devices and is safe and effective when used as intended.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent Laws or their application by the courts.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in black.
JAN 0 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Schalago Manager, Regulatory Affairs Becton Dickinson & Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1880
Re: K024112
Trade/Device Name: BD Insulin Syringe-Ultra-Fine™ and Ultra-Fine™ II Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: December 11, 2002 Received: December 13, 2002
Dear Mr. Schalago:
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. Schalago
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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment XI.1
Page 1 of 1