(128 days)
Not Found
No
The 510(k) summary describes a change in the formulation of a syringe plunger tip and provides performance data demonstrating equivalence to the predicate device. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on physical and chemical properties, not algorithmic performance.
No
The device, a syringe, is intended for aspiration and injection of fluids, which are procedures, not therapies. Its function is to facilitate the delivery or removal of substances, not to directly treat a medical condition itself.
No
The provided text describes general-use and insulin syringes for fluid aspiration and injection. The performance studies focus on physical and chemical properties like leak tests, autoclavibility, and plunger actuation forces, not on diagnosing medical conditions.
No
The device description and performance studies clearly indicate a physical medical device (syringes) with a change in a hardware component (plunger tip formulation). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "aspiration and injection of fluids" and "injection of insulin." This describes a device used for administering substances into or withdrawing substances from the body, which is a direct interaction with the patient's body.
- IVD Definition: In vitro diagnostics are devices used to examine specimens from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. They are used outside the body (in vitro).
- Device Description: The description focuses on the physical components and materials of a syringe, a device for administering or withdrawing fluids from the body.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
The device described is a medical device used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The general use syringes are intended for the aspiration and Insulin syringes are intended for the injection of fluids. injection of insulin.
Product codes
EMF
Device Description
This change in syringe plunger tip formulation is for the Becton Dickinson syringe. Products include:
- General purpose and insulin syringes.
- Sterile and non-sterile syringes.
- Syringes with and without needles attached.
No design changes are being made.
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
The following data demonstrates functional equivalence to the Becton Dickinson predicate plunger tip and fitness for use.
Syringe barrels molded with the alternate plunger tip formulation have demonstrated equivalence to barrels molded with the current plunger tip formulation.
- Leak Test - Syringes with the alternate plunger tip formulation passed ISO 7886 and ISO 8537 syringe leakage tests (as did control samples with current plunger tip formulation).
- Autoclavibility (for syringes that require autoclavibility resistance) -Syringes assembled with the alternate plunger tip satisfactorily passed autoclavibility testing. (Syringes were autoclaved at 270°F, 15 minutes then tested for ISO leakage resistance testing. All samples tested passed ISO leak testing.)
- Syringe Infusion Pump Performance (for syringes used in infusion pumps) - Syringes assembled with the altemate plunger tip demonstrated equivalent performance to natural rubber plunger tip samples in syringe pump application testing.
- Chemical Testing - Testing has been performed per ISO and USP requirements. Results were acceptable.
- Biocompatibility Biocompatibility testing was satisfactorily completed on the altemate plunger tip.
- Plunger Actuation Forces - Forces for the alternate plunger tip are equivalent or superior to the current plunger tip.
- Manufacturing Process Changes No manufacturing process changes are being made.
- Manufacturing Site Changes - No manufacturing site changes are being made.
- Packaging Component Changes - No packaging components are being changed.
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
JUN 25 1998 SUMMARY OF SAFETY AND EFFECTIVENESS DATA
B-D Contact Person 1.0
Peter Zurlo Becton Dickinson & Company Manager, Regulatory Affairs 1 Becton Drive, Building 2 Franklin Lakes, NJ 07417-1884 (201) 847-6447 - Phone (201) 848-0457 - FAX
2.0 Device Name
Becton Dickinson Single Use Hypodermic and Insulin Syringes
3.0 . Predicate Device
Becton Dickinson Single Use Hypodermic and Insulin Syringes
Product Description/Function 4.0
- Types This change in syringe plunger tip formulation is for the Becton 4.1 Dickinson syringe. Products include:
- General purpose and insulin syringes. 1.1.1
- Sterile and non-sterile syringes. 1.1.2
- 1.1.3 Syringes with and without needles attached.
No design changes are being made.
- Intended Use These syringes are intended for general purpose fluid 4.2 aspiration/injection and insulin injection.
Comparison of Modified and Predicate Devices 5.0
- Design Changes No design changes are being made. 5,1
- 5.2 Changes
- 5.2.1 Labeling - The syringe labeling will be revised to include :
"This product does not contain natural rubber latex."
Or (optionally) :
- "Latex Free".
1
5.2.2 Material Change: Becton Dickinson added an alternate latex free rubber formulation used for its molded syringe plunger tip in 1988.
6.0 Equivalence
.
.
The following data demonstrates functional equivalence to the Becton Dickinson predicate plunger tip and fitness for use.
Syringe barrels molded with the alternate plunger tip formulation have demonstrated equivalence to barrels molded with the current plunger tip formulation.
- 6.1 Leak Test - Syringes with the altemate plunger tip formulation passed ISO 7886 and ISO 8537 syringe leakage tests (as did control samples with current plunger tip formulation).
- 6.2 Autoclavibility (for syringes that require autoclavibility resistance) -Syringes assembled with the alternate plunger tip satisfactorily passed autoclavibility testing. (Syringes were autoclaved at 270°F, 15 minutes then tested for ISO leakage resistance testing. All samples tested passed ISO leak testing.)
- 6.3 Syringe Infusion Pump Performance (for syringes used in infusion pumps) - Syringes assembled with the altemate plunger tip demonstrated equivalent performance to natural rubber plunger tip samples in syringe pump application testing.
- 6.4 Chemical Testing - Testing has been performed per ISO and USP requirements. Results were acceptable.
- Biocompatibility Biocompatibility testing was satisfactorily completed on the 6.5 altemate plunger tip.
- 6.6 Plunger Actuation Forces - Forces for the alternate plunger tip are equivalent or superior to the current plunger tip.
- Manufacturing Process Changes No manufacturing process changes are 6.7 being made.
- ૯.૪ Manufacturing Site Changes - No manufacturing site changes are being made.
- 6.9 Packaging Component Changes - No packaging components are being changed.
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted in black, with its wings forming a shape that resembles human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1998
Mr. Peter Zurlo ·Manager, Regulatory Affairs Becton Dickinson Consumer Products 1 Becton Drive Franklin Lakes, New Jersey 07417-1883
K980580 Re : Becton Dickinson Syringes Trade Name: Regulatory Class: II Product Code: EMF June 9, 1998 Dated: Received: June 10, 1998
Dear Mr. Zurlo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. Zurlo
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance a (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at it 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
Timoth U Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page ol
510(k) Number (if known):_
Becton Dickinson Syringes Device Name:
Indications For Use:
.
The general use syringes are intended for the aspiration and Insulin syringes are intended for the injection of fluids. injection of insulin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Crescentz
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices
510(k) Number K9801580
Prescription Use_ (Per 21 CFR 801.109)
ಂದ
Over-The-Counter Use Insul
(Optional Format 1-2-96)