(36 days)
Not Found
No
The device description focuses on mechanical assemblies and manual operation for insulin delivery, with no mention of AI or ML capabilities.
Yes
The device is described as "designed for asse by and to freatment of diabetes," indicating a therapeutic purpose.
No
Explanation: The device description clearly states that the B-D insulin pen injector is designed for the "subcutaneous injection of a desired dose of insulin." It describes the mechanics of dispensing insulin, not of identifying a medical condition or disease.
No
The device description clearly outlines mechanical components (dosing mechanism, vial retainer, cap/clip assembly, dose set knob, clutch assembly, lead screw) and describes a physical injection process. This indicates a hardware-based device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous injection of insulin for the treatment of diabetes. This is a therapeutic action, not a diagnostic one.
- Device Description: The description details a mechanical device for delivering a substance (insulin) into the body. It does not describe any components or processes for analyzing samples (like blood, urine, etc.) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is solely for delivering medication.
N/A
Intended Use / Indications for Use
The B-D insulin pen injector is designed for use by and for diabetics for the subcutaneous injection of a desired dose of insulin.
The B-D insulin pen injection is designed for asse by and to freatment of diabetes.
Product codes
FMF
Device Description
The B-D Insulin pen injector is designed for use by and for diabetics for the subcutaneous injection of a desired dose of insulin. The pen injector uses a cartridge of insulin (supplied by others) and a single use, detachable and disposable pen needle (sold separately).
The product consists of three main mechanical assemblies: A dosing mechanism, vial retainer, and cap/clip assembly. The dose set knob can be adjusted to any two (2) unit increments between two (2) and sixty (60) units by rotating the dose set knob counter clockwise until the desired dose is set. The pen needle can then be inserted into the body and by pushing in the dose set knob, the clutch assembly rotates in the opposite direction (clockwise) and the lead screw moves forward causing pressure to build up in the cartingge and insulin to be dispensed through the injector needle. After repeated injections, the insulin cartridge becomes depleted and must be replaced. During cartridge replacement, the lead screw is reset by unlocking the retracting mechanism and returning the lead screw to its start position. A new cantridge can then be inserted into the vial retainer.
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 design verification reflects the recommendations made in recent ISO/TC 84/WG 3. In general, testing of pen-injectors with replaceable cartridges encompassed dose accuracy and functional assessments in relation to various environmental and mechanical challenges.
The pens were tested for accuracy after sequential standard, cool, and hot atmosphere conditions and across a simulated life-time use (life-cycle). They were also tested for accuracy and examined for visual defects following exposure to dry heat, cold storage and cyclical atmosphere conditions and following three onemetre free falls onto a concrete surface.
In general, the 3 ml B-D Pen has proven to be robust, repeatable and consistent across a range of environmental and mechanical challenges. Relative to the overall dose accuracy (ALL data points collected across all test conditions) at each of the dose settings tested, the 3 ml B-D Pen has met the proposed ISO standards for dose accuracy and functionality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
B-D MICRO-FINE PEN
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
SUMMARY OF SAFETY AND EFFECTIVENESS APR - 2 1998
- Submitted By:
Peter Zurlo Manager. Regulatory Affairs BECTON DICKINSON CONSUMER PRODUCTS 1 Becton Drive Franklin Lakes, NJ 07417-1883 Phone: 201-847-6447 Fax: 201-848-0457
-
Device Name: B-D 3 ml PEN
-
Predicate Device: B-D MICRO-FINE PEN
4. Device Description:
The B-D Insulin pen injector is designed for use by and for diabetics for the subcutaneous injection of a desired dose of insulin. The pen injector uses a cartridge of insulin (supplied by others) and a single use, detachable and disposable pen needle (sold separately).
The product consists of three main mechanical assemblies: A dosing mechanism, vial retainer, and cap/clip assembly. The dose set knob can be adjusted to any two (2) unit increments between two (2) and sixty (60) units by rotating the dose set knob counter clockwise until the desired dose is set. The pen needle can then be inserted into the body and by pushing in the dose set knob, the clutch assembly rotates in the opposite direction (clockwise) and the lead screw moves forward causing pressure to build up in the cartingge and insulin to be dispensed through the injector needle. After repeated injections, the insulin cartridge becomes depleted and must be replaced. During cartridge replacement, the lead screw is reset by unlocking the retracting mechanism and returning the lead screw to its start position. A new cantridge can then be inserted into the vial retainer.
1
-
- Intended Use:
The B-D insulin pen injector is designed for use by and for diabetics for the subcutaneous injection of a desired dose of insulin.
- Intended Use:
-
- Technological Characteristics:
The B-D 3 ml Pen and the predicate device (the B-D Micro-Fine Pen) have the same technological characteristics.
- Technological Characteristics:
SEE ITEM 4 ABOVE FOR A DESCRIPTION
N.B. The B-D 3 ml Pen can deliver a maximum dose of 60 units in 2 (two) unit increments while the B-D Micro-Fine pen delivers a maximum of 30 units in 1 (one) unit increments. Also the BD 3 ml Pen uses a 3 ml insulin cartridge and the BD Micro-Fine pen uses a 1.5 ml insulin cartridge.
7. Performance Summary:
The design verification reflects the recommendations made in recent ISO/TC 84/WG 3. In general, testing of pen-injectors with replaceable cartridges encompassed dose accuracy and functional assessments in relation to various environmental and mechanical challenges.
The pens were tested for accuracy after sequential standard, cool, and hot atmosphere conditions and across a simulated life-time use (life-cycle). They were also tested for accuracy and examined for visual defects following exposure to dry heat, cold storage and cyclical atmosphere conditions and following three onemetre free falls onto a concrete surface.
In general, the 3 ml B-D Pen has proven to be robust, repeatable and consistent across a range of environmental and mechanical challenges. Relative to the overall dose accuracy (ALL data points collected across all test conditions) at each of the dose settings tested, the 3 ml B-D Pen has met the proposed ISO standards for dose accuracy and functionality.
Based on the results of the ISO testing, the B-D Pen is safe and effective when used as intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 1998
Mr. Peter Zurlo ·Manager, Regulatory Affairs BECTON DICKINSON CONSUMER PRODUCTS 1 Becton Drive 07417-1883 Franklin Lakes, New Jersey
K980755 Re : Trade Name: B-D 3 ml Pen Requlatory Class: II Product Code: FMF February 23, 1998 Dated: Received: February 25, 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 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with ---the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
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Page 2 - Mr. Zurlo
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdalgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K970709
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The B-D insulin pen injector is designed for use by and for diabetics for the The B-D insulin pen injection is designed for asse by and to freatment of diabetes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUING ON ANOTHER PAGE IS PERMISSIBLE)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Labanca Crescent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
OR
- Over-The-Counter Use
(Optional Format 1-2-96)