(22 days)
B-D PEN ULTRA
Not Found
No
The description focuses on mechanical assemblies and performance testing related to dose accuracy and environmental robustness, with no mention of AI or ML technologies.
No.
The device is an injector for administering insulin, which is a therapeutic drug. While it aids in the treatment of diabetes, the pen itself does not directly treat the condition; it is a delivery mechanism for a therapeutic substance.
No
Explanation: The device is an insulin pen injector designed for the administration of insulin, not for diagnosing medical conditions.
No
The device description explicitly details multiple mechanical assemblies and sub-assemblies, indicating it is a physical hardware device for insulin injection.
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 subcutaneous injection of insulin, which is a therapeutic action performed on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a mechanical device for delivering medication, not a device for analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly described as a drug delivery system for the treatment of diabetes.
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 in the treatment of diabetes.
Product codes (comma separated list FDA assigned to the subject device)
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 B-D Pen Ultra™ Assembly consists of three (3) main mechanical assemblies:
- A dose setting mechanism in the upper body,
- An injection mechanism in the center body, and .
- An interlocking mechanism in the center body.
The B-D Pen Ultra™ Assembly also consists of three (3) sub-assemblies
- The window/upper body sub-assembly, ◆
- The half-nut/plunger sub-assembly, and ●
- The cap/clip sub-assembly. ●
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 the Draft ISO Standard ISO-11608-1. 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 one-meter free falls onto a concrete surface.
In general, the B-D Pen Ultra 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 B-D Pen Ultra 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.
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.
B-D PEN ULTRA
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
JUN 12 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
-
- Submitted by:
Peter Zurlo Manager, Regulatory Affairs BECTON DICKINSON CONSUMER PRODUCTS 1 Becton Drive Franklin Lakes, New Jersey 07417-1883 Phone: 201-847-6447 Fax: 201-848-0457
- Submitted by:
-
Device Name: B-D PEN ULTRA 1.5 ml and 3.0 ml Versions 2.
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Predicate Device: B-D PEN ULTRA 3.
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Device Description: 4
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 B-D Pen Ultra™ Assembly consists of three (3) main mechanical assemblies:
- A dose setting mechanism in the upper body, �
- An injection mechanism in the center body, and .
- An interlocking mechanism in the center body. �
The B-D Pen Ultra™ Assembly also consists of three (3) sub-assemblies
- The window/upper body sub-assembly, ◆
- The half-nut/plunger sub-assembly, and ●
- The cap/clip sub-assembly. ●
Method of Use
The dose set knob (Adjusting Knob) can be adjusted to any single unit increment between one (1) and fifty-nine (59 for 1.5 ml pen) and sixty-nine (69 for 3.0 ml pen) by rotating the dose set knob clockwise (viewing Pen from Push Button end). The dose can also be corrected by dialing counterclockwise (viewing Pen from Push Button end) if necessary. By rotating the dose set knob, the Leadscrew will move forward or backward to be positioned for the proper amount of displacement for the number of units dialed. After completing the dose setting procedure simply push in the rotating Push Button. This movement will cause the Leadscrew to push on the plunger of the cartridge and insulin to be dispensed through the injector needle. After repeated injections, the insulin cartridge becomes depleted and must be replaced. The pen needle is removed and discarded per instructions. The Vial Retainer is rotated 90° and removed. A new cartridge is set inside the Vial Retainer and the assembly is replaced. During cartridge replacement, the Leadscrew will be reset when the new cartridge/Vial Retainer assembly is replaced on the Center Body. This
1
replacement can only occur when the rotating Push Button is completely seated at the "injection completed" position. The cartridge replacement procedure will return the Leadscrew to its start position, which will be seated against the stopper in the cartridge.
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ર. 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. -
- Technological Characteristics:
The B-D Pen Ultra 1.5 and 3.0 ml and the predicate device (the B-D Pen Ultra) have the same technological characteristics.
- Technological Characteristics:
SEE ITEM 4 ABOVE FOR A DESCRIPTION
N.B. The B-D Pen Ultra 1.5 ml can deliver a maximum dose of 59 units while the B-D Pen Ultra 3.0 ml delivers a maximum of 69 units.
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- Performance Summary:
The design verification reflects the recommendations made in the Draft ISO Standard ISO-11608-1. In general, testing of pen injectors with replaceable cartridges encompassed dose accuracy and functional assessments in relation to various environmental and mechanical challenges.
- Performance Summary:
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 one-meter free falls onto a concrete surface.
In general, the B-D Pen Ultra 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 B-D Pen Ultra 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/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them, possibly representing hair or a sense of movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN | 2 |998
Mr. Peter Zurlo · Manager, Regulatory Affairs Becton Dickinson Consumer Products 1 Becton Drive Franklin Lakes, New Jersey 07417-1883
Re : K981797 Trade Name: B-D Pen Ultra Requlatory Class: ı İ Product Code: FMF Dated: May 14, 1998 Received: May 21, 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 Requlations, 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 Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 miqht have under sections 531
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Page 2 - Mr. Zurlo
through 542 of the Act for devices under the Electronic chrough 542 or the not to rovisions, 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 deberroom in your 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 ene regaración Shorion"(21CFR 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.fda.gov/cdrh/dsma/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 ___________
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510(k) Number (if known): K981797
Device Name:___ B-D Pen Ultra 1.5 and 3.0 ml Versions and the control of the country of the country of the country of the country of the country of the country of the country of the country of the country of the country of the c
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 in the treatment of diabetes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hetura Cussonite
(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
モール - ブラック - -
(Optional Format 1-2-96)