(22 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the B-D PEN ULTRA device:
Device: B-D PEN ULTRA 1.5 ml and 3.0 ml Versions
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Proposed ISO Standards) | Reported Device Performance |
|---|---|
| Dose Accuracy (across all test conditions) | Met the proposed ISO standards for dose accuracy. |
| Functionality (across all test conditions) | Met the proposed ISO standards for functionality. |
| Robustness | Proven to be robust. |
| Repeatability | Proven to be repeatable. |
| Consistency | Proven to be consistent across a range of environmental and mechanical challenges. |
| No visual defects | No visual defects observed after exposure to dry heat, cold storage, cyclical atmosphere, and three one-meter free falls. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size (i.e., number of pens tested) for the test set. It mentions "pens were tested" and refers to "ALL data points collected across all test conditions" but provides no concrete number.
Data Provenance: The study was a prospective design verification study conducted by the manufacturer, BECTON DICKINSON CONSUMER PRODUCTS. There is no information regarding the country of origin of the data provided in this summary, but the company is based in Franklin Lakes, New Jersey, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the device is a mechanical insulin pen injector, not an AI or diagnostic device that requires expert interpretation for ground truth. The "ground truth" here is the precise mechanical dose delivery and functional integrity, measured by instruments and observations against a standard.
4. Adjudication Method for the Test Set:
This information is not applicable as the study involved objective mechanical and environmental testing, not subjective human assessment needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is not relevant for a mechanical medical device like an insulin pen injector. MRMC studies are typically used for diagnostic or AI-assisted interpretation tasks where human readers' performance is being evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in essence. The performance assessment of the B-D Pen Ultra was a standalone device performance study. The device's ability to accurately deliver insulin and maintain functionality under various conditions was tested independently, without a human-in-the-loop component influencing its core mechanical operation.
7. The Type of Ground Truth Used:
The ground truth was established based on predefined technical specifications and proposed international standards (Draft ISO Standard ISO-11608-1) for dose accuracy and functional performance. This involved objective measurements of insulin dose delivery and visual/functional inspections after various challenge conditions.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a mechanical device, not a machine learning model, so there is no "training set" in the context of AI development. The device's design and manufacturing processes are likely informed by engineering principles and previous product iterations, but not a dataset used for model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a mechanical device.
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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.
-
Predicate Device: B-D PEN ULTRA 3.
-
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
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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.
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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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| Page | 1 of 1 |
|---|---|
| ------ | -------- |
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)
§ 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).