B-D E ML PEN by BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

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.

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.

AI/ML Overview

This document describes the B-D 3 ml Pen, an insulin injector for diabetics, and its performance evaluation.

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against proposed ISO standards for dose accuracy and functionality.

Acceptance Criteria (Proposed ISO Standards)	Reported Device Performance
Dose accuracy across various conditions (standard, cool, hot atmosphere, life-cycle, dry heat, cold storage, cyclical atmosphere)	Met proposed ISO standards for dose accuracy at all dose settings tested. Robust, repeatable, and consistent across environmental and mechanical challenges.
Functionality across various conditions (standard, cool, hot atmosphere, life-cycle, dry heat, cold storage, cyclical atmosphere)	Met proposed ISO standards for functionality.
Visual defects after exposure to environmental conditions and free falls	Examined for visual defects after exposure to dry heat, cold storage, cyclical atmosphere, and three one-meter free falls onto concrete. No specific findings regarding defects were reported in the provided text, but meeting overall ISO standards implies acceptable visual integrity.

2. Sample Size and Data Provenance

The document does not explicitly state the exact sample sizes used for testing (e.g., number of pens tested, number of injections performed). The studies appear to be prospective as they involved testing the pens under controlled conditions. The country of origin of the data is not specified, but the submission is to the U.S. FDA.

3. Number of Experts and Qualifications

The document does not mention the use of experts to establish a ground truth for the test set. The evaluation seems to be based on objective measurements of dose accuracy and functionality in relation to the ISO standards.

4. Adjudication Method

No adjudication method is mentioned or implied, as the performance evaluation relies on objective measurements against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device is a mechanical insulin injector, not an AI or imaging device that would typically involve human readers for interpretation.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Performance Summary" section details the testing of the B-D 3 ml Pen itself to assess its dose accuracy and functionality under various environmental and mechanical challenges. The results indicate the device's inherent performance.

7. Type of Ground Truth Used

The ground truth for the performance evaluation was based on objective measurements of dose accuracy and functionality against proposed ISO standards. This is a form of empirical measurement against pre-defined engineering and performance specifications.

8. Sample Size for the Training Set

This information is not applicable. The B-D 3 ml Pen is a mechanical device, not an AI model that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable, as there is no training set for a mechanical device.

Summary

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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:

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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.
1. Technological Characteristics:
  The B-D 3 ml Pen and the predicate device (the B-D Micro-Fine Pen) have the same 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.

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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

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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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).