(196 days)
The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penefration with needleless IV access cannula. The B-D@ Blunt Plastic Cannula provides access to fluid path for Injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. These devices can also be used to flush pre-slit injection sites.
Sterile, single-use plastic cannula used to penetrate pre-slit septums covering injection sites, as well as, vials designed for penetration with needleless IV access cannula. The cannula is pre-lubricated with medical grade silicone to reduce septum insertion forces.
The provided text is related to a 510(k) submission for a medical device, the Becton Dickinson Blunt Plastic Cannula. The primary claim supported by data is the effective flushing of pre-slit injection sites.
However, the document does not contain information about:
- Specific acceptance criteria in the form of numerical targets for performance metrics. Instead, the acceptance criterion seems to be "superior flushing effectiveness" compared to competitive cannulas, which is a comparative claim.
- A "device performance" table with quantitative results directly linked to acceptance criteria.
- Sample sizes for the test set in terms of the number of injection sites or repetitions for each cannula type.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or related effect sizes.
- Standalone performance (algorithm only without human-in-the-loop) because this is a physical medical device, not an AI/software device.
- Ground truth type for the flushing effectiveness (while red blood cell count is mentioned, it's the outcome of the test, not an externally established ground truth for a diagnostic claim).
- Sample size for the training set (not applicable for this type of device and study).
- How ground truth for the training set was established (not applicable).
Therefore, based only on the provided text, a comprehensive answer for all requested points cannot be generated. I will provide the information that is present and indicate where information is missing.
Acceptance Criteria and Study Details for B-D® Blunt Plastic Cannula
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claim | Performance Description |
|---|---|
| Superior Flushing Effectiveness compared to competitive cannulas for compatible pre-slit injection sites. | The B-D® Blunt Plastic Cannula demonstrated superior flushing effectiveness as compared to the competitive cannulas tested (Baxter InterLink® Syringe Cannula, Abbott LifeShield® Blunt Steel Cannula, McGaw SafeLine® Blunt Cannula, Abbott LifeShield® BlunTip™ Cannula). Flushing effectiveness was assessed by counting the remaining red blood cells in the injection site after flushing under controlled test conditions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of injection sites, number of trials) for the test set. It mentions four experiments were developed.
- Test Set Sample Size: Not explicitly stated (e.g., number of replicates for each condition).
- Data Provenance: The study was conducted internally by Becton Dickinson ("Becton Dickinson Test Protocol"). The country of origin and whether it was retrospective or prospective data are not specified, but typically, such testing is prospective and conducted in a lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" here is the physical outcome of flushing (number of remaining red blood cells), which is a measurable quantity, not an expert opinion or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication typically applies to expert review of diagnostic information, not to the direct measurement of a physical phenomenon in a laboratory test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study applies to diagnostic imaging or AI devices involving human interpretation, not to the functional performance of a physical medical device like a cannula.
6. If a Standalone Performance Study Was Done
Yes, a standalone study of the device's flushing performance was done. The "Injection Site Flushing Evaluation" was a controlled laboratory test assessing the B-D® Blunt Plastic Cannula's flushing effectiveness independently and compared to competitor devices. This is a standalone study of the device itself. (Note: "Standalone" in the context of AI often refers to algorithm-only performance, which is not relevant here).
7. The Type of Ground Truth Used
The ground truth for flushing effectiveness was established by direct measurement of the outcome: the "number of red blood cells remaining in the injection site measured flushing effectiveness." This is a quantifiable, objective outcome data, not expert consensus or pathology in the traditional sense.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm. The data presented is for validation testing of the physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this type of device.
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3 1098 JUN
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
B-D Contact Person 1.0
Gregory W. Morgan Manager, Regulatory Affairs Division Quality Assurance Becton Dickinson and Company 1 Becton Drive, Building 2 Franklin Lakes, NJ 07417-1884 (201) 847-4344 - Phone (201) 847-4855 - FAX
2.0 Device Name
Becton Dickinson Blunt Plastic Cannula
3.0 Predicate Device
Becton Dickinson Blunt Plastic Cannula
4.0 Product Description/Function
- Product Description No change from B-D® Blunt Plastic Cannula 510(k) 964654. 4.1 Sterile, single-use plastic cannula used to penetrate pre-slit septums covering injection sites, as well as, vials designed for penetration with needleless IV access cannula. The cannula is pre-lubricated with medical grade silicone to reduce septum insertion forces.
Product Identification
| B-D® Blunt Plastic Cannula | Cat. # 303345 |
|---|---|
| B-D® Blunt Plastic Cannula with 3cc Syringe | Cat. # 303346 |
| B-D® Blunt Plastic Cannula with 5cc Syringe | Cat. # 303347 |
| B-D® Blunt Plastic Cannula with 10cc Syringe | Cat. # 303348 |
Reference product drawing, Tab 4.
4.2 Product Function
The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penetration with needleless IV access cannula. The B-D® Blunt Plastic Cannula provides access to the fluid path for injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. As indicated in section 1.0, these devices can also be used to flush pre-slit injection sites.
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5.0 Supporting Date for More Effective Injection Site Flushing Claim
| Claim | Predicate Device | Testing |
|---|---|---|
| The B-D® Blunt Plastic Cannulaflushes compatible pre-slit injectionsites more effectively thancompetitive cannula | • Baxter InterLink®Syringe Cannula• Abbott LifeShield®Blunt Steel Cannula• McGaw SafeLine®Blunt Cannula• Abbott LifeShield®BlunTip™ Cannula | Injection Site FlushingEvaluation, BectonDickinson Test Protocol |
5.1 Injection Site Flushing Evaluation
Test Description:
The B-D® Blunt Plastic Cannula and competitive cannula were used to flush compatible blood filled injection sites per Becton Dickinson protocol (Tab 4). The number of red blood cells remaining in the injection site measured flushing effectiveness. The experiment was designed to examine the following variables: (1)Cannula brand, (2)Quantity of flush(3 or 10cc), (3) Rotation of syringe during flush, and (4) Cannula insertion depth.
The 0.80" outside diameter of the B-D® Blunt Plastic Cannula stem allows access to the Baxter InterLnk®, Abbott LifeShield®, and McGaw SafeLine® pre-slit septums. Unlike the B-D® Blunt Plastic Cannula, competitive cannula are not compatible with all of these injection sites.
The test accounted for the following variables for flushing injection sites:
- (1) Cannula Brand
- (2) Quantity of Flush The quantity of flush was limited to 3cc and 10cc of saline. For both quantities, the flow rate was 1cc/sec.
- (3) Rotation of Syringe The effect of rotation was examined by allowing rotation for some trials and no rotation for others. However, rotation was not performed with the Abbott LifeShield® pre-slit septum due to the restrictive internal diameter of the site.
- (4) Cannula insertion depth Cannula insertion depth, the length of the cannula within the site, was tested at full and partial insertion of the cannula into the site. For partial insertion, a spacer was placed over the cannula to reduce the length of the cannula within the site by .080". Because the stem length of each cannula and the septum thickness of each injection site varied, spacers were made so that the cannula insertion depth was identical for each cannula/site combination for full and partial insertion for a given experiment.
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Summary/Conclusion:
As noted in Section 7.1 of the 510(k), we developed four(4) experiments to assess the flushing effectiveness of competitive cannula. The experiments compared the performance of the cannula in their respective, compatible pre-slit injection sites. Flushing effectiveness was assessed by counting the remaining red blood cells in the injection site after flushing. The injection sites were flushed under controlled test conditions which reflect hospital protocol or user technique.
Conclusion: The B-D® Blunt Plastic Cannula was observed to provide superior flushing effectiveness as compared to the competitive cannula tested.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 JUN
Mr. Gregory W. Morgan · Manager, Regulatory Affairs Division Quality Assurance Becton Dickinson and Company 1 Becton Drive, Building 2 Franklin Lakes, New Jersey 07417-1884
Re : K974363 Becton Dickinson Blunt Plastic Cannula Trade Name: Requlatory Class: II Product Code: FMI Dated: February 18, 1998 Received: March 16, 1998
Dear Mr. Morgan:
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 qeneral 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. ਕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (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 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
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Page 2 - Mr. Morgan
through 542 of 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" (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/dsmamaim.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) K974363
Device Name: B-D Blunt Plastic Cannula
Indications for Use:
The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penefration with needleless IV access cannula. The B-D@ Blunt Plastic Cannula provides access to fluid path for Injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. These devices can also be used to flush pre-slit injection sites.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Patrina Cusimano
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices .. 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).