(26 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and physical testing, with no mention of AI or ML.
No
The device is described as a blood collection assembly for obtaining blood samples, not for treatment or therapy.
No
The device, a blood collection assembly, is used to obtain blood samples, but it does not perform any diagnostic function itself. It is a tool for sample collection, not for analysis or diagnosis.
No
The device description clearly indicates it is a physical assembly of a needle and adapter, intended for venipuncture. The performance studies focus on mechanical aspects like shield activation and force, not software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for venipuncture to obtain blood samples." This describes a device used to collect a biological sample from a patient.
- Device Description: The description focuses on the physical components and their function in collecting blood.
- Lack of IVD Characteristics: There is no mention of the device being used to perform tests on the collected blood sample, or to analyze the sample in any way to diagnose a condition. IVD devices are used in vitro (outside the body) to examine specimens.
The device is a blood collection assembly, which is a tool used to obtain the sample that might then be used with an IVD device.
N/A
Intended Use / Indications for Use
The VACUTAINER® Brand Safety Blood Collection Assembly is intended to provide a pre-assembled Direct Draw Adapter/safety needle combination for venipuncture to obtain blood samples. The VACUTAINER® Brand Safety Blood Collection Assembly contains a sliding shield that covers the needle point after use. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.
Product codes
KJA
Device Description
The VACUTAINER® Brand Safety Blood Collection Assembly is a configuration of the commercially available BDD SafetyGlide™ Needle preattached to a VACUTAINER® Direct Draw Adapter (Blood Collection Holder assembly). The VACUTAINER® Brand Safety Blood Collection Assembly is intended to be marketed as a sterile, multi-sample, single use device.
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
A total of 500 VACUTAINER Safety Blood Collection Assembly devices were tested.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The original SafetyGlide™ Needle 510(k) premarket notification K951254 described bench and simulated use testing to support the functional performance and a decision of substantial equivalence. The bench testing which compared the SafetyGlide™ Needle to two commercially available devices included force to activate; hub/arm separation force, safety barrier penetration resistance and reset force. The results demonstrated equivalent or improved performance of the SafetyGlide™ Needle force to activate, hub/arm separation force, safety barrier penetration resistance and reset force. Further, the SafetyGlide™ Needle could not be deactivated.
VACUTAINER Systems, in accordance with the Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions For Medical Devices with Sharps Injury Prevention Features, conducted a Simulated Use Study. The Simulated Use Study was designed to evaluate successful shield activation in a blood drawing environment, observe blood splatter and to evaluate Ease of Activation. The investigators were also requested to document any modification to the current venipuncture technique, observe left/right handed use and single handed use.
Results of the study demonstrated successful shield activation for all 500 devices, a 100% success rate with a 0.7% Upper 95% Confidence Limit and a 1.1% Upper 99% Confidence Limit. Over 90% of the investigators reported "As Expected" Ease of Use with the remaining investigators approximately equally divided in regards to "Easier Than Expected Activation" or "Harder than Expected Activation". Blood Splatter was observed in some instances of use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% success rate with a 0.7% Upper 95% Confidence Limit and a 1.1% Upper 99% Confidence Limit.
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.
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
§ 864.2240 Cell and tissue culture supplies and equipment.
(a)
Identification. Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.(b)
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
KA92404
JUL 22 1997
Image /page/0/Picture/2 description: The image shows a logo with the number 100 and a globe. The number 100 is stylized with horizontal lines, and the globe is positioned between the two zeros. The globe depicts a view of the Earth centered on the Arctic region.
CELEBRATING THE FIRST ONE HUNDRED: 1897-1997
BECTON
DICKINSON
Becton Dickinson VACUTAINEA Systems 1 Becton Drive Franklin Lakes, New Jersey 07417 (201) 847-4500
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information I.
This Summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92 Establishment:
| • | Address: | Becton Dickinson VACUTAINER Systems
1 Becton Drive
Franklin Lakes, NJ 07417-1885 |
|--------------|------------------------|---------------------------------------------------------------------------------------------------------------------------|
| • | Registration Number: | 2243072 |
| • | Contact Person: | • John A. Schalago
Regulatory Affairs Specialist
Telephone no.: 201 - 847 - 6280
Facsimile no.: 201 - 847 - 4858 |
| • | Date of Summary: | June 20, 1997 |
| Device Name: | | |
| • | Trade Name: | VACUTAINER® Brand Safety Blood
Collection Assembly
Pre-attached SafetyGlide™ Needle and Direct
Draw Adapter |
| • | Classification Name : | Blood Specimen Collection Device |
| • | Classification: | Class II |
| • | Performance Standards: | None Established under 514 of
the Food, Drug and Cosmetic Act |
Safety and Effectiveness Information Supporting the Substantial II. Equivalence Determination
· Device Description
The VACUTAINER® Brand Safety Blood Collection Assembly is a configuration of the commercially available BDD SafetyGlide™ Needle preattached to a VACUTAINER® Direct Draw Adapter (Blood Collection Holder assembly). The VACUTAINER® Brand Safety Blood Collection Assembly is
1
intended to be marketed as a sterile, multi-sample, single use device.
● Intended Use
The VACUTAINER® Brand Safety Blood Collection Assembly is intended to provide a pre-assembled Direct Draw Adapter/safety needle combination for venipuncture to obtain blood samples. The VACUTAINER® Brand Safety Blood Collection Assembly contains a sliding shield that covers the needle point after use. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.
· Synopsis of Test Methods and Results
The original SafetyGlide™ Needle 510(k) premarket notification K951254 described bench and simulated use testing to support the functional performance and a decision of substantial equivalence. The bench testing which compared the SafetyGlide™ Needle to two commercially available devices included force to activate; hub/arm separation force, safety barrier penetration resistance and reset force. The results demonstrated equivalent or improved performance of the SafetyGlide™ Needle force to activate, hub/arm separation force, safety barrier penetration resistance and reset force. Further, the SafetyGlide™ Needle could not be deactivated.
VACUTAINER Systems, in accordance with the Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions For Medical Devices with Sharps Injury Prevention Features, conducted a Simulated Use Study. The Simulated Use Study was designed to evaluate successful shield activation in a blood drawing environment, observe blood splatter and to evaluate Ease of Activation. The investigators were also requested to document any modification to the current venipuncture technique, observe left/right handed use and single handed use.
A total of 500 VACUTAINER Safety Blood Collection Assembly devices were tested. Results of the study demonstrated successful shield activation for all 500 devices, a 100% success rate with a 0.7% Upper 95% Confidence Limit and a 1.1% Upper 99% Confidence Limit. (The confidence limits is based on the table included in the Supplementary Guidance). Over 90% of the investigators reported "As Expected" Ease of Use with the remaining investigators approximately equally divided in regards to "Easier Than Expected Activation" or "Harder than Expected Activation". Blood Splatter was observed in some instances of use. The Package labeling instructions for use includes handling recommendations intended to reduce the risk of exposure.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jul 22 1997
John A. Schalago · Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems ' 1 Becton Drive Franklin Lakes, New Jersey 07417
Re : K972404 VACUTAINER® Brand Safety Blood Collection Assembly Regulatory Class: II Product Code: KJA Dated: June 25, 1997 Received: June 26, 1997
Dear Mr. Schalago:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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) 594-4588. 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.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): -- --------
Device Name:_VACUTAINER® Brand Safety Blood Collection Assembly
Indications for Use:
The VACUTAINER® Brand Safety Blood Collection Assembly is intended to provide a pre-assembled Direct Draw Adapter/safety needle combination for venipuncture to obtain blood samples. The VACUTAINER® Brand Safety Blood Collection Assembly contains a sliding shield that covers the needle point after use. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number -972404
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
510(K) Premarket Notification VACUTAINER® Brand Safety Blood Collection Assembly