(12 days)
Not Found
No
The description focuses on a mechanical safety feature (needle retraction via a push button) and does not mention any computational or learning capabilities.
No.
The device is used for blood collection, specifically for venipuncture to obtain blood specimens, and is primarily designed to prevent needlestick injuries, not to treat a disease or condition.
No
Explanation: The device is a blood collection set and its intended use is to obtain blood specimens, not to analyze them or diagnose conditions. Its safety feature is to prevent needlestick injuries.
No
The device description clearly indicates it is a physical blood collection set with a needle and a retraction mechanism, not a software-only device.
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 specimens from patients." This describes a device used to collect a sample from the body, not a device used to test a sample outside the body (which is the definition of an in vitro diagnostic).
- Device Description: The description focuses on the mechanism for safe blood collection (needle retraction) and doesn't mention any components or processes related to analyzing or testing the collected blood.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in samples
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis
- Reagents, calibrators, or controls used in testing
The device is a tool for collecting a sample that could then be used in an IVD test, but the device itself is not an IVD.
N/A
Intended Use / Indications for Use
The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiple-sample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The BD Vacutainer™ Push Button Blood Collection Set is for venous blood collection. The wing set contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks. The retraction of the needle occurs when the user presses the button.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venipuncture site
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)
Extensive mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness.
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.
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
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
SEP 1 1 2002
Attachment 4
510(k) Summary Of Safety and Effectiveness
- I. General Information
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92
Establishment:
| ● | Address: | Becton Dickinson Vacutainer Systems,
Preanalytical Solutions
1 Becton Drive
Franklin Lakes, NJ 07417-1885 |
|-------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| ● | Registration Number:
● Contact Person: | 2243072
M. Wendy Bosshardt
Regulatory Affairs Specialist
Telephone no.: 201-847-6280
Fax No. 201-847-4858 |
| ● | Date of Summary: | August 29, 2002 |
| Device
● | Trade Name: | BD Vacutainer™ Push Button Blood Collection
Set |
| ● | Classification Name:
● Classification:
● Performance Standards: | Blood Specimen Collection Devices
Class II
None Established under 514 of the Food, Drug
and Cosmetic Act |
BD Vacutainer™ Push Button Blood Collection Set
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence
· Device Description
The BD Vacutainer™ Push Button Blood Collection Set is for venous blood collection. The wing set contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks. The retraction of the needle occurs when the user depresses the button.
• Intended Use
The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.
- · Synopsis of Performance Study Results
Extensive mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness.
2
III. Predicate Device Summary Table
· Substantial Equivalence
Based on comparison of the device features, materials, intended use and performance, the BD Vacutainer™ Push Button Blood Collection Set be shown to be substantially equivalent to the commercially available predicate device indicated in the table below. The predicate device, K number, and clearance date are also identified in the table below.
| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---|---|---|---|
| Becton | BD Vacutainer™ | K011984 | August 29, 2001 |
| Dickinson | Push Button Blood | ||
| Collection Set |
.windu Boppshardt
August 29, 2002
Date
M. Wendy Bosshardt Regulatory Affairs Specialist Becton Dickinson Vacutainer Systems, PreAnalytical Solutions Becton Dickinson and Company
Becton Dickinson and Company
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 2002
Ms. M. Wendy Bosshardt Regulatory Affairs Specialist Becton Dickinson & Company Vacutanier Systems Preanalytical Solutions 1 Becton Drive Franklin Lakes, New Jersey 07417-1880
Re: K022875
Trade/Device Name: BD VACUTAINERTM Push Button Blood Collection Set Regulation Number: 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: August 29, 2002 Received: August 30, 2002
Dear Ms. Bosshardt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You mav, 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
4
Page 2 – Ms. Bosshardt
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Jlatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment 2
B. INDICATIONS FOR USE
22875
510(K) Number (IF Known):
DEVICE NAME: BD VACUTAINER™ PUSH BUTTON BLOOD COLLECTION SET
INDICATIONS FOR USE:
The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiple-sample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.
(Please do not Write Below this line-continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE) PRESCRIPTION USE Ов Over-The-Counter Use
(Per 21 CFR § 801.109)
(OPTIONAL FORMAT 1-2-96)
Patricia Cuscenti
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022875