(14 days)
Not Found
No
The device description and intended use are for blood collection syringes, which are mechanical devices and do not mention any computational or analytical capabilities that would involve AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is described as collecting whole blood specimens for diagnostic testing, not for treating any condition or disease.
No
The device, BD Preset™ and BD A-Line™ Blood Collection Syringe, is intended to collect whole blood specimens for diagnostic testing, rather than performing the diagnostic testing itself.
No
The device description explicitly states it is a sterile, single-use device designed to collect whole blood specimens, describing physical components like syringes, needles, and a venting system. This indicates a hardware medical device, not software-only.
Based on the provided text, the BD Preset™ and BD A-Line™ Blood Collection Syringes are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the devices are "intended to collect whole blood specimens for diagnostic testing".
- Diagnostic Testing: The list of tests mentioned (pH, blood gases, electrolytes, metabolytes, co-oximetry, etc.) are all common diagnostic tests performed on blood samples in vitro (outside the body).
- Device Description: The description reinforces that the devices are "designed to collect whole blood specimens for diagnostic testing".
The core function of these devices is to collect a biological specimen (blood) that will then be used for diagnostic testing performed in vitro. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Preset™ and BD A-Line™ Blood Collection Syringes are intended to collect whole blood specimens for diagnostic testing which may include: pH. blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry, and other tests.
Product codes
JKA
Device Description
The BD Preset™ and BD A-Line™ Blood Collection Syringes are sterile, single use devices designed to collect whole blood specimens for diagnostic testing.
BD A-Line™ Blood Collection Syringe is specifically designed for aspiration of blood samples from arterial lines.
BD Preset™ Blood Collection Syringe is a specifically designed (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the selfventing membrane (as blood fills the syringe), which ensures rapid filling.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance studies were done the performance and equivalence of the principal devices to the predicate devices currently marketed in the United States.
All results from the studies show equivalence between the principal devices and the predicate devices. Therefore, the BD Preset™ and BD A-Line™ Blood Collection Syringes are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 0 8 2002
1022426
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: | BD 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 |
| Device | Date of Summary: | July 22, 2002 |
| | Trade Name: | BD Preset™ and BD A-Line™ Blood
Collection Syringes |
| | Classification Name: | Tubes, Vials, Systems, Serum
Separators, Blood Collection |
| | Classification:
Performance Standards: | Class II
None Established under 514 of the
Food, Drug and Cosmetic Act |
Special 510(k): Device Modification
BD Preset™ and BD A-Line™
1
- II. Safety and Effectiveness Information Supporting Substantial Equivalence
- · Device Description
The BD Preset™ and BD A-Line™ Blood Collection Syringes are sterile, single use devices designed to collect whole blood specimens for diagnostic testing.
BD A-Line™ Blood Collection Syringe is specifically designed for aspiration of blood samples from arterial lines.
BD Preset™ Blood Collection Syringe is a specifically designed (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the selfventing membrane (as blood fills the syringe), which ensures rapid filling.
-
Intended Use
The BD Preset™ and BD A-Line™ Blood Collection Syringes are intended to collect whole blood specimens for diagnostic testing which may include: pH. blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry, and other tests. -
· Synopsis of Performance Study Results
Performance studies were done the performance and equivalence of the principal devices to the predicate devices currently marketed in the United States.
All results from the studies show equivalence between the principal devices and the predicate devices. Therefore, the BD Preset™ and BD A-Line™ Blood Collection Syringes are substantially equivalent to the predicate devices.
2
III. Predicate Device Summary Table
- · Substantial Equivalence
Based on comparison of the device features, materials, intended use and performance, the BD Preset™ and BD A-Line™ Blood Collection Syringes are shown to be substantially equivalent to the commercially available predicate devices indicated in the table below. The predicate devices, K number, and clearance date are also identified in the table below.
| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---|---|---|---|
| Becton | |||
| Dickinson | VACUTAINER™ | K982922 | Sept. 22, 1998 |
| Brand Blood | |||
| Collection Syringes |
M. Wendy Booshardt
M. Wendy Bosshardt Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems Becton Dickinson and Company
July 22, 2002
Date
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. M. Wendy Bosshardt Regulatory Affairs Specialist Becton, Dickinson and Co. 1 Becton Drive Franklin Lakes, NJ 07417
Re: K022426
Trade/Device Name: BD Preset™ and BD A-Line™ Blood Collection Syringe Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code:. JKA Dated: July 22, 2002 Received: July 25, 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 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. Iisting 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. 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.
4
Page 2 -
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" (21CFR 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.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
5
Attachment 2
Indications for Use Statement
.
. :
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510(k) Number (if known)
:
| Device Name | BD Preset™ and BD A-Line™ Blood Collection Syringe |
|---|---|
| Indications for Use | BD Preset™ and BD A-Line™ Blood Collection Syringe |
| are intended to collect whole blood specimens for | |
| diagnostic testing which may include: pH, blood gases, | |
| electrolytes (including ionized calcium), metabolytes, | |
| co-oximetry, and other tests |
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Sean Cooper | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Device. | |
| 510(k) Number | K0224266 |
| Prescription Use
| (per 21 CFR 801.109) | OR | Over-The Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |