(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and equivalence to a predicate needle, with no mention of AI or ML.
No.
The device is a needle intended for general purpose fluid injection/aspiration, not for treating a disease or condition.
No
The device is a needle intended for fluid injection/aspiration, not for identifying or characterizing diseases or medical conditions.
No
The device description clearly states it is a hypodermic single lumen needle, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for general purpose fluid injection / aspiration." This describes a device used to introduce or withdraw substances from the body, which is a clinical procedure, not an in vitro diagnostic test.
- Device Description: The description details a "hypodermic single lumen needle," which is a tool for accessing the body, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The document does not mention anything related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The BD Hypoint™ Needle is a tool used in the process of administering or collecting substances, but it does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The BD Hypoint™ Needle is intended for use with syringes and injection devices for general purpose fluid injection / aspiration.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The BD Hypoint™ Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The BD Hypoint™ Needles are offered in various gauge sizes and needle lengths. The BD Hypoint™ Needle is sterilized by gamma irradiation (Cobalt-60). The BD Hypoint™ Needle is Non-Toxic, Non-Pyrogenic, Disposable and intended for Single Use.
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)
Bench testing was performed to confirm the BD Hypoint™ Needle equivalence to the predicate device. The need for clinical analysis of the BD Hypoint™ Needle was assessed by the BD Medical Pharmaceutical Systems. Medical Affairs Department and with consideration to the extensive market history of this device outside of the United States, with the same intended use, the substantial device and design history on these other markets was the justification for not performing a clinical investigation for this device modification submission in the U.S. Therefore, based on the performance test results, the BD Hypoint TM Needle is safe and effective when used as intended.
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
§ 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).
0
... .
K070440 1 of 3
Attachment 5
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 Medical - Pharmaceutical Systems . 1 Becton Drive Franklin Lakes, NJ 07417-1885
2243072 -
. Registration Number:
-
Contact Person: .
Aileen Gilbert Senior Regulatory Affairs Specialist Telephone No .: 201-847-7197 Fax No.: 201-847-7040 E-Mail: aileen_gilbert@BD.com
Date of Summary: .
Device
- Trade Name: .
- . Common Name
- . Classification Name:
- . Classification:
- Performance Standards: ●
February 14, 2007
BD Hypoint™ Hypodermic Needle Single Lumen Hypodermic Needle Class II None Established under 514 of the Food, Drug and Cosmetic Act
Confidential & Proprietary
1
K070440 2013
II. Safety and Effectiveness Information Supporting Substantial Equivalence
-
· Device Description
The BD Hypoint™ Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The BD Hypoint™ Needles are offered in various gauge sizes and needle lengths. The BD Hypoint™ Needle is sterilized by gamma irradiation (Cobalt-60). The BD Hypoint™ Needle is Non-Toxic, Non-Pyrogenic, Disposable and intended for Single Use. -
· Intended Use
The BD Hypoint™ Needle is intended for use with svringes and iniection devices for general purpose fluid injection / aspiration. -
· Synopsis of Performance Study Results
Bench testing was performed to confirm the BD Hypoint™ Needle equivalence to the predicate device. The need for clinical analysis of the BD Hypoint™ Needle was assessed by the BD Medical Pharmaceutical Systems. Medical Affairs Department and with consideration to the extensive market history of this device outside of the United States, with the same intended use, the substantial device and design history on these other markets was the justification for not performing a clinical investigation for this device modification submission in the U.S. Therefore, based on the performance test results, the BD Hypoint TM Needle is safe and effective when used as intended.
2
K070440 3of3
III. Predicate Device Summary Table
· Substantial Equivalence
Based on comparison of the device features, materials, intended use and performance, the BD Hypoint™ Needle has shown to be substantially equivalent to the commercially available predicate device indicated in the table below. The predicate device, 510(k) number, and clearance date are also identified in the table below.
| Manufacturer | Predicate Device | 510(k)
Number | Clearance Date |
|------------------------------------|------------------------------|------------------|----------------|
| Becton
Dickinson and
Company | BD PrecisionGlide™
Needle | K021475 | July 19, 2002 |
Aileen Gilbert, RAC Senior Regulatory Affairs Specialist BD Medical - Pharmaceutical Systems Becton Dickinson and Company
2/14/2007
Date
Confidential & Proprietary
0034
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
.. . .
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Aileen C. Gilbert Senior Regulatory Affairs Specialist Becton Dickinson & Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1889
MAR 16 2007
Re: K070440
Trade/Device Name: BD Hypoint™ Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: February 14, 2007 Received: February 16, 2007
Dear Ms. Gilbert:
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, 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.
4
Page 2 - Mr. Gilbert
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.
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) - BD Hypoint™
.. . .
B. INDICATIONS FOR USE
KO70440 510(K) Number (IF Known): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME: BD Hypoint™ Needle
INDICATIONS FOR USE:
:
The BD Hypoint™ Needle is intended for use with syringes and injection devices for general purpose fluid injection / aspiration.
(Please do not Write Below This Line-Continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| PRESCRIPTION USE | X | OR OVER-THE-COUNTER USE | |
|---|---|---|---|
| ------------------ | ----------------------------------------- | ------------------------- | -- |
(PER 21 CFR § 801.109)
(OPTIONAL FORMAT 1-2-96)
Confidential & Proprietary