(91 days)
No
The device description and performance studies focus on the physical characteristics and functional performance of a hypodermic needle, with no mention of AI or ML.
No
The device is a hypodermic needle intended for injecting or withdrawing fluids, which are procedures, not the device itself providing therapy.
No
The device description clearly states its purpose is to "inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin," which are therapeutic or procedural actions, not diagnostic. A diagnostic device is used to identify or determine the nature of a disease or condition.
No
The device description clearly states it is comprised of a steel cannula and a Luer Lock hub, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin." This describes a direct interaction with the body for therapeutic or diagnostic purposes in vivo (within a living organism).
- IVD Definition: In vitro diagnostics are medical devices intended to be used to examine specimens, including blood, tissue, and urine, from the human body to provide information for diagnosis, monitoring, or screening. They are used in vitro (outside of a living organism).
- Device Description: The description of a hypodermic needle aligns with a device used for in vivo procedures, not for testing specimens in vitro.
The function of this device is to facilitate the delivery or removal of substances directly from the body, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
ExtaviPro™ Sterican™ 30G Hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
ExtaviPro™ Sterican™ 30G hypodermic needles are comprised of a steel cannula that is sharpened to a point at one end. The other end is bonded to a vellow color-coded female Luer Lock hub designed for attachment to a corresponding male connector, such as a syringe. A protective cap must be removed before injection.
ExtaviProTM Sterican™ 30G is sterile and pyrogen-free.
ExtaviPro™ Sterican™ 30G consists of the following materials:
- Needle tube AISI SUS 304 stainless steel .
- . Needle hub Polypropylene with masterbatch colorant (yellow)
- . Needle adhesive UV curing adhesive
- . Needle lubricant Silicone oil
- High Density Polyethylene (HDPE) . Needle cover
There are two differences between ExtaviPro™ Sterican™ 30G and Sterican™ hypodermic needles:
- The device is a 30G needle and is thus smaller than all other Sterican™ needles . marketed so far under K072247. There are, however, quite a number of 30 G hypodermic needles already on the US market, as for instance covered by K113186 (Novotwist needle, Novo Nordisk).
- ExtaviPro™ Sterican™ 30G will exclusively be sold to Novartis. As customer . requirement, a small collar is around the needle hub. This does not change the performance of the device because the inner surface geometry was not changed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin.
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)
Functional testing was performed to demonstrate safety and effectiveness and to ensure that the ExtaviPro "M Sterican"M 30G needles meet the requirements of the standards
- · ISO 7864:1993(E), Sterile hypodermic needles for singe use
- IS0 9626:1991/Amd. 1:2001(E), Stainless steel needle tubing for the manufacture of medical devices
- ISO 594-1, Conical fittings with 6% (Luer) taper for syringes, needles and certain . other medical equipment-Part 1: General requirements
- ISO 594-2, Conical fittings with 6% (Luer) taper for syringes, needles and certain ● other medical equipment-Part 2: Lock fittings.
Some of the tests have been executed on samples before EtO-Sterilization and after 3 sterilization cycles as well as after accelerated ageing, to demonstrate a shelf life of at least one vear.
The needles passed these tests and thus showed that they are as safe as the predicate needles.
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.
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
B BRAUN
SHARING EXPERTISE
B. Braun Melsungen AG Dr. Stefan Seidel Head of Regulatory Affairs
Non-active Medical Devices CoE IV-Systems Carl-Braun-Straße 1 34212 Melsungen Germany Tel. +49 5661 71-2608 Fax +49 5661 75-2608 Email stefan.seidel@bbraun.com
510(k) Summary
This 510(k) was prepared in April 2013
1. Name and address of the 510(k) Owner
| Company: | B. Braun Melsungen AG, Division Hospital Care |
|---|---|
| Name: | Dr. Stefan Seidel |
| Position: | Head of Regulatory Affairs Non-active Medical-Devices CoE IV- |
| Systems | |
| Address | Carl-Braun-Strasse 1 |
| 34212 Melsungen | |
| Germany | |
| Phone: | +49 5661 71-2608 |
| Fax: | +49 5661 75-2608 |
| Email: | stefan.seidel@bbraun.com |
| Establishment registration number: | 9610825 |
1
2. Name and classification of the device
| Name: | ExtaviPro™ Sterican™ 30G |
|---|---|
| Common name: | Hypodermic single lumen needle |
| Classification | Class II, Hypodermic single lumen needle, 21 CFR 880.5570 |
| Product Code FMI |
3. Predicate device
This applications claims substantial equivalence to the following predicate device: Sterican™ Needles Name: Common name: Hypodermic single lumen needle Classification: Class II, Hypodermic single lumen needle, 21 CFR 880.5570, Product Code: FMI 510(k)-number: K072247
4. Description of the device
ExtaviPro™ Sterican™ 30G hypodermic needles are comprised of a steel cannula that is sharpened to a point at one end. The other end is bonded to a vellow color-coded female Luer Lock hub designed for attachment to a corresponding male connector, such as a syringe. A protective cap must be removed before injection.
4.1. Intended Use
ExtaviProTM Sterican™ 30G Hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
4.2. Technological Characteristics
ExtaviPro™ Sterican™ 30G hypodermic needles are substantially equivalent to the predicate Sterican™ hypodermic needles. They are produced from the same materials, using the same equipment at the same manufacturing site. The sterilization process is the same and has been validated according to the same procedures. Primary packaging that assures sterility and shelf life is the same.
ExtaviProTTA Sterican™ 30G is sterile and pyrogen-free.
ExtaviPro™ Sterican™ 30G consists of the following materials:
- Needle tube AISI SUS 304 stainless steel .
- . Needle hub Polypropylene with masterbatch colorant (yellow)
- . Needle adhesive UV curing adhesive
- . Needle lubricant Silicone oil
- High Density Polyethylene (HDPE) . Needle cover
510(k) Summary
Section 7 - Page 2 of 3
2
There are two differences between ExtaviPro™ Sterican™ 30G and Sterican™ hypodermic needles:
- The device is a 30G needle and is thus smaller than all other Sterican™ needles . marketed so far under K072247. There are, however, quite a number of 30 G hypodermic needles already on the US market, as for instance covered by K113186 (Novotwist needle, Novo Nordisk).
- ExtaviPro™ Sterican™ 30G will exclusively be sold to Novartis. As customer . requirement, a small collar is around the needle hub. This does not change the performance of the device because the inner surface geometry was not changed.
5. Tests
5.1. Non-clinical tests
Functional testing was performed to demonstrate safety and effectiveness and to ensure that the ExtaviPro "M Sterican"M 30G needles meet the requirements of the standards
- · ISO 7864:1993(E), Sterile hypodermic needles for singe use
- IS0 9626:1991/Amd. 1:2001(E), Stainless steel needle tubing for the manufacture of medical devices
- ISO 594-1, Conical fittings with 6% (Luer) taper for syringes, needles and certain . other medical equipment-Part 1: General requirements
- ISO 594-2, Conical fittings with 6% (Luer) taper for syringes, needles and certain ● other medical equipment-Part 2: Lock fittings.
Some of the tests have been executed on samples before EtO-Sterilization and after 3 sterilization cycles as well as after accelerated ageing, to demonstrate a shelf life of at least one vear.
The needles passed these tests and thus showed that they are as safe as the predicate needles.
5.2. Clinical tests
Not applicable
5.3. Conclusion
ExtaviPro™ Sterican™ 30G needles passed the tests. Since materials, manufacturing and sterilization processes are the same as for the predicate device, no new questions arise from this side. It is therefore concluded that ExtaviPro™ Sterican™ 30G needles are as safe, as effective, and perform as well as the predicate device.
6. Other information
Not applicable
510(k) Summary
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
July 15, 2013
B. Braun Melsungen AG C/O Dr. Stefan Seidel Head of Regulatory Affairs Yes Medical Device Services GmbH Bahnstrasse 42-46 Friedrichsdorf, Hesse GERMANY 61381
Re: K131040
Trade/Device Name: ExtaviPro™ Sterican™ 30G Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 10, 2013 Received: April 22, 2013
Dear Dr. Seidel:
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 I ou may, meresore, manns of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and advices, good managemently provised, information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be may of subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm160622.htm
Sincerely vours.
MarySRunner-S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
S10(k) number (if known): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device Name: ExtaviPro™ Sterican™ 30G
Indications for Use:
ExtaviPro™ Sterican™ 30G Hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mary S. Runner -S | |
|---|---|
| Susan Runner | DOS MA 2013.07.15 |
| 11:20:52 -04'00' |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K131040 |
|---|---|
| ---------------- | --------- |