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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the ExtaviPro™ Sterican™ 30G device based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (hypodermic needle). Unlike AI/software devices, the acceptance criteria and performance evaluation for this type of hardware device fundamentally differ. There are no AI/ML components, human-in-the-loop scenarios, or ground truth establishment in the traditional sense of AI studies. Instead, the evaluation focuses on meeting established engineering standards and functional performance specific to the physical device.

Acceptance Criteria and Device Performance

Acceptance Criteria (from Standards)	Reported Device Performance
Conformance to ISO 7864:1993(E) - Sterile hypodermic needles for single use	Needles passed functional testing demonstrating safety and effectiveness, meeting the requirements of this standard.
Conformance to ISO 9626:1991/Amd. 1:2001(E) - Stainless steel needle tubing for the manufacture of medical devices	Needles passed functional testing demonstrating safety and effectiveness, meeting the requirements of this standard.
Conformance to ISO 594-1 - Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 1: General requirements	Needles passed functional testing demonstrating safety and effectiveness, meeting the requirements of this standard (specifically related to the Luer lock hub).
Conformance to ISO 594-2 - Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 2: Lock fittings.	Needles passed functional testing demonstrating safety and effectiveness, meeting the requirements of this standard (specifically related to the Luer lock hub).
Sterility and pyrogen-free status	Device is sterile and pyrogen-free (as stated in description). This is maintained through the same validated sterilization process and primary packaging as the predicate device.
Shelf life of at least one year	Demonstrated through tests performed on samples after accelerated aging.
Equivalence in safety and effectiveness to predicate device (Sterican™ Needles, K072247)	The device passed all functional tests, uses the same materials, manufacturing processes, and sterilization processes as the predicate device. It is concluded to be as safe, effective, and to perform as well as the predicate device.

Study Details (Interpreted for a Hardware Medical Device)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices (e.g., "N=100 needles"). However, the tests were performed on "samples" before EtO-Sterilization and after 3 sterilization cycles, as well as after accelerated aging. This implies a sufficient number of samples were used to meet the statistical requirements of the listed ISO standards.
- Data Provenance: The tests were conducted internally by B. Braun Melsungen AG, a German company ("B. Braun Melsungen AG Dr. Stefan Seidel... Germany"). This would be considered internal company data. The source is retrospective in the sense that the testing was completed prior to the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the AI/ML sense. "Ground truth" for this device is established by objective measurements against engineering standards (e.g., cannula dimensions, hub connection strength, flow rates). These are not determined by expert consensus in the same way as diagnosing medical images. The expertise lies in the engineers performing and interpreting the physical and chemical tests according to the standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert opinions, which isn't relevant for objective physical measurements against engineering standards. The results of the tests are binary (pass/fail) based on predefined criteria in the ISO standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a hypodermic needle, a physical medical instrument, not an AI or software-based diagnostic tool. There are no "human readers" or "AI assistance" involved in its functional evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective engineering standards and measurements. The "ground truth" for this device relates to its physical properties and functional performance as defined by international standards (ISO 7864, ISO 9626, ISO 594-1, ISO 594-2). For example, a needle's bending strength is measured against a specified force, not determined by expert opinion.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable. There is no "training set" or "ground truth" establishment in the context of AI/ML for this device.

Summary

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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 134212 MelsungenGermany
Phone:	+49 5661 71-2608
Fax:	+49 5661 75-2608
Email:	stefan.seidel@bbraun.com
Establishment registration number:	9610825

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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 880.5570Product 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

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

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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

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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,

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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

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Indications for Use

S10(k) number (if known): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Device Name: ExtaviPro™ Sterican™ 30G

Indications for Use:

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
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Regulation Number and Section

§ 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).