The VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® SAFETY Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

Device Description

The Greiner VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged infusion and blood collection needle bonded to flexible tubing with a female luer adapter. The VACUETTE® SAFETY Infusion Set is used for short-term administration of intravenous fluids and/or for blood collection. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with manufacturer's instructions. It can be used in conjunction with an intravascular administration set or with a syringe or other device in order to administer fluids. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.

AI/ML Overview

Here's an analysis of the provided text regarding the Greiner VACUETTE® SAFETY Infusion Set (K121908), focusing on the acceptance criteria and the study that proves the device meets them.

It's important to note that the provided documents are 510(k) Pre-market Notification summaries and FDA letters, not a detailed study report. Therefore, information typical of a comprehensive study (like specific sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or training set details) is generally not present in these types of regulatory submissions, especially for device modifications. These submissions primarily demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance (as inferred from the submission)

The primary acceptance criteria for this 510(k) submission are related to demonstrating substantial equivalence to the predicate device, specifically after a modification. This means the modified device must perform equivalently, without raising new questions of safety or effectiveness.

Acceptance Criteria (Inferred)	Reported Device Performance (Implied by Substantial Equivalence)
Safety Feature Functionality: The safety shield must effectively cover the needle immediately following venipuncture to protect against accidental needlestick injury, and lock in place.	The safety feature is described as "easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle... Once the needle is covered, the safety cover locks in place." This implies equivalent or maintained functionality as the predicate. The device is also labeled for single use, with no ability to deactivate the safety feature for reuse.
Intended Use: Device must remain suitable for blood collection and/or short-term infusion of intravenous fluids.	The intended use is re-stated exactly as per the predicate device: "used for blood collection and/or the short-term infusion of intravenous fluids."
Sterility: The device must be sterile.	The devices are packaged as sterile.
Single-Use: The device must be designed for single use only, with no ability to clean and reuse.	The devices are labeled for single use only, and the safety feature cannot be deactivated without rendering it unusable, precluding reuse.
Fundamental Scientific Technology: The underlying technology must remain the same as the predicate.	Explicitly stated: "The Greiner VACUETTE® SAFETY Infusion Set is substantially equivalent to the predicate device in fundamental scientific technology, intended use, and materials."
Materials: The materials used must be equivalent to the predicate device.	Explicitly stated: "substantially equivalent to the predicate device in... materials."
Additional Needle Gauges and Tubing Length (Specific to this modification): The new gauges and lengths must integrate safely and effectively with the existing design.	This submission is for the modification to include "additional needle gauges and tubing length." The FDA's clearance implies that the sponsor provided sufficient data (likely non-clinical testing) to demonstrate that these additions do not negatively impact safety or effectiveness and maintain substantial equivalence. The document does not detail how this was proven, but rather that the modification was accepted.

Study Details to Prove Acceptance Criteria:

Given the nature of the primary document (510(k) Summary for a device modification involving different sizes), a "study" in the traditional sense of a clinical trial with human subjects testing AI performance is not applicable here. The "study" is more accurately a design verification and validation process, primarily relying on non-clinical performance testing and comparison to a legally marketed predicate device.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided documents. For device modifications involving physical dimensions (like needle gauge and tubing length), the "test set" would typically involve multiple units of each new configuration manufactured and subjected to various engineering and performance tests (e.g., flow rate, safety activation force, material integrity, bond strength). The specific number of units tested would be detailed in the sponsor's test reports, which are not included in this summary.
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Greiner Bio-One North America, Inc. at their facilities or through qualified contract labs, consistent with manufacturing quality systems. This would be prospective testing of the modified device's technical specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device modification related to physical dimensions and core safety features, not a diagnostic AI tool requiring expert image interpretation. Ground truth would be established by objective measurements (e.g., flow rates, force measurements, dimensional checks) against engineering specifications and regulatory standards, not expert consensus on diagnostic interpretations.
Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective data (e.g., imaging reads). For this device, performance is evaluated against objective, measurable criteria and pre-defined acceptance limits in a controlled testing environment.
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 manual medical instrument (an infusion set), not an AI diagnostic tool. Therefore, MRMC studies are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. No algorithms or AI are mentioned or implied for the function of this infusion set.
The type of ground truth used:
- The "ground truth" for this device modification would be based on objective engineering specifications, material properties, performance standards (e.g., ISO standards for medical devices), and a comparison to the established performance of the predicate device. This involves:
  - Dimensional measurements for new needle gauges and tubing lengths.
  - Mechanical strength tests (e.g., bond strength of tubing to luer, integrity of safety mechanism).
  - Flow rate testing for infusion and blood collection (to ensure new dimensions don't hinder performance outside acceptable ranges).
  - Safety mechanism activation/lock tests to confirm user-friendliness and security.
  - Sterility testing (biological indicators or validated sterilization processes).
- These are all objective, verifiable data points rather than subjective expert consensus.
The sample size for the training set:
- Not Applicable. As this is not an AI/ML device, there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. No training set.

Summary of the "Study" (Design Verification & Validation):

The documentation states that the device is "substantially equivalent to the predicate device in fundamental scientific technology, intended use, and materials." This is the core "proof" presented in a 510(k) for a minor modification.

For this specific modification (additional needle gauges and tubing length), the sponsor (Greiner Bio-One) would have conducted various non-clinical performance tests to demonstrate that these changes maintain the safety and effectiveness profile of the cleared predicate device (K080235). These tests would typically include:

Mechanical testing: To ensure the integrity of the new configurations and the safety mechanism.
Flow rate testing: To confirm the functionality for blood collection and fluid infusion across the new sizes.
Dimensional verification: To ensure manufacturing accuracy.
Material compatibility: Confirmation that the materials for the new sizes are the same or equivalent to the predicate.
Biocompatibility: (If new materials were introduced, though not implied here).
Sterilization validation: To confirm the sterilization process remains effective for the new sizes.

The FDA's clearance (JUL 25 2012) indicates they reviewed these underlying test results (summarized by the sponsor) and agreed that substantial equivalence was demonstrated, and the modifications did not raise new safety or effectiveness concerns.

Summary

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K12 1908

page 1 of 2

JUL 2 5 2012

Special 510(k)

Device Modification of Greiner VACUETTE® SAFETY Infusion Set (K080235)

3 510(k) SUMMARY

June 26, 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

The assigned 510(k) number is:

CONTACT:

Manfred Abel Greiner Bio-One North America, Inc. P.O Box 1026 Monroe, NC 28111

NAME OF DEVICES:

Trade Name:	VACUETTE® SAFETY Infusion Set
Common Name:	IV Fluid Transfer Set
Classification Name:	Hypodermic Single Lumen Needle

PREDICATE DEVICE:

Greiner VACUETTE® SAFETY Infusion Set - K080235 (FDA cleared 4/24/2008) Greiner VACUETTE® SAFETY Blood Collection Set - K011786 (FDA cleared 7/12/2001)

DEVICE DESCRIPTION:

Intended Use: The VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer The VACUETTE® SAFETY Infusion Set is used for blood connector. collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

Product Description: The Greiner VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged infusion and blood collection needle bonded to flexible tubing with a female luer adapter.

The VACUETTE® SAFETY Infusion Set is used for short-term administration of intravenous fluids and/or for blood collection. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental The product is to be used by appropriately trained needlestick injury. healthcare professionals only in accordance with manufacturer's instructions. It can be used in conjunction with an intravascular administration set or with a syringe or other device in order to administer fluids.

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K121908 page 2 of 2

Special 510(k)

Device Modification of Greiner VACUETTE®SAFETY Infusion Set (K080235)

The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place.

The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.

SUBSTANTIAL EQUIVALENCE:

1 .

The Greiner VACUETTE® SAFETY Infusion Set is substantially equivalent to the predicate device in fundamental scientific technology, intended use, and materials.

This Special 510(k) is submitted for a device modification to the Greiner VACUETTE® SAFETY Infusion Set (K080235; FDA cleared 4/24/2008) to include additional needle gauges and tubing length.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the shape of a bird. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 2 5 2012

Greiner Bio-One North America, Incorporated C/O Ms. Judith Smith Principal P.O Box 103 Baldwin, Maryland 21013

Re: K121908

Trade/Device Name: VACUETTE® SAFETY Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 28, 2012 Received: June 29, 2012

Dear Ms. Smith:

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. Please note: CDRH does not evaluate 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 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.

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Page 2- Ms. Smith

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K121908

Device Name: VACUETTE® SAFETY Infusion Set

Indication For Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation

510(k)

lyl U for RZC July 20, 2012

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K121908

Page 1 of 1

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).