K Number
K071947
Device Name
VACU-MED BLOOD COLLECTION NEEDLES
Manufacturer
Date Cleared
2007-10-12

(91 days)

Product Code
Regulation Number
880.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VACU-MED® Blood Collection Needles are designed for use in venous blood collection.
Device Description
VACU-MED® Blood Collection Needles are manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is 1" or 1½" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity. VACU-MED® Blood Collection Needles are a sterile single-use disposable product. The needles are non-toxic and non-pyrogenic, and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1½").
More Information

Not Found

No
The device description and intended use are for a simple mechanical blood collection needle, with no mention of any computational or analytical capabilities.

No.

Explanation: Therapeutic devices are used for treatment or therapy. This device is a blood collection needle, which is a diagnostic tool used to collect blood samples, not to treat a condition.

No

Explanation: The device description states that VACU-MED® Blood Collection Needles are "designed for use in venous blood collection." Blood collection is a sample acquisition step, not a diagnostic step. Diagnosis involves interpreting test results.

No

The device description clearly describes a physical medical device (needles, hub, caps) and does not mention any software component.

Based on the provided information, the VACU-MED® Blood Collection Needles are not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is "for use in venous blood collection." This describes a device used to collect a biological sample (blood).
  • Device Description: The description details the physical components and function of a needle designed for drawing blood. It doesn't mention any components or processes related to analyzing or testing the collected blood.
  • Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VACU-MED® needles are simply the tool for obtaining the specimen; they don't perform any diagnostic function themselves.

In summary, the VACU-MED® Blood Collection Needles are a medical device used for sample collection, but they do not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

VACU-MED® Blood Collection Needles are designed for use in venous blood collection.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

VACU-MED® Blood Collection Needles are manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is 1" or 1½" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity.

VACU-MED® Blood Collection Needles are a sterile single-use disposable product. The needles are non-toxic and non-pyrogenic, and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1½").

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

venous

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)

The VACU-MED® Blood Collection Needles are substantially equivalent to the predicate devices based on the descriptive data, compliance with standards, and indications for use.

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.

K973620

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).

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SHINA CORPORATION VACU-MED® Blood Collection Needles Premarket Notification

001 1 8 780

510(k) Summary

Submitter

Date Prepared July 11, 2007

SHINA CORPORATION 691-1, Boheong-Lee Woosung-Myun Kongju Choongchungnam-Do Republic of Korea Contact Person: Y. N. Shin Telephone: (82) 31 711 8180 Fax: (82) 31 711 8190

Name of Device

Common Name:Disposable blood collection needles
Proprietary Name:VACU-MED® Blood Collection Needles (available in 20G, 21G, and 22G by 1" and 1½" lengths)
Classification Name:Hypodermic single lumen needles
Regulation:880.5570
Class:Class II
Product Code:FMI

Predicate Devices

The VACU-MED® Blood Collection Needles are substantially equivalent in intended use, function and basic composition to the currently marketed Greiner VACUETTE® (available in 20G, 21G, and 22G by 1" and 11/2" lengths), K973620.

Device Description

VACU-MED® Blood Collection Needles are manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is 1" or 1½" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity.

VACU-MED® Blood Collection Needles are a sterile single-use disposable product. The needles are non-toxic and non-pyrogenic, and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1½").

Intended Use

VACU-MED® Blood Collection Needles are designed for use in venous blood collection.

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