IMC BLOOD COLLECTION NEEDLE

K110656 · International Medsurg Connection · FMI · Aug 18, 2011 · General Hospital

Device Facts

• Record ID: K110656
• Device Name: IMC BLOOD COLLECTION NEEDLE
• Applicant: International Medsurg Connection
• Product Code: FMI · General Hospital
• Decision Date: Aug 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

This device is intended for use in venous blood collection.

Device Story

IMC Blood Collection Needle is a sterile, single-use disposable device used for venous blood collection. The device consists of a stainless steel (SUS 304) cannula sharpened at both ends, attached to an ABS hub. One end is designed to connect to a needle holder for insertion into an evacuated blood collection tube, protected by a rubber sleeve and cap. The opposite end is used for venipuncture. The device is operated by healthcare professionals in clinical settings. It facilitates the withdrawal of blood samples for diagnostic testing. The device is provided in various gauge sizes (20G, 22G) and lengths (1" and 1.5").

Clinical Evidence

Bench testing only. Performance characteristics, specifically hub/needle bond strength, were tested against ISO 7894:1993 standards. Results demonstrated that the IMC Blood Collection Needle meets the required acceptance criteria for 20G, 21G, and 22G sizes, consistent with the predicate device.

Technological Characteristics

Materials: SUS 304 stainless steel cannula, ABS hub, synthetic rubber resistance cover, HDPE/Polypropylene needle caps. Dimensions: 20G-22G, 1" and 1.5" lengths. Sensing/Actuation: Mechanical venipuncture device. Sterilization: Sterile and non-sterile options available. Standards: ISO 7894:1993 for bond strength.

Indications for Use

Indicated for venous blood collection in patients requiring blood sampling via 20G, 21G, or 22G needles.

Regulatory Classification

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.

Predicate Devices

• VACUETTE VISIO PLUS blood collection needle (K061483)

Submission Summary (Full Text)

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AUG 1 8 2011

# K 110656

#### 8. 510(K) SUMMARY

| Trade Name: | IMC Blood Collection Needle (non-sterile and sterile) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Collection Needle |
| Classification Name: | 21 CFR 880.5570 |
| Submitter Information: | International Medsurg Connection<br>935 N Plum Grove Rd, STE F<br>Schaumburg, Illinois 60173 |
| Summary Prepared By: | Peter Kim<br>Director of Quality Assurance<br>International Medsurg Connection<br>935 N Plum Grove Rd, STE F<br>Schaumburg, Illinois 60173<br>Telephone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared: | December 22, 2010 |
| Predicate Devices: | • VACUETTE VISIO PLUS blood collection needle (K061483) |

#### Device Name(s):

IMC Blood Collection Needle (non-sterile and sterile)

#### Classification Panel:

General Hospital

#### Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:

International Medsurg Connections, Inc is claiming substantial equivalence of the IMC Blood Collection Needle with the currently marketed:

| Description | 510(k) Number |
|---------------------------------------------|---------------|
| VACUETTE VISIO PLUS Blood Collection Needle | K061483 |

#### Device Description

This device is intended for use in venous blood collection.

IMC blood collection needles are manufactured from 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 shorter end and is fitted with a protective rubber sleeve. And a needle cap. The opposite end of the needle is 1" or 1 ½" for withdrawing blood. 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.

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IMC blood collection needles are a sterile single use disposable product. The needles are nontoxic and non-pyrogenic and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1 ½').

## Statement of Intended Use

Indications For Use: This device is intended for use in venous blood collection

# Name/Description

. .. .

| Description | Size | Sterility |
|----------------------------------|------------|-----------------------|
| 20 Gauge Blood collection needle | 1"and 1 ½" | Sterile & Non-sterile |
| 21 Gauge Blood collection needle | 1"and 1 ½" | Sterile & Non-sterile |
| 22 Gauge Blood collection needle | 1"and 1 ½" | Sterile & Non-sterile |

# New Devices as Compared to Marketed Device(s)

The IMC Blood Collection Needle and the predicate device are intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

| Feature/Characteristic | IMC Blood Collection Needle | VACUETTE VISIO PLUS Blood Collection Needle: K061483 (Predicate) |
|------------------------|-------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | This device is intended for use in venous blood collection. | This device is intended for use in venous blood collection. |
| Material<br>Needle cap | HDPE | Similar |
| Resistance cover | Rubber (Synthetic) | Similar |
| Hub | ABS | Similar |
| Label | 30g/m2 paper | Similar |
| Needle (Cannula) | SUS 304 | Similar |
| Needle cap | Polypropylene | Similar |
| colors | | |
| 20G | Yellow color | Yellow color |
| 21G | Deep green color | Green color |
| 22G | Black color | Black color |
| Length | 1"and 1 ½" | 1"and 1 ½" |
| Gauge | 20G, 21G & 22G | 21G & 22G |
| Cover dimension | 1" size: 47mm<br>1 ½" size: 47mm | 1" size: 47mm<br>1 ½" size: 47mm |
| Cover color | White (for all gauges) | Clear (for all gauges) |

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| | | |

# Performance Data:

| Performance Characteristics | Test Method | Acceptance<br>Criteria | IMC Blood<br>Collection Needle | VACUETTE VISION<br>PLUS Blood Collection<br>Needle<br>K061483 |
|-----------------------------|-----------------|--------------------------------------|--------------------------------|----------------------------------------------------------------|
| Hub/needle bond strength | ISO 7894 : 1993 | 20G : >54N<br>21G: >44N<br>22G: >40N | Meets Standard<br>Criteria | Meets Standard Criteria |

## Conclusions:

The indications for use, technology, specification, safety of the IMC Blood Collection Needle and the predicate devices K061483 are essentially the same. The differences between the Blood Collection Needle are minor and do not raise new issues of safety or effectiveness. Hence, the IMC Blood Collection Needles are substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows a black and white logo. The logo consists of a symbol on the right and text on the left. The symbol appears to be three curved lines stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & H.", arranged vertically along the left side of the symbol.

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

Mr. Peter Kim Director of Quality Assurance International Medsurg Connection 935 North Plum Grove Road, Suite F Schaumburg, Illinois 60173

AUG 1 8 2011

Re: K110656

Trade/Device Name: IMC Blood Collection Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: August 3, 2011 Received: August 8, 2011

Dear Mr. Kim:

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 docs 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- Mr. Kim

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), 1 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony La Rue

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 :

Device Name: IMC Blood collection needle

Indications For Use: This device is intended for use in venous blood collection.

Name/Description

| Gauge | Size | Sterility |
|----------------------------------|-------------|-----------------------|
| 20 Gauge Blood Collection needle | 1" and 1 ½" | Sterile & Non-sterile |
| 21 Gauge Blood Collection needle | 1" and 1 ½" | Sterile & Non-sterile |
| 22 Gauge Blood Collection needle | 1" and 1 ½" | Sterile & Non-sterile |

X Prescription Use __ (Part 21 CFR 801 Subpart D) (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)

Ri C. 8/18/4

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

110656 510(k) Number: _______________________________________________________________________________________________________________________________________________________________