IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET

K123987 · Innovative Medical Technologies, Inc. · JKA · Aug 27, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123987
• Device Name: IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
• Applicant: Innovative Medical Technologies, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Aug 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non- patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter. The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient's vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male luer adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device.

Device Story

Winged blood collection needles with flexible tubing; female luer adapter; optional male luer adapter for evacuated tube collection. Improsafe version includes manual safety shield for post-withdrawal needle coverage to prevent accidental sticks. Used in clinical settings by healthcare professionals for venipuncture and short-term IV fluid infusion. Device facilitates blood sampling and fluid delivery; safety shield reduces sharps injury risk.

Clinical Evidence

No clinical data.

Technological Characteristics

Winged needle set with flexible tubing; female luer adapter; optional male luer adapter; manual safety shield (Improsafe).

Indications for Use

Indicated for venipuncture to obtain blood samples and short-term (up to 2 hours) IV fluid administration in any patient population, considering patient size, solution appropriateness, and therapy duration.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Submission Summary (Full Text)

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December 4, 2020

Innovative Medical Technologies, Inc. Brad Brown President 15059 Cedar St. Leawood, Kansas 66224

Re: K123987

Trade/Device Name: Improve Blood Collection Set And Improsafe Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA

Dear Brad Brown:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 27, 2013. Specifically, FDA is updating this SE Letter to update the product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices, 240.402.6029, [e-mail].

Sincerely,

Alan M.
Stevens -
S3

CAPT Alan Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

## August 27, 2013

Innovative Medical Technologies, Incorporated Mr. Brad Brown President 15059 Cedar Street LEAWOOD KS 66224

Re: K123987

Trade/Device Name: Improve Blood Collection Set and Improsafe Blood Collection Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Il Product Code: FMI Dated: July 24, 2013 Received: July 26, 2013

Dear Mr. Brown:

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. Ilisting 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 - Mr. Brown

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -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

510(k) Number : K123987

Device Name: Improve Blood Collection Set and Improsafe Blood Collection Set

Indications for Use: Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non- patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter.

The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient's vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male luer adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device.

Prescription Use YES (Part 21 CFR 801 Subpart D)

Over-The-Counter Use NO (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) Richard C. Chapman 2013.08.27 15:03:31 -04'00'

- AND/OR

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Respiratory, Infection Control and

Dental Devices

510(k) Number:

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## Indications for Use

510(k) Number : K123987

Device Name: Improve Blood Collection Set and Improsafe Blood Collection Set

Indications for Use: Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a nonpatient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter.

The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient's vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male luer adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device.

- AND/OR Over-The-Counter Use ____NO___
(21 CER 801 Subpart C) Prescription Use YES (Part 21 CFR 801 Subpart D) (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)

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