(244 days)
Not Found
Not Found
No
The device description and intended use are for a standard blood collection set with a safety shield, and there is no mention of AI or ML capabilities.
No
The device is used for obtaining blood samples and for short-term intravenous fluid administration, which are diagnostic and procedural functions, not therapeutic.
No
The device is a blood collection set and an intravenous fluid administration set, used for obtaining blood samples and administering fluids, respectively. It does not perform any diagnostic function.
No
The device description clearly outlines physical components such as needles, tubing, luer adapters, and a safety shield, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for venipuncture to obtain blood samples from patients and for short-term intravenous administration of fluids. These are procedures performed on the patient, not on a sample in vitro (outside the body).
- Device Description: The description focuses on the physical components used for accessing the patient's bloodstream (needles, tubing, luer adapters, safety shield).
- Lack of IVD Characteristics: There is no mention of analyzing blood samples, detecting substances in blood, or any other activity that would be performed on a sample in vitro to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a tool for collecting the specimen and administering fluids, not for analyzing it.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JKA, FMI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venipuncture (for blood collection), patient's vein (for fluid administration)
Indicated Patient Age Range
any patient population
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)
Not Found
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.
Not Found
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
§ 862.1675 Blood specimen collection device.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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, payal.patel@fda.hhs.gov.
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
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
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.
2
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 (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/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
3
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:
4
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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