(367 days)
No
The summary describes a mechanical blood drawing kit with safety features and a needleless connector. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for vascular access for blood withdrawal" and "This device is not intended for blood transfusion." While the "Device Description" section inaccurately claims it's a "therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition," the primary intended use of a blood drawing kit is diagnostic (collecting blood for testing) or for donation, not directly for therapy. The act of "aiding in the treatment of a disease or other condition" through blood removal is typically associated with therapeutic phlebotomy for conditions like hemochromatosis, but the core function described (blood withdrawal and transfer to a reservoir) without specifying therapeutic phlebotomy as the primary indication for its use, positions it more as a diagnostic or collection tool.
No
Explanation: The device is described as a "therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition," and is intended for "blood withdrawal" and "blood sampling," not for diagnosing a condition.
No
The device description explicitly lists multiple physical components such as a needle protector, cannula, hub, tubing, and a blood bag reservoir, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "vascular access for blood withdrawal" and "needle-free blood withdrawal when blood sampling is required." This describes a device used to collect a sample from the patient, not to perform a diagnostic test on the sample.
- Device Description: The description focuses on the physical components and function of the device for accessing a vein and collecting blood into a reservoir. It explicitly states it's a "therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition." While blood is collected, the device itself is not performing a diagnostic function on that blood.
- Lack of Diagnostic Function: There is no mention of the device analyzing the blood, detecting biomarkers, or providing any diagnostic information. Its purpose is solely for the collection of the sample.
IVD devices are designed to perform tests on samples (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device is a tool for obtaining the sample, not for the diagnostic testing itself.
N/A
Intended Use / Indications for Use
The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.
Product codes (comma separated list FDA assigned to the subject device)
KSB, LHI, FMI
Device Description
The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. The device is not intended for blood transfusion.
The Kawasumi Laboratories Blood Drawing Kit (BDK) System consists of a Blood Drawing Kit device that is designed with an integral Antineedle Stick Protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein and may incorporate a needleless access connector site used for blood sampling.
The Blood Drawing Kit System is a single use, disposable Ethylene Oxide Sterilized medical device. Sterilization Validation was conducted per ISO 11135-1: 2007 – Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirement, Validation, and Routine Control of a Sterilization Process for Medical Devices. The Blood Drawing Kit System is considered blood path, indirect, limited contact (
§ 864.9875 Transfer set.
(a)
Identification. A transfer set is a device intended for medical purposes that consists of a piece of tubing with suitable adaptors used to transfer blood or plasma from one container to another.(b)
Classification. Class II (performance standards).
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September 28, 2018
Kawasumi Laboratories, Inc. % Lisa Michels Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158
Re: K172957
Trade/Device Name: Kawasumi Laboratories Blood Drawing Kit (BDK) System Regulation Number: 21 CFR 864.9875 Regulation Name: Transfer set Regulatory Class: Class II Product Code: KSB, LHI, FMI Dated: August 21, 2018 Received: August 28, 2018
Dear Lisa Michels:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting 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 (if known) K172957
Device Name
Kawasumi Laboratories Blood Drawing Kit (BDK) System
Indications for Use (Describe)
The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY (K172957)
l. SUBMITTER
Owner/Manufacturer:
Kawasumi Laboratories, Inc. Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-Ku, Tokyo, 108-6109, Japan Phone: (81)-3-5769-2663 Contact Person: Katsu Furuya
Date Prepared: September 12, 2017
ll. DEVICE
Trade Name of Device: Kawasumi Laboratories Blood Drawing Kit (BDK) System Common or Usual Name of Device: Blood Drawing Kit System Classification Name: Set, Transfer (Blood Plasma)
Primary Classification Product Code and Classification Regulation:
- KSB (Set, Transfer Blood/Plasma -21 CFR 864.9875) ●
Subsequent Classification Product Code(s) and Classification Regulation(s):
- . LHI (Set I.V Fluid Transfer - 21 CFR 880.5440)
- FMI (Needle, Hypodermic, Single Lumen 21 CFR 880.5570) .
Device Class: Class II
lll. PREDICATE DEVICE(S)
The Blood Drawing Kit (BDK) System is substantially equivalent to Kawasumi Laboratories' own predicate device(s) including the following Primary Predicate Device:
. Kawasumi Laboratories Blood Drawing Kit - cleared under (K001043)
IV. DEVICE DESCRIPTION
The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. The device is not intended for blood transfusion.
The Kawasumi Laboratories Blood Drawing Kit (BDK) System consists of a Blood Drawing Kit device that is designed with an integral Antineedle Stick Protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein and may incorporate a needleless access connector site used for blood sampling.
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The Blood Drawing Kit System is a single use, disposable Ethylene Oxide Sterilized medical device. Sterilization Validation was conducted per ISO 11135-1: 2007 – Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirement, Validation, and Routine Control of a Sterilization Process for Medical Devices. The Blood Drawing Kit System is considered blood path, indirect, limited contact (