(106 days)
No
The device description and performance studies focus on the mechanical function, materials, and sterilization of a blood collection set. There is no mention of AI or ML in the intended use, device description, or performance data.
No
The device is described as a blood collection set for accessing peripheral veins to collect blood, which is a diagnostic procedure, not a therapeutic one.
No
This device is designed for collecting blood, which is a step in the diagnostic process but does not itself provide a diagnosis.
No
The device description clearly outlines physical components such as a cannula, flexible tube, connection parts, and an anti-needle stick protector. It also details sterilization and biocompatibility testing, which are relevant to physical devices, not software.
Based on the provided information, the K-SHIELD Zen is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "accessing peripheral veins to collect blood." This is a procedure performed on the patient to obtain a sample.
- Mechanism of Action: The mechanism is described as "blood collection using syringes or vacuum blood collection tubes / blood culture bottles to assist the user with obtaining blood from a patient." This focuses on the collection of the sample, not the testing or analysis of the sample.
- Device Description: The description details the components involved in the physical act of drawing blood (needle, tube, connectors, safety mechanism). It does not mention any components or functions related to analyzing or testing the collected blood.
- Performance Studies: The performance studies listed are related to the safety and physical properties of the device (biocompatibility, sterilization residuals). There are no studies related to the accuracy or performance of a diagnostic test.
In Vitro Diagnostic (IVD) devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. The K-SHIELD Zen is a tool used to obtain the specimen, not to test it.
N/A
Intended Use / Indications for Use
K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.
Product codes
JKA, FMI
Device Description
The K-SHIELD Zen is a sterile, single use winged blood collection set consisting with a cannula, flexible tube, connection parts and the Press Button anti-needle stick protector designed to minimize accidental needlestick injuries when accessing peripheral veins to collect patient blood. The Press Button anti-needle stick protector stores the needle within the housing when the activation button is pressed after blood collection procedure.
This product has a variety of Needle gauge sizes (21G, 23G, 25G) and a lineup of 3 types of connection parts, Luer connector (PBM), Multiple Sample Luer Adapter (PBMA) and Preattached Holder (PBMH). During blood collection, the Luer connector is connected to a syringe. Multiple Sample Luer Adapter and Pre-attached holder are connected to vacuum blood collection tubes / blood culture bottles to obtain multiple samples. The different configurations (connection options) are chosen by the user based on facility blood collection procedure.
The mechanism of action for the device, all configurations, is blood collection using syringes or vacuum blood collection tubes / blood culture bottles to assist the user with obtaining blood from a patient.
The K-SHIELD Zen is a single use, disposable Ethylene Oxide Sterilized medical device. Sterilization Validation was conducted per ISO 11135: 2014 – Sterilization of Health-Care Products – Ethylene Oxide –Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.
The K-SHIELD Zen is considered blood path, indirect, limited contact (
§ 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.
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June 1, 2023
SB-Kawasumi Laboratories, Inc. % Valerie Followell Official Correspondent for SB-KAWASUMI LABORATORIES, INC. Regulatory Compliance Associates, Inc. (RCA) 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158
Re: K230408
Trade/Device Name: K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: May 2, 2023 Received: May 3, 2023
Dear Valerie Followell:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Walloschek
David Wolloscheck, Ph.D. Assistant 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
Page 2
Enclosure
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Indications for Use
510(k) Number (if known) K230408
Device Name
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBMA/ PBM)
Indications for Use (Describe)
K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary -K230408
DATE: 06/01/2023
I. SUBMITTER
Sponsor/Manufacturer
SB-KAWASUMI LABORATORIES, INC. 3-25-4 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-8602, Japan Tel:+81-44-589-9750 Fax:+81-44-589-9768
US Contact and Official Correspondent for SB-KAWASUMI LABORATORIES, INC.
Valerie Followell Official Correspondent Regulatory Compliance Associates®, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158 Phone: (847) 400-6187 Email: v.followell@rcainc.com
II. DEVICE
| Device Trade/Proprietary Name: | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) |
|---|---|
| Device Common or Usual Name: | Blood Specimen Collection Device |
| Device Classification Name: | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Regulatory Classification: | Class II |
| Device Classification Regulation: | 21 CFR 862.1675 |
| Product Code: | JKA - Blood Specimen Collection Device |
| FMI – Needle, Hypodermic, Single Lumen | |
| Submission Type: | 510(k) |
| Classification Panel: | General Hospital |
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III. PREDICATE DEVICE
K-SHIELD Zen (K220799) Predicate Device: ●
IV. DEVICE DESCRIPTION
The K-SHIELD Zen is a sterile, single use winged blood collection set consisting with a cannula, flexible tube, connection parts and the Press Button anti-needle stick protector designed to minimize accidental needlestick injuries when accessing peripheral veins to collect patient blood. The Press Button anti-needle stick protector stores the needle within the housing when the activation button is pressed after blood collection procedure.
This product has a variety of Needle gauge sizes (21G, 23G, 25G) and a lineup of 3 types of connection parts, Luer connector (PBM), Multiple Sample Luer Adapter (PBMA) and Preattached Holder (PBMH). During blood collection, the Luer connector is connected to a syringe. Multiple Sample Luer Adapter and Pre-attached holder are connected to vacuum blood collection tubes / blood culture bottles to obtain multiple samples. The different configurations (connection options) are chosen by the user based on facility blood collection procedure.
The mechanism of action for the device, all configurations, is blood collection using syringes or vacuum blood collection tubes / blood culture bottles to assist the user with obtaining blood from a patient.
The K-SHIELD Zen is a single use, disposable Ethylene Oxide Sterilized medical device. Sterilization Validation was conducted per ISO 11135: 2014 – Sterilization of Health-Care Products – Ethylene Oxide –Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.
The K-SHIELD Zen is considered blood path, indirect, limited contact (