K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)

K230408 · Sb-Kawasumi Laboratories, Inc. · JKA · Jun 1, 2023 · Clinical Chemistry

Device Facts

• Record ID: K230408
• Device Name: K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
• Applicant: Sb-Kawasumi Laboratories, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jun 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Sterile, single-use winged blood collection set; includes cannula, flexible tube, connection parts, and press-button anti-needle stick protector. Used in hospitals/clinics by healthcare professionals for peripheral venous access. User selects configuration (Luer connector, multiple sample Luer adapter, or pre-attached holder) based on procedure. After blood collection, pressing activation button retracts needle into housing to prevent needlestick injuries. Facilitates blood collection via syringes or vacuum tubes/bottles. Benefits include reduced risk of accidental needlestick injuries for clinicians.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility and chemical characterization testing (DEHP extraction, risk analysis, EtO residuals) performed per ISO 10993-7, 10993-17, and 10993-18 to support safety for pediatric use. All tests passed.

Technological Characteristics

Materials: Stainless steel needle, PP (wing, protector, hub), Isoprene rubber (sheath), PVC (tubing), ABS (Luer connector), heat-curing epoxy adhesive. Sterilization: Ethylene Oxide (ISO 11135:2014). Form factor: Winged set with 21G, 23G, 25G needle gauges. Connectivity: None. Software: None.

Indications for Use

Indicated for accessing peripheral veins to collect blood in adult and pediatric patient populations. Includes an integral safety device to minimize accidental needlestick injuries.

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.

Predicate Devices

• K-SHIELD Zen (K220799)

Submission Summary (Full Text)

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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 [phone] 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

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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:[phone] Fax:[phone]

#### 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: [phone] Email: [e-mail]

#### 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<br>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 (< 24 hours) per /SO 10993-1: 2018 - Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process. All device materials comply with ISO 10993-1.

The K-SHIELD Zen is a sterile, single-use device that consists of the following components:

●

- . Winged needle with Press Button Anti-needle Stick Protector
- Luer Connector

- . Main Tube
- Clip
- . Connector Tube
- Locking Cap (optional) Multiple Sample Luer Adapter (optional) ●
- Pre-attached Holder (optional) ●

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The K-SHIELD Zen is intended for use at healthcare facilities or in hospitals.

## V. INTENDED USE

K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button antineedle stick protector is an integral safety device intended to minimize accidental needlestick injuries.

## VI. INDICATIONS FOR USE

K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button antineedle stick protector is an integral safety device intended to minimize accidental needlestick injuries.

## VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

- The comparison of the similarities and differences between the K-SHIELD Zen (subject device) and the ● K-SHIELD Zen (K220799) (predicate device) is provided in the Substantial Equivalence (SE) Comparison Table below.

| Substantial Equivalence (SE) Comparison Table | | | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | K-SHIELD Zen<br>(Subject Device) | K-SHIELD Zen<br>(K220799)<br>(Predicate Device) | Same/Similarities/<br>Differences |
| Manufacturer | SB-KAWASUMI LABORATORIES, INC | SB-KAWASUMI LABORATORIES, INC | -- |
| Device Trade or<br>Proprietary<br>Name | K-SHIELD Zen | K-SHIELD Zen | -- |
| 510(k)<br>Number | K230408 | K220799 | -- |
| Device Class | Class II | Class II | Same |
| Device<br>Classification<br>Name | Tubes, Vials, Systems, Serum<br>Separators, Blood Collection | Tubes, Vials, Systems, Serum<br>Separators, Blood Collection | Same |
| Device Common<br>Name | Blood specimen collection device | Blood specimen collection device | Same |
| Product Code | JKA and FMI | JKA and FMI | Same |
| Regulation<br>Number | 21 CFR 862.1675 | 21 CFR 862.1675 | Same |
| Indications for<br>Use | K-SHIELD Zen is designed for<br>accessing peripheral veins to collect<br>blood. The Press Button anti-needle<br>stick protector is an integral safety<br>device intended to minimize<br>accidental needlestick injuries. | K-SHIELD Zen is designed for accessing<br>peripheral veins to collect<br>blood. The Press Button anti-needle<br>stick protector is an integral safety<br>device intended to minimize<br>accidental needlestick injuries. | Same |
| Intended Use | Same as Indications for Use | Same as Indications for Use | Same |
| Patient<br>Population | Adults and Pediatric | Adults Only | Different<br>(Biocompatibility<br>assessments (DEHP<br>extraction testing and<br>risk assessment<br>supports comparison) |
| Device Description | The K-SHIELD Zen is a sterile, single use<br>winged blood collection set<br>consisting with cannula, flexible<br>tube, connection parts and the Press<br>Button anti-needle stick protector<br>designed to minimize accidental<br>needlestick injuries when accessing<br>peripheral veins to collect patient<br>blood. The Press Button anti-needle<br>stick protector stores the needle<br>within the housing when the<br>activation button is pressed after<br>blood collection procedure. | The K-SHIELD Zen is a sterile, single<br>use winged blood collection set<br>consisting with cannula, flexible<br>tube, connection parts and the Press<br>Button anti-needle stick protector<br>designed to minimize accidental<br>needlestick injuries when accessing<br>peripheral veins to collect patient<br>blood. The Press Button anti-needle<br>stick protector stores the needle<br>within the housing when the<br>activation button is pressed after<br>blood collection procedure. | Same |
| Press Button<br>Feature | Yes | Yes | Same |
| Anti-Needle Stick<br>Prevention | Yes | Yes | Same |
| Color-Coded<br>Wing | Yes | Yes | Same |
| Needle | Stainless Steel | Stainless Steel | Same |
| Needle Gauge<br>Diameter OD | 21G, 23G, 25G | 21G, 23G, 25G | Same |
| Needle<br>Diameter ID | Ultra-Thin Wall | Ultra-Thin Wall | Same |
| Needle Protector | PP | PP | Same |
| Needle Sheath<br>Cover | Isoprene Rubber | Isoprene Rubber | Same |
| Wing | PP | PP | Same |
| Tubing | PVC | PVC | Same |
| Female Luer<br>Connector | ABS | ABS | Same |
| Luer Adaptor<br>Hub | PP | PP | Same |
| Adhesive | Heat Curing Epoxy | Heat Curing Epoxy | Same |
| Packaging | Envelope Pouch | Envelope Pouch | Same |
| Materials Comply<br>with<br>ISO 10993-1 | Materials comply with<br>ISO 10993-1 | Materials comply with ISO<br>10993-1 | Same |
| Non-Pyrogenic | Non-Pyrogenic | Non-Pyrogenic | Same |
| Non-Toxic | Non-Toxic | Non-Toxic | Same |
| Prescription (Rx)<br>or Over- the<br>Counter<br>(OTC) Use | Prescription Use | Prescription Use | Same |
| Use<br>Environment | Hospital / Clinic | Hospital / Clinic | Same |
| Single-Use | Single-Use Only | Single-Use Only | Same |
| Sterile | Sterile | Sterile | Same |
| Sterility<br>Assurance Level<br>(SAL 10-6) | SAL 10-6 | SAL 10-6 | Same |
| Sterilization<br>Method | Ethylene Oxide Sterilization (EtO) | Ethylene Oxide Sterilization (EtO) | Same |
| Shelf-Life | 3 Year Shelf-Life | 3 Year Shelf-Life | Same |

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### VIII. SUMMARY OF PERFORMANCE DATA AND PERFORMANCE TEST CONCLUSIONS

The following Performance Data were provided in support of the substantial equivalence (SE) determination.

| Summary of Non-Clinical Bench Performance Testing | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| This submission is for the same device but for an expanded patient population and non-clinical performance and<br>biocompatibility data is leveraged/referenced from K220799. | |
| The table below includes the list of the testing results submitted specific to supporting this expanded patient population. | |
| Biocompatibility Testing | |
| Biocompatibility Testing including:<br>• DEHP Extraction test<br>• Risk Analysis Report of DEHP Exposure<br>FDA Recognized Testing Standards:<br>• ISO 10993-17:2002(First Edition 2002-12-01) – Biological Evaluation of Medical<br>Devices – Part 17: Establishment of allowable limits for leachable substances<br>• ISO 10993-18:2020 (Second edition 2020-01 Amendment 1 2022-05) -<br>Biological evaluation of medical devices - Part 18: Chemical characterization of<br>medical device materials within a risk management process [Including<br>Amendment 1 (2022)] | Test Results: PASSED<br>The results of these Non-<br>Clinical Bench Performance<br>Data were provided in<br>support of the substantial<br>equivalence determination. |
| Chemical Testing | |
| Chemical Testing<br>• EtO Residuals<br>FDA Recognized Testing Standards:<br>• ISO 10993-7:2008 (Second Edition 2008-10-15) –<br>Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization<br>Residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability<br>of allowable limits for neonates and infants (2019)] | Test Results: PASSED<br>The result of the Non-<br>Clinical Bench Performance<br>Data was provided in<br>support of the substantial<br>equivalence determination. |

### IX. OVERALL CONCLUSIONS

- The K-SHIELD Zen [subject device] is substantially equivalent to the K-SHIELD Zen (K220799) [predicate device] with respect to indications for use, treatment method and technological characteristics.