K-SHIELD Zen

K220799 · Sb-Kawasumi Laboratories, Inc. · JKA · Aug 29, 2022 · Clinical Chemistry

Device Facts

• Record ID: K220799
• Device Name: K-SHIELD Zen
• Applicant: Sb-Kawasumi Laboratories, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Aug 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

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

Winged blood collection set; includes cannula, flexible tube, connection parts, and Press Button anti-needle stick protector. User accesses peripheral veins for blood collection; after procedure, user presses activation button to retract/store needle within housing to prevent needlestick injuries. Configurations include Luer connector (for syringe), Multiple Sample Luer Adapter, or Preattached Holder (for vacuum tubes/blood culture bottles). Used in hospitals/clinics by healthcare professionals. Single-use, sterile, disposable. Benefits include safe venous access and reduced risk of accidental needlestick injuries.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench performance testing, including biocompatibility (ISO 10993), sterility (USP <71>), particulate matter (USP <788>), and functional testing (ISO 1135-3, ISO 7864, ISO 23908, ISO 80369-7).

Technological Characteristics

Winged needle set; materials: stainless steel needle, PP wing/hub, PVC tubing, isoprene rubber sheath, ABS Luer connector. Sterilization: Ethylene Oxide (ISO 11135). Biocompatibility: ISO 10993-1. Connectivity: None. Form factor: 21G, 23G, 25G gauges. Mechanical safety feature: Press-button needle retraction.

Indications for Use

Indicated for accessing peripheral veins to collect blood in adult patients only. Contraindicated for pediatric age groups, including newborns, neonates, and children.

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

• BD VACUTAINER Push Button Blood Collection Set (K011984)

Submission Summary (Full Text)

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August 29, 2022

SB-Kawasumi Laboratories, Inc. % Valerie Followell Official Correspondent for Kawasumi Laboratories, Inc. / Regulatory Consultant Regulatory Compliance Associates, Inc. (RCA) 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158

Re: K220799

Trade/Device Name: K-SHIELD Zen Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FMI Dated: July 29, 2022 Received: August 1, 2022

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

David Wolloscheck, Ph.D. For Payal Patel 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

Enclosure

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# Indications for Use

510(k) Number (if known)

K220799

Device Name K-SHIELD Zen

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K220799 510(k) Summary

## 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 |
|-----------------------------------|-----------------------------------------------------------|
| 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

```
Predicate Device:
```
BD VACUTAINER Push Button Blood Collection Set (K011984)

#### IV. DEVICE DESCRIPTION

The K-SHIELD Zen is a 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 device is intended for the Adult population only. Do not use in pediatric age groups, including newborn, neonate, or children.

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 BD VACUTAINER Push Button Blood Collection Set (K011984) (predicate device) is provided in the Substantial Equivalence (SE) Comparison Table below.

| Substantial Equivalence (SE) Comparison Table | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K-SHIELD Zen<br>(Subject Device) | BD VACUTAINER Push Button Blood<br>Collection Set (K011984)<br>(Predicate Device) | Same/Similarities/<br>Differences |
| Manufacturer | SB-KAWASUMI LABORATORIES, INC | Becton Dickinson | -- |
| Device Trade or<br>Proprietary<br>Name | K-SHIELD Zen | BD VACUTAINER Push Button Blood<br>Collection Set | -- |
| 510(k)<br>Number | K220799 | K011984 | -- |
| Device Class | Class II | Class II | Same |
| Product Code | JKA and FMI | FMI and JKA | Same |
| Regulation<br>Number | 21 CFR 862.1675 | 21 CFR 880.5570<br>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 | The BD VACUTAINER Push Button<br>Blood Collection Set is a sterile,<br>multiple-sample, single-use winged<br>blood collection set intended for<br>venipuncture to obtain blood | Different. The<br>difference in wording<br>of Indications for use<br>does not raise any<br>new or different<br>questions of safety<br>and effectiveness. |
| | | | |
| | accidental needlestick injuries. | specimens from patients. The | |
| | | recommended use of the device is to | |
| | | activate the needle prior to removal | |
| | | from the venipuncture site. The | |
| | | retraction of the intravenous (IV) end | |
| | | of the needle aids in the prevention | |
| | | of needlestick injury. | |
| 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 BD VACUTAINER Push Button<br>Blood Collection Set is for venous<br>blood collection. The wing set<br>contains a needle that will retract<br>into the body of the device when a<br>button is depressed, helping to<br>prevent accidental needle sticks. The<br>retraction of the needle occurs<br>when the user depresses<br>the button. | 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 | Thin Wall | Different. The<br>difference in the<br>diameter does not<br>raise new or different<br>questions of safety<br>and effectiveness.<br>Performance<br>Testing was |
| | | | conducted to<br>demonstrate<br>substantial<br>equivalence. |
| Needle Protector | PP | Information not available | Different (assumed).<br>Subject device<br>materials comply<br>with ISO 10993-1<br>and have a long<br>history of use in<br>medical device<br>applications. |
| Needle Sheath<br>Cover | Isoprene Rubber | Isoprene Rubber | Same |
| Wing | PP | Polyolefin | Different. The<br>different but<br>comparable material<br>of the wing does not<br>raise new or<br>different questions<br>of safety and<br>effectiveness. Both<br>materials comply<br>with ISO 10993-1<br>and have a long<br>history of use in<br>medical device<br>applications. Non-<br>Clinical Testing was<br>conducted to<br>demonstrate SE. |
| Tubing | PVC | PVC | Same |
| Female Luer<br>Connector | ABS | ABS | Same |
| Luer Adaptor<br>Hub | PP | PP | Same…