Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

K223810 · Sb-Kawasumi Laboratories, Inc. · JKA · Feb 24, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223810
• Device Name: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
• Applicant: Sb-Kawasumi Laboratories, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Feb 24, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

Female luer type · The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with syringes when transferring blood specimen from a syringe to blood culture bottle. Male luer type · The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

Device Story

Sterile, single-use, non-invasive blood collection adapter; consists of plastic holder, stainless steel cannula, rubber sheath, and luer adapter. Two configurations: male luer (connects to vascular access devices) and female luer (connects to syringes). Used in hospitals/healthcare facilities by clinicians. For female luer type, clinician draws blood into syringe, connects device to syringe, and inserts blood collection tube/culture bottle; vacuum in tube/bottle draws blood through cannula. Facilitates safe blood transfer and collection; minimizes exposure risk.

Clinical Evidence

Bench testing only. Testing included luer connector evaluation (ISO 80369-7), simulation testing, physical testing (ISO 1135-3), particulate contamination (USP <788>), chemical testing (ISO 1135-3), usability testing (ISO 14971, IEC 62366-1), EtO residuals (ISO 10993-7), bacterial endotoxin (USP <85>), sterility (USP <71>), and transportation/packaging validation (ISO 11607, ASTM D4169). All tests passed.

Technological Characteristics

Sterile, single-use, non-invasive adapter. Materials: Polycarbonate hub, stainless steel cannula, isoprene rubber sheath, polypropylene holder, epoxy glue, silicone oil. Dimensions: 20G cannula, 64.1mm length. Sterilization: Ethylene Oxide. Connectivity: Mechanical luer connection (male or female). No software or electronic components.

Indications for Use

Indicated for use in hospitals or healthcare facilities for blood specimen collection. Female luer type: used to transfer blood from a syringe to a blood collection tube or blood culture bottle. Male luer type: used to collect blood into a blood collection tube by connecting to female luer connectors of vascular access devices (e.g., peripheral/central catheters, Huber needles).

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

• Kawasumi Multiple Sample Adapter with Pre-attached Holder (K190485)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 24, 2023

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

Re: K223810

Trade/Device Name: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: January 27, 2022 Received: January 27, 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,

Danil Walloschek

David Wolloscheck, Ph.D. Acting 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) K223810

### Device Name

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

## Indications for Use (Describe)

Female luer type

· The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with syringes when transferring blood specimen from a syringe to blood culture bottle.

### Male luer type

· The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

Type of Use (Select one or both, as applicable)

| <span> <b> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</b> </span> |
|-------------------------------------------------------------------------------------------------------------|
| <span> <b> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</b> </span> |

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# K223810 - 510(K) Summary

Manufacturer: SB-KAWASUMI LABORATORIES, INC.

## Address:

3-25-4, Tonomachi, Kawasaki-ku Kawasaki-shi. Kanagawa 210-8602, JAPAN

Corresponding Official/Contact: Valerie Followell Regulatory Consultant Telephone Number: 847-400-6187 Email: [e-mail]

#### Summary Date: Februarv 24, 2023

Trade Name: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

Common or Usual Name: Blood Collection Tubes, Vials, Systems, Serum Separators

Regulation Number: 21 CFR 862.1675

Regulation Name: Blood specimen collection device

Product Code: JKA

Class: Class 2

Panel: Clinical Chemistry

Predicate Device: Kawasumi Multiple Sample Adapter with Pre-attached Holder has only one configuration with Male Luer Adapter (K190485)

# Device Description:

The Kawasumi Multiple Sample Adapter with Pre-attached Holder (MBCH) is a sterile, single use device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a luer adapter. There are two types of the device with difference in luer adapter type; male luer adapter type and female luer adapter type. The predicate device (K190485) is the male luer type and the proposed device is the female luer type, and the subject of this special 510(k) premarket notification submission.

- The male luer adapter type is used to collect blood specimen into blood collection tube by . connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. (predicate [Item number MBCH-01])
- The female luer adapter type is used to transfer blood from a syringe into blood collection tube . or blood culture bottle. After drawing patient blood into a syringe, connect the female luer adapter of the device to the syringe. When inserting a tube, the blood is transferred into the tube using tube's vacuum. (subject [Item number MBCH-02])

The device is sterilized using Ethylene Oxide. The device is a prescription-use device intended to be used in hospitals or healthcare facilities.

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# Indications for Use:

### Female luer type

· The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with syringes when transferring blood specimen from a syringe to blood collection tube or blood culture bottle.

### Male luer type

· The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

| 510(k) Summary Device Comparison Table | | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature of the Device | Subject Device: | Predicate Device: | Discussion/Comment: |
| | SB-KAWASUMI LABORATORIES, INC.<br><br>Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Kawasumi Laboratories, Inc.<br><br>Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | The company name has been changed. Statement included in submission. |
| Item number (Model number) | MBCH-01 and MBCH-02 | MBCH-01 | Different<br>The new item number MBCH-02 is added. |
| 510(k) Number | K223810 | K190485 | - |
| Product Code | JKA | JKA | Same |
| Classification | 21 CFR 862.1675 | 21 CFR 862.1675 | Same |
| Classification Name | Tubes, Vials, Systems, Serum Separators, Blood Collection | Tubes, Vials, Systems, Serum Separators, Blood Collection | Same |
| Common Name | Blood Specimen Collection Device | Blood Specimen Collection Device | Same |
| Rx or OTC | Rx only | Rx Only | Same |
| Number of Uses | Single-Use | Single-Use | Same |
| Use Environment | Hospital and/or Healthcare Facility | Hospital and/or Healthcare Facility | Same |
| Indications for Use | Female luer type The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with syringes when transferring blood specimen from a syringe to blood collection tube or blood culture bottle. Male luer type The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube. | The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube. | Different<br>Although there is a difference in where to connect the device, both types are used for collecting blood specimen to blood collection tube or blood culture bottle. |
| Intended Use | Same as the Indications for Use | Same as the Indications for Use | Same |
| Design Feature | Gauge: 20G<br>Length (mm): $64.1 \pm 0.3$<br>Width (mm): $31 \pm 0.3 \times 23.5 \pm 0.2$ | Gauge: 20G<br>Length(mm): $64.1 \pm 0.3$<br>Width(mm): $31 \pm 0.3 \times 23.5 \pm 0.2$ | Same |
| Luer Adapter<br>Type | Female | Male | Different<br>Differences do not<br>change assertion of<br>equivalence of devices |
| Number of Uses | Single-Use Rx Only | Single-Use Rx Only | Same |
| Materials<br>Hub | Polycarbonate (PC) | Polycarbonate (PC) | Different<br>Material is identical with<br>the exception of its color.<br>Supportive information<br>included in submission. |
| Cannula | Stainless Steel | Stainless Steel | Same |
| Glue | Epoxy | Epoxy | Same |
| Silicone | Silicone Oil | Silicone Oil | Different<br>Supportive information<br>included in submission. |
| Sheath | Isoprene Rubber<br>Not made with Natural Rubber<br>Latex | Isoprene Rubber<br>Not made with Natural Rubber<br>Latex | Same |
| Holder | Polypropylene (PP) | Polypropylene (PP) | Same |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Same |
| Shelf Life | 3 years | 3 years | Same |

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# Technological Characteristics:

The Subject Device and the Predicate Device have similar technological characteristics. Both devices are sterile, single-use, non-invasive devices with a Pre-Attached Holder used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

The Kawasumi Multiple Sample Adaptor with Pre-Attached Holder (Subject Device [MBCH-02]) is substantially equivalent to the Predicate Device [MBCH-01] with regard to technologic characteristics, materials, performance and intended use.

# Non-Clinical Testing:

Non-Clinical Performance Testing was performed to ensure that the device meets design requirements and specifications and to confirm performance of the Kawasumi Multiple Sample Adaptor with Pre-Attached Holder [MBCH-02].

| Test Item | Referenced standard | Result |
|-------------------------------------------|-------------------------------------------------------|--------|
| Performance & Chemical Testing | | |
| Luer connector evaluation | ISO 80369-7:2021 | PASS |
| Simulation test | In-house | PASS |
| Physical test | ISO 1135-3:2016, in-house | PASS |
| Particulate contamination | USP<788> | PASS |
| Chemical test | ISO 1135-3:2016 | PASS |
| Usability test | ISO 14971:2019<br>IEC 62366-1:2015 + Amd.1:2020 | PASS |
| Sterilization, Transportation & Packaging | | |
| EtO residual | ISO 10993-7:2008/Amd.1:2019 | PASS |
| Bacterial endotoxin | USP <85> | PASS |
| Sterility test | USP <71> | PASS |
| Transportation & Package | ISO 11607-1:2019<br>ISO 11607-2:2019<br>ASTM D4169-16 | PASS |

### Conclusion:

Based on the Non-Clinical Performance Testing conducted on the subject device, intended use, and principles of operation it may be concluded that the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (Subject Device [MBCH-02]) is substantially equivalent to the legally marketed Predicate Device [MBCH-01].