(66 days)
No
The device description and performance studies focus on the physical characteristics and mechanical function of a blood collection adapter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as non-invasive and used for transferring blood specimens, not for treating a disease or condition.
No
This device is described as a non-invasive device used for transferring blood specimens, not for diagnosing medical conditions. Its purpose is to facilitate blood collection, not to analyze or interpret results.
No
The device description clearly states it is a physical device made of plastic and stainless steel, used for transferring blood specimens. It undergoes physical and chemical testing, sterilization, and packaging, indicating it is a hardware device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is described as a sterile, non-invasive device used for transferring blood specimens or collecting blood specimens into blood collection tubes or bottles. It facilitates the physical handling of the blood sample, but it does not perform any diagnostic testing on the blood itself.
- Device Description: The description focuses on the physical components and how it connects to syringes or luer systems to move blood. There is no mention of reagents, assays, or any components that would be used to analyze the blood for diagnostic purposes.
- Lack of Diagnostic Function: The device's function is purely mechanical – to safely and efficiently transfer or collect blood samples. It does not analyze the sample for any disease, condition, or biological marker.
- Performance Studies: The performance studies described are focused on the physical and functional aspects of the device (luer connection, simulation, physical tests, sterility, etc.), not on the accuracy or performance of a diagnostic test.
In summary, the Kawasumi Multiple Sample Adapter with Pre-Attached Holder is a device used in the collection and handling of biological specimens, which is a step prior to in vitro diagnostic testing, but it is not an IVD itself.
N/A
Intended Use / 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.
Product codes
JKA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals or healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Items and Referenced Standards with Results:
- 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 (PASS)
- Chemical test: ISO 1135-3:2016 (PASS)
- Usability test: ISO 14971:2019 IEC 62366-1:2015 + Amd.1:2020 (PASS)
- Sterilization, Transportation & Packaging
- EtO residual: ISO 10993-7:2008/Amd.1:2019 (PASS)
- Bacterial endotoxin: USP (PASS)
- Sterility test: USP (PASS)
- Transportation & Package: ISO 11607-1:2019 ISO 11607-2:2019 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].
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
1
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,
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: v.followell@rcainc.com
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.
4
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. |
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Kawasumi Laboratories, Inc.
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
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
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
Length (mm): $64.1 \pm 0.3$
Width (mm): $31 \pm 0.3 \times 23.5 \pm 0.2$ | Gauge: 20G
Length(mm): $64.1 \pm 0.3$
Width(mm): $31 \pm 0.3 \times 23.5 \pm 0.2$ | Same |
| Luer Adapter
Type | Female | Male | Different
Differences do not
change assertion of
equivalence of devices |
| Number of Uses | Single-Use Rx Only | Single-Use Rx Only | Same |
| Materials
Hub | Polycarbonate (PC) | Polycarbonate (PC) | Different
Material is identical with
the exception of its color.
Supportive information
included in submission. |
| Cannula | Stainless Steel | Stainless Steel | Same |
| Glue | Epoxy | Epoxy | Same |
| Silicone | Silicone Oil | Silicone Oil | Different
Supportive information
included in submission. |
| Sheath | Isoprene Rubber
Not made with Natural Rubber
Latex | Isoprene Rubber
Not made with Natural Rubber
Latex | Same |
| Holder | Polypropylene (PP) | Polypropylene (PP) | Same |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Shelf Life | 3 years | 3 years | Same |
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6
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 | PASS |
| Chemical test | ISO 1135-3:2016 | PASS |
| Usability test | ISO 14971:2019 | |
| IEC 62366-1:2015 + Amd.1:2020 | PASS | |
| Sterilization, Transportation & Packaging | ||
| EtO residual | ISO 10993-7:2008/Amd.1:2019 | PASS |
| Bacterial endotoxin | USP | PASS |
| Sterility test | USP | PASS |
| Transportation & Package | ISO 11607-1:2019 | |
| ISO 11607-2:2019 | ||
| 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].