(131 days)
Not Found
No
The device description and performance studies focus on the mechanical function and material properties of a blood collection adapter, with no mention of AI or ML.
No
This device is for collecting blood specimens and does not treat or diagnose a disease or condition.
No
Explanation: The device is used to collect blood specimens, which is a step sometimes involved in diagnostics, but the device itself does not perform any diagnostic function. It is a collection tool.
No
The device description clearly states it is a physical, sterile, single-use device made of plastic and stainless steel, used for blood collection. It undergoes physical and chemical testing, sterilization, and packaging integrity testing, all indicative of a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of blood specimens, not for the testing or analysis of those specimens. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical mechanism of blood collection (connecting to luer systems, inserting blood collection tubes). It does not mention any components or processes related to analyzing the blood itself.
- Lack of Diagnostic Function: The device's function is purely mechanical – facilitating the transfer of blood from a patient's vascular access device into a collection tube. It does not perform any diagnostic test or provide any diagnostic information.
The device is a tool used in preparation for potential in vitro diagnostic testing, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Kawasumi Multiple Sample Adapter with Pr-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 (comma separated list FDA assigned to the subject device)
JKA
Device Description
The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, singleuse device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used to collect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. As this device can be connected to various devices with female luer adapter, it is called "multiple sample adapter".
When blood is collected, the blood collection tube is placed over the cannula, pushing the rubber sheath back, allowing blood flow. After obtaining the correct amount of blood, the blood collection tube is removed from the holder. When the blood collection tube is removed, the rubber sheath extends back over the cannula and stopping blood flow. Blood collection may be continued by connecting additional blood collection tubes, if required.
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
The device is a prescription-use device intended to be used in 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).
Comparative Testing: Comparative Evaluation Testing was conducted to verify that the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) has equivalent function and performance as the predicate device, the Becton Dickinson BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder (K991088). This Comparative Evaluation Testing assessed the following criterion of the subject and predicate devices:
• Appearance and Measurement
• Attachment and Detachment
• Pressure Resistance
• Connection Strength
• Vacuum Tube Insertion and Removal
• Chemical Resistance
Shelf Life Evaluation:
Physical Testing - Accelerated Aging Testing was conducted on the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) [0 Month] / [6 Months] and [36 Months].
Chemical Testing - Accelerated Aging Testing was conducted on the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) [0 Month] and [36 Months].
Physical Testing Accelerated Aging [0 Month], [6 Months] and [36 Months]: Physical Testing - Accelerated Aging Testing was conducted on the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) to ensure the functionality, performance, quality, and safety of the device to demonstrate substantial equivalence to the predicate device. Physical Testing on the Ethylene Oxide (EtO) Sterilized Kawasumi Multiple Sample Adapter with Pre-Attached Holder for [0 Months] / [6 Months] and [36 Months] aging by assessing the following:
• Packaging Study / Stability Test
Transportation per ISTA 2A
Appearance per ISO 11607-1 2006/Amd.1:2014
Seal Strength per ISO 11607-2: 2006/Amd.1:2014
Dye Test per ISO 11607-2: 2006/Amd.1:2014
• Physical Study / Stability Test
Leakage per ISO 1135-3: 2016 5.2
Tensile Strength per ISO 1135-3: 2016 5.3
Chemical Testing Accelerated Aging [0 Months] and [36 Months]: Blood Taking Needle per ISO 1135-3: 2016 5.6 Chemical Testing - Accelerated Aging Testing was conducted on the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) to ensure the functionality, performance, quality, and safety of the device to demonstrate substantial equivalence to the predicate device. The following items were assessed on the [0 Months] and [36 Months] aging samples, per ISO 1135-3:2016.
- Reducing matter
- Metal ions
- Titration acidity and alkalinity
- Nonvolatile residue
- Absorbance
Sterilization Product Adoption: 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.
Sterility: Product Sterility Testing was performed according to United States Pharmacopeia Stability Test.
EO Residuals: Residual Gas & Chemical Testing was conducted on the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) to ensure the functionality, performance, quality, and safety of the device per ISO 10993-7: Biological Evaluation of Medical Devices Part 7 – Ethylene Oxide Sterilization Residuals including:
• Chemical Testing - Residual Gas & Chemical Testing - [0 Months]
• Chemical Testing - [36 Months]
Particulate Contamination Testing: Particulate Contamination Testing was conducted on the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) to ensure the functionality, performance, quality, and safety of the device to demonstrate substantial equivalence to the predicate device. This Particulate Contamination Testing was conducted per ISO 1135-3:2016, Item 5.1 on MBCH with accelerated aging at 55°C, 138 days for real-time equivalent [36 Months]. The test procedure follows Annex A.1 of ISO 1135-3:2018.
Packaging: Packaging Integrity Testing was conducted to verify the integrity of the packaging. The tests included:
• Transportation Test (ISTA 2A)
• Appearance Test (ISO 11607-1:2006/Amd.1:2014)
• Seal Strength Test (ISO11607-2:2006/Amd.1:2014)
• Dye Test (ISO11607-2:2006/Amd.1:2014)
Luer Fitting Testing (Conformance to ISO 80369-7:2016) [0 Months] and [36 Months]: Luer Fitting Testing [0 Months] and Luer Fitting Testing [36 Months] was conducted in accordance with ISO 80369-7:2016 - Small-Bore Connectors for Liquids and Gases in Healthcare Applications -- Part 7: Connectors for Intravascular or Hypodermic Applications to confirm that the products produced based on the output of the design conform to the needs of the user and the intended use. The dimensions of the MBCH were measured to verify the parts of the MBCH were within the tolerance range and conform the standard.
Biocompatibility: Biocompatibility Testing was conducted on the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) in accordance with ISO 10993-1:2009 (Fourth Edition 2009-10-15) Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Withi
Cytotoxicity Testing per ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
Sensitization Testing per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
Irritation or Intracutaneous Reactivity Testing per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
Acute Systemic Toxicity Testing per ISO 10993-11:2017 Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity
Material-Mediated Pyrogenicity Testing per USP General Chapter Pyrogen Test and ISO 10993-11:2017 Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity
Hemocompatibility Testing per ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-4:2017 Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood
Conclusion: Based on the Non-Clinical Performance Testing conducted on the subject device, intended use, and priciples of operation it may be concluded that the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (Subject Device) is substantially equivalent to the legally marketed Predicate Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2019
Kawasumi Laboratories, Inc. % Lisa Michels Regulatory Compliance Associates, Inc. (RCA) 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158
Re: K190485
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: June 6, 2019 Received: June 11, 2019
Dear Lisa Michels:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
for Nikhil Thakur 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
2
Indications for Use
510(k) Number (if known) K190485
Device Name
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
Indications for Use (Describe)
The Kawasumi Multiple Sample Adapter with Pr-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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3
510(K) Summary: K190485
Manufacturer:
Kawasumi Laboratories, Inc.
Address:
Shinagawa Intercity Tower B, 9th Floor 2-15-2. Konan. Minato-Ku. Tokyo, 108-6109, Japan
Corresponding Official/Contact:
Lisa L. Michels, J.D., M.S.O.L.Q Regulatory Consultant
Telephone Number: (602)-935-2565 Email: I.michels@rcainc.com
Summary Date: July 3, 2019
Trade Name: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
Common or Usual Name: Blood Specimen Collection Device
Requlation Number: 21 CFR 862.1675
Regulation Name: Blood specimen collection device
Product Code: JKA
Class: Class 2
Panel: Clinical Chemistry
Predicate Device: Becton Dickinson BD Vacutainer® Brand Multiple Sample Luer Adapter / BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder (K991088)
Device Description:
The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, singleuse device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used to collect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. As this device can be connected to various devices with female luer adapter, it is called "multiple sample adapter".
When blood is collected, the blood collection tube is placed over the cannula, pushing the rubber sheath back, allowing blood flow. After obtaining the correct amount of blood, the blood collection tube is removed from the holder. When the blood collection tube is removed, the rubber sheath extends back over the cannula and stopping blood flow. Blood collection may be continued by connecting additional blood collection tubes, if required.
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:
The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, noninvasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.
| Feature of the
| Device | Subject Device: | Primary Predicate: | Discussion/Comment: |
|---|---|---|---|
| Kawasumi Multiple Sample | |||
| Adapter with Pre-Attached | |||
| Holder (MBCH) | BD Vacutainer® Brand | ||
| Multiple Sample Luer | |||
| Adapter / BD Vacutainer® | |||
| Safety-Lok Blood Collection | |||
| Set with Pre-Attached Holder | |||
| (K991088) | |||
| Product Code | JKA | JKA | Same |
| Classification | 21 CFR 862.1675 | 21 CFR 862.1675 | Same |
| Number of Uses | Single-Use Rx Only | Single-Use Rx Only | Same |
| Materials | Hub: Polycarbonate (PC) | Hub: Polystyrene | Biocompatibility Testing |
| and Performance | |||
| Testing was conducted | |||
| to demonstrate SE. | |||
| Cannula: Stainless Steel | Cannula: Stainless Steel | Same | |
| Glue: Epoxy | Glue: Epoxy | Same | |
| Silicon: Silicon Oil | Silicon: Silicon Oil | Same | |
| Sheath: Isoprene Rubber | |||
| Not made with Natural | |||
| Rubber Latex | Sheath: Isoprene Rubber | ||
| Not made with Natural | |||
| Rubber Latex | Same | ||
| Holder: Polypropylene (PP) | Holder: Polypropylene (PP) | Same | |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Sterilization | |||
| Method | Ethylene Oxide | Ethylene Oxide | Same |
| Indication for | |||
| Use | 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 Vacutainer Brand | ||
| Multiple Sample Luer | |||
| Adapter / BD Vacutainer® | |||
| Safety-Lok Blood Collection | |||
| Set with Pre-Attached Holder | |||
| is a sterile, non-invasive | |||
| device used to connect | |||
| venous access device such | |||
| as needles, blood collection | |||
| sets, and infusion sets to | |||
| blood collection tubes. They | |||
| are also used in connection | |||
| with non-needle devices for | |||
| collection of blood from | |||
| catheters. The Vacutainer | |||
| Brand Luer Adapter is sold | |||
| by itself and as a component | |||
| of other Vacutainer Brand | |||
| devices. | Similar-The difference | ||
| is in the name of the | |||
| device, this does not | |||
| raise any questions of | |||
| safety or effectiveness. | |||
| Design Feature | Gauge: 20G | ||
| Length: 64.1 mm | |||
| Width (A): 31.1 mm | |||
| Width (B): 23.6 mm | Gauge: 20G | ||
| Length: 64.3 mm | |||
| Width (A): 30.5 mm | |||
| Width (B): 24.9 mm | Non-Clinical | ||
| Performance Testing | |||
| was conducted to | |||
| demonstrate SE. |
5
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 (MBCH) (Subject Device) is substantially equivalent to the Becton Dickinson Vacutainer Brand Multiple Sample Luer Adapter / BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder (K991088) (Predicate Device) 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).
| Test Name | Test Description |
|---|---|
| Comparative | |
| Testing | Comparative Evaluation Testing was conducted to verify that the |
| Kawasumi Multiple Sample Adapter with Pre-Attached Holder | |
| (MBCH) has equivalent function and performance as the | |
| predicate device, the Becton Dickinson BD Vacutainer® Safety- | |
| Lok Blood Collection Set with Pre-Attached Holder (K991088). | |
| This Comparative Evaluation Testing assessed the following | |
| criterion of the subject and predicate devices: | |
| • Appearance and Measurement | |
| • Attachment and Detachment | |
| • Pressure Resistance | |
| • Connection Strength | |
| • Vacuum Tube Insertion and Removal | |
| • Chemical Resistance | |
| Shelf Life | |
| Evaluation | Physical Testing - Accelerated Aging Testing was conducted |
| on the Kawasumi Multiple Sample Adapter with Pre-Attached | |
| Holder (MBCH) | |
| [0 Month] / [6 Months] and [36 Months]. | |
| Chemical Testing - Accelerated Aging Testing was conducted | |
| on the Kawasumi Multiple Sample Adapter with Pre-Attached | |
| Holder (MBCH) | |
| [0 Month] and [36 Months]. | |
| Physical Testing | |
| Accelerated Aging | |
| [0 Month] | |
| [6 Months] | |
| [36 Months] | Physical Testing - Accelerated Aging Testing was conducted on |
| the Kawasumi Multiple Sample Adapter with Pre-Attached Holder | |
| (MBCH) to ensure the functionality, performance, quality, and | |
| safety of the device to demonstrate substantial equivalence to the | |
| predicate device. Physical Testing on the Ethylene Oxide (EtO) | |
| Sterilized Kawasumi Multiple Sample Adapter with Pre-Attached | |
| Holder for [0 Months] / [6 Months] and [36 Months] aging by | |
| assessing the following: | |
| • Packaging Study / Stability Test | |
| Transportation per ISTA 2A | |
| Appearance per ISO 11607-1 2006/Amd.1:2014 | |
| Seal Strength per ISO 11607-2: 2006/Amd.1:2014 | |
| Dye Test per ISO 11607-2: 2006/Amd.1:2014 | |
| • Physical Study / Stability Test | |
| Leakage per ISO 1135-3: 2016 5.2 | |
| Tensile Strength per ISO 1135-3: 2016 5.3 | |
| Chemical Testing | |
| Accelerated Aging | |
| [0 Months] | |
| [36 Months] | Blood Taking Needle per ISO 1135-3: 2016 5.6 |
| Chemical Testing - Accelerated Aging Testing was conducted on | |
| the Kawasumi Multiple Sample Adapter with Pre-Attached Holder | |
| (MBCH) to ensure the functionality, performance, quality, and | |
| safety of the device to demonstrate substantial equivalence to the | |
| predicate device. The following items were assessed on the [0 | |
| Months] and [36 Months] aging samples, per ISO 1135-3:2016. |
- Reducing matter
- Metal ions
- Titration acidity and alkalinity
- Nonvolatile residue
- Absorbance |
| Sterilization
Product Adoption | 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. |
| Sterility | Product Sterility Testing was performed according to United
States Pharmacopeia Stability Test. |
| EO Residuals | Residual Gas & Chemical Testing was conducted on the
Kawasumi Multiple Sample Adapter with Pre-Attached Holder
(MBCH) to ensure the functionality, performance, quality, and
safety of the device per ISO 10993-7: Biological Evaluation of
Medical Devices Part 7 – Ethylene Oxide Sterilization Residuals
including:
• Chemical Testing - Residual Gas & Chemical Testing - [0 Months]
• Chemical Testing - [36 Months] |
| Particulate
Contamination
Testing | Particulate Contamination Testing was conducted on the
Kawasumi Multiple Sample Adapter with Pre-Attached Holder
(MBCH) to ensure the functionality, performance, quality, and
safety of the device to demonstrate substantial equivalence to the
predicate device. This Particulate Contamination Testing was
conducted per ISO 1135-3:2016, Item 5.1 on MBCH with
accelerated aging at 55°C, 138 days for real-time equivalent [36
Months]. The test procedure follows Annex A.1 of ISO 1135-
3:2018. |
| Packaging | Packaging Integrity Testing was conducted to verify the integrity
of the packaging. The tests included:
• Transportation Test (ISTA 2A)
• Appearance Test (ISO 11607-1:2006/Amd.1:2014)
• Seal Strength Test (ISO11607-2:2006/Amd.1:2014)
• Dye Test (ISO11607-2:2006/Amd.1:2014) |
| Luer Fitting Testing
(Conformance to
ISO 80369-7:2016)
[0 Months]
[36 Months] | Luer Fitting Testing [0 Months] and Luer Fitting Testing [36
Months] was conducted in accordance with ISO 80369-7:2016 -
Small-Bore Connectors for Liquids and Gases in Healthcare
Applications -- Part 7: Connectors for Intravascular or Hypodermic
Applications to confirm that the products produced based on the
output of the design conform to the needs of the user and the
intended use. The dimensions of the MBCH were measured to
verify the parts of the MBCH were within the tolerance range and
conform the standard. |
| Biocompatibility | Biocompatibility Testing was conducted on the Kawasumi Multiple
Sample Adapter with Pre-Attached Holder (MBCH) in accordance
with ISO 10993-1:2009 (Fourth Edition 2009-10-15) Biological
Evaluation of Medical Devices – Part 1: Evaluation and Testing
Withi |
| Cytotoxicity Testing per ISO 10993-5:2009 Biological
Evaluation of Medical Devices – Part 5: Tests for In Vitro
Cytotoxicity | |
| Sensitization Testing per ISO 10993-10:2010 Biological
Evaluation of Medical Devices - Part 10: Tests for Irritation
and Skin Sensitization | |
| Irritation or Intracutaneous Reactivity Testing per ISO
10993-10:2010 Biological Evaluation of Medical Devices -
Part 10: Tests for Irritation and Skin Sensitization | |
| Acute Systemic Toxicity Testing per ISO 10993-11:2017
●
Biological Evaluation of Medical Devices – Part 11: Tests
for Systemic Toxicity | |
| Material-Mediated Pyrogenicity Testing per USP General
Chapter Pyrogen Test and ISO 10993-11:2017
Biological Evaluation of Medical Devices – Part 11: Tests
for Systemic Toxicity | |
| Hemocompatibility Testing per ASTM F756-17 Standard
Practice for Assessment of Hemolytic Properties of
Materials and ISO 10993-4:2017 Biological Evaluation of | |
| Medical Devices – Part 4: Selection of Tests for
Interactions with Blood | |
6
7
Conclusion:
Based on the Non-Clinical Performance Testing conducted on the subject device, intended use, and priciples of operation it may be concluded that the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (Subject Device) is substantially equivalent to the legally marketed Predicate Device.