(393 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a simple blood collection accessory, with no mention of AI or ML.
No
The device is used for the collection of blood specimens, which is a diagnostic purpose, not therapeutic.
No
Explanation: The device is a blood collection accessory designed for collecting blood specimens. It does not perform any analysis or interpretation of the collected specimens, which are the functions of a diagnostic device. Its purpose is solely for sample acquisition.
No
The device description explicitly details physical components made of plastic and stainless steel, and the performance studies focus on physical properties and biocompatibility, not software functionality.
Based on the provided information, the Blood Collection Accessory (BUCA) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the collection of blood specimens, not for the examination of the blood specimens to provide information about a physiological state, health, or disease.
- Device Description: The device is a tool for physically collecting blood. It does not contain reagents, calibrators, or controls typically associated with IVD devices used for testing.
- Performance Studies: The performance studies focus on the physical characteristics of the device (luer lock, flow rate, holding strength, biocompatibility, sterilization) and its ability to collect blood effectively, not on the analytical performance of a diagnostic test.
- Predicate Device: The predicate device (Vacutainer® Brand Multiple Sample Luer Adapter) is also a blood collection device, not an IVD.
IVD devices are used to perform tests on biological samples (like blood) to get diagnostic information. The BUCA is a tool used to obtain the biological sample.
N/A
Intended Use / Indications for Use
The Blood Collection Accessory (BUCA) is a single use, sterile and non invasive device used for connecting to venous access device for the collection of blood specimens.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The Blood Collection Accessory (BUCA) is a single use device comprising of a holder made from polypropylene plastic with a male luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder.
The Blood Collection Accessory (BUCA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Collection Accessory (BUCA) also house the sample collection tube and protects the user or healthcare personnel from direct contact with blood specimen. The Adapter connected to the blood collection device for the blood transfer. The sample collection tube is inserted from the far end of the holder where the opening is located. This transfer is conducted until the required amount of blood is completed. The sample collection tube is then evacuated from the Blood Collection Accessory (BUCA) by pulling it away from the latter.
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
Not Found
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)
Performance Data/Non-Clinical Testing:
The Blood Collection Accessory (BUCA) was tested for validation and verification of functions based on risk analysis and the results passed predetermined acceptance criteria.
Biocompatibility: Evaluated per the FDA Guidance titled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff issued in June 2016 with the following endpoints: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelets and Hemolysis).
Performance Data: Performance testing was carried out on the Blood Collection Accessory (BUCA) using applicable international standards as reference and predicate device as benchmark for comparison.
- Luer Lok Adapter: Tested with reference to the ISO 80369-7:2016 and ISO 80369-20:2015.
- Performance Testing (benchmarking tests related to the predicate device):
- Flow Rate: The time taken to fill up a 3.0 ml blood collection Test tube with liquid of viscosity similar to blood is recorded.
- Leakage: The maximum numbers of round of insertion and Test evacuation of blood collection tube the device can withstand before leakage start occurring at the device is recorded.
- Evacuation Force Test: The force taken to insert or evacuate a blood collection tube into the holder of the device is recorded.
- Holding Strength of Needle to Adapter Test: The force taken to dislodge the needle from the adapter is recorded.
- Holding Strength of Sleeve to Adapter Test: The force taken to dislodge the sleeve from the adapter is recorded.
- Deformation Test: Permanent change in outer diameter of the holder of the device before and after compression by an applied 5 kg force for 5 minutes is measured and recorded. This test assesses the quality of the holder.
Sterilization: Sterilization is done in accordance to ISO 11135-1:2014. The Sterility Assurance Level (SAL) is 10-6.
Key results: Results passed predetermined acceptance criteria. The non-clinical testing demonstrates that the Blood Collection Accessory (BUCA) is substantially equivalent to the 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 30, 2019
NSP Tech Pte Ltd HC Tan 10 Admiralty Street, Northlink Building, #02-06 757695 Singapore
Re: K181754
Trade/Device Name: Blood Collection Accessory (BUCA) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: April 16, 2019 Received: June 28, 2019
Dear HC Tan:
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/cfpmp/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
1
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 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 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,
for Alan Stevens 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) K181754
Device Name Blood Collection Accessory (BUCA)
Indications for Use (Describe)
The Blood Collection Accessory (BUCA) is a single use, sterile and non invasive device used for connecting to venous access device for the collection of blood specimens.
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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1. SUBMITTER:
Applicant Name:
NSP Tech Pte Ltd 10 Admiralty Street, Northlink Building, #02-06 Singapore 757695
Contact Person:
Name: HC Tan Phone: (65)98180450 Fax: (65)67476533 Email: hockchoon.tan@nsptech.com.sg
| Establishment registration number | : 3008337059 |
|---|---|
| Date prepared | : July 29, 2019 |
DEVICE 2.
| Trade Name : | Blood Collection Accessory (BUCA) |
|---|---|
| Common Name : | Blood Specimen Collection Device |
| Regulatory Class : | Class II |
| Regulation Number: | 21 CFR 862.1675 |
| Regulation Name: | Blood Specimen Collection Device |
| Product Code : | JKA |
| Panel : | Clinical Chemistry |
PREDICATE DEVICE 3.
Vacutainer® Brand Multiple Sample Luer Adapter
| 510(k) Number: | K991088 |
|---|---|
| Regulatory Class: | Class II |
| Regulation Number: | 21 CR 862.1675 |
| Product Code: | JKA |
DEVICE DESCRIPTION: 4.
The Blood Collection Accessory (BUCA) is a single use device comprising of a holder made from polypropylene plastic with a male luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder.
The Blood Collection Accessory (BUCA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Collection Accessory (BUCA) also house the sample collection tube and protects the user or healthcare personnel from direct
4
contact with blood specimen. The Adapter connected to the blood collection device for the blood transfer. The sample collection tube is inserted from the far end of the holder where the opening is located. This transfer is conducted until the required amount of blood is completed. The sample collection tube is then evacuated from the Blood Collection Accessory (BUCA) by pulling it away from the latter.
INDICATION FOR USE STATEMENT 5.
The Blood Collection Accessory (BUCA) is a single use, sterile and non invasive device used for connecting to venous access device for the collection of blood specimens.
SUBSTANTIAL EQUIVALENCE COMPARISON 6.
TABLE OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
| | NSP Tech Pte Ltd
Blood Collection
Accessory (BUCA) | Vacutainer® Brand
Multiple Sample Luer
Adapter | Discussion/Comment |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number | K181754 | K991088 | |
| Classification | Class II | Class II | same |
| Product Code | JKA | JKA | same |
| Indication For Use | The Blood Collection
Accessory (BUCA) is
a single use, sterile
and non invasive
device used for
connecting to
venous access device
for the collection of
blood specimens. | The Vacutainer Brand
Luer Adapter is a sterile,
non-invasive device used
to connect venous
access devices 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.
The predicate specifies
the devices that it
connects with and the
subject device does not. |
| Manufacturer | NSP Tech Pte Ltd | Becton Dickinson | |
| Product
Configuration | Holder –
Polypropylene
Adapter - Acrylonitrile
butadiene
styrene
Sleeve – Not made
with natural
rubber latex
Needle - Stainless
Steel | Holder – Polypropylene
Adapter - Polycarbonate
Sleeve - Not made
with natural
rubber latex
Needle - Stainless Steel | The only major
difference between the
subject device and the
predicate device is in the
material used for the
part, Adapter. The
subject device, Blood
Collection Accessory
(BUCA) uses the
polymer, Acrylonitrile
butadiene styrene (ABS)
for the Adapter part
while the predicate
device uses
Polycarbonate (PC)
polymer.
Biocompatibility Testing
and Performance
Testing was conducted
to demonstrate SE. |
| Sterilization | Ethylene Oxide (EtO)
Gas sterilization | Ethylene Oxide (EtO) Gas
sterilization same | |
| Sterility | Meet the Sterility
Assurance Level of 10-
6 as per the
requirement of ISO
11135:2014 | Not known | Non-Clinical Performance
Testing was conducted to
demonstrate SE. |
| Packaging | Sealed Blister
Packaging | Sealed Blister Packaging | Non-Clinical
Performance Testing
was conducted to
demonstrate SE. |
| Use | Single-Use only | Single-Use only | same |
| Bio compatibility | ISO 10993 series | ISO 10993 series | same |
| Shelf Life | 1 year | 3 years | Non-Clinical Performance
Testing was conducted to
demonstrate SE. |
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7. TECHNOLOGICAL CHARACTERISTICS COMPARISON
The Blood Collection Accessory (BUCA) device has similarities with the predicate device in areas such as Intended Use Product Configuration, and performance.. The only difference between the subject device and the predicate device is in the use of material for the part, Adapter. The Blood Collection Accessory (BUCA) uses the polymer material, Acrylonitrile butadiene styrene (ABS) while the Page 3 of 5
6
predicate device uses the polymer material, Polycarbonate (PC). Biocompatibility tests and performance tests based on international standards demonstrated the device performs as intended. The indications for use of the predicate device specifies the blood collection devices it connects to. The Subject device does not specify the blood collection devices, this does not raise different questions of safety or effectiveness.
8. Performance Data/Non-Clinical Testing:
The Blood Collection Accessory (BUCA) was tested for validation and verification of functions based on risk analysis and the results passed predetermined acceptance criteria.
Biocompatibility
Biocompatibility was evaluated per the FDA Guidance titled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff issued in June 2016 with the following endpoints:
Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Pyrogenicity
Hemocompatibility (Coagulation, Platelets and Hemolysis)
PerformanceData
Performance testing was carried out on the Blood Collection Accessory (BUCA) using applicable international standards as reference and predicate device as benchmark for comparison.
-
. Luer Lok Adapter
For international standard related test, the Luer Lok adapter is tested with reference to the ISO 80369-7:2016 and ISO 80369-20:2015. -
Performance Testing
As for the benchmarking tests related to the predicate device, blood collection performances such as the flow rate and quality of holding strength of sleeve to adapter and needle to adapter are assessed and compared against that of the predicate device.. The test methods employed are as summarized below: -
o Flow Rate The time taken to fill up a 3.0 ml blood collection Test tube with liquid of viscosity similar to blood is recorded.
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- o Leakage With the device held in place by a fixture, the maximum numbers of round of insertion and Testevacuation of blood collection tube the device can withstand before leakage start occurring at the device is recorded.
- The device is held in place by a fixture and a force Evacuation o Force Test taken to insert or evacuate a blood collection tube into the holder of the device is recorded.
- Using fixture to hold the adapter in place, the o Holding Strength of needle is pull in a direction away from the adapter. The force taken to dislodge the needle Needle to Adapter Test from the adapter is recorded.
- With the adapter held in place by a fixture, the Holding o sleeve is pull in a direction away from the adapter Strength of and the force taken to dislodge the sleeve from the Sleeve to adapter is recorded. Adapter Test -
- Deformation The device is held in place by a fixture and a 5 kg o Test force is applied on the device for a period of 5 minutes. The permanent change in outer diameter of the holder of the device before and after compression by the applied force is measured and recorded. This test assesses the quality of the holder.
Sterilization
Sterilization is done in accordance to ISO 11135-1:2014.
The Sterility Assurance Level (SAL) is 10-6.
SUBSTANTIAL EQUIVALENCE CONCLUSION 9.
The result of non-clinical testing demonstrates that the Blood Collection Accessory (BUCA) is substantially to the predicate device, Vacutainer® Brand Multiple Sample Luer Adapter and has been demonstrated to meet its predetermined specifications.