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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the Blood Collection Accessory (BUCA) device to demonstrate substantial equivalence to a predicate device, the Vacutainer® Brand Multiple Sample Luer Adapter.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device "passed predetermined acceptance criteria" for various tests, but it does not explicitly list the numerical acceptance criteria for each test. Instead, it states that the tests demonstrated substantial equivalence.

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Biocompatibility	Evaluated per FDA Guidance ISO 10993-1, with endpoints of Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelets, and Hemolysis). Result: Biocompatibility Testing was conducted to demonstrate SE.
Luer Lok Adapter Conformance	Tested with reference to ISO 80369-7:2016 and ISO 80369-20:2015.
Blood Collection Performance (Benchmarking)	Compared against the predicate device for: - Flow Rate: Time taken to fill a 3.0 ml blood collection Test tube with liquid of viscosity similar to blood. - Leakage: Maximum number of insertion/evacuation rounds before leakage. - Evacuation Force: Force to insert/evacuate a blood collection tube. - Holding Strength of Needle to Adapter: Force to dislodge needle. - Holding Strength of Sleeve to Adapter: Force to dislodge sleeve. - Deformation Test: Permanent change in outer diameter after 5 kg force for 5 minutes.
Sterilization	Achieved a Sterility Assurance Level (SAL) of 10^-6 as per ISO 11135-1:2014.
Shelf Life	1 year (The predicate device had 3 years; Non-Clinical Performance Testing was conducted to demonstrate SE for 1 year).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes (number of devices tested) for the performance and biocompatibility tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a physical blood collection accessory, and the "ground truth" for its performance is established through objective physical and chemical testing, not through expert consensus on interpretation.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading), not for the direct measurement of physical device properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is not relevant for this type of device, which is evaluated based on its physical and biological performance characteristics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical device, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that it is measured directly without human interpretive involvement in the outcome.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on objective measurements and adherence to international standards and benchmarks against a predicate device. For example:

Biocompatibility: Adherence to ISO 10993 series and FDA guidance.
Luer Lok Adapter: Conformance to ISO 80369-7:2016 and ISO 80369-20:2015.
Performance Testing (Flow Rate, Leakage, Holding Strength, Deformation): Direct physical measurements and comparison to the predicate device's performance benchmarks.
Sterilization: Achievement of a specific Sterility Assurance Level (SAL) according to ISO 11135-1:2014.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

Summary

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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

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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.

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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 LtdBlood CollectionAccessory (BUCA)	Vacutainer® BrandMultiple Sample LuerAdapter	Discussion/Comment
510 (k) Number	K181754	K991088
Classification	Class II	Class II	same
Product Code	JKA	JKA	same
Indication For Use	The Blood CollectionAccessory (BUCA) isa single use, sterileand non invasivedevice used forconnecting tovenous access devicefor the collection ofblood specimens.	The Vacutainer BrandLuer Adapter is a sterile,non-invasive device usedto connect venousaccess devices such asneedles, blood collectionsets, and infusion sets toblood collection tubes.They are also used inconnection with non-needle devices forcollection of blood fromcatheters. TheVacutainer Brand LuerAdapter is sold by itselfand as a component ofother Vacutainer Branddevices.	Similar- The difference isin the name of thedevice, this does notraise any questions ofsafety or effectiveness.The predicate specifiesthe devices that itconnects with and thesubject device does not.
Manufacturer	NSP Tech Pte Ltd	Becton Dickinson
ProductConfiguration	Holder –PolypropyleneAdapter - AcrylonitrilebutadienestyreneSleeve – Not madewith naturalrubber latexNeedle - StainlessSteel	Holder – PolypropyleneAdapter - PolycarbonateSleeve - Not madewith naturalrubber latexNeedle - Stainless Steel	The only majordifference between thesubject device and thepredicate device is in thematerial used for thepart, Adapter. Thesubject device, BloodCollection Accessory(BUCA) uses thepolymer, Acrylonitrilebutadiene styrene (ABS)for the Adapter partwhile the predicatedevice usesPolycarbonate (PC)polymer.Biocompatibility Testingand PerformanceTesting was conductedto demonstrate SE.
Sterilization	Ethylene Oxide (EtO)Gas sterilization	Ethylene Oxide (EtO) Gassterilization same
Sterility	Meet the SterilityAssurance Level of 10-6 as per therequirement of ISO11135:2014	Not known	Non-Clinical PerformanceTesting was conducted todemonstrate SE.
Packaging	Sealed BlisterPackaging	Sealed Blister Packaging	Non-ClinicalPerformance Testingwas conducted todemonstrate 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 PerformanceTesting was conducted todemonstrate 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

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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.

Regulation Number and Section

§ 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.