The Blood Transfer Accessory is a sterile non invasive device for use in venous blood collection procedures in combination with blood collection devices with a male luer feature.

Device Description

The Blood Transfer Accessory (BTA) is a single use device comprising of a holder made from polypropylene plastic with a female luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder.

The Blood Transfer Accessory (BTA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Transfer Accessory (BTA) 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 Transfer Accessory (BTA) by pulling away.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the Blood Transfer Accessory (BTA), by the FDA. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and performance studies in the context of an AI/human-in-the-loop system. The document focuses on the substantial equivalence of the BTA to a predicate device, primarily through biocompatibility and performance testing of the physical device, not an AI algorithm.

Specifically, the document discusses:

Acceptance Criteria for the physical device: Things like sterility assurance level, material biocompatibility (ISO 10993 series), and physical performance (flow rate, leakage, holding strength, deformation).
Studies conducted: Biocompatibility testing and performance testing against international standards (e.g., ISO 80369-7:2016) and benchmarking against the predicate device.

Missing Information:
The document does not include:

A table of acceptance criteria for an AI system or its reported performance.
Sample sizes for test sets in an AI context.
Information on data provenance (country, retrospective/prospective).
Number of experts, their qualifications, or adjudication methods for ground truth in an AI context.
Any mention of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone (algorithm only) performance or human-in-the-loop studies for an AI system.
The type of ground truth used for an AI system (expert consensus, pathology, etc.).
Sample size for a training set or how ground truth was established for a training set (as this is not an AI device).

Therefore, I can only provide information based on the physical device's characteristics and its equivalence to a predicate, not for an AI component.

Based on the provided text, here's what can be extracted and what remains unknown regarding acceptance criteria and device performance:

Acceptance Criteria and Device Performance (for the physical Blood Transfer Accessory):

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vacutainer® Brand Multiple Sample Luer Adapter) based on material, function, and performance tests for the physical device. It does not describe an AI component.

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Acceptance Criteria (as implied/tested)	Reported Device Performance/Conclusion
Biocompatibility	Compliance with FDA Guidance: ISO 10993-1 for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelets, Hemolysis).	"Biocompatibility Testing... was conducted to demonstrate SE [Substantial Equivalence]." "Biocompatibility was evaluated per the FDA Guidance... with the following endpoints: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelets and Hemolysis)." The implication is that the BTA passed these tests.
Luer Lock Adapter Standard	Compliance with ISO 80369-7:2016 and ISO 80369-20:2015.	"the Luer Lok adapter is tested with reference to the ISO 80369-7:2016 and ISO 80369-20:2015." The implication is that it met the standards.
Flow Rate	Comparable time to fill a 3.0 ml blood collection tube with liquid of similar viscosity to blood (benchmarked against predicate).	"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." The conclusion is that "Performance testing demonstrated that this does not raise different questions of safety or effectiveness" implying comparable performance to the predicate.
Leakage Test	Withstand maximum number of insertion/evacuation rounds before leakage (benchmarked against predicate).	"Leakage Test: maximum numbers of round of insertion and evacuation of blood collection tube the device can withstand before leakage start occurring at the device is recorded." Implied comparable performance.
Evacuation Force Test	Force required to insert/evacuate a blood collection tube (benchmarked against predicate).	"Evacuation Force Test: The force taken to insert or evacuate a blood collection tube into the holder of the device is recorded." Implied comparable performance.
Needle Holding Strength	Force to dislodge the needle from the adapter (benchmarked against predicate).	"Holding Strength of needle to Adapter Test: The force taken to dislodge the needle from the adapter is recorded." Implied comparable performance.
Sleeve Holding Strength	Force to dislodge the sleeve from the adapter (benchmarked against predicate).	"Holding Strength of sleeve to Adapter Test: The force taken to dislodge the sleeve from the adapter is recorded." Implied comparable performance.
Deformation Test	Permanent change in outer diameter after 5kg force for 5 minutes (assesses holder quality).	"Deformation Test: The permanent change in outer diameter of the holder of the device before and after compression by the applied force is measured and recorded." Implied the device maintained integrity.
Sterilization	Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135-1:2014.	"Sterilization is done in accordance to ISO 11135-1:2014. The Sterility Assurance Level (SAL) is 10-6." (This is stated as both criterion and met performance).
Shelf Life	Maintain performance for 1 year.	"Non-Clinical Performance Testing was conducted to demonstrate SE." (indicating the 1-year shelf life was supported by testing, though the predicate had 3 years).
Overall	Meet predetermined specifications, be substantially equivalent to predicate, and not raise different questions of safety or effectiveness.	"The result of non-clinical testing demonstrates that the Blood Transfer Accessory (BTA) is substantially equivalent to the predicate device... and has been demonstrated to meet its predetermined specifications."

2. Sample sizes used for the test set and the data provenance:

Sample Size: Not specified in the document for any of the performance or biocompatibility tests.
Data Provenance: Not applicable as this is a physical device testing, not a data-driven AI model. The manufacturing applicant is NSP Tech Pte Ltd, Singapore.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for a physical medical device typically comes from laboratory testing against established standards and engineering specifications, often involving engineers and lab technicians, not clinical experts for "ground truth" in the AI sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This concept applies to human reader studies, not physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI device.

7. The type of ground truth used:

For physical device performance: Established international standards (e.g., ISO 80369-7:2016, ISO 11135-1:2014) and benchmarking against a legally marketed predicate device's measured performance characteristics.
Not applicable for AI-related ground truth types like expert consensus, pathology, or outcomes data, as this is not an AI device.

8. The sample size for the training set:

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

9. How the ground truth for the training set was established:

Not applicable. This is not an AI 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: K181743

Trade/Device Name: Blood Transfer Accessory (BTA) 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/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 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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Blood Transfer Accessory (BTA)

Indications for Use (Describe)

The Blood Transfer Accessory is a sterile non invasive device for use in venous blood collection procedures in combination with blood collection devices with a male luer feature.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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SUBMITTER: 1.

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

2. DEVICE

Trade Name	:	Blood Transfer Accessory (BTA)
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 CFR 862.1675 JKA Product Code:

DEVICE DESCRIPTION: 4.

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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 Transfer Accessory (BTA) by pulling away.

INDICATION FOR USE STATEMENT 5.

The Blood Transfer Accessory is a sterile non invasive device for use in venous blood collection procedures in combination with blood collection devices with a male luer feature.

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	K181743	K991088	same
Classification	Class II	Class II	same
Product Code	JKA	JKA	same
Indication For Use	The Blood TransferAccessory is asterile non invasivedevice for use invenous bloodcollectionprocedures incombination withblood collectiondevices with a maleluer feature.	The Vacutainer BrandLuer Adapter is a sterile,non-invasive device usedto connect venous accessdevices such as needles,blood collection sets, andinfusion sets to bloodcollection tubes. Theyare 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 differenceis in the name of thedevice and this does notraise any questions ofsafety or effectiveness.The predicate alsospecifies that devicesthat it connects to. Thesubject device states itconnects to deviceswith a male luer.
Manufacturer	NSP Tech Pte Ltd	Becton Dickinson	same
ProductConfiguration	Holder –PolypropyleneAdapter - Acrylonitrilebutadiene styreneSleeve — Not madewith naturalrubberlatexNeedle - StainlessSteel	Holder – PolypropyleneAdapter - PolycarbonateSleeve – Not madewith naturalrubber latexNeedle - Stainless Steel	The only majordifference between thesubject device and thepredicate device is inthe material used forthe part, Adapter. Thesubject device, BloodTransfer Accessory (BTA)uses the polymer,Acrylonitrile butadienestyrene (ABS) for theAdapter part while thepredicate device 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 of10-6 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 Transfer Accessory (BTA)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 Transfer Accessory (BTA) uses the polymer material, Acrylonitrile butadiene styrene (ABS) while the predicate device uses the polymer material, Polycarbonate (PC). Biocompatibility tests and performance tests based on international standards demonstrated the device performs as intended.

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In addition the indications for use statement is different in that the subject device connects to male luer blood collection devices and the predicate device specifies the devices it may connect to. Performance testing demonstrated that this does not raise different questions of safety or effectiveness.

8. PERFORMANCE DATA/NON-CLINICAL TESTING

The Blood Transfer Accessory (BTA)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)

Performance Data

Performance testing was carried out on the Blood Transfer Accessory (BTA) 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.
PerformanceTesting
As for the benchmarking tests related to the predicate device, blood collection performances such as the flow rate and quality of holder, 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.
With the device held in place by a fixture, the o Leakage Testmaximum numbers of round of insertion and evacuation of blood collection tube the device can withstand before leakage start occurring at the device is recorded.

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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. Needle to The force taken to dislodge the needle from the adapter is recorded. Adapter Test -
With the adapter held in place by a fixture, the o Holding Strength of sleeve is pulled in a direction away from the adapter and the force taken to dislodge the sleeve Sleeve to from the adapter is recorded. Adapter Test -
o Deformation The device is held in place by a fixture and a 5 kg 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 Transfer Accessory (BTA) is substantially equivalent 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.