The ITL SampLok® Luer Kit is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests.

Device Description

Luer Kit for use with blood collection systems for collecting blood samples from Y connectors.

AI/ML Overview

This document details a Special 510(k) Summary for a medical device called the ITL SampLok® Luer Kit. A Special 510(k) is used for modifications to a manufacturer's own legally marketed device. In this case, the modification is the pre-attachment and co-packaging of two previously cleared devices: the SampLok® Needle Holder and the Nipro Luer Adaptor.

The core of a Special 510(k) relies on demonstrating that the modification does not introduce new risks or alter the fundamental safety and effectiveness of the device as previously cleared. Therefore, the "acceptance criteria" and "study" are not presented in the traditional sense of a de novo device submission with extensive clinical trials. Instead, the demonstration revolves around showing that the modified device's performance is either identical to or within the established safety and effectiveness parameters of its predicate components.

Here's the breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for ITL SampLok® Luer Kit

The provided document describes a Special 510(k) Summary for the ITL SampLok® Luer Kit. For a Special 510(k), the "acceptance criteria" and "device performance" are typically demonstrated by showing that the modified device's technical characteristics and intended use are identical or substantially equivalent to its legally marketed predicate components, and that the modification (pre-attachment and co-packaging) does not negatively impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from Special 510(k))	Reported Device Performance (from document)
Intended Use Equivalence: The modified device must perform its intended function equivalently to the predicate devices.	"The ITL SampLok® Luer Kit is intended to be used as part of a vacuum blood collection equipment for the collection of blood samples for various types of blood tests." This is the same intended use as the individual predicate components.
Technical Equivalence: The modified device's components must be identical to those of legally marketed predicate devices.	"The ITL SampLok® Luer Kit consists of preattached SampLok® Needle Holder and Nipro Luer Adaptor, individually packaged and sterilized using ETO. The individual components are identical to previously cleared devices." This directly states technical equivalence of the components.
Safety and Effectiveness: The modification (pre-attachment and co-packaging) must not introduce new safety concerns or compromise the effectiveness of the individual components.	The document explicitly states: "The difference is that the previously cleared devices were packaged separately. The ITL SampLok® Luer Kit packages these two accessories together." The implication of a Special 510(k) is that this difference has been evaluated and deemed not to raise new questions of safety or effectiveness. No specific study data is presented because the modification is considered minor and not impacting fundamental performance.
Sterility: The device must maintain sterility.	"individually packaged and sterilized using ETO." This indicates the established sterilization method is applied to the combined product.

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

The document does not provide details on a specific test set, its sample size, or data provenance in the context of a performance study. For a Special 510(k) regarding the pre-attachment of two already cleared devices, the "proof" primarily relies on:

The fact that the individual components have already been cleared and demonstrated safety and effectiveness (their "test sets" and data would have been part of their original 510(k)s).
Justification that the act of pre-attaching and co-packaging does not alter the fundamental characteristics or introduce new risks. This typically involves engineering analysis, risk assessments, and perhaps basic functional testing if deemed necessary, rather than a large-scale performance study.

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

Not applicable. As noted above, there is no mention of a traditional "test set" requiring ground truth establishment by experts in this Special 510(k) summary. The reliance is on the prior clearance of the individual components.

4. Adjudication Method for the Test Set:

Not applicable. No test set or ground truth adjudication described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study assesses human reader performance, typically with image interpretations or similar diagnostic tasks. The ITL SampLok® Luer Kit is a physical medical device for blood collection; therefore, an MRMC study is not relevant to its clearance.

6. Standalone Performance Study:

Not applicable in the traditional sense of an algorithm's standalone performance. The "standalone performance" of the ITL SampLok® Luer Kit is inherent in the demonstrated performance and clearance of its individual components (SampLok® Needle Holder and Nipro Luer Adaptor). The Special 510(k) argues that packaging them together does not diminish this performance.

7. Type of Ground Truth Used:

Not applicable. The clearance is based on the substantial equivalence of the components and the lack of new risks from the packaging modification, rather than performance against a specific "ground truth" derived from patient outcomes or pathology.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device is not an AI/ML algorithm requiring a training set.

Summary

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JUL - 2 2002

XIII. Special 510k Summary

Contact Person: Bill Mobbs, Managing Director

Date of Summary Preparation: June 5, 2002

Trade Name: ITL SampLok® Luer Kit

Common Name: Needle holder and luer adaptor for blood sample collection for testing

Classification Name: Tubes, vials, systems, serum separators, blood collection

Establishment Registration Number: 9033436

Class: II

Product Code: JKA

Legally Marketed Substantially Equivalent Devices: SampLok® Needle Holder (K000777) and Nipro Luer Adaptor (K992729)

Description of Device: Luer Kit for use with blood collection systems for collecting blood samples from Y connectors.

Intended Use: The ITL SampLok® Luer Kit is intended to be used as part of a vacuum blood collection equipment for the collection of blood samples for various types of blood tests.

Comparison of Technical Characteristics: The ITL SampLok® Luer Kit consists of preattached SampLok® Needle Holder and Nipro Luer Adaptor, individually packaged and sterilized using ETO. The individual components are identical to previously cleared devices. The difference is that the previously cleared devices were packaged separately. The ITL SampLok® Luer Kit packages these two accessories together.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Mr. William Mobbs Director ITL Corporation 41-45 Tennant St, Fyshwick, Canberra, ACT 2609 AUSTRALIA

Re: K021941

Trade/Device Name: ITL SampLok® Luer Kit Regulation Number: 872.1675 and 880.5570 Regulation Name: Blood Specimen Collection Device and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: JKA and FMI Dated: June 6, 2002 Received: June 13, 2002

Dear Mr. Mobbs:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.

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Page 2 - Mr. Mobbs

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 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_KOA194/

Device Name: _________________________________________________________________________________________________________________________________________________________________

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Indications for Use XII.

The ITL SampLok® Luer Kit is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests..

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Paltus Cicente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 02 510(k) Number .

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.