The Saf-T Closed Blood Collection System® device is attached to a peripheral IV catheter at the time of IV catheter placement for use as a direct blood draw device into a vacuum tube or to allow a syringe blood draw and transfer to fill vacuum tubes.

The Saf-T Closed Blood Collection System® device is intended for use as a direct blood draw device into a vacuum tube or to allow a syringe blood draw and transfer to fill vacuum tubes.

Device Description

The Saf-T Closed Blood Collection System® device is a venous blood drawing device that is currently used as syringe draw and transfer device to fill vacuum tubes. This submission expands the indications to allow a direct blood draw into a vacuum tube. A syringe draw and transfer remains as an option - the Clinician can choose the method depending upon patient status. The use of this device involves minimal Luer manipulations, which minimizes the risk of sample contamination. This submission also increases the holder length to be equal to similar devices, the longer length will aid in vacuum tube alignment into the holder.

AI/ML Overview

The provided text describes a 510(k) summary for the "Saf-T Closed Blood Collection System®" device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way typically required for a novel AI/software medical device.

Instead, this submission is for a traditional medical device (venous blood collection device) seeking a 510(k) clearance based on substantial equivalence to predicate devices. The study mentioned is "Bench testing," which confirmed similar performance specifications between the proposed and predicate devices. This type of testing is generally mechanical or functional and doesn't involve clinical performance metrics like sensitivity, specificity, or reader studies.

Therefore, many of the requested items (acceptance criteria, device performance, sample size for test sets, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not present in this document because it describes a traditional device clearance, not an AI/software device.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Implied: Similar performance specifications to predicate device.	Bench testing confirms that the proposed device and the predicate device have similar performance specifications.
Implied: Safety and Effectiveness for intended use.	Bench testing conducted demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

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

Sample Size: Not specified in the document. The term "bench testing" typically implies testing of manufacturing samples, but the exact number is not provided.
Data Provenance: Not specified. "Bench testing" usually occurs in a laboratory or manufacturing setting. No information on country of origin or retrospective/prospective nature is given.

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

Not applicable / Not specified. As this is a physical device and the study is "bench testing," there is no indication of expert involvement in establishing a "ground truth" in the diagnostic sense. The performance is likely measured against predefined engineering specifications.

4. Adjudication Method for the Test Set

Not applicable / Not specified. Adjudication methods (like 2+1) are typically used for expert review of images or clinical cases to establish ground truth. This is not mentioned in the context of bench testing for a physical device.

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

No. An MRMC study was not done. This type of study is relevant for AI/software devices that assist human readers in diagnosis or interpretation, which is not the function of this blood collection system.

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

Not applicable. This device is a physical venous blood collection system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

Implicitly, engineering specifications/design requirements. For bench testing of a physical device, the "ground truth" would be the device's adherence to its design specifications, functional requirements (e.g., blood flow, luer connection integrity, vacuum tube alignment), and safety standards. No pathology or outcomes data is mentioned for ground truth.

8. The Sample Size for the Training Set

Not applicable / Not specified. This document describes a physical medical device, not an AI/machine learning algorithm, so there is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

Summary regarding AI/Software Device Context:

The provided text is for a 510(k) submission of a traditional, physical medical device. The "Non-Clinical Data" section explicitly states "Bench testing confirms that the proposed device and the predicate device have similar performance specifications" and "Clinical Data: Not Required." This indicates that the regulatory pathway relied on engineering and functional testing to demonstrate substantial equivalence, rather than clinical trials or performance assessments relevant to AI/software diagnostic devices. Therefore, most of the detailed questions about acceptance criteria for AI performance, clinical study design, and AI model evaluation are not addressed in this document.

Summary

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SECTION 5, 510(k) Summary

bringing technology to

Smiths Medical ASD Inc. Critical Care Division 10 Bowman Drive Keene, NH 03431 0724, USA T: +1 603 352 3812 F: +1 603 355 8157 www.smiths-medical.com

'JUL 2 1 2008

Company Information:

Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812, prompt 4, ext 2493 Contact: Brian D. Farias Regulatory Affairs Manager

Summary Prepared: April 25, 2008

Product Name:

Trade Name: Saf-T Closed Blood Collection System®

Common Name: Venous Blood Collection Device

Classification Name: 862.1675 Blood Specimen Collection Device

Predicate Device(s):

K.072783 (Smiths Medical ASD, Inc.) Saf-T Closed Blood Collection System® Device

K922445 (Smiths Medical ASD, Inc.- formerly Concord/Portex) Venipuncture Needle Pro® Device

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Device Description:

REF Code 99200

Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and Male Luer Connector

Indications for Use:

REF Code 992XX

Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® and Saf-T Wing® Device

Indications for Use:

The Saf-T Closed Blood Collection System® device is intended for use as a direct blood draw device into a vacuum tube or to allow a syringe blood draw and transfer to fill vacuum tubes.

Technological Characteristics:

The proposed and predicate devices have the same characteristics, i.e. vascular access via a newly placed IV catheter line or direct access via a safety needle; with tubing and clamps to control blood flow, and a vacuum tube holder for vacuum tube placement.

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Non-Clinical Data:

Bench testing confirms that the proposed device and the predicate device have similar performance specifications.

Clinical Data:

Not Required

Conclusion:

The bench testing conducted demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

Brian D. Farias Regulatory Affairs Managcr

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian Farias Regulatory Affairs Manager Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

JUL 2 1 2008

Re: K081229

Trade/Device Name: Saf-T Closed Blood Collection System® Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: April 25, 2008 Received: April 30, 2008

Dear Mr. Farias:

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 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.

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Page 2 - Mr. Farias

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

Enclosure

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KV,81229

SECTION 4, Indications for Use Statement

Indications for Use

510(k) Number (if known):

REF Code 99200

Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and Male Luer Connector

Indications for Use:

REF Code 992XX

Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® and Saf-T Wing® Device

Indications for Use:

The Saf-T Closed Blood Collection System® device is intended for use as a direct blood draw device into a vacuum tube or to allow a syringe blood draw and transfer to fill vacuum tubes.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Klaell for Chulin
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081227

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.