REF Code 99200 and 99300
Device Name: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and Male Luer Connector
Indications for Use:
The Saf-T Closed Blood Collection System® is attached to a peripheral IV catheter at the time of IV catheter placement to allow syringe blood draw and transfer to fill vacuum tubes.

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® is intended for use as syringe blood draw device and sample transfer device from a syringe to a vacuum tube.

Device Description

The Saf-T Closed Blood Collection System® is a venous blood drawing device that consists of three distinct configurations with distinct uses as follows.

REF Code 99200: Syringe line draw and transfer
This device consists of IV tubing with a male and female Luer, clamps to control blood flow, and a Saf-T Holder® Device.

The male Luer is attached to a peripheral IV catheter hub at the time of IV . catheter insertion.
A sample syringe is attached to the female Luer to collect the blood sample. .
Transfer from the sample syringe is accomplished by inserting vacuum tubes into . the Saf-T Holder® device.

REF Code 992XX*: Syringe draw and transfer via Saf-T Wing® access
*XX corresponds to the needle gauge, example: REF 99223 is the 23G needle This device consists of IV tubing with a female Luer , clamps to control blood flow, a Saf-T Wing® needle and a Saf-T Holder® Device. The Saf-T Wing® needle is offered in three sizes: 21G, 23G, 25G all 3/4" long.

· The vein is accessed via the Saf-T Wing® needle
· Blood is drawn into a syringe which is attached to the female Luer
· The blood sample is then transferred from the syringe by inserting vacuum tubes into the Saf-T Holder® device.

REF Code 99300: Syringe line draw, transfer and flush
This device consists of IV tubing with a male Luer, two female Luers , clamps to control blood flow, and a Saf-T Holder® Device.

· The male Luer is attached to a peripheral IV catheter hub at the time of IV catheter insertion.
· A sample syringe is attached to the female Luer to collect the blood sample.
· A pre-filled flush syringe is attached to the second female Luer.
· The blood sample is then transferred from the syringe by inserting vacuum tubes into the Saf-T Holder® device.
· The catheter is flushed using the attached pre-filled syringe

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Saf-T Closed Blood Collection System®". This document focuses on demonstrating substantial equivalence to predicate devices through bench testing. It explicitly states that clinical data was NOT required. Therefore, the study described does not involve human subjects, expert adjudication, or MRMC studies. It also does not involve an AI algorithm, as this is a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Bench testing confirms that the proposed device and the predicate device have similar performance specifications." However, it does not provide explicit acceptance criteria with specific numerical targets or detailed reported device performance values for comparison. It only states that the performance is "similar."

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document, but implicitly refers to performance similar to predicate devices in areas such as:	Not explicitly stated beyond "similar performance specifications" to predicate devices.
- Blood flow control	- Demonstrated similar control during bench testing
- Luer attachment integrity	- Demonstrated similar integrity during bench testing
- Vacuum tube placement effectiveness	- Demonstrated similar effectiveness during bench testing
- Overall safety and effectiveness	- Demonstrated overall safety and effectiveness through bench testing

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

Test Set Sample Size: The document does not specify a sample size for the bench tests.
Data Provenance: The data is from "Bench testing," meaning it was conducted in a laboratory setting. No country of origin is specified, but the applicant company, Smiths Medical ASD, Inc., is based in Keene, NH, USA. The testing was retrospective in the sense that it compared the new device's performance to existing predicates, but the tests themselves would have been conducted prospectively on the new device.

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

Not applicable. This device is a physical blood collection system, and the evaluation was based on bench testing (engineering and functional assessments), not clinical data requiring expert review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was bench testing of a physical device, not a study requiring expert adjudication of clinical outcomes or images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical blood collection system and does not involve AI or human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical blood collection system and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was established through bench testing protocols and engineering standards. The goal was to demonstrate that the device performs functionally in a manner "similar" to its legally marketed predicate devices, ensuring safety and effectiveness for its intended use.

8. The Sample Size for the Training Set

Not applicable. This refers to a "training set" for AI models. This device is a physical medical device and does not use AI.

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

Not applicable. As above, this device is a physical medical device and does not use AI.

Summary

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SECTION 5, 510(k) Summary

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

NOV 2 4 2007

072783

P I

Summary Prepared: September 28, 2007 (Revised November 21, 2007)

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):

K923090 (Ryan Medical - subsequently acquired from MPS Acacia by Smiths Medical ASD, Inc) Saf-T Holder multi sample Luer adapter with blood

K895705 (Ryan Medical - subsequently acquired from MPS Acacia by Smiths Medical ASD, Inc) Shamrock Safety Blood Collection Set

K895367 (Medical Product Specialists) Intravenous Extension Set

MPS Acacia marketed the Saf-T Closed Blood Collection System® under the trade name CVSC Closed Venous Blood Sample Collection System. MPS Acacia wrote a "letter to file" which identifies the above 510(k)'s and is found in attachment 1.

{1}------------------------------------------------

Device Description:

The Saf-T Closed Blood Collection System® is a venous blood drawing device that consists of three distinct configurations with distinct uses as follows.

1. REF Code 99200: Syringe line draw and transfer

This device consists of IV tubing with a male and female Luer, clamps to control blood flow, and a Saf-T Holder® Device.

The male Luer is attached to a peripheral IV catheter hub at the time of IV . catheter insertion.
A sample syringe is attached to the female Luer to collect the blood sample. .
Transfer from the sample syringe is accomplished by inserting vacuum tubes into . the Saf-T Holder® device.

2. REF Code 992XX*: Syringe draw and transfer via Saf-T Wing® access

*XX corresponds to the needle gauge, example: REF 99223 is the 23G needle This device consists of IV tubing with a female Luer , clamps to control blood flow, a Saf-T Wing® needle and a Saf-T Holder® Device. The Saf-T Wing® needle is offered in three sizes: 21G, 23G, 25G all 3/4" long.

· The vein is accessed via the Saf-T Wing® needle
· Blood is drawn into a syringe which is attached to the female Luer
· The blood sample is then transferred from the syringe by inserting vacuum tubes into the Saf-T Holder® device.

3. REF Code 99300: Syringe line draw, transfer and flush

This device consists of IV tubing with a male Luer, two female Luers , clamps to control blood flow, and a Saf-T Holder® Device.

· The male Luer is attached to a peripheral IV catheter hub at the time of IV catheter insertion.
· A sample syringe is attached to the female Luer to collect the blood sample.
· A pre-filled flush syringe is attached to the second female Luer.
· The blood sample is then transferred from the syringe by inserting vacuum tubes into the Saf-T Holder® device.
· The catheter is flushed using the attached pre-filled syringe

{2}------------------------------------------------

Indications for Use:

Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The text at the top appears to be a code or identifier, reading 'K072753'. Below this, there is another line of text that reads 'P3'. The handwriting is somewhat rough, with the numbers and letters not perfectly formed.

REF Code 99200 and 99300

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

Indications for Use:

The Saf-T Closed Blood Collection System® is attached to a peripheral IV catheter at the time of IV catheter placement to allow syringe blood draw and transfer to fill vacuum tubes.

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® is intended for use as syringe blood draw device and sample transfer device from a syringe to a vacuum tube.

Technological Characteristics:

The proposed and predicate devices have the same characteristics, i.e. vascular access via a peripheral IV catheter or a safety needle with tubing and clamps to control blood flow, Luers for syringe attachment and a Saf-T Holder® device for vacuum tube placement.

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 Manager

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human figures, representing the department's focus on health and human well-being. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2007

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

Re: K072783

Trade/Device Name: REF Code 99200: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and male Luer Connector

REF Code 992XX: Saf-T Closed Blood Collection System® with Saf-T Holder® and Saf-T Wing® Device

REF Code 99300: Saf-T Closed Blood Collection System® with Saf-T Holder® Device and male Luer Connector

Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: September 28, 2007 Received: October 2, 2007

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.

{4}------------------------------------------------

Page 2 - Mr. Farias

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.

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 (QS) 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

CARS

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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SECTION 4, Indications for Use Statement

Indications for Use

510(k) Number (if known): K072783

REF Code 99200 and 99300

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

Indications for Use:

The Saf-T Closed Blood Collection System® is attached to a peripheral IV catheter at the time of IV catheter placement to allow syringe blood draw and transfer to fill vacuum tubes.

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® is intended for use as syringe blood draw device and sample transfer device from a syringe to a vacuum tube.

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 1 anthe 19 m (Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices 10(k) Number: K472787 9

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.