(60 days)
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.
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
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.
§ 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.