The BD Vacutainer® Safety-Lok™ Administration Set with Filter is a sterile, single-use wing set intended for the intravenous administration of fluids and may be used for any patic population with consideration given to patient size, appropriateness for the solution being infus and duration of therapy. The BD Vacutainer® Safety-Lok™ Administration Set with Fil minimizes the possibility of needlesticks if manually activated following administration.

Device Description

The BD Vacutainer® Safety-Lok™ Administration Set with Filter is intended for the infusion of fluids. The wing set contains a safety shield that is manually activated once infusion is complete, helping to prevent accidental needle sticks.

AI/ML Overview

The provided text describes the BD Vacutainer® Safety-Lok™ Administration Set with Filter, but it does not contain specific acceptance criteria or a detailed study report with the information requested in your bullet points.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions "Extensive mechanical and compatibility testing was performed to demonstrate the device's safety and effectiveness," but it does not provide the results of these tests against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Here's what I can extract based on the limited information provided:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	"Extensive mechanical and compatibility testing was performed to demonstrate the device's safety and effectiveness." (No specific performance metrics are reported.)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no information on expert review or ground truth establishment is provided for testing an AI/ML device.

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

Not applicable. This is not an AI/ML device requiring clinical image/data interpretation.

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/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground truth as typically understood for AI/ML performance evaluation is not relevant here. The evaluation involved "mechanical and compatibility testing," implying engineering and material science evaluations, likely against predefined specification limits.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

Summary

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NOV 1 8 2003

K033350

Attachment 4

510(k) Summary Of Safety and Effectiveness

I. General Information
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92

Establishment:

• Address:	BD Diagnostics, Preanalytical Systems1 Becton DriveFranklin Lakes, NJ 07417-1885
• Registration Number:	2243072
• Contact Person:	M. Wendy BallesterosRegulatory Affairs Specialist

Date of Summary: ● Device

Trade Name:

October 17, 2003

Fax No. 201-847-4858

BD Vacutainer® Safety-Lok™ Administration Set with Filter

Classification Name: ●
Classification:
Performance Standards: ●

Intravascular Administration Set

Telephone no.: 201-847-6280

Class II None Established under 514 of the Food, Drug and Cosmetic Act

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II. Safety and Effectiveness Information Supporting Substantial Equivalence
- · Device Description

· Intended Use
The BD Vacutainer® Safety-Lok™ Administration Set with Filter is a sterile, single-use winged set intended for the intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The BD Vacutainer® Safety-Lok™ Administration Set with Filter minimizes the possibility of needlesticks if manually activated following administration.
· Synopsis of Performance Study Results
Extensive mechanical and compatibility testing was performed to demonstrate the device's safety and effectiveness.

III. Predicate Device Summary Table

· Substantial Equivalence
Based on comparison of the device features, materials, intended use and performance, the BD Vacutainer® Safety-Lok™ Administration Set with Filter is shown to be substantially equivalent to the commercially available predicate device indicated in the table below. The predicate device, K number, and clearance date are also identified in the table below.

Manufacturer	Predicate Device	K-Number	Clearance Date
BectonDickinson	BD Vacutainer®Safety-Lok™ BloodCollection Set	K980414	March 3, 1998

u Ballisterf

Oct. 17, 2003
Date

M. Wendv Ballesteros Regulatory Affairs Specialist BD Diagnostics, PreAnalytical Systems Pecton Dickinson and Company

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2003

Becton Dickinson Company M. Wendy Ballesteros Regulatory Affairs Specialist BD Diagnostics, Preanalytical Systems 1 Becton Drive Franklin lakes, New Jersey 07417

Re: K033350

Trade/Device Name: BD Vacutainer® Safety-Lok™ Administration Set with Filter Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 17, 2003 Received: October 24, 2003

Dear Ms. Ballesteros:

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 - Ms. Ballesteros

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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chuls

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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Attachment 2

B. INDICATIONS FOR USE

510(K) Number (IF Known):

DEVICE NAME: BD Vacutainer® Safety-Lok™ Administration Set with Filter

INDICATIONS FOR USE:

(Please do not Write Below this line-continue on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PRESCRIPTION USE

سسا

OR Over-The-Counter Use

(Per 21 CFR § 801.109)

(OPTIONAL FORMAT 1-2-S

Patricia Cucenté

ision Sign-Off) on of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K033350

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.