The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

Device Description

The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes fro the transfer of liquid. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Item#	Performance Specification: Acceptance Criteria	Status of BD PhaSeal® System (Reported Performance)
1	Leakproof Connections	No Leaks (Fluorescein Test)
2	Airtight Connections	No Visible Smoke (TiCl4 Test)
3	Microbial Ingress	No Ingress at the Protector or Connector

Description of the Study Proving Acceptance Criteria

The study described is a series of non-clinical tests designed to demonstrate that the BD PhaSeal® Closed System Drug Transfer Device meets the specified performance criteria for leakproofness, airtightness, and microbial ingress. The summary states, "As there is no change to the subject device in comparison to the predicate devices, the performance data provided represent the performance of both the predicate and subject device of this 510(k)." The tests were conducted to substantiate its use as a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System (ONB product code).

Details on the Tests:

Leakproof Connections: Tested using a Fluorescein Test.
Airtight Connections: Tested using a TiCl4 Test (which detects vapor/smoke).
Microbial Ingress: Tested to ensure no ingress at the Protector or Connector.

Additional Information Not Present in the Document:

The provided 510(k) summary focuses on demonstrating substantial equivalence through technological characteristics and a summary of performance tests. It does not contain the following information typically found in detailed study reports:

Sample size used for the test set and the data provenance: Not specified. The document only mentions "additional tests referenced in the table" without detailing sample sizes or the origin (country, retrospective/prospective) of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for these types of physical performance tests (leak, airtight, microbial ingress). Ground truth is established by the test method itself, not expert consensus.
Adjudication method for the test set: Not applicable for these performance tests. The outcome is typically a pass/fail based on direct observation (e.g., presence/absence of leaks, smoke, or microbial growth).
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 device is a medical device for drug transfer, not an imaging or diagnostic AI product, so MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm-driven device.
The type of ground truth used: The ground truth for these tests is defined by the objective results of the specified testing methodologies (Fluorescein Test, TiCl4 Test, and microbial ingress testing). For example, "no leaks" is the ground truth from the fluorescein test.
The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
How the ground truth for the training set was established: Not applicable. This device does not use machine learning or require a training set.

Summary

{0}------------------------------------------------

510(K) Summary of Safety and Effectiveness

JAN 0 9 2013

Date Prepared: 12 October 2012

Submitted By: 1.
John Roberts Regulatory Affairs Specialist BD Medical - Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417 Tel: 201 847 5473; Fax: 201 847 5307

2. Device Name:

BD PhaSeal® Closed System Drug Transfer Device Trade Name: Common Name: Closed antineoplastic & hazardous drug reconstitution & transfer system Classification Name: Intravascular administration set Classification: Class II, 21 CFR 880.5440

3. Predicate Device:

BD PhaSeal® Connector, Injector, Protector - K120384

4. Device Description:

5. Indications for Use:

6. Technological Characteristics:

· The technological characteristics of the subject device are identical to those of the predicate devices.

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

K123213. page 2 of 3

Characteristic	Subject Device: BD PhaSeal	Predicate Device: BD PhasSeal K120384	Equivalence
Transfer Mechanism	Elastomeric Double Membrane	Elastomeric Double Membrane	Identical to Predicate
Connection between PhaSeal Components	Bayonet Fitting with Elastomeric Double Membrane	Bayonet Fitting with Elastomeric Double Membrane	Identical to Predicate
Components	Protector, Injector, Connector	Protector, Injector, Connector	Identical to Predicate
Protector Spike	Stainless Steel or Plastic	Stainless Steel or Plastic	Identical to Predicate
Injector Cannula	Stainless Steel	Stainless Steel	Identical to Predicate
Fitting Connection to external standard syringe	Injector: Luer / Luer Lock Connection	Injector: Luer / Luer Lock Connection	Identical to Predicate
Fitting Connection to external standard IV line	Luer Lock or Spike Port	Luer Lock or Spike Port	Identical to Predicate
Fitting Connection to external standard IV bag	Spike	Spike	Identical to Predicate
Needle Safety Feature (Injector Only)	Safety sleeve	Safety sleeve	Identical to Predicate
Sterilization Method	EO	EO	Identical to Predicate

7. Performance:

The additional tests referenced in the table have been provided in order to substantiate the use of product code ONB - Closed antineoplastic and hazardous drug reconstitution and transfer system - for the BD PhaSeal® Closed System Drug Transfer Device. BD has included the additional airtight and leakproof requirement as both of these requirements are cited by the National Institute for Occupational Safety and Health (NIOSH) and the International Society of Oncology Pharmacy Practitioners (ISOPP) as essential requirements necessary to reduce health care workers from exposure to hazardous drugs. In addition, NIOSH also cites the need to prevent contaminates from entering the closed system during transfer. As such. BD proposes to extend the microbial ingress claim to the entire system; not just the PhaSeal Protector. As there is no change to the subject device in comparison to the predicate devices, the performance data provided represent the performance of both the predicate and subject device of this 510(k).

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

Item#	Performance Specification:	Status of BD PhaSeal® System
1	Leakproof Connections	No Leaks (Fluorescein Test)1,2
2	Airtight Connections	No Visable Smoke (TiCl4 Test)3
3	Microbial Ingress	No Ingress at the Protector or Connector

73213

8. Conclusion:

Based on comparison to the predicate device and the nonclinical tests provided, the modified BD PhaSeal® Closed System Drug Transfer Device is as safe, as effective, and performs as well as the legally marketed predicate device. ·

Spivey S, Connor T. Determining sources of workplace contamination with antineoplastic drugs and comparing

conventional IV drug preparation with a closed system. Hosp Pharm. 2003; 38(2): 13-139.
3 Jorgenson J, Spivey S, Au C et al. Contamination comparison of transfer devices inte Hosp Pharm. 2008; 43(9): 723-727 ·
³ Ibid.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is centered on the page. There is a horizontal line below the text. To the left of the text is a symbol that appears to be three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2013

Mr. John Roberts Regulatory Affairs Specialist Becton Dickinson & Company l Becton Drive MC237 FRANKLIN LAKES NJ 07417

Re: K123213

Trade/Device Name: PhaSeal® - Closed System Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ONB Dated: October 12, 2012 Received: October 15, 2012

Dear Mr. Roberts:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony De mint

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K123113

Device Name:

PhaSeal® - A Closed System Transfer Device

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use	____________________
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER
PAGE OF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of Sajjad H. Syed

ate: 2013.01.09 15:12:01 -05'00

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

16173 213

VIII

510(k) Number:_

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.