Nitroglycerin Sets with DUO-VENT Spike

K150860 · Baxter Healthcare Corporation · FPA · Apr 16, 2015 · General Hospital

Device Facts

• Record ID: K150860
• Device Name: Nitroglycerin Sets with DUO-VENT Spike
• Applicant: Baxter Healthcare Corporation
• Product Code: FPA · General Hospital
• Decision Date: Apr 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

For the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device.

Device Story

Single-use disposable IV administration set; designed for delivery of Nitroglycerin solution. Features vented spike (DUO-VENT), drip chamber, PVC pump segment, and trilayer tubing with inner polyethylene (PE) layer to prevent drug absorption/loss associated with standard PVC. Includes roller clamp, slide clamp, and optional injection sites (Interlink, Clearlink, or needle-accessed). Operated by clinicians in clinical settings to connect drug containers to patient vascular access devices. Modifications include updated PE material in tubing inner layer and transition to latex-free needle-accessed y-sites. Device ensures accurate drug delivery by maintaining Nitroglycerin concentration during infusion.

Clinical Evidence

Bench testing only. Evaluated functional performance (clear passage, roller clamp force/shut-off/leak, bond strength, air pressure, drug compatibility) and biocompatibility (ISO-10993-1 for prolonged duration, external communicating, indirect blood path). Tests included cytotoxicity, systemic toxicity, irritation, sensitization, hemocompatibility, and USP physiochemical testing. All results met acceptance criteria.

Technological Characteristics

Single-use IV administration set. Materials: non-DEHP drip chamber, PVC pump segment, trilayer tubing (inner PE layer), luer lock. Connectivity: None. Sterilization: Not specified. Software: None. Biocompatibility per ISO-10993-1.

Indications for Use

Indicated for the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Nitroglycerine Administration Sets (Solution Admin. Set 2C9096 w/10 PVC) (K832284)
• Solution Sets/Extension Sets (K142011)

Submission Summary (Full Text)

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

April 16, 2015

Baxter Health Corporation c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K150860

Trade/Device Name: Nitroglycerin Set with DUO-VENT Spike Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Sets Regulatory Class: II Product Code: FPA Dated: March 30, 2015 Received: April 1, 2015

Dear Mr. Job:

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.

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Page 2 - Mr. Mark Job

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) TBD

K150860

Device Name

Nitroglycerin Sets with DUO-VENT Spike

Indications for Use (Describe)

For the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### Section 5 - 510(k) Summary

April 14, 2015

### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

# CONTACT PERSON:

Dhiraj Bizzul Specialist, Global Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: [phone] Fax: [phone]

### DEVICE NAME:

Trade Name: Nitroglycerin Sets with DUO-VENT Spike

Common name: Intravascular (IV) Administration Sets

Classification Panel: 80 General Hospital

Classification: 21 CFR 880.5440

Class: Class II

Product Code: FPA

## Table 1. Representative Product Codes for Nitroglycerin Sets with DUO-VENT Spike

| Code Number | Name |
|-------------|------------------------------------------------------------------------|
| 1C8043 | Nitroglycerin Set with DUO-VENT Spike |
| 2C7551 | Nitroglycerin Set with DUO-VENT Spike (INTERLINK System) |
| 2C7552 | Nitroglycerin Set with DUO-VENT Spike (Needle-Accessed Injection Site) |
| 2C8851 | Nitroglycerin Set with DUO-VENT Spike (CLEARLINK System) |

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# PREDICATE DEVICE:

| Device | Company | Predicate 510(k) | Clearance date |
|---------------------------------------------------------------------------------|----------------------------------|------------------|-------------------|
| Nitroglycerine Administration<br>Sets(Solution Admin. Set 2C9096 w/10<br>PVC).a | Travenol<br>Laboratories, S.A.b | K832284 | December 29, 1983 |
| Solution Sets/Extension Sets | Baxter Healthcare<br>Corporation | K142011 | August 18, 2014 |

### Table 2. Predicate 510(k)

4 Nitroglycerine Administration Sets have been renamed Nitroglycerin Sets with DUO-VENT Spike. K832284 was submitted to the FDA under the device name of Nitroglycerine Administration Sets but was cleared under the device name of Solution Admin. Set 2C9096 w/10 PVC.

6 Travenol Laboratories, S.A. became Baxter International Inc. in 1988

### DEVICE DESCRIPTION:

The proposed devices, which are the subject of this Traditional 510(k) premarket notification, consist of Nitroglycerin Sets with DUO-VENT Spike. They are single use disposable devices intended for the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notification K832284 (cleared on December 29, 1983).

Baxter's Nitroglycerin Sets with DUO-VENT Spike are comprised of non-DEHP drip chamber with a vented spike. PVC tubing pump segment, polyethylene (PE) lined trilayer tubing, and a luer lock. On all sets there is a fixture slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink, Clearlink, needle-accessed, or none), and type of drip chamber (10 or 60 drops per minute).

Polyethylene lined tubing is used to administer Nitroglycerin due to the compatibility issues between the drug and polyvinyl chloride (PVC). Nitroglycerin concentration can be significantly reduced when infused using standard PVC administration sets, due to absorption into the tubing. For this reason, trilayer tubing with an inner polyethylene layer is used in Baxter's line of Nitroglycerin Sets with DUO-VENT Spike.

The basis for this premarket notification is a modification to the PE lined trilayer tubing used in Baxter's Nitroglycerin Sets with DUO-VENT Spike. The modification consists of a change to the Polyethylene material used in the inner layer of the PE lined trilayer tubing.

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Along with this modification, the needle-accessed injection site (y-site) is changing from a latex-containing y-site to one that is not manufactured with latex. This proposed needle-accessed y-site is currently used in Baxter's Intravascular (IV) Administration Sets with y-site(s) and has been previously cleared under 510(k) premarket notification K142011 (cleared on August 18, 2014).

These modifications do not impact the intended use or the fundamental scientific technology of the device. No other materials of construction are being introduced into this device as part of this update. The product labels are also being updated to add the indications for use statement of the device, revise statements regarding latex and references to pump devices, and make any other changes to comply with Baxter's labeling standards.

## STATEMENT OF INTENDED USE:

For the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices are equivalent to Baxter's current legally marketed device cleared under 510(k) premarket notification K832284 (cleared on December 29, 1983). The modification consists of a change to the Polyethylene material used in the inner layer of the PE lined trilayer tubing. In addition to this, the needle-accessed y-sites will be changing, which has been previously cleared under 510(k) premarket notification K142011 (cleared on August 18, 2014). The intended use, the basic design, and function for the proposed device are equivalent to the predicate device.

### DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

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# Performance Data:

The following bench tests were conducted to evaluate the effect of the PE lined trilayer tubing modification on the functional performance of the Nitroglycerin Sets with DUO-VENT Spike:

- Clear Passage Test .
- Roller Clamp Force Test ●
- Roller Clamp Shut-Off Test ●
- Roller Clamp Tubing Leak Test ●
- . Solvent Bond Tensile Strength Test
- Solvent Bond Air Pressure Test
- . Drug Compatibility Test

The following bench tests were previously conducted in K142011 (cleared on August 18, 2014) to evaluate the effect of the design modification on the functional performance of the IV Administration Sets with a needle-accessed y-site:

- Puncture Test .
- 7-Day Indwell Test ●
- Burst Test ●
- Vacuum Leakage Test ●
- Solvent Bond Tensile Strength Test ●
- . Solvent Bond Air Pressure Test
- Coring Test ●
- Insertion Force Test .

All tests met the acceptance criteria.

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# Biocompatibility:

Biocompatibility assessments of the Nitroglycerin Sets with DUO-VENT Spike were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged duration, external communicating device, indirect blood path, and Blue Book Memorandum G95-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", as recommended in the IV Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]". The following tests were conducted:

- Cytotoxicity ●
- Systemic Toxicity ●
- Irritation/Intracutaneous .
- . Sensitization
- Hemocompatibility ●
- USP Physiochemical

Based upon the results of this prolonged duration, external communicating, indirect blood path testing, the Nitroglycerin Sets with DUO-VENT Spike have been shown to be biocompatible and appropriate for its intended use.

# CONCLUSION:

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in Table 2.