BUSSE EXTENSION SET

K141285 · Busse Hospital Disposables · FPA · Feb 19, 2015 · General Hospital

Device Facts

• Record ID: K141285
• Device Name: BUSSE EXTENSION SET
• Applicant: Busse Hospital Disposables
• Product Code: FPA · General Hospital
• Decision Date: Feb 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Busse Extension Sets are intended for use with a vascular access device for administration and withdrawal of fluids.

Device Story

Busse Extension Set is a sterile, single-use medical device consisting of PVC tubing, connectors (male/female luer lock, luer slip), 3-way connectors, clamps, and valves. It functions as an extension to vascular access devices to facilitate fluid administration or withdrawal. Used in clinical settings, it is operated by healthcare professionals. The device provides a physical conduit for fluid flow; it does not involve electronic processing, software, or automated decision-making. It benefits patients by extending the reach of vascular access lines, allowing for flexible fluid management.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing included L929 MEM Elution, Kligman Maximization, Intracutaneous Injection, Systemic Injection, Rabbit Pyrogen, and Hemolysis tests. Performance testing included liquid leakage, pull test, durameter test, and conical fitting test.

Technological Characteristics

Materials: PVC. Sterilization: Ethylene oxide (ISO 11135-1) to 10^-6 SAL. Dimensions: 6 to 36 inches. Connectivity: None (mechanical). Packaging: ISO 11607-2. Biocompatibility: ISO 10993-1.

Indications for Use

Indicated for use with a vascular access device for the administration and withdrawal of fluids in patients requiring intravenous access.

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

• Centurion Pressure Injectable Extension Set, Centurion Medical Products (K103562)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.

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

February 19, 2015

Busse Hospital Disposables Mr. Muhamad Ansari Director of Regulatory Affairs 75 Arkay Drive Hauppauge, NY 11788

Re: K141285

Trade/Device Name: Busse Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FPK Dated: January 15, 2015 Received: January 20, 2015

Dear Mr. Ansari:

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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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 vours.

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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K141285

# Device Name

Busse Extension Set

# Indications for Use (Describe)

Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/4/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a bold, sans-serif font, with the letters closely spaced together. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, less bold font. The logo is simple and professional, and it is likely used to represent a company that manufactures or distributes disposable medical supplies.

# 510(k) Summary

| Regulatory Affairs Contact: | Muhamad Ansari<br>Busse Hospital Disposables<br>75 Arkav Dr.<br>Hauppauge NY 11788 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 631-435-4711 Ext: 254 |
| Fax: | 631-435-2849 |
| Date Summary Prepared: | May 7, 2014 |
| Product Trade Name: | Busse Extension Set |
| Common Name: | Intravascular Administration Set |
| Classification Name: | Class II, 21 CFR 880.5440, Product code FPK and<br>FPA |
| Predicate Device: | Centurion Pressure Injectable Extension Set, Centurion<br>Medical Products, K103562 |
| Device Description: | Busse Extension Set consists of PVC tubing with or<br>without connectors. The tubing accessories include; 3-<br>way connectors, clamps, male and female luer lock,<br>luer slip fitting, and valves. The Extension Set will be<br>provided as sterile, single use only and will be<br>packaged individually and in medical convenience kits.<br>The Extension Sets will be available in a variety of<br>lengths, starting from 6" to 36". |
| Intended Use: | Busse Extension Sets are intended for use with a<br>vascular access device for administration and<br>withdrawal of fluids. |

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Image /page/5/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is written in a bold, sans-serif font, with the letters overlapping each other. Below the word "busse", the words "Hospital Disposables" are written in a smaller, sans-serif font. The logo is simple and professional, and it is likely used to represent a company that sells hospital supplies.

## Technological Characteristics:

The subject device has the same Technological Characteristics as a legally marketed predicate device. Below is summary of Technological Characteristics as compared to the Predicate Device.

| Technological<br>Characteristics | Proposed Device | Centurion<br>Medical<br>Products |
|----------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended Use | Intended for use with a vascular<br>access device for administration<br>and withdrawal of fluids | Intended to allow the<br>aspiration injection, or<br>gravity/pump flow of<br>fluids |
| Labeling | 21 CFR Part 801 | 21 CFR Part 801 |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 |
| Sterilization | ISO 11135-1 Ethylene oxide | ISO 11135-1 Ethylene<br>oxide |
| Sterility<br>Assurance Level | 10-6 | 10-6 |
| Product Name | Busse Extension Set | Centurion Pressure<br>Injectable Extension<br>Set |
| Packaging | ISO 11607-2 | ISO 11607-1 |
| Material | PVC | PVC |

This type of device has been marketed in the Unites States for many years, using the same materials used by the Extension Sets, and no issues of safety and effectiveness have been raised.

### Summary of Testing:

All materials used in the fabrication of the Busse Extension Sets were evaluated through biological qualification safety tests.

The biocompatibility tests performed were:

- L929 MEM Elution Test .
- Kligman Maximization Test .
- Intracutaneous Injection Test .
- Systemic Injection Test .
- Rabbit Pyrogen Test .
- Hemolysis Test .

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Image /page/6/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a bold, sans-serif font, with the letters closely spaced together. Below the word "busse", the words "Hospital Disposables" are written in a smaller, less bold font. The logo is simple and professional, and it is likely used to represent a company that sells medical supplies.

Summary of Performance Testing:

Busse Extension Sets has been tested for the following performance tests:

- Liquid Leakage .
- . Pull Test
- Durameter Test .
- . Conical Fitting

These materials have met the testing requirements and were found to be acceptable for the intended use.

Conclusion:

The above statements are accurate representations of the device Busse intents to market. Based on all the testing and comparison Busse believes the subject device is substantially equivalent to the predicate device. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.

Official Correspondent:

Mudmad Chsen (Signature)

Muhamad Ansari (printed name)

Title: Director of Regulatory Affairs

Date: 2/19/2015