(279 days)
Not Found
No
The device description and performance testing focus on the physical properties and functionality of a simple medical tubing set, with no mention of AI or ML.
No
The device, an extension set, is described as being used with a vascular access device for administering and withdrawing fluids, which is a supportive function and not a direct therapeutic intervention.
No
The device, an extension set, is intended for administrative and withdrawals of fluids, which is a functional purpose, not a diagnostic one. It is an accessory used with a vascular access device rather than for identifying or detecting a medical condition.
No
The device description clearly outlines physical components like PVC tubing, connectors, clamps, and valves, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used with a vascular access device for administrative and withdrawals of fluids." This describes a device used for delivering or removing substances directly from the body, which is a characteristic of medical devices used in patient care, not for testing samples in vitro (outside the body).
- Device Description: The description of the components (PVC tubing, connectors, clamps, luer fittings, valves) aligns with devices used for fluid management in a clinical setting.
- Lack of IVD Indicators: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The performance tests listed are related to the physical integrity and functionality of the tubing and connectors, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for fluid administration and withdrawal.
N/A
Intended Use / Indications for Use
Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.
Product codes
FPA, FPK
Device Description
Busse Extension Set consists of PVC tubing with or without connectors. The tubing accessories include; 3-way connectors, clamps, male and female luer lock, luer slip fitting, and valves. The Extension Set will be provided as sterile, single use only and will be packaged individually and in medical convenience kits. The Extension Sets will be available in a variety of lengths, starting from 6" to 36".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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
Busse Hospital Disposables
75 Arkav Dr.
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
FPA |
| Predicate Device: | Centurion Pressure Injectable Extension Set, Centurion
Medical Products, K103562 |
| Device Description: | Busse Extension Set consists of PVC tubing with or
without connectors. The tubing accessories include; 3-
way connectors, clamps, male and female luer lock,
luer slip fitting, and valves. The Extension Set will be
provided as sterile, single use only and will be
packaged individually and in medical convenience kits.
The Extension Sets will be available in a variety of
lengths, starting from 6" to 36". |
| Intended Use: | Busse Extension Sets are intended for use with a
vascular access device for administration and
withdrawal of fluids. |
5
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
Characteristics | Proposed Device | Centurion
Medical
Products |
|----------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended Use | Intended for use with a vascular
access device for administration
and withdrawal of fluids | Intended to allow the
aspiration injection, or
gravity/pump flow of
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
oxide |
| Sterility
Assurance Level | 10-6 | 10-6 |
| Product Name | Busse Extension Set | Centurion Pressure
Injectable Extension
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 .
6
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