(279 days)
Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.
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".
This document describes a 510(k) premarket notification for the "Busse Extension Set," which is an intravascular administration set. The provided text, however, focuses on demonstrating substantial equivalence to a predicate device rather than detailing acceptance criteria and the study proving direct performance against those criteria in the way one might expect for a novel AI/software device.
Instead, the document primarily lists standard tests performed on medical devices of this type to ensure safety and performance compared to existing, legally marketed devices. It does not contain information about an AI/software component, nor does it present the study design typical for evaluating an AI's diagnostic or predictive performance against specific metrics like sensitivity, specificity, or AUC, as would be common in the context of the requested information.
Therefore, many of the requested fields cannot be directly answered because the document describes a physical medical device (an extension set) and not an AI or software-based medical device.
Based on the provided text, here is the information that can be extracted, and where relevant, why other information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a numerical or statistical format often seen for AI/software performance. Instead, it describes various tests and states that the materials and tests "met the testing requirements and were found to be acceptable for the intended use."
| Test Category | Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | L929 MEM Elution Test | Acceptable for contact with biological systems | Materials met testing requirements, found acceptable. |
| Kligman Maximization Test | Acceptable for contact with biological systems | Materials met testing requirements, found acceptable. | |
| Intracutaneous Injection Test | Acceptable for contact with biological systems | Materials met testing requirements, found acceptable. | |
| Systemic Injection Test | Acceptable for contact with biological systems | Materials met testing requirements, found acceptable. | |
| Rabbit Pyrogen Test | Apyrogenic | Materials met testing requirements, found acceptable. | |
| Hemolysis Test | Non-hemolytic | Materials met testing requirements, found acceptable. | |
| Sterilization | Sterilization (ISO 11135-1) | Sterilized using Ethylene Oxide, SAL 10⁻⁶ | Met ISO 11135-1, SAL 10⁻⁶ |
| Performance Testing | Liquid Leakage | No leakage | Met testing requirements, found acceptable. |
| Pull Test | Adequate tensile strength/connection integrity | Met testing requirements, found acceptable. | |
| Durometer Test | Appropriate material hardness | Met testing requirements, found acceptable. | |
| Conical Fitting | Fittings meet standard specifications for connection integrity | Met testing requirements, found acceptable. | |
| Packaging | Packaging (ISO 11607-2) | Packaging maintains sterility and integrity | Met ISO 11607-2 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing appears to be on physical samples of the device, not a "test set" of data in the AI/software context.
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)
This information is not applicable and not provided. "Ground truth" in the traditional sense, as it relates to expert consensus for diagnostic tasks, is not relevant to the evaluation of a physical medical device like an extension set. The "ground truth" here would be objective physical measurements and chemical/biological assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. The device is a physical medical extension set, not an AI or software for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a physical medical extension set.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the "ground truth" for the device's acceptable performance is based on established industry standards and regulatory requirements (e.g., ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization, ISO 11607-2 for packaging) as well as established physical and biological testing protocols (e.g., specific liquid leakage, pull tests, durometer tests, and various biocompatibility assays). The success of these tests (e.g., no leakage, non-hemolytic, apyrogenic, meeting specified strength) confirms the "ground truth" of the device's functional and safety characteristics.
8. The sample size for the training set
This information is not applicable and not provided. This document refers to the evaluation of a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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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 (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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 AnsariBusse Hospital Disposables75 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 andFPA |
| Predicate Device: | Centurion Pressure Injectable Extension Set, CenturionMedical Products, K103562 |
| Device Description: | Busse Extension Set consists of PVC tubing with orwithout connectors. The tubing accessories include; 3-way connectors, clamps, male and female luer lock,luer slip fitting, and valves. The Extension Set will beprovided as sterile, single use only and will bepackaged individually and in medical convenience kits.The Extension Sets will be available in a variety oflengths, starting from 6" to 36". |
| Intended Use: | Busse Extension Sets are intended for use with avascular access device for administration andwithdrawal 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.
| TechnologicalCharacteristics | Proposed Device | CenturionMedicalProducts |
|---|---|---|
| Intended Use | Intended for use with a vascularaccess device for administrationand withdrawal of fluids | Intended to allow theaspiration injection, orgravity/pump flow offluids |
| 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 Ethyleneoxide |
| SterilityAssurance Level | 10-6 | 10-6 |
| Product Name | Busse Extension Set | Centurion PressureInjectable ExtensionSet |
| 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
§ 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.