(142 days)
The InviroBlunt and InviroBlunt w/EZ Wings Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.
The InviroBlunt/InviroBlunt Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites. The family of InviroBlunt Plastic Cannulas are 18 gauge stainless steel blunt cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. The InviroBlunt Cannulas are used in conjunction with a syringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.
Here's an analysis of the provided text regarding the InviroBlunt/InviroBlunt w/EZ Wings Cannula, focusing on acceptance criteria and supporting studies:
This document is a 510(k) summary for a medical device (K083851). It focuses on demonstrating substantial equivalence to a predicate device, not on presenting a comprehensive study of device performance to specific clinical acceptance criteria in the way a novel AI algorithm might. Therefore, many of the requested data points (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not present in this type of FDA submission summary for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Requirement (from 'G. Summary and Conclusion of Nonclinical and Clinical Tests:') | Reported Device Performance |
|---|---|
| Visual Inspection: Smooth surface, no oil contamination, no extraneous matter, no other defects. | Met requirement |
| Visual Inspection: Lubricant invisible. | Met requirement |
| Visual Inspection: Free of flash and burrs. | Met requirement |
| Color: Hub and cap color met product requirement. | Met requirement |
| Dimensional: All components met dimensional, visual, and functional requirements listed on part/assembly drawing. | Met requirement |
| Functional: Cap Pull off Force. | Met requirement |
| Functional: InviroBlunt/Syringe interface. | Met requirement |
| Functional: Penetration. | Met requirement |
| Functional: Bending and tip breaking Forces. | Met requirement |
| Functional: Flow rate. | Met requirement |
| Interface: Secure interfaces between InviroBlunt and medicine vial stopper. | Withstood 330 kPa for 30 seconds without leakage. |
| Interface: Secure interfaces between InviroBlunt and syringe luer lock fitting. | Withstood 330 kPa for 30 seconds without leakage. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify the sample size for any "test set" in the context of clinical or performance studies. For a physical device like a cannula, "test set" would typically refer to a number of units tested. The information provided is a summary of non-clinical tests.
- Sample Size: Not specified.
- Data Provenance: The tests described are non-clinical performance requirements, likely conducted internally by the manufacturer (Inviro Medical) in a controlled laboratory environment. No country of origin for clinical data is provided as no clinical data is referenced in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The "ground truth" for the performance criteria listed (e.g., smooth surface, dimensional accuracy, force requirements) would be established by engineering specifications and objective measurements, not by expert medical opinion in the way clinical ground truth is established for diagnostic AI.
4. Adjudication Method for the Test Set
Not applicable. As described above, the acceptance criteria are based on objective, non-clinical engineering and performance metrics, not on human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a physical medical device (cannula), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to readers or AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance criteria are:
- Engineering Specifications: Dimensional requirements, force measurements (Cap Pull off, penetration, bending, tip breaking), flow rate.
- Visual Inspection Criteria: Smoothness, absence of contamination/defects/flash/burrs, invisible lubricant, correct color.
- Pressure Resistance Standards: Ability to withstand 330 kPa for 30 seconds without leakage.
8. The Sample Size for the Training Set
Not applicable. This is for a physical device, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for a physical device.
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K083851
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510(k) Summary (As required by 21 CFR 807.92(a))
- Submitter Information ilə
MAY 15 2009
Inviro Medical 1755 North Brown Road Suite 150 Lawrenceville, GA 30043
Phone Number: Fax Number: Contact:
678-405-4031 678-405-4044 Jim Barley Director RA/QA
Trade Name:
InviroBlunt/InviroBlunt w/EZ Wings Cannula
- B. Device Information
Trade/Proprietary Name:
InviroBlunt and /InviroBlunt w/EZ Wings Cannula
Set, I.V. Fluid Transfer
Common name of device: Syringe Cannula
Classification Name:
Product Code:
Regulatory Class:
Classification Number: 880.5440
Reason for 510(k):
New Device
80 LHI
II
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K083851/
2 of 3
C. Predicate Device:
Inviro Medical InviroLink and InviroLink w/EZ Wings Cannula
Predicate 510(k) #:
Predicate product code: LHI
- Device Description D.
The InviroBlunt/InviroBlunt Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites.
The family of InviroBlunt Plastic Cannulas are 18 gauge stainless steel blunt cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. Following is a list of the InviroBlunt Cannulas:
- InviroBlunt, Model # 120022 1.
- InviroBlunt with EZ wings, Model # 120522 2.
The InviroBlunt Cannulas are used in conjunction with a svringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.
Statement of Indications for Use E.
The InviroBlunt and InviroBlunt w/EZ Wings Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.
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K08 3857
3 of 3
- Comparison of Required Technological Characteristics: F.
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the InviroBlunt and InviroBlunt w/EZ Wings Cannulas and the cited predicate device.
Summary and Conclusion of Nonclinical and Clinical Tests: G.
The InviroBlunt/InviroBlunt w/EZ Wings Cannulas met the following product/performance requirements:
A visual inspection of the device showed that the surface of the device was smooth and without oil contamination or extraneous matter or other defects. The lubricant on the cannula was invisible and the device was free of flash and burrs.
The color of each hub and cap met the product requirement.
Dimensional - All components of the InviroBlunt and InviroBlunt w/EZ Wings met the dimensional, visual and functional requirements listed on the part/assembly drawing.
Functional - The InviroBlunt and InviroBlunt w/EZ Wings met the requirements for Cap Pull off Force, InviroBlunt/Syringe interface, penetration, bending and tip breaking Forces and flow rate.
Interface - The interfaces between the InviroBlunt and the medicine vial stopper and the InviroBlunt and the syringe luer lock fitting were secure and able to withstand 330 kPa of pressure for 30 seconds without leakage.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service .
MAY 15 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Barley Director of Regulation Affairs/Quality Assurance Inviro Medical Devices, Incorporated 1755 North Brown Road, Suite 150 Lawrenceville, Georgia 30043
Re: K083851
Trade/Device Name: InviroBlunt and /InviroBlunt w/EZ Wings Cannula Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 31, 2009 Received: April 22, 2009
Dear Mr. Barley:
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, thereforc, 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.
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. Barley
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Bunner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, 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):
" | Device Name:
Indications For Use:
The InviroBlunt and InviroBlunt w/EZ Wings Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.J. Musick for LCAR. Colburn 05/15/09
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083851
Page 1 of
§ 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.