SMART LABEL, PROPOFOL
Device Facts
| Record ID | K142333 |
|---|---|
| Device Name | SMART LABEL, PROPOFOL |
| Applicant | American I.V. Products, Inc. Dba Aiv, Inc. |
| Product Code | MRZ · General Hospital |
| Decision Date | Dec 18, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Smart Label for Propofol is intended for controlled rate delivery of small volume parenteral fluids when used with the InfusO.R. Pump. The Smart Label is intended for use with Propofol as indicated on the label at the specified concentration for delivery using the syringe size also indicated on the Smart Label.
Device Story
Smart Label for Propofol is a magnetic accessory for the InfusO.R. pump; replaces OEM labels. Device consists of ferrite bonded with synthetic rubber; contains no electronic components. Label features printed numeric values for user reference and embedded magnets for pump identification. When applied to the pump, internal hall effect sensors detect the magnetic pattern; pump identifies the label and automatically selects the corresponding internal data table for drug delivery calculations. Healthcare providers use the label to guide rotary switch settings on the pump. Device ensures the pump recognizes the specific drug/concentration/syringe configuration; failure to recognize the label triggers an error message and safe-state shutdown. Used in clinical settings by biomedical technicians or patient care providers. Benefits include ensuring correct pump configuration for Propofol delivery, reducing potential for manual entry errors.
Clinical Evidence
No clinical data. Bench testing only, including verification of construction, material selection, and operation; storage and cleaning cycle testing; and performance testing to confirm proper label recognition and dosage delivery consistent with the predicate device.
Technological Characteristics
Ferrite bonded with synthetic rubber. Dimensions: 5.950" x 2.315" x 0.065". Passive magnetic label; no electrical/electronic components. Operates via magnetic coupling with pump-side hall effect sensors. No connectivity; no software. Sterilization not specified.
Indications for Use
Indicated for controlled rate delivery of small volume parenteral fluids containing Propofol via the InfusO.R. Pump. Intended for use by healthcare providers.
Regulatory Classification
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Predicate Devices
- C.R. BARD, INC. (K883577)
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
December 18,2014
American I.V. Products, Inc. dba AIV, Inc. Ms. Shannon Houchen QA Manager 7485 Shipley Avenue Harmans, MD 21077
Re: K142333
Trade/Device Name: Smart Label, Propofol Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: November 14, 2014 Received: November 19, 2014
#### Dear Ms. Houchen:
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 - Ms. Houchen
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Susan Runno, DDS, MA
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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## Indications for Use
510(k) Number (if known) K142333
Device Name Smart Label for Propofol
#### Indications for Use (Describe)
The Smart Label for Propofol is intended for controlled rate delivery of small volume parenteral fluids when used with the InfusO.R. Pump. The Smart Label is intended for use with Propofol as indicated on the label at the specified concentration for delivery using the syringe size also indicated on the Smart Label.
Type of Use (Select one or both, as applicable)
| <span style="text-decoration: underline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for AIV, which is written in blue, blocky, sans-serif font. Above the letters "ai" is a large red star. The letters "aiv" are stacked on top of each other, with the "a" on top and the "v" on the bottom.
# 510(k) Summary
## K142333
#### Device Name
| AIV Device Name: | Smart Label for Propofol |
|----------------------|-------------------------------|
| Classification Name: | Accessory to Infusion Pump |
| Common Name: | Smart Label for Infusion Pump |
#### Applicant
American IV Products, Inc. 7485 Shipley Avenue Harmans, MD 21077
#### Submittal Date
November 14, 2014
#### Contact Name
Dr. Mark Walter Director of Engineering (410)787-1300 Ext. 131
#### Establishment Registration Number
1121996
#### Device Classification
| Device Regulation Number: | 21 CFR 880.5725 |
|---------------------------|-----------------------------------|
| Regulation Name: | Pump, infusion |
| Class: | Class II |
| Product Code: | MRZ - Accessories, pump, infusion |
00.990.2911 · f 410.787.1337 · www.aiv-inc.com 7482 Shipley Avenue · Harmans, MD
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Image /page/4/Picture/0 description: The image shows the logo for AIV, which is a company or organization. The logo features the letters "aiv" in blue, with a red star positioned above and to the left of the letters. The letters are in a bold, sans-serif font, and the star has five points.
Applicable Panel:
General Hospital
## 514 Performance Standards
None established under section 514
#### Prescription Status
The subject devices are a prescription device.
#### Compliance to Standards and Regulations
None
#### Summary of Risk Management Process
The risk management file was used throughout the development process. This file consists of three sections:
Image /page/4/Figure/13 description: The image shows a flowchart of risk management files. The main file is connected to the Top-Down Report and FMECA Report. The main file includes determination of intended use and characteristics, identification of the possible hazards, risk assessment and evaluation system, and residual risk evaluation. The Top-Down Report includes evaluation of possible hazards and its potential cause, assessment of the risks posed by the hazards, and description of the risk management methods that shall be employed for each identified hazard while design phase. The FMECA Report includes identification of the safety-related components, ranking of the effects of single component failures, and description of the mitigation techniques to reduce the potential hazard.
## Reason for Submission
**MASTER COPY**
- f 410.787.1337 · www.aiv-inc.com 7482 Shipley Avenue · Harmans, MD
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Image /page/5/Picture/0 description: The image shows the logo for AIV, which is a company that provides services for the oil and gas industry. The logo consists of the letters "aiv" in blue, with a red star above the letters. The letters are in a bold, sans-serif font. The star is five-pointed and is positioned slightly to the left of the letters.
This is a new device to be marketed by our firm.
#### Labeling
Proposed labeling is provided in Section C.
#### Statement of Indications for Use
The Smart Label for Propofol is intended for controlled rate delivery of small volume parenteral fluids when used with the InfusO.R. Pump. The Smart Label is intended for use with Propofol as indicated on the label at the specified concentration for delivery using the syringe size also indicated on the Smart Label.
| AIV Part # | Description |
|------------|-----------------------|
| BX12812 | Smart Label, Propofol |
## Product Description
AlV's Smart Label for Propofol is a replacement for the Smart Label manufactured by the Original Equipment Manufacturers (OEM) for the InfusO.R. pump. AIV does not manufacture the pump. The Smart Label for Propofol is an accessory for the pump and is also available as a replacement part.
The AIV Smart Label for Propofol uses the same type of construction and has the same technological characteristics as the predicate device - the accessory supplied with the InfusO.R. pump. This device is not a kit and does not contain any electronic components. Construction of this device is substantially equivalent to the predicate device.
AIV Smart Label for Propofol is not intended to make contact with the patient.
The AIV Smart Label for Propofol is limited by the indications for use of the InfusO.R. pump.
Section E contains product specification drawings.
Image /page/5/Picture/15 description: The image shows the words "MASTER COPY" in large, bold, blue letters. The words are stacked on top of each other, with "MASTER" on the top line and "COPY" on the bottom line. The background is white. The text is centered in the image.
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Image /page/6/Picture/0 description: The image shows a logo with the letters 'aiv' in bold, blue font. Above the letters, there is a red star. The star is positioned slightly to the left of the letters, creating a visually balanced composition. The logo appears to be for a company or organization with the initials 'AIV'.
#### Principle of Operation
The Smart Label for Propofol is a magnetic label that attaches to the front label of the pump. It has 2 main functions – to display to the user the values of each switch setting and for the pump to properly recognize the label and apply in its internal calculations the data table corresponding to those label values. On the face of the labels are numeric values that the user (healthcare provider) uses to select the available options through the rotary dial selection process. The Smart Label is also magnetically coded with individual magnets to allow the InfusO.R. pump through an internal bank of hall effect sensors, to recognize which label is applied and to select the internal data table corresponding to that label and set the delivery rate per the label and the rotary switches on the pump as set by the user. The output of the hall effect sensors is a digital value. Only a subset of the possible outputs of the hall effect sensors is valid. On power up, the pump displays the code of the detected label on the pump's LCD display. The pump conducts the necessary calculations required to deliver the drug as indicated on the respective label and the location of rotary switch settings as set by the health care provider.
#### Proposed Conditions of Use
The Smart Label for Propofol is to be used with the InfusO.R. pump. They are to be applied to the pump by a biomedical technician or patient care provider knowledgeable in the operation of the pump. The pump is then used according to its specific conditions of use. No interaction is expected with other devices or with the patient.
Image /page/6/Picture/7 description: The image contains the words "MASTER COPY" in large, bold, blue font. The words are stacked on one line and centered in the image. The background is white.
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Image /page/7/Picture/0 description: The image shows a logo with the letters 'aiv' in blue, stylized with a cursive 'a' and a blocky 'iv'. Above the letters, there is a red star with five points. The star is positioned slightly to the left and above the 'aiv' text, creating a visual hierarchy.
#### Predicate Device Information
This AIV device is Substantially Equivalent to the accessory available with/for the following legally marketed devices:
C.R. BARD, INC.
K883577
#### AIV Bard (Baxter) Intended Use This device is an accessory and a Same replacement part for a pump (not manufactured by AIV, Inc.). The healthcare provider applies the device to the pump. The pump will recognize the label applied and adjust the delivery rate per the label and the rotary switches on the pump as set by the healthcare provider. The pump conducts the necessary calculations required to deliver the drug as indicated. The Smart Label for Propofol is intended for Indications for Same Use controlled rate delivery of small volume parenteral fluids when used with the InfusO.R. Pump. The Smart Label is intended for use with Propofol as indicated on the label at the specified concentration for delivery using the syringe size also indicated on the Smart Label. Operating Numeric Values on label convey to the Same Principle healthcare provider the value of the rotary switch settings. Magnetic coding of Smart Label allows the InfusO.R. pump through the use of a bank of internal hall effect sensors to recognize which label was applied to the pump and to select the internal data table corresponding to those settings.
#### Substantial Equivalence Comparison Chart
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Image /page/8/Picture/0 description: The image shows a logo with the letters 'aiv' in blue, with a red star above the letters. The letters are in a bold, sans-serif font, with the 'a' being smaller than the 'i' and 'v'. The star is a five-pointed star and is positioned slightly to the left of the letters.
| Technology | Magnetic label that allows for attachment to<br>the pump. They are also magnetically coded<br>with individual magnets. | Same |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Performance<br>Features | Dose Units, Dose/Delivery Accuracy | Same |
| Health Care<br>Provider<br>Settings | No configuration settings available for<br>customization on the Smart Label. All the<br>settings are entered in the InfusO.R. pump. | Same |
| Size | L 5.950" X W 2.315" X H 0.065" | Same |
| Material | Ferrite Bonded with Synthetic Rubber | Same |
| Functions | To display to the user the values of each<br>switch setting and for the pump to properly<br>recognize the Propofol label and apply in its<br>internal calculations the data table<br>corresponding to the Propofol label values | Same |
| Shelf Life | Shelf life and expiration are not required as the pump will<br>provide an indication when the Smart Label applied is not<br>recognized. This will cause the pump to produce an error<br>message thus failing to a safe state. This finding is detailed in<br>our report titled “Analysis of Weak or Missing Magnet". The<br>devices were subjected to repeated cleaning cycles prior to<br>testing - the process and findings are detailed in the report<br>titled "Cleaning and Storage Tests". | |
| Cleaning &<br>Disinfection | The devices were subjected to repeated<br>cleaning cycles prior to testing - the process<br>and findings are detailed in the report titled<br>"Cleaning and Storage Tests". | Same |
Reports characterizing the predicate device are included in Section H. The engineering drawings specifying the AIV product are in Section E.
Performance, General Safety and Effectiveness
Image /page/8/Picture/6 description: The image shows the words "MASTER COPY" in large, bold, blue letters. The words are stacked on a single line and are centered in the image. The font is sans-serif and the letters are evenly spaced. The background is plain white.
7482 Shipley Avenue · Harmans, MD p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com
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Image /page/9/Picture/0 description: The image shows a logo with the letters 'aiv' in blue, with a red star above the letters. The letters are in a stylized, italicized font, with the 'a' and 'i' connected. The star is a five-pointed star and is positioned slightly to the left of the letters. The logo has a clean and modern design.
AIV's device in this submittal is only the Smart Label for Propofol and is only intended as a replacement for the OEM accessory for the InfusO.R. pump. Performance criteria of the label are the label content and the recognition of the Propofol label by the pump. The pump adjusts the delivery rate per the applied label and the rotary switches on the pump as set by the user. Once proper content of the Propofol Smart Label is confirmed and proper detection of the label by the pump is established, accuracy of measurement is a function of the InfusO.R. pump. The AIV Smart Label for Propofol is limited by the indications for use of the InfusO.R. pump.
The following non clinical test protocol was identified for the AIV Smart Label for Propofol model:
- 1. Verification Testing Construction, material selection, content and operation consistent with the technical specifications, proper recognition of the label by the pump.
- 2. Storage and Cleaning Tests Subjecting the Smart Label to repeated cleaning cycles and to storage environmental limits and confirming that operation remains consistent with the technical specifications - legibility to user and proper recognition by the pump.
- 3. Performance Testing A test protocol was developed to confirm proper recognition and delivery dosage consistent with the predicate device and the technical specifications of the InfusO.R. pump.
Testing was performed by AIV at their facility in Harmans, MD. All test reports are in Section F.
Because of the extreme similarities of the AIV product to the OEM, the consequences of a modified device are the same for both AIV and OEM devices. Also, because of these extreme similarities, the consequences of a device failure are the same for both AIV and OEM devices.
A risk management file was developed and used throughout the development process please see Section G.
## Device Shelf Life / Expiration Date / Aging
Shelf life and expiration are not required as the pump will provide an indication when the
Image /page/9/Picture/13 description: The image shows the words "MASTER COPY" in large, bold, blue letters. The words are stacked on a single line and centered. The background is plain white.
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Image /page/10/Picture/0 description: The image shows the logo for AIV, which is a company or organization. The logo features the letters "aiv" in a bold, sans-serif font, with the letters colored in blue. Above the letters, there is a red star. The star is positioned slightly to the left of the letters, creating a visually appealing design.
Smart Label applied is not recognized. This will cause the pump to produce an error message thus failing to a safe state. This finding is detailed in our report titled "Analysis of Weak or Missing Magnet". The devices were subjected to repeated cleaning cycles prior to testing - the process and findings are detailed in the report titled "Cleaning and Storage Tests".
#### EMC and Electrical Safety Evaluation
The devices do not contain any electrical or electronic components. The magnets on the labels activate a bank of hall effect sensors in the pump. Since we are using substantially equivalent magnets, the effect on the pump of any electromagnetic interference is not altered. No EMC or Electrical Safety Evaluation is required.
#### Clinical Testing
No clinical testing was performed for these devices.
#### Conclusion
The non clinical testing has demonstrated that the AIV Smart Label for Propofol is as safe, as effective, and perform as well as the legally marketed accessories for the InfusO.R. pump. Construction of this device is substantially equivalent to the predicate device.
Image /page/10/Picture/10 description: The image contains the words "MASTER COPY" in large, bold, blue font. The words are stacked on a single line and centered. The background is plain white, which makes the blue text stand out.
