PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
Device Facts
| Record ID | K120209 |
|---|---|
| Device Name | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE |
| Applicant | American I.V. Products, Inc. |
| Product Code | MRZ · General Hospital |
| Decision Date | Apr 12, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
Indications for Use
This device is an accessory for a syringe or infusion pump. The healthcare worker connects the device to the corresponding pump. The patient uses the switch on the cable to signal the syringe pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker.
Device Story
Patient Pendant Bolus Cable is a passive accessory for syringe/infusion pumps; serves as a replacement for OEM cables. Device consists of a push-button switch, cable, and connector. Operated by patients in clinical or home settings to request medication boluses; signal is processed by the host pump based on pre-programmed clinician parameters. Device uses low-voltage (3.3-5 VDC) from the pump to detect switch state changes. No electronic or software components. Benefits include enabling patient-controlled analgesia (PCA) within pump-defined safety limits. Healthcare providers connect the device to the pump and configure delivery parameters.
Clinical Evidence
No clinical testing performed. Bench testing only: verification of construction, cleaning/storage durability, and performance testing using a custom test system to confirm switch activation patterns and dose request consistency compared to predicate pump accessories.
Technological Characteristics
Passive device; no electronic or software components. Materials: Biocompatible PVC for cables, jackets, and over-molded connectors with integral strain relief. Operating voltage: 3.3-5 VDC (supplied by host pump). Connectivity: Wired connection to specific syringe/infusion pumps. Double insulation of conductors. 6-foot nominal length.
Indications for Use
Indicated for patients in hospital, ambulatory, and home care environments requiring medication delivery via compatible syringe or infusion pumps. Contraindications are limited by the connected pump's indications.
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
Submission Summary (Full Text)
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APR 1 2 2012
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Section A Page 1 of 6
American IV Products, Inc. 510(k) Summary Patient Pendant Bolus Cables
K1202
## 510(k) Summary
This product is not sterile, has no software component, has no electronic components and is not a kit.
#### Device Name
| AIV Device Name: | Patient Pendant Bolus Cable |
|----------------------|--------------------------------------------------|
| Classification Name: | Patient Controlled Analgesia (PCA) Button Cables |
| Common Name: | Bolus Cables |
#### Applicant
American IV Products, Inc. 7485 Shipley Avenue Harmans, MD 21077
#### Submittal Date
January 17, 2012
#### Contact Name
Majdi F. Shomali VP - 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
# MASTER COPY
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Section A Page 2 of 6
American IV Products, Inc. 510(k) Summary Patient Pendant Bolus Cables
## 514 Performance Standards
None established under section 514
## Prescription Status
The subject devices are a prescription device.
# Compliance to Standards and Regulations
EN ISO 14971:2007 Medical devices - Application of Risk Management to Medical Devices
## Reason for Submission
This is a new device to be marketed by our firm.
### Labeling
Proposed labeling is provided in Section C.
# Statement of Indications for Use
This device is an accessory for a syringe or infusion pump (not manufactured by AIV, Inc.). The healthcare worker connects the device to the corresponding pump. The patient uses the switch on the cable to signal the pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker.
| AIV Part # | Infusion / Syringe Pump |
|------------|--------------------------------------------|
| BC10746 | Baxter I Pump |
| BC10747 | Baxter PCA II |
| BC10925 | Abbott / Hospira PCA 3 |
| BC10969 | Abbott / Hospira Lifecare 4100 PCA Plus II |
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Image /page/2/Picture/0 description: The image shows a logo with the letters 'aiv' in bold, black font. Above the letters, there is a five-pointed star, also in black. The star is positioned slightly to the left of the letters, creating a visual hierarchy where the star is above and slightly offset from the 'aiv' text.
Section A Page 3 of 6
American IV Products, Inc. 510(k) Summary Patient Pendant Bolus Cables
### Product Description
AIV's Patient Pendant Bolus Cables are a replacement for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective syringe and infusion pumps. AIV does not manufacture the pumps. These Patient Pendant Bolus Cables are an accessory for the pump and are also available as a replacement part. These cables include a switch and are plugged into a mating connector on the syringe or infusion pump to allow the patient to request medication within the parameters entered into the syringe pump by the healthcare provider and the designed limits on the pumps.
The AIV Patient Pendant Bolus Cables use the same type of construction and have the same technological characteristics as the predicate device – the accessory supplied with the original pump. These are passive devices that contain no electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.
AIV Patient Pendant Bolus Cables use Biocompatible PVC for the cables, cable jackets and over molded connectors with an integral strain relief. (See Section F for biocompatibility test reports)
The AIV Patient Pendant Bolus Cables are limited by the indications for use of the connected syringe pump equipment.
Section D contains product drawings and wiring diagrams.
### Predicate Device Information
These AIV devices are Substantially Equivalent to the accessory available with the following legally marketed devices:
BAXTER HEALTHCARE CORP. ABBOTT LABORATORIES
K052973, K993387 K022203
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Section A Page 4 of 6
American IV Products, Inc. 510(k) Summary Patient Pendant Bolus Cables
# Substantial Equivalence Comparison Chart
| AIV | | Baxter | Abbott |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------|
| Intended Use | This device is an accessory and a<br>replacement part for a syringe or<br>infusion pump (not manufactured by<br>AIV, Inc.). The healthcare worker<br>connects the device to the<br>corresponding pump. The patient<br>uses the switch on the cable to signal<br>the pump to deliver medication<br>consistent with the parameters<br>entered into the pump by the<br>healthcare worker and limitations set<br>by the pump design. | Same | Same |
| Indications for<br>Use | Connects to designated syringe or<br>infusion pump model used in<br>hospital, ambulatory and home care<br>environments. | Same | Same |
| Operating<br>Principle | The patient presses on the button<br>integral to the design of the cable and<br>signals a request for medication to<br>the syringe or infusion pump that<br>processes this request in accordance<br>with the parameters entered by the<br>healthcare worker and the limitations<br>established in the pump. | Same | Same |
| Operating<br>Voltage | 3.3 VDC to 5 VDC | Same | Same |
| Safety | Double insulation of conductors | Same | Same |
| Performance<br>Features | Dose Units, Dose/Delivery Accuracy | Same | Same |
| Environmental<br>Features | Operating Temperature, Storage<br>Temperature, Relative Humidity,<br>Pressure | Same | Same |
| Cable Length | 6 feet nominal | Same | Same |
| BioMed<br>Settings | No configuration settings available for<br>customization on the PCA Button<br>Cable. All the settings are entered in<br>the mating syringe or infusion pump. | Same | Same |
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Image /page/4/Picture/0 description: The image shows a logo with the letters "aiv" in a stylized, bold, sans-serif font. Above the letters, there is a five-pointed star. The star is positioned slightly to the left of the letters, creating a visual balance. The entire logo is in black, contrasting with what is presumably a white background.
American IV Products, Inc. 510(k) Summary Patient Pendant Bolus Cables
## Performance, General Safety and Effectiveness
AIV's devices in this submittal are only the Patient Pendant Bolus Cables and are only intended as replacements for the OEM accessories for the syringe and infusion pump. Performance criteria are the indication of a patient request for medication event when the patient presses the button, and an absence of this event when the button is not activated. The accuracy of measurement is more a function of the patient syringe or infusion pump rather than the cable accessories. The AIV Patient Pendant Bolus Cables are limited by the indications for use of the connected syringe or infusion pump equipment.
The following non clinical test protocol was identified for each of the AIV Patient Pendant Bolus Cables models:
- 1. Verification Testing Construction and operation consistent with the technical specifications.
- 2. Storage and Cleaning Tests Subjecting the Cables to repeated cleaning cycles and to storage environmental limits and confirming that operation remains consistent with the technical specifications.
- 3. Performance Testing A switch activation test pattern and pump test program were used to show that under identical activation patterns and pump programs, the number of dose requests is equivalent and the fluid dispensed is consistent with the accuracy of the target pump. A custom test system was constructed and validated to generate the patient activation patterns and conduct these tests.
Testing was performed by AIV at their facility in Harmans, MD. All test reports are in Section E.
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Image /page/5/Picture/0 description: The image shows a logo with the letters "aiv" in bold, black, slanted font. Above the letters, there is a five-pointed star, also in black. The star is positioned slightly to the left of the letters, creating a visual balance. The logo appears to be simple and modern, with a focus on the letters and the star.
Section A Page 6 of 6
American IV Products, Inc. 510(k) Summary Patient Pendant Bolus Cables
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.
# Clinical Testing
No clinical testing was performed for these devices.
#### Conclusion
The non clinical testing has demonstrated that the AIV Patient Pendant Bolus Cables are as safe, as effective, and perform as well as the legally marketed accessories for syringe and infusion pumps.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Majdi F. Shomali Vice President - Engineering American IV Products, Inc. 7485 Shipley Avenue Harmans, Maryland 21077
Re: K120209
Trade/Device Name: Patient Pendant Bolus Cable Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: March 26, 2012 Received: March 27, 2012
Dear Mr. Shomali:
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.
APR 1 2 2012
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#### Page 2 - Mr. Shomali
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Anania
John D. Anania, P.C., M.S.
Anthony D. Watson, B.S., M.S., M.B.A. 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): K120209
Device Name: Patient Pendant Bolus Cable
Indications For Use:
This device is an accessory for a syringe or infusion pump. The healthcare worker connects the device to the corresponding pump. The patient uses the switch on the cable to signal the syringe pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker.
| AIV Part # | Corresponding Pump |
|------------|--------------------------------------------|
| BC10746 | Baxter Pump |
| BC10747 | Baxter PCA II |
| BC10925 | Abbott / Hospira PCA 3 |
| BC10969 | Abbott / Hospira Lifecare 4100 PCA Plus II |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
eithy Can for RZC. 4/1/12
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K120209
