Elite Biomedical Solutions Dose Request Cord
Device Facts
| Record ID | K220695 |
|---|---|
| Device Name | Elite Biomedical Solutions Dose Request Cord |
| Applicant | Elite Biomedical Solutions |
| Product Code | MRZ · General Hospital |
| Decision Date | Apr 29, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
Intended Use
The Elite Biomedical Solutions Dose Request Cord is intended for use with the BD Alaris PCA Pump Model 8120 for facilities that use syringe pumps for the delivery of medications or fluids. The Elite Biomedical Solutions Dose Request Cord is indicated for prescription use on adults and adolescents (over 12 years of age) for delivery of medication consistent with the parameters entered into the pump by the healthcare worker.
Device Story
The Elite Biomedical Solutions Dose Request Cord is a non-sterile, reusable accessory for the BD Alaris PCA Pump Model 8120. It consists of a handpiece with an integrated button and cable that connects to the pump. The device is operated by the patient, who presses the button to request a medication dose. The cord transmits this signal to the pump, which then delivers medication based on pre-programmed parameters set by a healthcare worker. The device is used in clinical environments where the pump is utilized. It contains no powered electronic components and is powered by the pump via low voltage (3.3 VDC to 5 VDC). The device facilitates patient-controlled analgesia by providing a manual interface for dose requests, potentially improving patient comfort and pain management. It is designed for multi-patient use and is cleaned using 0.55% sodium hypochlorite wipes.
Clinical Evidence
No clinical data. Bench testing only, including functional performance, cable pull testing, IPX1 water intrusion testing, and cleaning/disinfection validation.
Technological Characteristics
Passive accessory; no powered electronic components. Operates at 3.3 VDC to 5 VDC. Features a manual push-button, cable, and LEMO connector. IPX1 water ingress rating. Double insulation of conductors. 6.5 feet nominal cable length. Reusable, non-sterile. Compatible with BD Alaris PCA Pump Model 8120.
Indications for Use
Indicated for prescription use in adult and adolescent (over 12 years of age) populations as an accessory for the BD Alaris PCA Pump Model 8120 to signal the pump to deliver medication.
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
- Patient Pendant Bolus Cable (K120209)
Related Devices
- K120209 — PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE · American I.V. Products, Inc. · Apr 12, 2012
- K992072 — BOLUS ACCESSORY SET · I-Flow Corp. · Sep 15, 1999
- K984638 — PARAGON BOLUS ACCESSORY SET · I-Flow Corp. · Feb 9, 1999
- K090300 — MODIFICATION TO AUTOFUSER · Ace Medical Us, LLC · Apr 30, 2009
- K972158 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES · Princeton Regulatory Assoc. · Feb 20, 1998
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 29, 2022
Elite Biomedical Solutions Brenda Compliment Director of Quality 756 Cincinnati-Batavia Pike Suite C Cincinnati, Ohio 45245
Re: K220695
Trade/Device Name: Elite Biomedical Solutions Dose Request Cord Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ Dated: March 4, 2022 Received: March 9, 2022
## Dear Brenda Compliment:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
Device Name
Elite Biomedical Solutions Dose Request Cord
### Indications for Use (Describe)
The Elite Biomedical Solutions Dose Request Cord is an accessory for a syringe pump and may be used in the same environment as the corresponding pump. The healthcare worker connects the device to 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. The Elite Biomedical Solutions Dose Request Cord is a non-sterile, reusable device intended for multi-patient use in adult and adolescent (over 12 years of age) populations.
Elite Biomedical Part #: 10013795 EBS Corresponding Pump: BD Alaris PCA Pump Model 8120
| 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)
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Image /page/3/Picture/0 description: The image shows the logo for Elite Biomedical Solutions. The logo consists of a blue shield with a white geometric design inside, and the words "ELITE BIOMEDICAL SOLUTIONS" in black and gray text to the right of the shield. The word "ELITE" is in a larger, bolder font than the words "BIOMEDICAL SOLUTIONS".
Real Needs. Real Partnerships Real Sol
756 Old State Route 74 Suite C Cincinnati, OH 45245 Phone: 855-291-6701 Fax: 866-941-4887
# 510(k) Summary
#### I. Submitter's Information
| Company Name: | Elite Biomedical Solutions |
|----------------------------------------|-------------------------------------------------------------|
| Address: | 756 Cincinnati Batavia Pike Suite C<br>Cincinnati, OH 45245 |
| Phone Number: | 855-291-6701 |
| Fax Number: | 513-586-0494 |
| FDA Establishment Registration Number: | 3009712113 |
| Contact Person: | Brenda Compliment |
|-----------------|------------------------------------------|
| Phone Number: | 855-291-6701 ext. 214 |
| Email: | bcompliment@elitebiomedicalsolutions.com |
Date Prepared:
February 23, 2022
#### II. Device Information
| Device Name: | Elite Biomedical Solutions Dose Request Cord |
|-------------------|----------------------------------------------|
| Common Name: | Bolus Cables |
| Regulatory Class: | II |
| Regulation: | 880.5725 |
| Product Code: | MRZ |
#### III. Predicate Device
| Device Name: | Patient Pendant Bolus Cable |
|---------------|-----------------------------|
| Manufacturer: | American IV Products, Inc. |
| 510(k): | K120209 |
#### IV. Device Description
Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump.
Section 005 - 510(k) Summary - Page 1 of 6
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Image /page/4/Picture/0 description: The image shows the logo for Elite Biomedical Solutions. The logo consists of a blue shield with a white geometric design on the left and the company name in black text on the right. Below the logo, there is a tagline that reads "Real Needs. Real Partnerships Real Solutions."
756 Old State Route 74 Suite C Cincinnati, OH 45245 Phone: 855-291-6701 Fax: 866-941-4887
The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps.
The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered 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. Section 010 - Device Description contains the engineering drawings for the product.
#### V. Intended Use
The Elite Biomedical Solutions Dose Request Cord is intended for use with the BD Alaris PCA Pump Model 8120 for facilities that use syringe pumps for the delivery of medications or fluids. The Elite Biomedical Solutions Dose Request Cord is indicated for prescription use on adults and adolescents (over 12 years of age) for delivery of medication consistent with the parameters entered into the pump by the healthcare worker.
#### VI. Indications for Use
The Elite Biomedical Solutions Dose Request Cord is an accessory for a syringe pump and may be used in the same environment as the corresponding pump. The healthcare worker connects the device to the 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. The Elite Biomedical Solutions Dose Request Cord is a non-sterile, reusable device intended for multi-patient use in adult and adolescent (over 12 years of age) population.
Elite Biomedical Part #: 10013795 EBS Corresponding Pump: BD Alaris PCA Pump Model 8120
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Image /page/5/Picture/0 description: The image is a logo for Elite Biomedical Solutions. The logo consists of a blue shield with a white geometric design inside, and the words "ELITE BIOMEDICAL SOLUTIONS" in black and gray text to the right of the shield. The word "ELITE" is in black, and the words "BIOMEDICAL SOLUTIONS" are in gray.
Real Needs. Real Partnerships Real Solutions.
756 Old State Route 74 Suite C Cincinnati, OH 45245 Phone: 855-291-6701 Fax: 866-941-4887
#### VII. Technological Characteristics
## Table 1: Overview of Substantial Equivalence
| | Elite Biomedical Solutions Dose<br>RequestCord<br>(Subject Device) | American IV Patient Pendant<br>Bolus Cable<br>(K120209 - Predicate Device) | Determination |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Elite Biomedical SolutionsDose<br>Request Cord | Patient Pendant Bolus Cable | NA |
| 510(k) Holder | Elite Biomedical Solutions | American IV | NA |
| Regulatory Information | | | |
| 510(k) Number | TBD | K120209 | NA |
| Product Code | MRZ | MRZ | Same |
| Regulation | 880.5725 | 880.5725 | Same |
| Class | II | II | Same |
| Intended Use | The Elite Biomedical Solutions<br>Dose Request Cord is intended for<br>use with the BD Alaris PCA Pump<br>Model 8120 for facilities that use<br>syringe pumps for the delivery of<br>medications or fluids. The Elite<br>Biomedical Solutions Dose Request<br>Cord is indicated for prescription<br>use on adults and adolescents (over<br>12 years of age) for delivery<br>medication consistent with the<br>parameters entered into the pump<br>by the healthcare worker. | American IV Patient Pendant<br>Bolus Cable is intended to signal<br>the syringe pump to deliver<br>medication. | Equivalent. The<br>subject device<br>intended use<br>includes specific<br>information such<br>as the patient<br>population and<br>for prescription<br>use. The intended<br>use of the device<br>including the<br>patient population<br>and environments<br>of use, are the<br>same as the<br>predicate devices. |
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Image /page/6/Picture/0 description: The image contains the logo for Elite Biomedical Solutions. On the left is a blue shield with a white diamond shape inside. To the right of the shield is the company name, with "ELITE" in large black letters and "BIOMEDICAL SOLUTIONS" in smaller gray letters below.
Real Needs. Real Partnerships Real Solutions.
# 756 Old State Route 74 Suite C Cincinnati, OH 45245
Phone: 855-291-6701
Fax: 866-941-4887
| Indications for<br>Use | The Elite Biomedical Solutions<br>Dose Request Cord is an accessory<br>for a syringe pump and may be used<br>in the same environment as the<br>corresponding pump. The healthcare<br>worker connects the device to the<br>pump. The patient uses the switch<br>on the cable to signal the syringe<br>pump to deliver medication<br>consistent with the parameters<br>entered into the pump by the<br>healthcare worker. The Elite<br>Biomedical Solutions Dose Request<br>Cord is a non-sterile, reusable<br>device intended for multi-patient<br>use in adult and adolescent (over 12<br>years of age) populations.<br><br>Elite Biomedical Part #: 10013795<br>EBS<br>Corresponding Pump: BD Alaris<br>PCA Pump Model 8120 | This device is an accessory for a<br>syringe pump. The healthcareworker<br>connects the device to the<br>corresponding pump. The patient<br>uses the switch on the cable to<br>signal the syringe pump to deliver<br>medication consistent with the<br>parameters<br>entered into the pump by the<br>healthcare worker. | AIV Part # | Corresponding<br>Pump | Equivalent. Devices<br>are labeled for use<br>with different<br>brands of syringe<br>pumps; however, the<br>intended use is the<br>same. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | | | BC10746 | Baxter I Pump | |
| | | | BC10747 | Baxter PCA II | |
| | | | BC10925 | Abbott/Hospira<br>PCA 3 | |
| | | | BC10969 | Abbott/Hospira<br>Lifecare 4100<br>PCA Plus II | |
| How Supplied | Non-sterile, reusable | | Non-sterile, reusable | | Same |
| Design Information | | | | | |
| Principle of<br>operation | The patient presses on thebutton<br>integral to the design of the cable<br>and signals a request for medication<br>to the syringe or infusion pump that<br>processes this request in accordance<br>with the parameters entered by the<br>healthcare worker and the<br>limitations established in the pump. | The patient presses on the button<br>integral to the design of the cable<br>and signals a request for medication<br>to the syringe orinfusion pump that<br>processes this request in accordance<br>with the parameters entered by the<br>healthcare worker and the<br>limitations established in the pump. | | | Same |
| Operating<br>Voltage | 3.3 VDC to 5 VDC | 3.3 VDC to 5 VDC | | | Same |
| Safety | Double insulation ofconductors | Double insulation of conductors | | | Same |
| Performance<br>Features | Dose/delivery accuracy | Dose/delivery accuracy | | | Same |
| Dosing | Dose units determined by<br>inputs into compatiblePCA pump | Dose units determined by<br>inputs into compatible PCA<br>pump | | | Same |
| Lock out features | Controlled and programmed into the<br>PC unit. Time elapse between<br>availability of PCA doses.<br><br>Max limit may also be programed<br>into the PC unit. This allows a total<br>amount of drug which can be<br>infused over a specific period of<br>time. Once the max limit is reached, | Unknown | | | NA |
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Image /page/7/Picture/0 description: The image shows the logo for Elite Biomedical Solutions. On the left is a blue shield with a white geometric design inside. To the right of the shield is the company name, with "ELITE" in large, bold, black letters, "BIOMEDICAL" in smaller gray letters below it, and "SOLUTIONS" in the same gray letters below that.
756 Old State Route 74 Suite C Cincinnati, OH 45245 Phone: 855-291-6701 Fax: 866-941-4887
Real Needs. Real Partnerships Real Solutions.
| Key<br>pressed/stuck<br>alarm | the pump will not dispense even when the dose request cord is activated (i.e., button pressed).<br>If the Dose Request Cord button becomes pressed/stuck for ≥30 seconds, the PC unit will have an audible alarm. Scrolling message on display in the 8120 PCA unit. | Unknown | NA |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Communication<br>Mode/Interface | The patient requests a dose of analgesia by pressing the button on the Dose Request Cord. The button is attached to a simple circuit board in the hand piece. The board then sends a signal to the PCA pump through the LEMO connector. | Unknown | NA |
| Power supply | Power supplied from PC unit through IUI connector to the PCA pump. | Unknown | NA |
| Cable Length | 6.5 feet nominal | 6 feet nominal | Equivalent |
| Weight | 160.2g | unknown | NA |
| Storage<br>Environment | Non-temperature-controlled environment | unknown | NA |
| Water Ingress<br>BioMedSettings | IPX1<br>No configuration settings available for customization on the Dose Request Cord. All settings are entered in the mating syringe infusion pump. | Unknown<br>No configuration settings available for customization on the Dose Request Cord. All settings are entered in the mating syringe infusion pump. | NA<br>Same |
| Method of<br>Activation | Manually depress activation button | Manually depress activation button | Same |
| Cleaning | Wipe with commercially available 0.55% sodium hypochlorite concentration wipe | Wipe with commercially available 0.55% sodium hypochlorite concentration wipe | Same |
#### VIII. Performance Data
## Non-Clinical
Non-clinical testing was performed for Elite Biomedical Solutions Dose Request Cord. The performance criteria include delivery of a dose when the activation button is depressed, and absence of delivery when
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Image /page/8/Picture/0 description: The image shows the logo for Elite Biomedical Solutions. The logo consists of a blue shield with a white diamond shape inside, and the words "ELITE BIOMEDICAL SOLUTIONS" in black text. Below the logo is the phrase "Real Needs. Real Partnerships Real Solutions."
756 Old State Route 74 Suite C Cincinnati, OH 45245 Phone: 855-291-6701 Fax: 866-941-4887
the activation button is not depressed. The accuracy of the dose is determined by the syringe infusion pump and is not a function of the Dose Request Cord. The following testing was performed:
- -Verification - Construction and operation consistent with the technical specifications including cable pull test and IPX water intrusion testing
- -Cleaning and Disinfection Testing - Cleaning and disinfection validation
- -Performance Testing - Functional testing verifying device performance
Testing demonstrates that the device performs as intended and is considered substantially equivalent to the predicate device.
## Clinical
Clinical testing was not performed in support of this submission.
#### IX. Conclusion
Elite Biomedical Solutions Dose Request Cord has the same intended use and indications for use as the predicate American IV Patient Pendant Bolus Cable. The conclusion drawn from the riskbenefit assessment and from nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. The design/technological differences do not raise any new types of questions and the performance data provided reasonable assurance of safety and effectiveness to demonstrate substantial equivalence
