(51 days)
Not Found
No
The device is described as a passive accessory cable with no powered electronic components, simply detecting a button press. There is no mention of any computational or learning capabilities.
No.
The device is an accessory that signals a syringe pump to deliver medication, but it does not directly administer or provide therapy itself. The syringe pump is the therapeutic device.
No
The device is an accessory (cord with a switch) for a syringe pump that allows a patient to request medication. It does not perform any diagnostic function; its purpose is to signal the pump for drug delivery.
No
The device is described as a physical cable with a handpiece and switch, explicitly stating it is a "non-sterile, reusable device" and a "passive device that contain no powered electronic components." This indicates it is a hardware accessory, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Elite Biomedical Solutions Dose Request Cord is an accessory for a syringe pump. Its function is to allow a patient to signal the pump to deliver medication. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's an accessory for a syringe pump used for medication delivery.
- Device Description: The description details its construction as a cable and handpiece that plugs into the pump to activate medication delivery. There is no mention of analyzing biological samples.
Therefore, the device's purpose and function fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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
Product codes (comma separated list FDA assigned to the subject device)
MRZ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and adolescent (over 12 years of age) populations.
Intended User / Care Setting
healthcare worker connects the device to the pump.
facilities that use syringe pumps for the delivery of medications or fluids.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 testing was not performed in support of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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
2
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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3
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 |
| 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
4
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
5
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
RequestCord
(Subject Device) | American IV Patient Pendant
Bolus Cable
(K120209 - Predicate Device) | Determination |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Elite Biomedical SolutionsDose
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
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
medication consistent with the
parameters entered into the pump
by the healthcare worker. | American IV Patient Pendant
Bolus Cable is intended to signal
the syringe pump to deliver
medication. | Equivalent. The
subject device
intended use
includes specific
information such
as the patient
population and
for prescription
use. The intended
use of the device
including the
patient population
and environments
of use, are the
same as the
predicate devices. |
6
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
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) populations.
Elite Biomedical Part #: 10013795
EBS
Corresponding Pump: BD Alaris
PCA Pump Model 8120 | This device is an accessory for a
syringe pump. The healthcareworker
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 | Equivalent. Devices
are labeled for use
with different
brands of syringe
pumps; however, the
intended use is the
same. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | | | BC10746 | Baxter I Pump | |
| | | | BC10747 | Baxter PCA II | |
| | | | BC10925 | Abbott/Hospira
PCA 3 | |
| | | | BC10969 | Abbott/Hospira
Lifecare 4100
PCA Plus II | |
| How Supplied | Non-sterile, reusable | | Non-sterile, reusable | | Same |
| Design Information | | | | | |
| Principle of
operation | The patient presses on thebutton
integral to the design of the cable
and signals a request for medication
to the syringe or infusion pump that
processes this request in accordance
with the parameters entered by the
healthcare worker and the
limitations established in the pump. | The patient presses on the button
integral to the design of the cable
and signals a request for medication
to the syringe orinfusion pump that
processes this request in accordance
with the parameters entered by the
healthcare worker and the
limitations established in the pump. | | | Same |
| Operating
Voltage | 3.3 VDC to 5 VDC | 3.3 VDC to 5 VDC | | | Same |
| Safety | Double insulation ofconductors | Double insulation of conductors | | | Same |
| Performance
Features | Dose/delivery accuracy | Dose/delivery accuracy | | | Same |
| Dosing | Dose units determined by
inputs into compatiblePCA pump | Dose units determined by
inputs into compatible PCA
pump | | | Same |
| Lock out features | Controlled and programmed into the
PC unit. Time elapse between
availability of PCA doses.
Max limit may also be programed
into the PC unit. This allows a total
amount of drug which can be
infused over a specific period of
time. Once the max limit is reached, | Unknown | | | NA |
7
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
pressed/stuck
alarm | the pump will not dispense even when the dose request cord is activated (i.e., button pressed).
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
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
Environment | Non-temperature-controlled environment | unknown | NA |
| Water Ingress
BioMedSettings | IPX1
No configuration settings available for customization on the Dose Request Cord. All settings are entered in the mating syringe infusion pump. | Unknown
No configuration settings available for customization on the Dose Request Cord. All settings are entered in the mating syringe infusion pump. | NA
Same |
| Method of
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
8
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