(51 days)
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 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.
The provided document describes the Elite Biomedical Solutions Dose Request Cord, an accessory for a syringe pump. The submission focuses on demonstrating substantial equivalence to a predicate device, the American IV Patient Pendant Bolus Cable (K120209), rather than presenting a study where a device's performance is measured against specific acceptance criteria in the context of improving human reader performance with AI.
Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device submissions) are not applicable or cannot be extracted from this document.
However, I can provide information based on the available performance data for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance: | |
| * Delivery of a dose when the activation button is depressed. | Functional testing verified that the device performs as intended, including delivery of a dose when the activation button is depressed. |
| * Absence of delivery when the activation button is not depressed. | Functional testing verified that the device performs as intended, including absence of delivery when the activation button is not depressed. |
| Construction and Operation Consistency: | |
| * Consistent with technical specifications. | Verification testing confirmed construction and operation consistent with technical specifications. |
| * Cable pull test requirements met. | Cable pull test was performed and met acceptance. |
| * IPX water intrusion testing requirements met (IPX1). | IPX1 water intrusion testing was performed and met acceptance. |
| Cleaning and Disinfection: | |
| * Compatibility with specified cleaning and disinfection agents (0.55% sodium hypochlorite concentration wipe). | Cleaning and Disinfection Testing validated the cleaning and disinfection procedure using a commercially available 0.55% sodium hypochlorite concentration wipe. |
| Safety: | |
| * Double insulation of conductors (comparable to predicate). | Device has double insulation of conductors, consistent with the predicate. |
| * Key pressed/stuck alarm functionality (if applicable for the integrated system). | If the Dose Request Cord button becomes pressed/stuck for ≥30 seconds, the integrated PCA unit (BD Alaris PCA Pump Model 8120) will have an audible alarm and a scrolling message on display. (Note: This is a function of the pump, not solely the cord, but the cord's interaction is confirmed). |
| Performance Features (inherited from pump): | |
| * Dose/delivery accuracy (determined by syringe infusion pump). | The accuracy of the dose is determined by the syringe infusion pump and is not a function of the Dose Request Cord. The cord's performance in allowing the pump to function accurately is thus implied. |
| * Dosing based on inputs into compatible PCA pump. | Dose units are determined by inputs into the compatible PCA pump. |
| * Lock out features (controlled and programmed into the PC unit). | Lock out features are controlled and programmed into the PC unit, allowing time elapse between doses and max limit programming. |
| * Operating Voltage (3.3 VDC to 5 VDC). | Consistent with predicate (3.3 VDC to 5 VDC). |
| Physical Characteristics: | |
| * Cable Length (6.5 feet nominal, comparable to predicate's 6 feet nominal). | Cable length: 6.5 feet nominal. Considered equivalent to predicate. |
| * Weight (160.2g). | Weight: 160.2g. (No explicit acceptance criterion provided, but part of descriptive data). |
| * Non-temperature-controlled storage environment. | Device can be stored in a non-temperature-controlled environment. (No explicit acceptance criterion but part of specified characteristics). |
| * No configuration settings available for customization on the Dose Request Cord; all settings entered in mating syringe infusion pump. | No configuration settings available for customization on the Dose Request Cord. All settings are entered in the mating syringe infusion pump. |
2. Sample Size and Data Provenance
This document describes non-clinical performance testing for a medical device accessory (a cable), not an AI/ML diagnostic system. Therefore, concepts like "test set" in the context of clinical data are not directly applicable.
- Sample Size for Test Set: Not specified in terms of patient data. The non-clinical testing likely involved a specific number of manufactured units of the Dose Request Cord, though this number is not detailed in the summary.
- Data Provenance: The data is from non-clinical laboratory testing performed by Elite Biomedical Solutions to verify the device's functional and safety characteristics. Country of origin for the testing is not specified but is implicitly tied to the submitter (Elite Biomedical Solutions, Cincinnati, Ohio, USA). This testing is prospective as it was performed specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The "ground truth" for this device is its physical integrity and functional performance (e.g., button press accurately signals the pump, cable withstands a pull test, electrical insulation is sufficient). This is established through engineering and laboratory testing against established specifications and standards, not through expert consensus on medical images or patient outcomes.
4. Adjudication Method
Not applicable. This is not an AI/ML diagnostic device requiring adjudication of clinical data. Testing involved objective measurements and validations against predetermined engineering and functional specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a physical medical device accessory (cable), not an AI-powered diagnostic tool. Therefore, an MRMC study and the concept of human readers improving with or without AI assistance are not applicable.
6. Standalone Performance
Yes, in the sense of the device's intrinsic function. Non-clinical performance testing was conducted on the Dose Request Cord itself (and in conjunction with the compatible pump to verify its signaling function). The testing demonstrated that the device "performs as intended." The performance involves:
- Delivering a dose when the activation button is pressed.
- Not delivering a dose when the button is not pressed.
- Meeting construction, operational, cleaning, disinfection, and safety specifications.
- The accuracy of the dose itself being determined by the associated syringe infusion pump, confirming the cable's role as an accurate signaling accessory rather than a dosing mechanism.
7. Type of Ground Truth Used
The ground truth used for non-clinical testing comprises:
- Engineering Specifications: Design documents detailing required electrical, mechanical, and safety characteristics (e.g., cable length, operating voltage, double insulation).
- Functional Requirements: Specifications for how the device should operate (e.g., button press triggers signal, no signal when button not pressed).
- Test Standards: Compliance with relevant industry and regulatory standards for medical device accessories (e.g., IPX water intrusion, cleaning/disinfection validation methods).
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for such a set.
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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 CCincinnati, 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 DoseRequestCord(Subject Device) | American IV Patient PendantBolus Cable(K120209 - Predicate Device) | Determination | |
|---|---|---|---|
| Product Name | Elite Biomedical SolutionsDoseRequest 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 SolutionsDose Request Cord is intended foruse with the BD Alaris PCA PumpModel 8120 for facilities that usesyringe pumps for the delivery ofmedications or fluids. The EliteBiomedical Solutions Dose RequestCord is indicated for prescriptionuse on adults and adolescents (over12 years of age) for deliverymedication consistent with theparameters entered into the pumpby the healthcare worker. | American IV Patient PendantBolus Cable is intended to signalthe syringe pump to delivermedication. | Equivalent. Thesubject deviceintended useincludes specificinformation suchas the patientpopulation andfor prescriptionuse. The intendeduse of the deviceincluding thepatient populationand environmentsof use, are thesame as thepredicate 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 forUse | The Elite Biomedical SolutionsDose Request Cord is an accessoryfor a syringe pump and may be usedin the same environment as thecorresponding pump. The healthcareworker connects the device to thepump. The patient uses the switchon the cable to signal the syringepump to deliver medicationconsistent with the parametersentered into the pump by thehealthcare worker. The EliteBiomedical Solutions Dose RequestCord is a non-sterile, reusabledevice intended for multi-patientuse in adult and adolescent (over 12years of age) populations.Elite Biomedical Part #: 10013795EBSCorresponding Pump: BD AlarisPCA Pump Model 8120 | This device is an accessory for asyringe pump. The healthcareworkerconnects the device to thecorresponding pump. The patientuses the switch on the cable tosignal the syringe pump to delivermedication consistent with theparametersentered into the pump by thehealthcare worker. | AIV Part # | CorrespondingPump | Equivalent. Devicesare labeled for usewith differentbrands of syringepumps; however, theintended use is thesame. |
|---|---|---|---|---|---|
| BC10746 | Baxter I Pump | ||||
| BC10747 | Baxter PCA II | ||||
| BC10925 | Abbott/HospiraPCA 3 | ||||
| BC10969 | Abbott/HospiraLifecare 4100PCA Plus II | ||||
| How Supplied | Non-sterile, reusable | Non-sterile, reusable | Same | ||
| Design Information | |||||
| Principle ofoperation | The patient presses on thebuttonintegral to the design of the cableand signals a request for medicationto the syringe or infusion pump thatprocesses this request in accordancewith the parameters entered by thehealthcare worker and thelimitations established in the pump. | The patient presses on the buttonintegral to the design of the cableand signals a request for medicationto the syringe orinfusion pump thatprocesses this request in accordancewith the parameters entered by thehealthcare worker and thelimitations established in the pump. | Same | ||
| OperatingVoltage | 3.3 VDC to 5 VDC | 3.3 VDC to 5 VDC | Same | ||
| Safety | Double insulation ofconductors | Double insulation of conductors | Same | ||
| PerformanceFeatures | Dose/delivery accuracy | Dose/delivery accuracy | Same | ||
| Dosing | Dose units determined byinputs into compatiblePCA pump | Dose units determined byinputs into compatible PCApump | Same | ||
| Lock out features | Controlled and programmed into thePC unit. Time elapse betweenavailability of PCA doses.Max limit may also be programedinto the PC unit. This allows a totalamount of drug which can beinfused over a specific period oftime. 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.
| Keypressed/stuckalarm | 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 |
|---|---|---|---|
| CommunicationMode/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 |
| StorageEnvironment | Non-temperature-controlled environment | unknown | NA |
| Water IngressBioMedSettings | IPX1No configuration settings available for customization on the Dose Request Cord. All settings are entered in the mating syringe infusion pump. | UnknownNo configuration settings available for customization on the Dose Request Cord. All settings are entered in the mating syringe infusion pump. | NASame |
| Method ofActivation | 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
§ 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).