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.

Connects to designated syringe or infusion pump model used in hospital, ambulatory and home care environments.

Device 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.

AI/ML Overview

The provided document describes the predicate devices as "Patient Controlled Analgesia (PCA) Button Cables," and focuses on demonstrating that the AIV Patient Pendant Bolus Cables are substantially equivalent to these existing, legally marketed devices. It is explicitly stated that this device "is not sterile, has no software component, has no electronic components and is not a kit." Therefore, the details requested about clinical studies, MRMC studies, training/test sets, and ground truth are not applicable to this type of device and submission.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Features)	Reported Device Performance
Verification Testing: Construction and operation consistent with technical specifications.	Consistent with technical specifications.
Storage and Cleaning Tests: Operation remains consistent with technical specifications after repeated cycles.	Operation remains consistent with technical specifications after repeated cleaning cycles and exposure to storage environmental limits.
Performance Testing:	A switch activation test pattern and pump test program were used, showing that under identical activation patterns and pump programs, the number of dose requests is equivalent to the predicate devices, and the fluid dispensed is consistent with the accuracy of the target pump (which implies the cable accurately transmits the patient's request).
Safety: Double insulation of conductors.	Same as predicate devices.
Operating Principle: Patient presses button to signal medication request to pump.	Same as predicate devices. The device functions as intended: registering a patient request when the button is pressed and not registering one when it is not activated.
Operating Voltage: 3.3 VDC to 5 VDC.	Same as predicate devices.
Biocompatibility: Use of Biocompatible PVC.	Biocompatible PVC used for cables, jackets, and over-molded connectors with integral strain relief. (Referenced Section F for biocompatibility test reports, which were not provided in the excerpt but are stated as completed).
Intended Use & Indications for Use: As an accessory/replacement part for syringe/infusion pumps.	Same as predicate devices; connects to designated syringe or infusion pump models in various healthcare environments. The patient uses the switch to signal the pump to deliver medication consistent with entered parameters and pump limitations.
Technological Characteristics: Same construction and passive nature.	Uses the same type of construction and has the same technological characteristics as the predicate devices. These are passive devices with no electronic components, powered by mating equipment using low voltages to detect push-button state changes. Shielding and insulation are substantially equivalent to the predicate device.
Device Failure Consequences: Same as OEM devices.	Due to extreme similarities, the consequences of a modified device and a device failure are the same for both AIV and OEM devices. (A risk management file was developed and used throughout the development process, referenced Section G, not provided here).
Clinical Testing: Not performed.	The non-clinical testing demonstrated 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. No clinical testing was performed as the device is an accessory with no direct patient interaction other than the button press, and its function relies on the primary pump's accuracy, not its own.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify a distinct "test set" sample size in terms of patient numbers or data records. The testing described focuses on the physical devices themselves. The tests involved "each of the AIV Patient Pendant Bolus Cables models" with specific test patterns and programs. This implies testing each manufactured cable model rather than a statistical sample size of patient data.
Data Provenance: The tests were conducted by AIV at their facility in Harmans, MD, USA. The testing is non-clinical, involving device verification and performance testing, not patient data. Therefore, the concept of "data provenance" related to patient data (e.g., country of origin, retrospective/prospective) is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a simple mechanical accessory (a cable with a button). The "ground truth" for its operation is whether the button press is correctly registered by the connected pump and whether it withstands cleaning/storage. This would be verified through engineering tests rather than expert interpretation of complex data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. The device validation involves objective pass/fail criteria for physical and functional performance, not subjective review requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. The AIV Patient Pendant Bolus Cable is a non-AI, non-diagnostic accessory.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a cable with a button; it does not contain an algorithm or software. Its function is to facilitate human-in-the-loop interaction (patient presses button) with the main infusion pump.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is its direct functional operation according to engineering specifications and its equivalence to predicate devices. This includes:
- Functional Correspondence: Verification that when the button is pressed, the signal is sent, and when not pressed, no signal is sent.
- Durability and Environmental Stability: Performance remains consistent after cleaning and storage cycles.
- Material Biocompatibility: Conformance to biocompatibility standards (referenced in Section F).
- Physical and Electrical Equivalence: Matching construction, operating voltage, and safety features of predicate devices.

8. The sample size for the training set

This information is not applicable. There is no AI component or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this device.

Summary

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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

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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Section A Page 3 of 6

American IV Products, Inc. 510(k) Summary Patient Pendant Bolus Cables

Product Description

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 areplacement part for a syringe orinfusion pump (not manufactured byAIV, Inc.). The healthcare workerconnects the device to thecorresponding pump. The patientuses the switch on the cable to signalthe pump to deliver medicationconsistent with the parametersentered into the pump by thehealthcare worker and limitations setby the pump design.	Same	Same
Indications forUse	Connects to designated syringe orinfusion pump model used inhospital, ambulatory and home careenvironments.	Same	Same
OperatingPrinciple	The patient presses on the buttonintegral to the design of the cable andsignals a request for medication tothe syringe or infusion pump thatprocesses this request in accordancewith the parameters entered by thehealthcare worker and the limitationsestablished in the pump.	Same	Same
OperatingVoltage	3.3 VDC to 5 VDC	Same	Same
Safety	Double insulation of conductors	Same	Same
PerformanceFeatures	Dose Units, Dose/Delivery Accuracy	Same	Same
EnvironmentalFeatures	Operating Temperature, StorageTemperature, Relative Humidity,Pressure	Same	Same
Cable Length	6 feet nominal	Same	Same
BioMedSettings	No configuration settings available forcustomization on the PCA ButtonCable. All the settings are entered inthe mating syringe or infusion pump.	Same	Same

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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.
1. 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.
1. 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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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

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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

Page 1 of 1

510(k) Number: K120209

Regulation Number and Section

§ 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).