The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional.

Device Description

The Z-800 Infusion System consists of the infusion pumps and approved external IV administration sets. The major modifications are as following: 1. Added a counter in software for cumulative volume of fluid infused in order to monitor pump utilization. The odometer feature enables pump display a reminder for user to service the pump once a preset volume limit is reached. 2. Implemented optional set based free flow protection. Modified set based free flow protection mechanism consists of a proprietary pinch clamp on the standard IV set tubing and an optional spring loaded clamp holder module on the pump. The pinch clamp can be manually opened for priming. The clamp holder is designed such that the pinch clamp is automatically closed once it is loaded into the clamp holder. Upon pump door close, the pump door activates the pinch clamp loaded in the clamp holder to open to allow flow go through. Upon pump door open, the spring in the clamp holder forces the pinch clamp to close. When the IV set is removed from the pump, the pinch clamp remains at closed position to avoid unintended free flow. A sensor on the clamp holder detects presence of the pinch clamp. "No Clamp" status can be displayed on pump screen to inform user that the clamp is absent. 3. Implemented optional Wi-Fi communication module for serial port to enable bidirectional communication through RF signal. A self-contained serial Wi-Fi convertor module is embedded into the Z-800 infusion pump to enable wireless communication. The Z-800 infusion pump sends serial command to the Wi-Fi convertor module. The Wi- Fi convertor module translates the serial communication command from the Z-800 infusion pump to RF signals and responsible for handling communication protocol with external devices. The serial Wi-Fi convertor enables the user to initiate a query on the pump for external information by entering partial patient identifier information as search criteria. External information returned from the query may include patient information, such as name, date of birth, and IV medication order. The patient and order information are presented to the healthcare professional during infusion programming process to be confirmed for association with the infusion. The Wi-Fi convertor also enables Z-800 infusion pump to publish infusion status data, with the associated patient and order identifiers, which can be utilized by external systems such as EMR. 4. Added an ESD/EMI shielding cap for serial port to enhance pump survivability under injection of Electromagnetic noise and Electrostatic Discharge. 5. Optimized pressure sensor zero point value determination process for better accuracy. 6. Optimized peristaltic plate to maximize durability of peristaltic module. 7. Optimized peristaltic cams in peristaltic module to maximize its durability. 8. Optimized rubber feet for increased durability.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for a Special 510(k) Device Modification for the Z-800 Infusion System. It focuses on device changes and comparison to a predicate device, rather than a clinical study with detailed performance metrics and ground truth establishment.

However, I can extract the general performance parameter for flow rate accuracy, which serves as an implicit acceptance criterion based on its comparison to the predicate device.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

Based on the "Equivalency Matrix," the primary performance parameter stated is Flow Rate Accuracy.

Acceptance Criteria (Stated Performance of Predicate Device)	Reported Device Performance (Z-800 Infusion System with Odometer)
$±5%$ Flow Rate Accuracy	$±5%$ Flow Rate Accuracy

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

This information is not provided in the document. The document describes engineering modifications and an equivalency comparison, not a detailed clinical study with a test set.

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 provided in the document. The type of device (infusion pump) typically relies on engineering and laboratory testing for performance validation, not expert-based ground truth for a test set in the way a diagnostic AI might.

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

This information is not provided in the document.

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

This information is not provided in the document. The device is an infusion pump, which does not involve "human readers" or AI assistance in the context of diagnostic interpretation.

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

This information is not provided in the document in the context of a "standalone" performance study for an AI algorithm. The device itself is a standalone infusion pump, and its performance (e.g., flow rate accuracy) would have been evaluated independently in engineering tests, but these details are not given here.

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

For flow rate accuracy, the ground truth would be established through metrology and calibrated reference standards in a laboratory setting. This is implied by the nature of the device and the performance metric, but not explicitly stated as "ground truth" using those terms within the document.

8. The sample size for the training set

This information is not provided in the document. The document describes modifications to an existing medical device, not the development and training of a new AI algorithm where a "training set" would be relevant. The "optimization" mentioned (e.g., pressure sensor, peristaltic plate/cams) would typically involve engineering design iterations and testing, not machine learning training.

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

This information is not provided in the document, as there is no mention of a "training set" in the context of AI or machine learning.

Summary

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K1,30690

SPECIAL 510(K) SUMMARY

JUN 1 2 2013

Submitted By:

Chaoyoung Lee, PhD President / CEO Zyno Medical LLC 177 Pine Street Natick, MA, 01760 Fax: 508-650-2006 Phone: 508-650-2008 x 103 Email: cylee@zynomed.com

Company Contact:

Mei Zhang, PhD Director of Engineering Zyno Medical LLC 177 Pine Street Natick, MA, 01760 Fax: 508-650-2006 Phone: 508-650-2008 x 205 Email: mei.zhang@zynomed.com

Date Originated: March 12th, 2013 Trade Name: Z-800 Infusion System Models: Z-800, Z-800W, Z-800F, Z-800WF Common Name: Volumetric Infusion Pump Classification Name: Infusion Pump Product code: FRN 880.5725

Establishment Registration Number: 3006575795

Predicate Devices

Z-800 Infusion System (K100705)

Intended Use

The intended use of the modified device is the same as the predicate device.

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Device Description and Comparison:

The Z-800 Infusion System consists of the infusion pumps and approved external IV administration sets.

Zyno Medical LLC is submitting this Special 510(k): Device Modification to request a modification for the approved infusion system. The major modifications are as following:

1. Added a counter in software for cumulative volume of fluid infused in order to monitor pump utilization. The odometer feature enables pump display a reminder for user to service the pump once a preset volume limit is reached.
1. Implemented optional set based free flow protection. Modified set based free flow protection mechanism consists of a proprietary pinch clamp on the standard IV set tubing and an optional spring loaded clamp holder module on the pump. The pinch clamp can be manually opened for priming. The clamp holder is designed such that the pinch clamp is automatically closed once it is loaded into the clamp holder. Upon pump door close, the pump door activates the pinch clamp loaded in the clamp holder to open to allow flow go through. Upon pump door open, the spring in the clamp holder forces the pinch clamp to close. When the IV set is removed from the pump, the pinch clamp remains at closed position to avoid unintended free flow. A sensor on the clamp holder detects presence of the pinch clamp. "No Clamp" status can be displayed on pump screen to inform user that the clamp is absent.
1. Implemented optional Wi-Fi communication module for serial port to enable bidirectional communication through RF signal. A self-contained serial Wi-Fi convertor module is embedded into the Z-800 infusion pump to enable wireless communication. The Z-800 infusion pump sends serial command to the Wi-Fi convertor module. The Wi- Fi convertor module translates the serial communication command from the Z-800 infusion pump to RF signals and responsible for handling communication protocol with external devices. The serial Wi-Fi convertor enables the user to initiate a query on the pump for external information by entering partial patient identifier information as search criteria. External information returned from the query may include patient information, such as name, date of birth, and IV medication order. The patient and order information are presented to the healthcare professional during infusion programming process to be confirmed for association with the infusion. The Wi-Fi convertor also enables Z-800 infusion pump to publish infusion status data, with the associated patient and order identifiers, which can be utilized by external systems such as EMR.
1. Added an ESD/EMI shielding cap for serial port to enhance pump survivability under injection of Electromagnetic noise and Electrostatic Discharge.

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1. Optimized pressure sensor zero point value determination process for better accuracy.
Optimized peristaltic plate to maximize durability of peristaltic module. 6.
1. Optimized peristaltic cams in peristaltic module to maximize its durability.
1. Optimized rubber feet for increased durability.

All engineering changes since the last 510K (K100705) approval have been listed above. We believe these modifications are eligible for the Special 510 (k) process since they have the same fundamental scientific technology and intended use as the predicate device. The principles of operation, method of manufacturing, and the application remain the same.

The equivalency matrix (Table 1) compares the modified infusion system with the predicate device (K100705).

Parameter	Z-800 InfusionSystem(with Odometer)	Z-800 InfusionSystem(K100705)
Pump Type	Volumetric Infusion Pump	Volumetric Infusion Pump
Intended use	The Z-800 Infusionsystem is intended toprovide intravenousinfusion of parenteralfluids, blood and bloodproducts to a patientunder the direction orsupervision of physicianor other certified healthcare professional.	The Z-800 Infusionsystem is intended toprovide intravenousinfusion of parenteralfluids, blood and bloodproducts to a patientunder the direction orsupervision of physicianor other certified healthcare professional.
Flow RateAccuracy	$±5%$	$±5%$
Pumpingmechanism	Linear peristaltic pump	Linear peristaltic pump
Free FlowProtection	Yes	Yes
Power source	AC: 100-250V 50-60 HzDC: Internal Nickel MetalHydride	AC: 100-250V 50-60 HzDC: Internal Nickel MetalHydride
Battery Life	8 hours at 125 ml/hr	8 hours at 125 ml/hr
Display	Program controlled dotmatrix LCD	Program controlled dotmatrix LCD

Table 1: Equivalency Matrix

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Parameter	Z-800 InfusionSystem(with Odometer)	Z-800 InfusionSystem(K100705)
SerialCommunications	Bidirectional	Bidirectional
Case construction	Milled Aluminum &Sheet Metal Enclosure	Milled Aluminum &Sheet Metal Enclosure
Occlusion PressureSetting	14 Level Adjustable	14 Level Adjustable
Warnings / Status	Low BatteryNear EndInfusion CompletePump unattendedKVONo Clamp (available whenequipped with optional clampholder)Service Due SoonService Due	Low BatteryNear EndInfusion CompletePump unattendedKVO
Alarms	OcclusionBattery EmptyAir-In-LineDoor OpenSystem ErrorNo Drip (with optional dripsensor)Drip sensor connection (withoptional drip sensor)	OcclusionBattery EmptyAir-In-LineDoor OpenSystem ErrorNo Drip (with optional dripsensor)Drip sensor connection (withoptional drip sensor)
Operation Modes	Continuous Mode (Primary& Secondary)10 Steps SequenceTPNIntermittentBlood Infusion	Continuous Mode (Primary& Secondary)10 Steps SequenceTPNIntermittentBlood Infusion

1000

100 - 100 -

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2013

Mei Zhang, PhD President/ Chief Executive Officer Zyno Medical LLC 10 Tech Circle NATICK MA 01760

Re: K130690

Trade/Device Name: Z-800 Series Volumetric Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 15, 2013 Received: May 21, 2013

Dear Dr. Zhang:

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.

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Page 2 - Dr. Zhang

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); 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 contact 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. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kwame Ulmer M.S. Acting Division Director

Division of Anesthesiology, General Hospital, Respiratory, 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): _________________

K 130690 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: Z-800 Series Volumetric Infusion System

Indications for Use: The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

T(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE ---------OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 2013.06.11 13:32:20 -04'00'

(Division Sign-Off) Tivision of Anesthesiology, General Hospital fection Control, Dental Devices

Page 1 of 1

510(k) Number: _ K1300 90

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).