The Z-800 Infusion pump is intended to provide accurate delivery of parenteral fluids to a human patient under the direction or supervision of physician or other certified health care professional.

Device Description

The Z-800 Infusion pump contains the filter assemblies. The electronics subsequently contains all of the electronics in the microprocessors that run the software. The electronics assembly also contains communications electronics. The pump has two microprocessors, one master processor which controls operation of the device, another pump processor which controls operation of the motor and sensors specific to the pump.

AI/ML Overview

This document does not contain the information required to answer the request. The provided text is a 510(k) summary for an infusion pump, which focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria and ground truth establishment.

Specifically, the document lacks:

A table of acceptance criteria and reported device performance related to specific endpoints. The document provides a general intended use statement ("accurate delivery of parenteral fluids") and a comparison table of basic parameters (pump type, intended use) with predicate devices, but no quantified performance metrics or acceptance criteria are listed.
Study details: There is no mention of a specific study design, sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or adjudication methods.
Comparative effectiveness or standalone performance studies: The document does not describe any MRMC comparative effectiveness studies or standalone algorithm performance studies. The approval is based on equivalence to existing devices.

Summary

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1 0(K) SUMMA

07154

yno Medical LLC.
95 Totten Pond Rd. Suite 20
Taltham MA 0245 l

Contact Person

Shaoyoung Lee
System Medical R.L.C.
Britan Medical M.L.C.
Wis Thanks Moral M. R. Suite 20 Suite 20
78 Transis M. B. 24

te Prepared: May 1, 200

ade Name: Z-800 Infusion Pump
mmon Name: Volumetric Infusion Pun
assification Name: Infusion Pump

redicate Devices
.Braun Vista basic, Sigma 8000, Abbott Acclaim Enco

ntended Use

e Z-800 Infision pump is intended to provide acurate delivery of parenteral fluids to a human patient under the direction or supervision
ysician or other certified health ca

ice Descriptio

800 Premarket Notification - 1 May 2007, Revised per FDA Review October 17,

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Infusion pump is intended to provide accurate delivery of parenteral fluids to a human patient under the direction or supervision
or other certified health care professional.

sion purp contains the filter assembles

nics subssently contains all of the electronics in the microprocessors that tun the software. The electrere The electr
ly also contains communications electronics.

oump has two microprocessors, one master processor which controls operation of the device, another pump processor which controls
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quivalency Mat

Parameter	2-001	· VistaB. Braun	Sigma 80	Abbott Acclain.
	. .	basic	,感觉	Encore
Pump Type	olumetric InfusioA BREAK A BELL A BELL BE A BELL BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE B	olumetric Infusio	olumetric Infusio	olumetric Infusio
	ump	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Pump	Pumr	ump
Intended use	ntra-venous	Intra-venous	ntravenous	ntrovenous
			Epidura

Premarket Notification – 1 May 2007, Revised per FDA Review October

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2007

Mr. Chaoyoung Lee President Zyno Medical LLC 395 Totten Pond Road, Suite 201 Waltham, Massachusetts 02451

Rc: K071545

Trade/Device Name: Z-800 Volumetric Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 22, 2007 Received: October 22, 2007

Dear Mr. Lee:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Lee

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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): _K071545

Device Name: _Z-800 Volumetric Infusion Pump

Indications for Use: The Z-800 Infusion pump is intended to provide accurate delivery of parenteral fluids to a human 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chun On

Page 1 of 1

ivision Sign-Off) Jivision of Anesthesiology, General Hospital infection Control, Dental Devices

:10(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).