(147 days)
Not Found
Not Found
No
The summary describes a standard infusion pump with microprocessors for control and communication, without mentioning any AI/ML-specific terms, functionalities, or performance metrics typically associated with such technologies.
Yes
The device is intended for the "accurate delivery of parenteral fluids to a human patient," which is a form of medical treatment, classifying it as a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is an "Infusion pump ... intended to provide accurate delivery of parenteral fluids". This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly mentions hardware components such as filter assemblies, electronics, microprocessors, and a motor, indicating it is not a software-only device.
Based on the provided information, the Z-800 Infusion pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide accurate delivery of parenteral fluids to a human patient". This describes a device used on a patient for therapeutic purposes (delivering fluids directly into the body), not a device used to test samples from a patient (like blood, urine, or tissue) to diagnose or monitor a condition.
- Device Description: The description focuses on the mechanical and electronic components involved in pumping fluids, not on components used for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on samples, or providing diagnostic information based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Z-800 Infusion pump's function is to deliver substances into the body.
N/A
Intended Use / 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.
Product codes
FRN
Device Description
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
tion of the motor and sensors specific to th
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
Not Found
Intended User / Care Setting
physician or other certified health care professional
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Braun Vista basic, Sigma 8000, Abbott Acclaim Enco
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
67
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,
1
0 €
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
tion of the motor and sensors specific to th
quivalency Mat
| Parameter | 2-001 | · Vista
B. Braun | Sigma 80 | Abbott Acclain
. |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------|
| | . . | basic | ,感觉 | Encore |
| Pump Type | olumetric Infusio
A 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
2
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.
3
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
4
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: _______________________________________________________________________________________________________________________________________________________________