(218 days)
Not Found
No
The description focuses on a microcomputer controlling a pump based on gravimetric principles and fluid viscosity, which are standard engineering controls, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
No.
The device's intended use and description clearly state it is for dispensing cyclosporine oral solution and managing dose information, not for directly treating a disease or condition.
No
The device is described as a dispenser for cyclosporine oral solution. Its functions include dispensing the solution, displaying dose information, and storing data related to dispensing. There is no mention of it being used to diagnose any medical condition, only to deliver medication.
No
The device description explicitly details hardware components such as a plastic shell, user buttons, LCD display, battery, pump technology, control processor, liquid dispensing valve assembly, and a fluid path assembly. It is a physical dispensing device with integrated software for control and data management.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to dispense a specific oral solution (cyclosporine), display information about dosing, and store data related to dispensing. This is a drug delivery and management function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the mechanical and electronic aspects of dispensing liquid medication, measuring volume, timing doses, and storing data. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly designed for the controlled delivery of a medication, which falls under the category of a drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is used to dispense fluid in laboratories and pharmacies.
The CycloTech™ device is intended to dispense SangCya™ cyclosporine oral solution USP (for microdispersion) as well as display and store dose size; time to next dose, remaining available doses, and doses dispensed.
The CycloTech™ Cyclosporine Oral Solution Dispenser (Dispenser) is intended to dispense SangCya™ cyclosporine oral solution USP (for microdispersion) as well as display and store dose size, time to next dose, remaining available doses, and doses dispensed.
Product codes (comma separated list FDA assigned to the subject device)
KYX
Device Description
The CycloTech™ Cyclosporine Oral Solution Dispenser (SangStat Medical Corporation, Menlo Park, CA) is a medical device which provides dose measurement capabilities. This product has been designed to be convenient and easy to use by SangCya™ cyclosporine oral solution USP (for microdispersion) recipients. CycloTech™ can measure and dispense SangCya™ while recording the time of dosing and dose sizes for up to one (1) year (12 months). Stored information can be downloaded into a personal computer (PC) for use by a health-care provider. CycloTech™ utilizes a disposable, motor driven pump to provide volume range, while maintaining adequate accuracy and reducing the risk of individual errors that might occur with manual dispensing (e.g., via syringe).
CycloTech™ is designed for use with a standard fifty (50) mL bottle. A disposable fluid path, fully enclosed by the outer plastic shell, has a 0.1 to 5.0 mL dose range with 0.1 mL per step resolution and an accuracy of plus or minus five percent (+ 5%) for dispensed volumes. This device has two (2) user buttons, a custom LCD display, one (1) year memory at two (2) doses per day (uploadable to a PC), six (6) months battery life using common AA-type alkaline batteries, and pump technology for a specified volume range.
Use of a pump mechanism and microcomputer allows control of fluid delivery. The primary system upon which this product is based is the gravimetric principle of fluid delivery. The pump mechanism is used to assist the microcomputer in measuring amounts of liquid cyclosporine as well as dispensing the medication. The microcomputer, taking into account fluid viscosity, is able to provide an accurate, reproducible amount of liquid medication.
CycloTech™ is comprised of a molded plastic case assembly with an interchangeable disposable fluid path assembly. The fluid path assembly will only accept the original container of cyclosporine oral solution obtained from the drug manufacturer (reservoir or medication supply bottle). The case assembly provides for setting or adjusting the amount of liquid delivered, for measuring time, and for storing data. This apparatus also provides visual and audio output to the user, a control processor for monitoring and recording the time and number of dispensed doses of medication, a method for alerting a user of the time for taking their dose(s) of medicine, and monitoring the amount of medication remaining in the fluid path and reservoir. Audio alarms for alerting a user are also included in the Dispenser. The control processor, via interface, may be linked with an external computer. A liquid dispensing valve assembly and pump are used for dispensing liquid medicines from the reservoir through the fluid path assembly.
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
laboratories and pharmacies.
recipients of SangCya™ cyclosporine oral solution USP (for microdispersion)
health-care provider
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)
Non-Clinical Performance Data: CycloTech™ has been tested to and found to be in compliance with the following voluntary standards: a) FCC Part 15, Class B and b) EN60601-1-2 [electrical unit testing (EUT) relative to radiated emissions and electrostatic discharge (ESD) susceptibility]. CycloTech™ components and materials have also been tested to and found to be in compliance with established bioburden and biocompatibility (e.g., genotoxicity, subchronic toxicity, cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, and physiochemical analysis) parameters. Non-clinical performance testing results for CycloTech™ indicate accuracy and precision data met specified internal standards and are available for review.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6430 Liquid medication dispenser.
(a)
Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
AUG | 8 1998 SangStat Medical Corporation The Transplant Company®
510(k) Summary of Safety and Effectiveness Information
Date Prepared: 22 June 1998
Sponsor I.
-
a. Sponsor Name
SangStat Medical Corporation 1505 Adams Drive Menlo Park, CA 94025 Telephone: (650) 328-0300 (650) 328-8892 Fax: -
b. Official Correspondent
Derek Williams, RAC Manager, Regulatory Affairs SangStat Medical Corporation 1505 Adams Drive Menlo Park, CA 94025 Telephone: (650) 328-2305
II. System Identification
-
a. Proprietary Product Name
CycloTech™ Cyclosporine Oral Solution Dispenser -
b. Common or Usual Product Name
Dispenser or Cyclosporine Oral Solution Dispenser -
c. Classification Name
Liquid Medication Dispenser (21 CFR §880.6430)
III. Predicate Device
-
a. Name
Burron Medical Inc. (Bethlehem, Pennsylvania) Multi-Ad Fluid Dispensing Pump MP-3000 [510(K) Notification Number K801008, Class Code with Panel Number 80-KYX]. -
b. Device Description
A pumping mechanism is used for the ejection of fluid. The pump generates energy, which pushes plunger to eject liquid contents.
1
Image /page/1/Picture/0 description: The image is a logo that features a stylized letter "S" inside a diamond shape. The letter "S" is bold and black, and it appears to be three-dimensional. The diamond shape is also three-dimensional, with the top half shaded with diagonal lines. The logo has a modern and geometric design.
c. Indications for Use
The device is used to dispense fluid in laboratories and pharmacies.
IV. CycloTech™ Device Information
a. Product Background
The CycloTech™ Cyclosporine Oral Solution Dispenser (SangStat Medical Corporation, Menlo Park, CA) is a medical device which provides dose measurement capabilities. This product has been designed to be convenient and easy to use by SangCya™ cyclosporine oral solution USP (for microdispersion) recipients. CycloTech™ can measure and dispense SangCya™ while recording the time of dosing and dose sizes for up to one (1) year (12 months). Stored information can be downloaded into a personal computer (PC) for use by a health-care provider. CycloTech™ utilizes a disposable, motor driven pump to provide volume range, while maintaining adequate accuracy and reducing the risk of individual errors that might occur with manual dispensing (e.g., via syringe).
b. Indication for Use
The CycloTech™ device is intended to dispense SangCya™ cyclosporine oral solution USP (for microdispersion) as well as display and store dose size; time to next dose, remaining available doses, and doses dispensed.
c. Device Description
CycloTech™ is designed for use with a standard fifty (50) mL bottle. A disposable fluid path, fully enclosed by the outer plastic shell, has a 0.1 to 5.0 mL dose range with 0.1 mL per step resolution and an accuracy of plus or minus five percent (+ 5%) for dispensed volumes. This device has two (2) user buttons, a custom LCD display, one (1) year memory at two (2) doses per day (uploadable to a PC), six (6) months battery life using common AA-type alkaline batteries, and pump technology for a specified volume range.
Use of a pump mechanism and microcomputer allows control of fluid delivery. The primary system upon which this product is based is the gravimetric principle of fluid delivery. The pump mechanism is used to assist the microcomputer in measuring amounts of liquid cyclosporine as well as dispensing the medication. The microcomputer, taking into account fluid viscosity, is able to provide an accurate, reproducible amount of liquid medication.
CycloTech™ is comprised of a molded plastic case assembly with an interchangeable disposable fluid path assembly. The fluid path assembly will only accept the original container of cyclosporine oral solution obtained from the drug manufacturer (reservoir or medication supply bottle). The case assembly provides for setting or adjusting the amount of liquid delivered, for measuring time, and for storing data. This apparatus also provides visual and audio output to the user, a control processor for monitoring and recording the time and number of dispensed doses of medication,
2
Image /page/2/Picture/0 description: The image is a black and white logo. The logo is a diamond shape with the letter "S" in the center. The top left portion of the diamond has horizontal lines. The letter "S" is bold and has a three-dimensional effect.
angStat Medical Corporation The Transplant Company®
a method for alerting a user of the time for taking their dose(s) of medicine, and monitoring the amount of medication remaining in the fluid path and reservoir. Audio alarms for alerting a user are also included in the Dispenser. The control processor, via interface, may be linked with an external computer. A liquid dispensing valve assembly and pump are used for dispensing liquid medicines from the reservoir through the fluid path assembly.
Substantial Equivalence v.
CycloTech™ is substantially equivalent to the indications for use and technological characteristics of the "Multi-Ad" Fluid Dispensing Pump MP-3000 (Burron Medical, Inc.).
While the software component of CycloTech™ is an added feature (when compared with the "Multi-Ad" Fluid Dispensing Pump MP-3000), the software does not adversely affect patient safety (e.g., addition of audible dosing alarms, a microcomputer, programming capability, pump stroke accuracy, and volume controls) or the effectiveness (precise volume dispensing, recording and storing data) of the device. The addition of the features improves the overall safety parameters of the Dispenser by providing information to the user.
VI. Non-Clinical Performance Data
CycloTech™ has been tested to and found to be in compliance with the following voluntary standards: a) FCC Part 15, Class B and b) EN60601-1-2 [electrical unit testing (EUT) relative to radiated emissions and electrostatic discharge (ESD) susceptibility].
CycloTech™ components and materials have also been tested to and found to be in compliance with established bioburden and biocompatibility (e.g., genotoxicity, subchronic toxicity, cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, and physiochemical analysis) parameters.
Non-clinical performance testing results for CycloTech™ indicate accuracy and precision data met specified internal standards and are available for review.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of a human figure with three faces in profile, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Derek Williams, RAC Manager, Regulatory Affairs SangStat Medical Corporation 1505 Adams Drive Menlo Park, California 94025
K980109 Re : CycloTech™ Cyclosporine Oral Solution Trade Name: Dispenser Requlatory Class: I Product Code: KYX Dated: June 22, 1998 Received: June 24, 1998
Dear Mr. Williams:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
4
Paqe 2 - Mr. Williams
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to one 10gazaootification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Butman
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| 510(k) Number (if known): | K980109 |
|---|---|
| --------------------------- | --------- |
CycloTech™ Cyclosporine Oral Solution Dispenser Device Name:
- The CycloTech™ Cyclosporine Oral Solution Dispenser Indications for Use: SangCya™ is intended to to dispense (Dispenser) cyclosporine oral solution USP (for microdispersion) as well as display and store dose size, time to next dose, remaining available doses, and doses dispensed.
(Please Do Not Write Below This Line - Continue On Another Page If Needed Concurrence of CDRH, Office of Device Evaluation (ODE)
Lrene Moreau for PKC
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K 980109
Prescription Use V (Per 21 CFR §801.109) Or
Over-The-Counter Use (Optional Format 1-2-96)