CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER

K980109 · Sangstat Medical Corp. · KYX · Aug 18, 1998 · General Hospital

Device Facts

• Record ID: K980109
• Device Name: CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
• Applicant: Sangstat Medical Corp.
• Product Code: KYX · General Hospital
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6430
• Device Class: Class 1
• Attributes: Therapeutic

Indications 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.

Device Story

CycloTech™ is a motor-driven, microcomputer-controlled oral solution dispenser for SangCya™ cyclosporine. Device accepts standard 50 mL medication bottles via an interchangeable disposable fluid path. User operates device via two buttons; custom LCD displays dose size, time to next dose, and remaining volume. Microcomputer uses gravimetric principles and fluid viscosity data to control pump mechanism for precise dispensing (0.1 to 5.0 mL range; ±5% accuracy). Device stores dosing history for up to 12 months; data is uploadable to a PC for healthcare provider review. Audio/visual alarms alert patients to dosing times. Used by patients at home to improve medication adherence and reduce manual dispensing errors. Benefits include increased dosing accuracy and automated record-keeping for clinical monitoring.

Clinical Evidence

Bench testing only. Device tested for compliance with FCC Part 15 Class B and EN60601-1-2 (electrical/EMC). Biocompatibility and bioburden testing performed (genotoxicity, subchronic toxicity, cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, physiochemical analysis). Accuracy and precision data met internal specifications.

Technological Characteristics

Molded plastic case with interchangeable disposable fluid path. Motor-driven pump mechanism. Microcomputer-controlled. Powered by AA alkaline batteries. Connectivity: PC interface for data download. Standards: FCC Part 15 Class B, EN60601-1-2.

Indications for Use

Indicated for patients prescribed SangCya™ cyclosporine oral solution USP (for microdispersion) to facilitate accurate dose measurement, dispensing, and adherence tracking.

Regulatory Classification

Identification

A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.

Predicate Devices

• Burron Medical Inc. Multi-Ad Fluid Dispensing Pump MP-3000 (K801008)

Submission Summary (Full Text)

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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: [phone] [phone] Fax:

- b. Official Correspondent
Derek Williams, RAC Manager, Regulatory Affairs SangStat Medical Corporation 1505 Adams Drive Menlo Park, CA 94025 Telephone: [phone]

#### 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.

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## 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,

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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.

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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| 510(k) Number (if known): | K980109 |
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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)