3.0 ML RESERVOIR, MODEL 103/193

K991936 · Medtronic Minimed · FRN · Jan 18, 2000 · General Hospital

Device Facts

• Record ID: K991936
• Device Name: 3.0 ML RESERVOIR, MODEL 103/193
• Applicant: Medtronic Minimed
• Product Code: FRN · General Hospital
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MiniMed 3.0 ml Reservoir Model 103/193 is intended for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not intented for use with blood or blood products.

Device Story

The MiniMed 3.0 ml Reservoir Model 103/193 is a single-use 3.0 ml piston syringe designed for subcutaneous medication delivery. It consists of a hollow barrel, a movable plunger with silicone rubber O-rings, and a male Luer lock fitting. The device is loaded with medication and placed into an external infusion pump; the Luer lock connects to an infusion set. Model 103 is individually packaged with an attached needle; Model 193 is multi-packed with a vented cap. The device facilitates controlled medication delivery by the infusion pump, benefiting patients requiring continuous or programmed subcutaneous infusion, such as insulin therapy. It is intended for use in clinical or home settings under the direction of a healthcare provider.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use 3.0 ml piston syringe. Materials: silicone rubber O-rings, fluorosilicone fluid lubricant. Features male Luer lock fitting. Model 103 includes 0.5 in. needle; Model 193 includes vented cap. Assembly process is automated.

Indications for Use

Indicated for the infusion of medicine, including insulin, via an external infusion pump. Not for use with blood or blood products.

Regulatory Classification

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.

Predicate Devices

• Single Use Syringe Model 103

Submission Summary (Full Text)

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MiniMed Inc. Premarket Notification - 510(k) 3.0 ml Reservoir Model 103/193

JAN 18 2000

Image /page/0/Picture/2 description: The image shows the logo for MiniMed. The logo consists of a black square with white wavy lines inside, followed by the word "MiniMed" in a bold, serif font. Above the word "MiniMed" is the text "K99/1936" in a smaller font.

## Section D. 510(k) Summary

In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, a 510(k) Summary follows:

Submitter: MiniMed® Inc. 12744 San Fernando Rd., Sylmar, California 91342

Contact: Jennifer Lyons, Regulatory Affairs [phone], ext. 3111

Name of Device: MiniMcd 3.0 ml Reservoir Model 103/193

Original Device: Single Use Syringe Model 103

Description of the Device: The MiniMed 3.0 ml Reservoir Model 103/193 is a single use 3.0 ml piston syringe consisting of a hollow barrel, movable plunger with O-rings for sealing, and a male Luce lock fitting at the distal end of the barrel. The device is used in conjunction with an external infusion punp and infusion set to deliver medication subcutancously. The male Luer lock fitting of the reserved is connected to the female Luer fitting of an infusion set, and the reservoir is placed in an externs. Infusion pump. The 103/193 reservoir is designed for use with MiniMed infusion purpos. Models 103 and 193 differ only in end configuration and packaging. The 103 is individually packaged with a covered needly attached to the male connector, while the 193 is multi-packed with a vented cap instead of a necdle.

The modifications which are the subject of this premarket notification have no unloward effect on the safety and effectiveness of the device.

Intended Use of the Device: The MiniMed 3.0 ml Reservoir Model 103/193 is intended for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not intented for use with blood or blood products.

Comparison of the Tcchnological Features of the Modified and Original Devices: The modified device is substantially equivalent to the lawfully marketed original device. The differences between the modified and original devices are: 1) The name of the device has been changed from the Single Use Syringe Model 103 to the MiniMed 3.0 ml Reservoir Model 103/193. 2) The O-ring material has changed from a rubber compound to siliconc rubber. 3) The lubricant has changed from a silicone fluoco fluorosilicone fluid. 4) Model 193 uses bulk packaging as opposed to single packaging. 5) Model 193 has a vented cap on the distal end instead of a needle. 6) The I in. needle of the original device was changed to a 0.5 in. needle in Model 103. 7) The assembly process has been automated.

Jennifer Lyons 6/8/99
Jennifer Lyons Date

Regulatory Affairs Specialist Regulatory Affairs MiniMed Inc.

Date

®MiniMed is a Registered Trademark of MiniMed Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN | 8 2000

Ms. Jennifer Lyons Regulatory Affairs Specialist MiniMed™, Incorporated 12744 San Fernando Road Sylmar, California 91342-3728

Re : K991936 MiniMed 3.0 ml Reservoir Trade Name: Regulatory Class: II Product Code: FRN Dated: October 18, 1999 Received: October 20, 1999

Dear Ms. Lyons:

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 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 against 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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Lyons

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Amarbe at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A Ulatowski
Director

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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MiniMed Inc. Premarket Notification - 510(k) 3.0 ml Reservoir Model 103/193

Image /page/3/Picture/1 description: The image shows the logo for MiniMed. The logo consists of a black square with white wavy lines inside, followed by the word "MiniMed" in a serif font. There is a trademark symbol after the word "MiniMed".

## INDICATIONS FOR USE

510(k) Number:

Device Name: MiniMed 3.0 ml Reservoir Model 103/193

Indications for Use: The MiniMed 3.0 ml Reservoir Model 103/193 is indicated for use Indications for Use: The Nimmived J.v in Leso. Con Resort Creat infusion pump. The rol "the midslow of or use with blood or blood or blood products.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div style="display:flex; align-items:center;">✓</div> | or | Over-the Counter Use _____ |
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Alta Cucerule

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

R091936

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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