SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B

K984561 · Msr, Inc. · FPA · Feb 4, 1999 · General Hospital

Device Facts

• Record ID: K984561
• Device Name: SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B
• Applicant: Msr, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Feb 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MSR Model A and B Subcutaneous Infusion Sets are intended to be used to administer insulin and medications under the skin.

Device Story

MSR Model A and B Subcutaneous Infusion Sets facilitate subcutaneous delivery of insulin or medications from an infusion pump. Model A utilizes a 28-gauge AISI 304 stainless steel introducer needle and a 25-gauge soft cannula; Model B utilizes a 28-gauge AISI 304 stainless steel needle for direct subcutaneous insertion. Tubing is polyethylene-lined polyurethane with a female Luer connector. The device is used in clinical or home settings to connect a medication reservoir to the patient. The introducer needle is removed after insertion, leaving the cannula or needle in place. The tubing set is detachable for pump disconnection. The device provides a pathway for medication delivery, potentially improving patient convenience and glycemic control.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: AISI 304 stainless steel needles, polyethylene-lined polyurethane tubing, medical-grade acrylic adhesive (non-fluid path). Design: Subcutaneous infusion set with female Luer connection. Dimensions: 28G/25G needles/cannulas, 0.36 mm tubing ID. Connectivity: Mechanical interface to infusion pump. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring subcutaneous administration of insulin or other medications via an infusion pump.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Disetronic Tender Set (K9972135)

Submission Summary (Full Text)

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FEB 4 1449

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## 510(K) Summary

## Submitter: MRS 124 Heritage Avenue, Portsmouth, New Hampshire 03801

Contact: Joyce McDougall, General Manager, phone: [phone] or Fax: [phone]

Trade Name: MSR Model A & Model B Subcutaneous Infusion Set Common Name: Subcutaneous Infusion Set Classification Name: Intravascular Administration Set

Predicate Device: Disetronic Tender Set K9972135

Device Description: The MSR Model A and Model B Subcutaneous Infusion Sets connect at the female luer connection to a reservoir containing insulin or other medications delivered by an infusion pump. The 28 gauge AISI 304 stainless steel introducer needle and 25 gauge soft cannula connected to the hub is inserted into the subcutaneous tissue . The introducer needle is removed and the hub and soft cannula remains in place. The Model B Subcutaneous Infusion Set has a 28 gauge AIS1 needle connected to a hub is inserted directly into the subcutaneous tissue. The cannula hub are affixed by an acrylic medical grade adhesive. The tubing is polvethylene lined polyurethane has a female Luer on one end and a connector that attaches to the hub on the other end. The tubing set portion can be removed and capped off when the pump is not in use while the hub and cannula remain in place.

Intended Use of the New Device: The MSR Model A and B Subcutaneous Infusion Sets are intended to be used to administer insulin and medications under the skin.

Comparison of the Technical Features of the New Device and Predicate Device: The intended use of the MSR Model B Subcutaneous Infusion Set is the same as the legally marketed predicate device. The instructions for use is the same as the predicate device. The MSR Model A and Model B Subcutaneous Infusion Set and the predicate device use identical materials contacting the fluid path with the exception of the connector, and hub which is identical to the another predicate device.

No significant technological differences exist between the MSR Model A and Model B Infusion Sets and the predicate device.

The adhesive used to manufacture the device is medical grade acrylic adhesive. This adhesive does not come in contact with the fluid path of the device.

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The slight differences are the 90 degree insertion angle (commonly used) of various length needles at 6 mm. 8 mm. 10 mm. and the AISI 304 stainless steel needle availability in the MSR Subcutaneous Infusion Sets Vs the 30 degree insertion angle of the predicate device available in a soft cannula of 17 mm length.

The inner diameter of the tubing is slightly smaller at 0.36 mm in the MSR Subcutaneous Infusion Set Vs the predicate device at 0.4 mm.

The outer diameter is identical in these sets. MSR Model A and Model B Subcutaneous Infusion Set offers an additional tubing set length at 30 mm.

These differences do not affect the safety and effectiveness of the device.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1999 FEB

MSR, Incorporated C/O Ms. McNamara-Cullinane Consultant Medical Device Consultants, Incorporated 49 plain street 02760-4153 North Attleboro, Massachusetts

Re : K984561 Subcutaneous Infusion Sets, MSR Model A & B Trade Name: Requlatory Class: II Product Code: FPA Dated: December 22, 1998 Received: December 23, 1998

Dear Ms. McNamara-Cullinane:

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 reqistration, 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 Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. McNamara-Cullinane

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 requlation (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" (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,

Timothy A. Ulatowski

Timot Ulatowski Directd Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): _

Device Name: Model A & B Subcutaneous Infusion Sets

Indications For Use:

Model A & B Subcutaneous Infusion Set is intended to be used to administer insulin and medications under the skin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Patricia Guercio
Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K984561

(Optional Format 1-2-96)