STERILE AMBULATORY RESERVOIR 60ML/100ML

• K Number: K962159
• Device Name: STERILE AMBULATORY RESERVOIR 60ML/100ML
• Manufacturer: FAULDING MEDICAL DEVICE CO.
• Date Cleared: 1997-07-18 ( 409 days)
• Product Code: MRZ
• Regulation Number: 880.5725
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The S.P.A.R.TM Sterile Ambulatory Reservoir is intended for use with the Pharmacia Deltec CADD® Model 5800 Ambulatory Infusion Pump, manufactured and distributed by Sims Deltec Inc. St. Paul, Minnesota. The S.P.A.R.™ Medication Reservoir is intended for use as an accessory to the Pharmacia Deltic CADD® infusion punip by replacing the Deltic Medication Cassette™, Model 2050 - 50 mL and 2100 - 100 mL with the S.P.A.R. Reservoir.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) notification from the FDA regarding a Sterile Ambulatory Reservoir (S.P.A.R.™). It is a letter of substantial equivalence, which means the device is deemed equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria, device performance, studies to prove performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Therefore, I cannot provide the requested information based on the provided text.

The document primarily focuses on:

• The FDA's decision regarding the 510(k) submission.
• The regulatory classification of the device (Class II).
• General controls and potential additional controls applicable to the device.
• Contact information for further regulatory inquiries.
• The intended use of the S.P.A.R.™ Sterile Ambulatory Reservoir as an accessory to specific infusion pumps.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and appears to be in a sans-serif font.

JUL 18 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bruce Craney ·Director Product Development Faulding Medical Device Company 8777 East Via De Ventura, Suite 315 Scottsdale, Arizona 85258

Re : K962159 Sterile Ambulatory Reservoir 60mL/100mL Trade Name: Requlatory Class: II Product Code: MRZ Dated: June 26, 1997 Received: June 27, 1997

Dear Mr. Craney:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 current Good Manufacturing Practice requirement, 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 - Mr. Craney

through 542 of the Act for devices under the Electronic enrough Siz or other l 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 deborized substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

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): K962159 Device Name: S.P.A.R.™ Sterile Ambulatory Reservoir Cat. No. 900621 - 60 mL and 900915 - 100 mL

Indications For Use:

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The S.P.A.R.TM Sterile Ambulatory Reservoir is intended for use with the Pharmacia Deltec CADD® Model 5800 Ambulatory Infusion Pump, manufactured and distributed by Sims Deltec Inc. St. Paul, Minnesota. The S.P.A.R.™ Medication Reservoir is intended for use as an accessory to the Pharmacia Deltic CADD® infusion punip by replacing the Deltic Medication Cassette™, Model 2050 - 50 mL and 2100 - 100 mL with the S.P.A.R. Reservoir.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)
(Division Sign-Off)	Patricia Ciuente
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K962159
Prescription Use ✓(Per 21 CRF 801.109)	OR	Over-The-Counter Use ____
		(Optional Format 1-2-96)

Regulation Number and Section

§ 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).