PACER MODEL 100 INFUSION CONTROLLER

K963136 · Health Watch, Inc. · LDR · Oct 10, 1997 · General Hospital

Device Facts

• Record ID: K963136
• Device Name: PACER MODEL 100 INFUSION CONTROLLER
• Applicant: Health Watch, Inc.
• Product Code: LDR · General Hospital
• Decision Date: Oct 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pacer Model 100 Infusion Controller is indicated for use in: 1. The delivery if Intravenous (parenteral) fluids where positive pressure (above 36° of water) is not required. 2. The delivery of intravenous drugs where positive pressure (above 36° of water) is not required.

Device Story

Pacer Model 100 Infusion Controller; gravity-fed infusion control device. Regulates flow rate of intravenous fluids/drugs; operates without positive pressure. Used in clinical settings; managed by healthcare professionals. Provides controlled fluid delivery; ensures accurate administration of parenteral therapy. Benefits patient by maintaining consistent infusion rates without requiring active pumping mechanisms.

Technological Characteristics

Infusion controller; gravity-based flow regulation; non-positive pressure design (below 36° of water).

Indications for Use

Indicated for patients requiring intravenous delivery of fluids or drugs where positive pressure (above 36° of water) is not required.

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.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002

Health Watch Incorporated
C/O John D. Greenbaum
20310 SW 4 8th Street
Ft. Lauderdale, Florida 33332

JAN 10 2017

Re: K963136
Trade/Device Name: Pacer Model 100 Infusion Controller
Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion Pump
Regulatory Class: Class II
Product Code: LDR
Dated: July 6, 1997
Received: July 18, 1997

Dear: Dear Mr. Greenbaum

This letter corrects our substantially equivalent letter of October 10, 1997.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

{1}

Page 2 – Mr. John Greenbaum

as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Erin I. Keith -S**

Erin I. Keith, M.S.
Director
Division of Anesthesiology,
General Hospital, Respiratory,
Infection Control, and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{2}

510(k) Number: K963136

Device Name: Pacer Model 100 Infusion Controller

Indications For Use:

The Pacer Model 100 Infusion Controller is indicated for use in:

1. The delivery if Intravenous (parenteral) fluids where positive pressure (above 36° of water) is not required.
2. The delivery of intravenous drugs where positive pressure (above 36° of water) is not required.

(PLEASE DONOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off) *Patricia Cucarola*
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number *K963136/5*

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)