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510(k) Data Aggregation
K Number
K162165Device Name
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
Manufacturer
SUMMIT MEDICAL PRODUCTS, INC
Date Cleared
2017-08-29
(391 days)
Product Code
MEA, FRN, PCA
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT MEDICAL PRODUCTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ambIT PCA*PIB Pump is used to infuse medicines and/or fluids into patients primarily for pain management.
The routes of administration are generally intravenous, epidural and/or regional.
The ambIT PCA*PIB Pump is not intended to supersede, augment, or replace any other medical device or drug indications for use or intended uses.
The ambIT PCA*PIB Pump is intended to be used in the home and in healthcare facilities.
Device Description
The new ambIT PCA*PIB is an electro-mechanically controlled, rotary-peristaltic, infusion pump that consists of two components: (1) the reusable pump driver; and (2) the sterile, single-use cassette (tubing set).
The ambIT PCA*PIB Pump has a microprocessor-controlled motor that turns the rollers in the cassette at a set frequency to provide the desired infusion rate/therapy. The ambIT PCA*PIB Pump is powered by two (2) standard 1.5-volt "AA" batteries, and cannot be powered by electrical mains. The batteries are replaceable but cannot be recharged inside the pump.
The controls consist of two buttons and an OFF/ON switch. One button toggles the pump between pause and infusing. The other button (BOLUS button) is used to request a bolus. An LCD display shows the pump status, alarms, and history. The pump monitors downstream occlusions, pump malfunctions, and other pump error conditions. The materials of construction are all medical grade plastics. Specifically, the materials are ABS, polycarbonate, nylon, and glass-filled nylon.
The part of the pump that comes into indirect contact with the body is the cassette or tubing set. The medications flow through the tubing into a catheter and then into the body. The tubing set is classified to be used for less than 30 days. The length of time the pump is used is based on the therapy requirements.
The ambIT PCA*PIB product has been validated and verified to meet healthcare providers', lay users', and patients' needs for pain management infusions. The pump meets all applicable national and international consensus standards.
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K Number
K113043Device Name
DIRECT ANTIBIOTIC INFUSION KIT
Manufacturer
SUMMIT MEDICAL PRODUCTS, INC
Date Cleared
2011-12-20
(68 days)
Product Code
LJS, FRO, GAT, JCY
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT MEDICAL PRODUCTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Direct Antibiotic Infusion Kit is intended for direct administration of mediation and/or fluids into the body. The Direct Antibiotic Infusion kit is intended for use by a physician or by a trained individual under the supervision of a physician. Any drug(s) used with this kit is (are) at the discretion of the physician and the indications for the drug should be verified and followed.
Device Description
The Direct Antibiotic Infusion kit product line is a convenience kit for doctors. The Direct Antibiotic Infusion kit is designed to allow a physician or heath care provider to have the devices needed to administer antibiotics. The Direct Antibiotic Infusion kit consists of the following components: 1. Short or long term in-dwelling Catheter. 2. Suture. 3. Tubing anchor. 4. Tegaderm dressing. 5. Providone Iodine 10% ointment
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K Number
K110814Device Name
AMBIT TUNNELER
Manufacturer
SUMMIT MEDICAL PRODUCTS, INC
Date Cleared
2011-04-08
(15 days)
Product Code
BSO
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT MEDICAL PRODUCTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ambIT Tunnelers are intended for the perculaneous introduction of catheters.
Device Description
The ambIT® Tunneler is a non-sterile, reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve. The ambIT® Tunneler is packaged and shipped non-sterile and must be cleaned and autoclaved by the purchaser/facility prior to use.
Summit Medical Products, Inc. is adding a tunneling device to the ambIT® Tunneler product line for use in the placement of catheters. This specification is specifically for a 16 gauge (GA), 12 inch shaft length, re-useable tunneler and single use sterilized peelable sheath.
The ambIT® Tunneler will consist of 2 components:
· The component is a stainless steel shaft (blunt end) with a handle. The diameter of the shaft is 16 GA (S French) and the length of the shaft will accommodate a 12 inch useable length sheath, The end of the shaft will have a rounded blunt tip.
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K Number
K102460Device Name
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
Manufacturer
SUMMIT MEDICAL PRODUCTS, INC
Date Cleared
2011-01-13
(139 days)
Product Code
BSO
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT MEDICAL PRODUCTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ambIT™ Introducer products are intended allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle.
The ambIT Introducer product line is intended for use by a physician or by a trained individual under direct supervision of a physician.
Device Description
The ambIT™ Introducer is intended for the percutaneous introduction of a catheter
1. A stainless steel shaft with a sharp tip.
a. Stainless steel shafts with sharp tips (various configurations such as beveled or touhy) may or may not be solid (may be hollow).. The diameter of the stainless steel shaft ranges from 11 to 17 GA and the length is from 3.25 to 12 inches.
2. A plastic peelable sheath (split T-handle) on the outside of the stainless steel shaft and/or a plastic/metal inserts inside hollow stainless steel shafts.
a. Introducers that have a plastic sheath will allow the catheter to be inserted after the stainless steel shaft has been withdrawn. The tips of the stainless steel shaft will be blunt or sharp.
b. Introducers that do not have a plastic sheath will allow the catheter to be inserted through the stainless steel shaft, after the plastic/metal insert has been withdrawn.
The ambiT Introducers may have a handle or luer hub connected to the stainless steel shaft.
The following are the configurations and names for the amblT Introducers:
1. amblT Introducer Sheath
a. Sterile single use product
b. Made for use with ambIT Tunneler (without sheath) reusable product.
2. amblT Introducer Needle
a. Sterile single use product
b. Stainless steel shaft with sharp tip and insert inside stainless steel shaft.
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