(73 days)
Not Found
Not Found
No
The device description focuses on mechanical components (silicone balloon, fixed rate administration set, bolus button) and flow control mechanisms (glass orifice, PVC tubing). There is no mention of software algorithms, data processing, or learning capabilities that would indicate AI/ML. The comparison to predicate devices also highlights similar mechanical and flow control principles.
Yes
The device is indicated for "pain management" and delivers substances "for regional anesthesia", which are therapeutic interventions.
No
Explanation: The device is described as an ambulatory infusion pump, meaning it is used to deliver fluids for treatment, rather than to diagnose a condition. Its indications for use include general infusion for regional anesthesia and pain management.
No
The device description clearly details a physical pump with a silicone balloon reservoir, administration set, and a Patient Medication Control Module (PCM), indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the infusion of substances into the body (intravenous, percutaneous, subcutaneous, etc.). This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description details a pump that delivers fluid using a balloon and administration set. This mechanism is for delivering substances, not for analyzing samples from the body to diagnose conditions.
- Lack of Diagnostic Language: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.), detection of markers, or any other activity typically associated with in vitro diagnostics.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The AutoFuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, are indicated for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites.
Within the AutoFuser family are pump models intended for patient-controlled infusion using the integrated bolus button.
General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Product codes
MEB
Device Description
- The AutoFuser pump (Continuous type Silicone Balloon)
- The pump provides continuous fluid delivery with attached, fixed rate administration set.
- The pumps are supplied as fixed flow rates.
- A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.
- The AutoFuser pump family includes models of the standard AutoFuser with the addition of a Patient Medication Control Module (PCM)
- Patient Medication Control Module allows the patient to administer a bolus of fixed volume with a fixed lockout (re-fill) time.
- The pump is a disposable device intended for single patient use.
- The pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
- The AutoFuser and the AutoFuser PCM pumps are substantially similar to the I-Flow Homepump (Eclipse) C-Series (included in the I-Flow PainBuster kit and the On-Q pain management kit), the Baxter Infuser and Intermate, the McKinley Accufuser, and the B Braun spring pump (used in the Sgarlato pain kit).
Specifications
- The AutoFuser and the AutoFuser PCM pumps have fill volumes and flow rates substantially similar to the pumps of the McKinley Medical Accufuser, the I-Flow PainBuster (Homepump Eclipse C-Series), the B Braun spring pump included in the Sgarlato PCIP, and the Baxter Infusor and Intermate pumps.
Flow Control
- The AutoFuser and AutoFuser PCM pumps and the identified predicate device use either a glass orifice or PVC tubing to control the flow rate.
Materials
- All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravenous, percutaneous, subcutaneous, intra-arterial and epidural and into the intra-operative (soft tissue / body cavity) site.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, home environment or alternative care sites.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
AUG 2 6 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
June 1, 2004
Trade Name: AutoFuser Elastomeric Infusion Pump
Common Name: Elastomeric Infusion Pump
Classification Name: Pump, Infusion, Elastomeric
Classification Panel: General Hospital and Personal Use Device
All questions and/or comments concerning this document should be made to:
Robert J. Bard, Esq. Managing Director
HealthCare Technologies Consultants 150 Lake Village Dr Suite 203 Telephone: 949.235.0545 Fax: 949.240.3460
1
DESCRIPTION OF THE AUTOFUSER PRODUCT 1.0
- The AutoFuser pump (Continuous type Silicone Balloon) 1.1
- 1.1.1 The pump provides continuous fluid delivery with attached, fixed rate administration set.
- The pumps are supplied as fixed flow rates. 1.1.2
- 1.1.3 A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.
- The AutoFuser pump family includes models of the standard 1.2 AutoFuser with the addition of a Patient Medication Control Module (PCM)
- Patient Medication Control Module allows the patient to 1.2.1 administer a bolus of fixed volume with a fixed lockout (re-fill) time.
- 1.2.2 The pump is a disposable device intended for single patient use.
- 1.2.3 The pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
- 1.2.4 The AutoFuser and the AutoFuser PCM pumps are substantially similar to the I-Flow Homepump (Eclipse) C-Series (included in the I-Flow PainBuster kit and the On-Q pain management kit), the Baxter Infuser and Intermate, the McKinley Accufuser, and the B Braun spring pump (used in the Sgarlato pain kit).
THE AUTOFUSER/AUTOFUSER PCM PUMP AND ITS PREDICATE 2.0 DEVICES ARE INTENDED:
- For general infusion use. Routes of infusion include intravenous, 2.1 percutaneous, subcutaneous, intra-arterial and epidural and into the intra-operative (soft tissue / body cavity) site.
- 2.2 General infusion use Includes pain management for pre-operative, perioperative and postoperative surgery.
- The predicate pumps (and the pumps included with the I-2.2.1 Flow PainBuster and ON-Q Infusion Kit and the Sgarlato Pain Control Infusion Pump (PCIP)) have the same intended use as the device under review:
2
- 2.2.2 The AutoFuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, and its predicate devices are indicated for general infusion use. Routes of infusion include intravenous. percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites.
Members of the AutoFuser family and the predicate devices are also intended for patient-controlled infusion using the integrated bolus button.
General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
- 2.3 Device Descriptions
- 2.3.1 Specifications
- 2.3.1.1 The AutoFuser and the AutoFuser PCM pumps have fill volumes and flow rates substantially similar to the pumps of the McKinley Medical Accufuser, the I-Flow PainBuster (Homepump Eclipse C-Series), the B Braun spring pump included in the Sgarlato PCIP, and the Baxter Infusor and Intermate pumps.
- 2.3.2 Flow Control
- The AutoFuser and AutoFuser PCM pumps and 2.3.2.1 the identified predicate device use either a glass orifice or PVC tubing to control the flow rate.
- 2.3.3 Materials
- 2.3.3.1 All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1.
- 2.3.1 Specifications
3
Image /page/3/Picture/1 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" around the perimeter. In the center of the seal is a stylized image of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2004
ALGOS, LC C/O Mr. Robert J. Bard Managing Director Healthcare Technologies Consultants 150 Lake Village Drive, Suite 203 Ann Arbor, Michigan 48103
Re: K041585
Trade/Device Name: AutoFuser Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: June 1, 2004 Received: June 14, 2004
Dear Mr. Bard:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Bard
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 nfour that or any Federal statutes and regulations administered by other Federal agencies. or not ret of any ly with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF CF th 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.
This letter will allow you to begin marketing your device as described in your Section 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), 11 yea contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K041585
AutoFuser infusion pump Device Name:
Indications For Use:
The AutoFuser family of ambulatory infusion pumps with integrated administration set, The AutoFuser family of ambulatory intrason paniped for general infusion use.
either separately or as part of a convenience subentageous inter-arterial an either separately of as part of a convenience in the rubert of the readers, inter-arterial and
Routes of infusion include intravenous, percutaneous, subout announces in the Routes of infusion intra-operative (soft tissue / body cavity) sites.
Within the AutoFuser family are pump models intended for patient-controlled infusion using the integrated bolus button.
General infusion uses include continuous infusion of a local anesthetic near a nerve for
e General music uses infolude contined of the pre-operative, perioperative and postoperative surgery.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFF 801 Subpart C)
(PLFASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cluif
nesthesiology, General Hospitali Infection Cor trol, Dental
Page 1 of 1
510(k) Number: K041595