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.

Device Description

The AutoFuser pump (Continuous type Silicone Balloon) 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). The 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).

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.

The AutoFuser and AutoFuser PCM pumps and the identified predicate device use either a glass orifice or PVC tubing to control the flow rate.

All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "AutoFuser Elastomeric Infusion Pump." This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics, ground truth, or statistical analyses common in AI/ML device studies.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be directly extracted or inferred from this document.

However, I can provide the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for an elastomeric infusion pump, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices and meeting general device requirements rather than specific performance metrics like sensitivity, specificity, or accuracy (which are common for diagnostic AI/ML devices). The document states the device is "substantially similar" to predicate devices in several aspects.

Acceptance Criterion (Inferred from Substantial Equivalence Claim)	Reported Device Performance (as stated in the document)
Intended Use Equivalence: General infusion use, routes, and pain management.	The AutoFuser and AutoFuser PCM pumps have the same intended use as predicate devices like the I-Flow Homepump (Eclipse) C-Series, Baxter Infuser and Intermate, McKinley Accufuser, and B Braun spring pump.
Design/Functionality Equivalence: Continuous fluid delivery, fixed flow rates, silicone balloon reservoir, optional patient-controlled bolus (PCM).	The AutoFuser pump provides continuous fluid delivery with attached, fixed rate administration set. A silicone balloon is used as both the fluid reservoir... and the pressure (energy) source. The AutoFuser PCM allows patient to administer a bolus of fixed volume with a fixed lockout (re-fill) time.
Specifications Equivalence: Fill volumes and flow rates.	The AutoFuser and AutoFuser PCM pumps have fill volumes and flow rates substantially similar to pumps of the McKinley Accufuser, I-Flow PainBuster (Homepump Eclipse C-Series), B Braun spring pump, and Baxter Infusor and Intermate.
Flow Control Mechanism Equivalence: Use of glass orifice or PVC tubing.	The AutoFuser and AutoFuser PCM pumps use either a glass orifice or PVC tubing to control the flow rate, similar to identified predicate devices.
Biocompatibility: Fluid path materials conformance to ISO 10993 Part 1.	All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1.
Disposability: Single patient use.	The pump is a disposable device intended for single patient use.
Ambulatory Suitability: Use in various environments.	The pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. This document does not describe a clinical study with a test set in the way an AI/ML device submission would. The submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through comparison of design, functionality, materials, and intended use. Performance testing related to flow accuracy and other physical parameters would have been conducted by the manufacturer, but the details (sample size, data provenance) are not part of this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided. This type of information is relevant for studies validating diagnostic algorithms against expert consensus or pathology. For an infusion pump, "ground truth" would relate to precise fluid delivery, which is typically measured mechanically or chemically, not by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. Adjudication methods are used in studies involving subjective expert review, typically in diagnostic or qualitative assessments. This is not relevant for the type of device and submission described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Not Provided. MRMC studies are specific to evaluating diagnostic systems, particularly those that involve human interpretation assisted by AI. The AutoFuser is an infusion pump, a therapeutic device, and does not involve "human readers" or AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided. This question is also focused on AI/ML algorithms. The AutoFuser is a mechanical/elastomeric device, not an algorithm. Its performance is inherent to its design and manufacturing, not an algorithm's output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable / Not Provided (for the document content). For an infusion pump, "ground truth" for performance would be established through engineering and bench testing. This would involve precise measurements of flow rate, fill volume, pressure, and material compatibility against established standards and specifications. The document states "All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1," indicating adherence to material safety standards. However, the details of flow rate accuracy testing are not described in this summary.

8. The sample size for the training set

Not Applicable / Not Provided. This refers to AI/ML model training data. This device is not an AI/ML product.

9. How the ground truth for the training set was established

Not Applicable / Not Provided. This refers to AI/ML model training data. This device is not an AI/ML product.

Summary

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AUG 2 6 2004

K041585

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

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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:

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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.

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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.

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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

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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

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).