The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.

Device Description

The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and accessories. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate. The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.

AI/ML Overview

The provided text describes a 510(k) summary for a Disposable Infusion Pump Kit and does not contain information about an AI/ML-based device. Therefore, I cannot extract the specific details related to acceptance criteria and studies that prove an AI device meets these criteria.

However, I can provide a summary of the device's characteristics and the changes that were submitted for 510(k) clearance, as an example of acceptance criteria and device performance for a traditional medical device:

Device Acceptance Criteria and Performance (Based on Modified Device Information)

The acceptance criteria for the modified Disposable Infusion Pump Kit and its reported performance are primarily based on equivalence to the predicate device K051474, with specific changes outlined below.

1. Table of Acceptance Criteria and the Reported Device Performance

Feature/Parameter	Acceptance Criteria (Equivalent to Predicate)	Reported Device Performance (Modified Device)
Pump Performance
Fill Volume	100 ml (Predicate)	150 ml (Modified, previously capable but not tested to this volume)
Flow Rate	2.0 ml/hr	2.0 ml/hr
Flow Profile	Continuous	Continuous
Accuracy	± 15%	± 15%
Pressure Source	Strain energy of elastomeric membrane	Strain energy of elastomeric membrane
Reservoir Material	Synthetic rubber, latex-free elastomeric membrane	Synthetic rubber, latex-free elastomeric membrane
Catheter Needle/Introducer
FDA Status	Exempt (878.4200)	Exempt (878.4200)
Material - Needle	Stainless steel	Stainless steel
Material - Introducer Catheter	Teflon	Teflon or Polyethylene (Modified)
Needle Size	16 GA	Up to 14 GA (Modified)
Needle Length	2.75"	Up to 10" (Modified)
Sterility
Sterility Assurance Level	10^-6	10^-6
Sterilization Method	ANSI/AMMI/ISO 11135-1994 (EtO)	ANSI/AMMI/ISO 11135-1994 (EtO)
EtO Residuals	Ethylene Oxide <25ppm, Ethylene Chlorohydrin <25ppm, Ethylene Glycol <250ppm	Ethylene Oxide <25ppm, Ethylene Chlorohydrin <25ppm, Ethylene Glycol <250ppm

Note: The "acceptance criteria" here are largely defined by the predicate device's established performance and the demonstration that the modified device either maintains that performance for unchanged features or achieves acceptable new performance for modified features within a recognized safety and effectiveness profile.

The study proving the device meets the acceptance criteria is implicitly the 510(k) submission process itself, where Symbios Medical Products, LLC provided data to the FDA to demonstrate substantial equivalence to the predicate device. For the mechanical and material aspects, this would involve engineering testing and verification.

The other points of your request are not applicable as the provided document does not describe an AI/ML-based medical device. There is no information on:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth and their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm-only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How the ground truth for the training set was established.

Summary

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JUL 1 9 2007

510(k) SUMMARY

Submitters Name: Michael James, Director of Quality Symbios Medical Products, LLC 7301 Georgetown Road, Suite 150 Indianapolis, IN 46268 Office: 317-225-4447 Mobile: 812-521-7074 Fax: 317-225-4451

Contact Person: Same as submitter. Facility Registration Number: 3005203102 Date Summary Prepared: May 1, 2007

IDENTIFICATION OF MODIFIED DEVICE

Trade Name: Disposable Infusion Pump Kit Common Name: Disposable Infusion Pump Kit Panel: General Hospital

Classification Name and Reference:

Pump

Pump, Infusion, Elastomeric, External (21 CFR 880.5725) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 80 Device Product Code: MEB

Catheter Needle/Introducer Catheter, Accessories (21 CFR 878.4200) Device Classification for the predicate devices: Class | Exempt Device Panel Code: 79 Device Product Code: KGZ

Infusion Catheter

Catheter, Conduction, Anesthetic (21 CFR 868.5120) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 73 Device Product Code: BSO

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IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Trade Name: Disposable Infusion Pump Kit Common Name: Disposable Infusion Pump Kit 510(k) Number: K051474 Panel: General Hospital

Classification Name and Reference:

Pump

Pump, Infusion, Elastomeric, External (21 CFR 880.5725) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 80 Device Product Code: MEB

Catheter Needle/Introducer

Catheter, Accessories (21 CFR 878.4200) Device Classification for the predicate devices: Class I Exempt Device Panel Code: 79 Device Product Code: KGZ

Infusion Catheter

Catheter, Conduction, Anesthetic (21 CFR 868.5120) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 73 Device Product Code: BSO

DESCRIPTION OF THE DEVICE

Infusion of liquids into a patient in the general hospital setting as well as at home is frequently required in medical treatment. For example, in orthopedics a disposable device is often indicated after outpatient arthroscopic surgery in order to infuse local anesthetics for several days following the patient's return home. The infusion catheter is usually removed when the patient returns to the physician's office for a follow-up visit.

The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.

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INTENDED USE OF THE DEVICE

(Same for both the modified and unmodified predicate device)

The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.

NEW DEVICE IN COMPARISON WITH PREDICATE DEVICE

Minor modifications have been made to the Disposable Infusion Pump Kit cleared in 510(k) Number K051474.

1. The fill volume has been increased from 100 ml to 150 ml. The design (dimensions, materials, assembly methods) of the pump remains unchanged. Note - The design of the predicate device was capable of a 150 ml fill volume, but only tested and verified to 100 ml. Diagrams of the modified and predicate pump assemblies are shown in Attachment 2.
1. The catheter needle/introducer included in the kit has been extended to include needle/introducers that are as long as 10 inches in length, and up to 14 gauge (GA) in diameter. The increased size is needed for patients with larger bodies. The needle material remains stainless steel, while the introducer catheter material could be either Teflon or polyethylene.

	Modified Device	Predicate Device
510(k) Number	New	K051474
Manufacturer	Symbios Medical Products, LLC	Symbios Medical Products, LLC
Type	Elastomeric Pump	Elastomeric Pump
Fluid Reservoir	Sold empty and capable of beingfilled via a fill port	Sold empty and capable of beingfilled via a fill port
Reservoir Material	Synthetic rubber, latex-freeelastomeric membrane	Synthetic rubber, latex-freeelastomeric membrane
Pressure Source	Strain energy of elastomericmembrane	Strain energy of elastomericmembrane
Fill Volume	150 ml	100 ml
Flow Rate	2.0 ml/hr	2.0 ml/hr
Flow Profile	Continuous	Continuous
Accuracy	± 15%	± 15%
Power Requirement	None	None
Tubing	Integrated	Integrated
Tubing Material	PVC	PVC
Flow Control	Consistent flow rate throughout theentire course of therapy is achievedby orifice size (no change)	Consistent flow rate throughout theentire course of therapy is achievedby orifice size
Safety Features	Fixed Flow rate tubing prevents fluidrunaway conditions. Each	Fixed Flow rate tubing prevents fluid
	administration set is supplied with aclamp to stop the infusion ifnecessary. (no change)	runaway conditions. Eachadministration set is supplied with aclamp to stop the infusion ifnecessary. (no change)

Pump

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Catheter Needle/Introducer

	Modified Device	Predicate Device
FDA Status	Exempt (878.4200)	Exempt (878.4200)
Sponsor/Manufacturer	Martech	Martech
Material - Needle	Stainless Steel	Stainless steel
Material - Introducer Catheter	Teflon or Polyethylene	Teflon
Needle Size	Up to 14 GA	16 GA
Needle Length	Up to 10"	2.75"

STERILITY INFORMATION

EtO sterilization with the following parameters:

Sterility Assurance Level: 10-6

Sterility Validation Method: ANSI/AMMI/ISO 11135-1994

The maximum levels of residuals allowable:

Ethylene Oxide (EtO)	<25ppm
Ethylene Chlorohydrin	<25ppm
Ethylene Glycol	<250ppm

Packaging Description: The kit will be packaged in a sealed Tyvek/polymylar pouch, and then placed with the Directions for Use inside another larger sealed Tyvek/polymylar pouch.

Labeling: All packages will display a statement that the device has been sterilized by EtO

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2007

Mr. Michael James Director of Quality Symbios Medical Products, LLC 7301 Georgetown Road, Suite 150 Indianapolis, Indiana 46268

Re: K071735

Trade/Device Name: Disposable Infusion Pump Kit Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump, Introduction/drainage Catheter, Anesthesia Conduction Catheter Regulatory Class: II Product Code: MEB, KGZ, BSO Dated: June 25, 2007 Received: June 27, 2007

Dear Mr. James:

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. James

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 Part 801); good manufacturing practice requirements 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.

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). please contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.

Sincerely yours.

Carls

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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ATTACHMENT 1

Indications for Use

K071735 510(k) Number: _ _ _ _ _ _

Device Name: Disposable Infusion Pump Kit

Indications for Use:

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) のお気になる。

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K421235

Page 1 of

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).