Prepare™ Cartridge is used as a drug reservoir and fluid path for administering intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid drugs to a patient's access site using specified infusion pumps and extension sets.

For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration

Prepare™ Cartridge must be used only with SIMS Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps for the infusion of various medicinal solutions. Prepare™ Cartridge is indicated for use in acute and alternate care settings. Alternate care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare.

Device Description

Prepare™ Cartridge is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides a reservoir for holding up to 100ml of prepared drug and interfaces with various models of SIMS Deltec infusion pumps to provide a pathway from the reservoir to the patient's access site.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Prepare™ Cartridge:

This 510(k) summary describes a device that is an accessory to an infusion pump, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI performance, ground truth, and expert review are not applicable. The device is a physical cartridge that holds medication, and its evaluation focuses on physical characteristics, biocompatibility, and sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Physical/Technical
Comparable to Predicate	"Physical and technical characteristics, including materials used in construction, size, intended use, and ability to interface with specified CADD® pumps are comparable."	This is a qualitative statement of comparability to the predicate device, CADD® 1 Medication Cassette Reservoir. No specific quantitative acceptance criteria or performance metrics are provided for general physical/technical aspects beyond the more specific items below.
Cartridge Capacity	"Prepare™ Cartridge capacity... are substantially equivalent to the CADD® Administration Set."	Specific capacity value not given, but stated to be substantially equivalent to the predicate.
Accuracy of Delivery	"Accuracy of delivery... are substantially equivalent to the CADD® Administration Set."	Specific accuracy metric not given, but stated to be substantially equivalent to the predicate.
Volume Delivered per Pump Cycle	"Volume delivered per pump cycle... are substantially equivalent to the CADD® Administration Set."	Specific volume metric not given, but stated to be substantially equivalent to the predicate.
Fit to Pump	"Fit to pump are substantially equivalent to the CADD® Administration Set."	Qualitative and comparative.
Biocompatibility
Non-irritating	"Certified as non-irritating"	Meets ISO-10993-1 recommendations.
Non-cytotoxic	"Certified as non-cytotoxic"	Meets ISO-10993-1 recommendations.
Non-toxic	"Certified as non-toxic"	Meets ISO-10993-1 recommendations.
Non-hemolytic	"Certified as non-hemolytic"	Meets ISO-10993-1 recommendations.
Non-sensitizing	"Certified as non-sensitizing"	Meets ISO-10993-1 recommendations.
Sterility
Sterilized by Ethylene Oxide Gas	"Sterilized by ethylene oxide gas in a validated sterilization process."	Indicates method and validation. No specific sterility assurance level (SAL) is explicitly stated, but "validated process" implies meeting regulatory requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided text for the bench tests. The description only states "The device and the predicate were subjected to various bench tests."
Data Provenance: Not explicitly stated beyond being "bench tests." It can be inferred that these were laboratory tests conducted by the manufacturer, APPRO Healthcare, Inc. There is no mention of country of origin of data in a clinical sense, nor is it a retrospective or prospective clinical study. These are engineering and laboratory tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is hardware for drug delivery, not an interpretative medical device (like imaging or diagnostics). Therefore, "ground truth" established by human experts in the context of diagnostic accuracy is not relevant here. The "truth" for physical/technical performance, biocompatibility, and sterility is determined by validated test methods and established scientific principles, not expert consensus interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for bench testing of a physical medical device accessory.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a physical device accessory, not an AI/ML diagnostic or interpretive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not applicable.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Not applicable. This is a physical non-AI device. There is no "algorithm only" performance to evaluate. The performance described is of the physical cartridge itself in conjunction with the specified infusion pumps.

7. The Type of Ground Truth Used

Engineering/Laboratory Test Standards and Specifications: The "ground truth" for the performance criteria (capacity, accuracy of delivery, volume, fit) would be derived from the design specifications of the device and established test methods, likely involving measurements against a standard for the predicate device. For biocompatibility, the ground truth is the absence of adverse biological responses as defined by ISO-10993 standards and validated assays. For sterility, it's the successful completion of a validated sterilization process to achieve a specific Sterility Assurance Level (SAL), typically 10^-6.

8. The Sample Size for the Training Set

Not applicable. This is a physical non-AI device. There is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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K023890

、

510(k) SUMMARY

Date:	November 19, 2002FEB 07 2003
Manufacturing Facility:	APPRO Healthcare, Inc.847 Main StreetBuffalo, NY 14203
Telephone:	(716) 855-1068
Contact Person:	John R. SemlerVice President, RD&EExtension 309Email: jrsemler@approhealthcare.com
Device Trade Name:	Prepare™ Cartridge
Device Common Name:	Accessory to an Infusion Pump
Classification Name:	Accessories, Pump, Infusion
Regulatory Reference:	MRZ
Predicate Device	CADD® 1 Medication Cassette Reservoir

Registered trademark of SIMS Deltec, Inc.

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Description:

Intended Use / Indications for Use:

Physical/Technical Comparison

Prepare™ Cartridge can be used in place of Medication Cassette Reservoir. Physical and technical characteristics, including materials used in construction, size, intended use, and ability to interface with specified CADD® pumps are comparable.

Performance Summary:

The device and the predicate were subjected to various bench tests to demonstrate comparable performance characteristics. Prepare™ Cartridge capacity, accuracy of delivery, volume delivered per pump cycle, and fit to pump are substantially equivalent to the CADD® Administration Set.

Biocompatibility Testing:

Prepare™ Cartridge was subjected to biocompatibility testing as recommended by ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The device is certified as non-irritating, non-cytotoxic, non-toxic, non-hemolytic, and nonsensitizing.

Sterilitv:

Prepare™ Cartridge is sterilized by ethylene oxide gas in a validated sterilization process.

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Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 7 2003

Mr. John R. Semler Vice President, RD & E APPRO Healthcare Incorporated 847 Main Street Buffalo, New York 14203

Re: K023890

Trade/Device Name: Prepare™ Cartridge Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: November 19, 2002 Received: November 21, 2002

Dear Mr. Semler:

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. Semler

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 (OS) 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 vour 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 (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,

Susan Russer

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number, if known:	Not yet assigned M023890
Device Name:	Prepare TM Cartridge

For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	/
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Over-the-Counter Use

(Per 21CFR 801,109)

Patina Cucente

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

510(k) Number: _

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).