The Zimmer Ambulatory Pump Kit, Pain Management System is indicated for patients requiring continuous infusion of medications directly into an intraoperative, subcutaneous or epidural site for postoperative pain management. The system is convenient for use by ambulatory patients. It is the responsibility of the user to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

Device Description

The Zimmer Ambulatory Pump Pain Management System is a convenience kit that is comprised of legally marketed devices. The devices are purchased non-sterile and subsequently packaged in tray kits by Zimmer. Once packaged, the kit will be sent to a contract sterilizer for irradiation sterilization. The proposed convenience kit does not change the intended use of the legally marketed devices which comprise the kit.

The Zimmer Ambulatory Pump Pain Management System (kit) does not raise any new safety and effectiveness concerns when compared to the similar legally marketed devices. The Zimmer Ambulatory Pump Pain Management System should therefore be considered substantially equivalent to the existing predicate devices.

AI/ML Overview

This document describes the Zimmer Ambulatory Pump Pain Management System, a convenience kit comprising legally marketed devices for continuous infusion of medications for postoperative pain management.

Here's an analysis of the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics with numerical thresholds. Instead, it relies on the concept of substantial equivalence to predicate devices. The performance data presented focuses on the impact of sterilization and biological evaluation for the components of the kit.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Kit components maintain intended use after sterilization. (Implied: Sterilization process does not degrade the functionality or safety of individual components.)	"The devices in this kit have been tested to determine the impact of sterilization as per the guidance document, 'Sterilized convenience kits for clinical and surgical use; final guidance for industry,' January 7, 2002 was utilized as guidance for this submission."
Kit components meet biological evaluation standards. (Implied: Components are biocompatible and safe for patient contact.)	"The previously cleared devices have been tested and does meet the applicable sections of the ANSI/AAMI/ ISO 10993-1:1997, 'Biological evaluation of Medical Devices.'"
Overall safety and effectiveness equivalent to predicate devices. (Implied: The convenience kit, formed by packaging existing devices, does not introduce new safety or effectiveness concerns compared to existing, cleared products.)	"The Zimmer Ambulatory Pump Pain Management System (kit) does not raise any new safety and effectiveness concerns when compared to the similar legally marketed devices. The Zimmer Ambulatory Pump Pain Management System should therefore be considered substantially equivalent to the existing predicate devices."

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

The document does not detail specific "test sets" in the context of a typical clinical study with patient samples. The performance data is primarily focused on non-clinical testing related to sterilization effects and biocompatibility of the components. Therefore, information on sample size and data provenance in a clinical sense is not applicable to this submission's provided performance data.

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)

This information is not applicable to this submission. The "ground truth" here is established through regulatory guidance and validated standards (e.g., sterilization protocols, ISO 10993-1). There is no mention of human experts interpreting data or establishing clinical ground truth for novel findings.

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

This information is not applicable to this submission. Adjudication methods are typically used in clinical studies where multiple human readers or evaluators assess data, which is not the case here.

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

This information is not applicable. The Zimmer Ambulatory Pump Pain Management System is a medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI-assisted performance improvements are not relevant.

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

This information is not applicable. The device is a physical medical kit and does not involve an algorithm or AI.

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

The "ground truth" for this submission is based on:
* Regulatory Guidance Documents: Specifically, "Sterilized convenience kits for clinical and surgical use; final guidance for industry," January 7, 2002.
* International Standards: ANSI/AAMI/ ISO 10993-1:1997, "Biological evaluation of Medical Devices."
* Predicate Device Performance and Clearance: The fact that the individual components are "legally marketed devices" and the predicate devices (Accufuser, Accufuser Plus, Standard Procedure Kit, PainPump® Local Anesthesia Kit) have already demonstrated safety and effectiveness.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device submission.

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

This information is not applicable for the same reasons as point 8.

Summary

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APR 1 3 2005

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Summary of Safety and Effectiveness

Submitter:	Zimmer Orthopaedic Surgical Products200 West Ohio AvenueP.O. Box 10Dover, Ohio 44622
Contact Person:	Cindy J. DickeyRegulatory Compliance ManagerTelephone: (330) 364-9493Fax: (330) 364-9490
Date:	February 21, 2005
Trade Name:	ZIMMER AMBULATORY PUMP PAINMANAGEMENT SYSTEM
Common Name:	Pump, Infusion, Elastomeric
Classification Nameand Reference:	Pump, Infusion, Elastomeric21 CFR § 880.5725
Predicate Devices:	Accufuser, Accufuser Plus, & Standard ProcedureKit manufactured by McKinley, Inc., K033039,cleared October 7, 2003.
	PainPump® Local Anesthesia Kit, manufactured byStryker Corporation, K031249, cleared July 21,2003.
Device Description:	The Zimmer Ambulatory Pump Pain ManagementSystem is a convenience kit that is comprised oflegally marketed devices. The devices arepurchased non-sterile and subsequently packaged intray kits by Zimmer. Once packaged, the kit will besent to a contract sterilizer for irradiationsterilization. The proposed convenience kit does notchange the intended use of the legally marketeddevices which comprise the kit.
	The Zimmer Ambulatory Pump PainManagement System (kit) does not raise anynew safety and effectiveness concerns whencompared to the similar legally marketeddevices. The Zimmer Ambulatory PumpPain Management System should thereforebe considered substantially equivalent tothe existing predicate devices.
Indications for Use:	The Zimmer Pain Management System is indicatedfor patients requiring continuous infusion ofmedications directly into an intraoperative,subcutaneous or epidural site for postoperative painmanagement. The system is convenient for use byambulatory patients. It is the responsibility of theuser to assure that the medication is prepared andadministered in accordance with the drugmanufacturer's package insert.
Comparison to Predicate Device:	The Zimmer Ambulatory Pump Pain ManagementKit is substantially equivalent to the legallymarketed pain management kits, specifically theMcKinley Accufuser, Accufuser Plus, & StandardProcedure Kit and the Stryker PainPump® LocalAnesthesia Kit in that the kits are similar in design,materials, and indications for use.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:The devices in this kit have been tested to determinethe impact of sterilization as per the guidancedocument, "Sterilized convenience kits for clinical'and surgical use; final guidance for industry,"January 7, 2002 was utilized as guidancefor this submission.The previously cleared devices have been tested anddoes meet the applicable sections of theANSI/AAMI/ ISO 10993-1:1997, "Biologicalevaluation of Medical Devices.
Clinical Performance and Conclusions:	Clinical data and conclusions were not needed forthis kit.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.

APR 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cindy J. Dickey Regulatory Compliance Manager Zimmer Orthopaedic Surgical Products 200 West Ohio Avenue P.O. Box 10 Dover, Ohio 44622-0010

Re: K050433

K030455
Trade/Device Name: Zimmer Ambulatory Pump Kit, Pain Management System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 21, 2005 Received: February 22, 2005

Dear Ms. Dickey:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your because of the device is substantially equivalent (for the relevelect above and have attermclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, of to devroos that nave of Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval upprivation (The Act. The general controls provisions of the Act include controls provisions of the restration, 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 II your device is classified (oo as additional controls. Existing major regulations affecting (I MA), It may be subject to tach adam adam frederal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Beas nouncements concerning your device in the Federal Register.

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Page 2 - Ms. Dickey

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 mean that I DA mas made a actes and regulations administered by other Federal agencies. of the Act of ally I oderal blacks and survey including, but not limited to: registration r ou intest comply with and 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality sjoceans (Sections (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) I mis letter will and in you to began finding of substantial equivalence of your device to a premarket nonnomical - The evice 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), If you desire specific at not tee for younce at (240) 276-0115. 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 may overn of Small Manufacturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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): KOSO4 33

Device Name:

Zimmer Ambulatory Pump Kit, Pain Management System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ar Dr

Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices

(!)(k) Number. 1595433

000031

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).