The Zimmer Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow, continuous or subcutaneous administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, or subcutaneous site for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. The system is convenient for use by ambulatory patients. It is the responsibility of the healthcare provider 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 Accessory Kits are convenience kits that are comprised of legally marketed devices. The devices are purchased non-sterile and subsequently packaged into double-pouched kits by Zimmer . Once packaged, the kit will be sent to a contract sterilizer for irradiation sterilization. The proposed accessory kit does not change the intended use of the legally marketed devices which comprise the kit.

The Zimmer Ambulatory Pump Pain Management System Kits are comprised of approved Zimmer systems with the addition of the convenience kits. comprised of legally marketed devices. The devices are purchased non-sterile and subsequently packaged into tyvek-sealed trays sealed by Zimmer . Once packaged, the System will be sent to a contract sterilizer for irradiation sterilization. The proposed addition of the convenience kit(s) does not change the intended use of the legally marketed devices which comprise the kit.

AI/ML Overview

Here's an analysis of the provided text regarding the Zimmer Ambulatory Pump Pain Management System, focusing on acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on the concept of substantial equivalence to predicate devices. The primary "performance" reported is that the devices in the kit have been tested to determine the impact of sterilization, and that previously cleared devices meet applicable sections of ANSI/AAMI/ISO 10993-1:1997, "Biological evaluation of Medical Devices."

Since specific quantitative acceptance criteria are not provided, this table will reflect the general nature of the claims made.

Acceptance Criterion (Implicit)	Reported Device Performance
Impact of sterilization on device components	Devices in the kit have been tested to determine the impact of sterilization as per "Sterilized convenience kits for clinical and surgical use; final guidance for industry," January 7, 2002. (Specific results or acceptance thresholds for impact are not detailed, but the submission implies acceptable results based on the clearance.)
Biocompatibility	Previously cleared devices (which comprise part of these kits) have been tested and do meet applicable sections of ANSI/AAMI/ISO 10993-1:1997, "Biological evaluation of Medical Devices." (Again, specific detailed results or acceptance criteria of this testing are not provided, but the statement implies compliance and acceptability.)
Consistency with predicate device's intended use and safety	The proposed accessory kit/system does not change the intended use of the legally marketed devices which comprise the kit. The Zimmer Ambulatory Pump Pain Management System Kits do not raise any new safety and effectiveness concerns when compared to the similar legally marketed devices. (This is a statement of claim rather than a quantifiable performance metric.)
Substantial Equivalence to Predicate Devices	The Zimmer Ambulatory Pump Pain Management Kit (with and without PCM) and flow splitter wye and fenestrated catheter kits are substantially equivalent to legally marketed pain management kits (specifically Zimmer Ambulatory Pump Pain Management Systems, McKinley Accufuser; Accufuser Plus, Standard Procedure Kits) in that the kits are similar in design, materials, and indications for use.

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

The document does not specify a "test set" in the context of clinical or performance data for AI/software. The evaluation is focused on substantial equivalence for a medical device (infusion pump and accessory kits) rather than a software algorithm.
- Sample Size: Not applicable in the traditional sense of a clinical trial or algorithm test set. The devices themselves were tested for sterilization impact and biocompatibility, but the document doesn't provide specific sample sizes for these engineering tests.
- Data Provenance: Not specified, but likely refers to internal testing by the manufacturer (Zimmer Orthopaedic Surgical Products, based in Dover, Ohio, USA).
- Retrospective or Prospective: Not applicable as there is no clinical data or mention of a study involving patients over time.
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. This device is a hardware medical device (infusion pump and accessories), not an AI or imaging diagnostic tool that would require expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set requiring expert adjudication.
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. This is not an AI/imaging device. No MRMC study was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware medical device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" here would relate to the physical and biological integrity of the device components after sterilization and their biocompatibility, which are assessed through engineering and laboratory testing, not clinical ground truth types like pathology or expert consensus.
The sample size for the training set

Not applicable. This is a hardware medical device, not an AI/machine learning model that requires a training set.
How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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s-3226

JAN 3 1 2006

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:	November 15, 2005
Trade Name:	ZIMMER AMBULATORY PUMP PainManagement System, MULTIRATE INFUSOR2,4,6 ml/hr and 2.5 inch fenestrated catheter
	ZIMMER AMBULATORY PUMP PainManagement System, MULTIRATE INFUSOR2,4,6 ml/hr with PCM and 2.5 inch fenestratedcatheter
	ZIMMER AMBULATORY PUMP PainManagement System, MULTIRATE INFUSOR3,5,8 ml/hr and 2.5 inch fenestrated catheter
	ZIMMER AMBULATORY PUMP PainManagement System, MULTIRATE INFUSOR3,5,8 ml/hr with PCM and 2.5 inch fenestratedcatheter
	ZIMMER AMBULATORY PUMP PainManagement System, MULTIRATE INFUSOR2,4,6 ml/hr and 5.0 inch fenestrated catheter
	ZIMMER AMBULATORY PUMP PainManagement System, MULTIRATE INFUSOR2,4,6 ml/hr with PCM and 5.0 inch fenestratedcatheter

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ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 3,5,8 ml/hr and 5.0 inch fenestrated catheter

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 3,5,8 ml/hr with PCM and 5.0 inch fenestrated catheter

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 2,4,6 ml/h with Flow Splitter Kit

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 3,5,8 ml/h with Flow Splitter Kit

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 2,4,6 ml/h with PCM and Flow Splitter Kit

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 3,5,8 ml/h with PCM and Flow Splitter Kit

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 2,4,6 ml/h with Flow Splitter Kit and 2,5 inch fenestrated catheters

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 3,5,8 ml/h with Flow Splitter Kit and 2.5 inch fenestrated catheters

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 2,4,6 ml/h with PCM and Flow Splitter Kit and 2.5 inch fenestrated catheters

ZIMMFR AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 3,5,8 ml/h with PCM and Flow Splitter Kit and 2.5 inch fenestrated catheters

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KCS3226

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 2,4,6 ml/h with Flow Splitter Kit and 5.0 inch fenestrated catheters

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 3,5,8 ml/h with Flow Splitter Kit and 5.0 inch fenestrated catheters

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 2,4,6 ml/h with PCM and Flow Splitter Kit and 5.0 inch fenestrated catheters

ZIMMER AMBULATORY PUMP Pain Management System, MULTIRATE INFUSOR 3,5,8 ml/h with PCM and Flow Splitter Kit and 5.0 inch fenestrated catheters

ZIMMER AMBULATORY PUMP Flow Splitter Kit

ZIMMER AMBULATORY PUMP 2.5 inch Fenestrated Catheter Kit

ZIMMER AMBULATORY PUMP 5.0 inch Fenestrated Catheter Kit

Common Name:

Classification Name and Reference:

Predicate Devices:

Pump, Infusion, Elastomeric

Pump, Infusion, Elastomeric 21 CFR § 880.5725

Zimmer Ambulatory Pump Kit Pain Management System manufactured by Zimmer Orthopaedic Surgical Products, K050433, cleared April 13, 2005.

Zimmer Ambulatory Pump Kit Pain Management System with PCM, manufactured by Zimmer Orthopaedic Surgical Products, K052171, cleared September 27, 2005.

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KOS-3996

Accufuser; Accufuser Plus; Standard Procedure Kit, manufactured by McKinley, Inc., K033039, cleared October 7, 2003.

Accufuser; Accufuser Plus; Standard Procedure Kit, manufactured by McKinley, Inc., K023098, cleared December 9, 2002.

Accessory kits:

Pump kits with included accessories:

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

Indications for Use:

Device Description:

The Zimmer Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow,

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Kis3226

	continuous or subcutaneous administration of painmedications. It may also include the slow,continuous infusion of pain medications directlyinto an intraoperative, or subcutaneous site forpostoperative pain management or the continuousinfusion of a local anesthetic near a nerve forregional anesthesia. The PCM allows forintermittent bolus doses of medication on patientdemand. The system is convenient for use byambulatory patients. It is the responsibility of thehealthcare provider to assure that the medication isprepared and administered in accordance with thedrug manufacturer's package insert.
Comparison to Predicate Device:	The Zimmer Ambulatory Pump Pain ManagementKit (with and without PCM) and flow splitter wyeand fenestrated catheter kits are substantiallyequivalent to the legally marketed pain managementkits, specifically the Zimmer Ambulatory PumpPain Management Systems, McKinley Accufuser;Accufuser Plus, Standard Procedure Kits in that thekits are similar in design, materials, and indicationsfor 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 clinicaland surgical use; final guidance for industry,"January 7, 2002 was utilized as guidance for thissubmission.The previously cleared devices have been tested anddo meet the applicable sections of the ANSI/AAMI/ISO 10993-1:1997, "Biological evaluation ofMedical Devices."
Clinical Performance and Conclusions:	Clinical data and conclusions were not needed forthese kits.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol associated with medicine and healthcare, but in this case, it is a more abstract representation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2006

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

Re: K053226

Trade/Device Name: Zimmer Ambulatory Pump Pain Management System with Fenestrated Catheter and/or Flow Splitter and the Zimmer Ambulatory Pump Pain Management System with PCM and Fenestrated Catheter and or Flow Splitter. Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 15, 2005 Received: November 17, 2005

Dear Ms. Dickey:

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 gencral 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.

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

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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 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 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) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilitics 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,

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):

K05-3226

Device Name:

Zimmer Ambulatory Pump Pain Management System with fenestrated catheter and/or flow splitter and the Zimmer Ambulatory Pump-Pain Management System with PCM and fenestrated catheter and/or flow splitter. Optional fenestrated catheter kits in various fenestrated lengths and multi-site flow splitter kit are also offered separately.

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)

Anton Viner

Henry General Hospital
Control, Dental Devices

853226

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).