MODIFICATION TO STRYKER PAINPUMP by STRYKER INSTRUMENTS

The Stryker PainPump delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate. Medications are infused through intramuscular or subcutaneous routes,

The Stryker PainPump is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.

Device Description

The Stryker PainPump kit models are available in fill volumes from 120 to 270 cc and flow rates from 0.60 - 8.32 cc/hr. Each pump kit consists of a pump, introducer needle(s), infusion set(s), syringe(s), dressing(s), attachment strap, and accessories.

AI/ML Overview

This document is a 510(k) premarket notification for the Stryker PainPump, which is a medical device for infusing medication. The document asserts the device's substantial equivalence to previously marketed devices rather than presenting a study to prove its performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted directly from the provided text because it describes a regulatory submission, not a performance study.

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance Study Information

Information Point	Response from Document
1. Table of acceptance criteria and reported device performance	Cannot be extracted. The document is a 510(k) submission, asserting substantial equivalence to predicate devices, not reporting on a study against specific performance acceptance criteria for the Stryker PainPump itself. It states: "The Stryker PainPump does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. The Stryker PainPump is substantially equivalent to these existing devices."
2. Sample size for test set and data provenance	Not applicable / Cannot be extracted. No specific test set or study data is presented for the Stryker PainPump. The claim is based on substantial equivalence.
3. Number and qualifications of experts for ground truth	Not applicable / Cannot be extracted. No ground truth establishment process for a performance study is described.
4. Adjudication method for the test set	Not applicable / Cannot be extracted. No test set or adjudication process is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study	No. No MRMC study is mentioned. The submission relies on substantial equivalence.
6. Standalone (algorithm only) performance study	No. This device is an infusion pump, which does not involve an algorithm in the sense of AI/image analysis. No standalone performance study is described; the submission relies on substantial equivalence to predicate devices.
7. Type of ground truth used	Not applicable. No ground truth for a performance study is described. The equivalency is based on intended use, safety, and effectiveness compared to existing, legally marketed devices.
8. Sample size for the training set	Not applicable. There is no mention of a training set as this is not an AI/machine learning device, nor is a new performance study's training phase described. The submission focuses on demonstrating equivalence to predicate devices already on the market.
9. How ground truth for the training set was established	Not applicable. As above, no training set or ground truth establishment process for a training set is described in the context of this 510(k) submission. The regulatory approval is based on a comparison to "legally marketed predicate devices." Its "safety and effectiveness" are derived from its similarity to already approved devices.

Summary of the Document's Approach:

The provided text is a 510(k) Premarket Notification, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve conducting new large-scale clinical trials or detailed performance studies against specific acceptance criteria in the way a PMA (Premarket Approval) might.

Instead, the submission for the Stryker PainPump relies on:

Comparison of Intended Use: The Stryker PainPump's intended use (delivering medication for pain management and/or antibiotic administration) is equivalent to existing infusion pump systems.
Comparison of Technological Characteristics/Design: The document indirectly implies structural and functional similarity by stating it "does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed."
Comparison to Predicate Devices: The document explicitly names competitors' devices (Stryker, I-Flow Corporation, Sgarlato for pumps; Styker, I-Flow, and Sims Portex for catheters) as benchmarks for equivalence in intended use, safety, and effectiveness.

Therefore, the "study" proving the device meets criteria is effectively the 510(k) submission itself, where "meeting criteria" means demonstrating substantial equivalence to already approved predicate devices. The acceptance criteria in this context are those required by the FDA for 510(k) clearance, primarily proving that the device is as safe and effective as a legally marketed predicate device.

Summary

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JUL 2 1 2003

K03 1249

INSTRUMENTS

4100 East Million Avenue Kalamazço, MI 40001 Phone (209) 323-7 /00 (300) 253-3210

Device Name:

Trade Name:	Stryker PainPump
Common Name:	Infusion Pump
Classification Name:	Pump, Infusion: 21 CFR 880.5725, Class I

Device Sponsor:

Manufacturer:	Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001Registration No.: 1811755
Regulatory Class:	Class II

Summary of Safety and Effectiveness:

The Stryker PainPump infusion pump is equivalent in intended use, safety, and effectiveness to existing infusion pump systems being marketed by Stryker, I-Flow Corporation, and Sgarlato,

The Stryker PainPump catheters are equivalent in intended use, safety, and effectiveness to existing catheters being marketed by companies such as Styker, I-Flow and Sims Portex.

The Stryker PainPump does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. The Stryker PainPump is substantially equivalent to these existing devices.

By: Nicole Petty
Regulatory Analyst

Dated: 7-15-03

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle are three stylized human profiles facing to the right, with wavy lines below them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Ms. Nicole Petty Regulatory Affairs Analyst Stryker Instruments 4100 East Miiham Avenue Kalamazoo, Michigan 49001

Re: K031249

Trade/Device Name: Stryker Painpump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: FRN Product Code: II Dated: April 17, 2003 Received: April 18, 2003

Dear Ms. Petty

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 dc 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 - Ms. Nicole Petty

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 (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 vours.

Sincerely yours,

Susan Runner, DDDS, MA Interim 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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Page_1__ of 1

KO31249

510(k) Number:

Device Name:

Stryker PainPump

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The- Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Van Nostrum

y, General Hospital. Intection Control, Dental Devic

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).