ARTISAN PULSE LAVAGE SYSTEM by HOWMEDICA CORP.

The Artisan Pulse Lavage System is intended to be used in the preparation of the intramedullary canal and/or bone surfaces in orthopedic procedures, including primary and/or revision total joint arthroplasty. This device may also be used to provide lavage for wound/burn irrigation/debridement in trauma situations, or any other situation where irrigation may be indicated. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative/wound site. When connected to a suction source the device can be used to aspirate material/fluids from the operative/wound site.

Device Description

The Artisan Pulse Lavage System is a hand held pneumatic powered lavage system which utilizes a resterilizable handpiece, and sterile disposable pump cartridge with a choice of tubing configurations for intramedullary or soft tissue debridement. The system can also provide suction via the use of a pump cartridge with suction adapter. The system is connected to the power source by a resterilizable air hose.

AI/ML Overview

This 510(k) summary (K972551) describes a pulse lavage system, a device intended for orthopedic procedures and wound/burn irrigation. The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device already on the market, rather than prove effectiveness through clinical trials with specific acceptance criteria and performance metrics in the same way a PMA submission would.

Therefore, the provided document does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies.

Here's why and what can be inferred:

Substantial Equivalence: The core of a 510(k) is to show that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness. This is generally achieved through bench testing, comparisons to standards, and demonstrating performance analogous to the predicate, rather than extensive clinical efficacy studies.
Lack of Performance Data: The summary states: "The Artisan Pulse Lavage System is substantially equivalent to several other legally marketed devices." It then lists these predicate devices. This implies that the "study" proving it meets acceptance criteria is primarily an engineering and design comparison.

Based on the provided text, I can only report what is not present in terms of your specific requests:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided. This type of detailed performance data and predefined acceptance criteria (e.g., specific flow rates, pressure ranges, cleaning efficiency percentages) are not typically included in a 510(k) summary for a device like this. The substantial equivalence argument relies on the predicate's established safety and effectiveness.

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

Not explicitly stated. No information is given about a specific "test set" in the context of clinical or performance data for the Artisan Pulse Lavage System itself. Data provenance (country of origin, retrospective/prospective) is also not mentioned, as detailed clinical studies are not the primary basis of a 510(k).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable/Not provided. Establishing "ground truth" with expert consensus is typically relevant for diagnostic devices or AI algorithms that interpret complex data (e.g., medical images). This is a physical device; its function is mechanical. Therefore, there's no "ground truth" to be established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Without a test set requiring interpretation or evaluation by human readers, an adjudication method is irrelevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. MRMC studies are used for diagnostic interpretation tasks, often for imaging devices or AI systems, to compare human performance with and without AI assistance. This device is not an interpretive diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

Not applicable/Not provided. This is not an AI algorithm. If "standalone performance" refers to the device's mechanical operation, it would likely be covered by engineering bench testing designed to show it performs similarly to the predicate, but specific details of such tests are not in the summary.

7. Type of Ground Truth Used

Not applicable. As described in point 3, there's no "ground truth" in the sense of expert annotation, pathology, or outcomes data for this type of mechanical device. Its "truth" is its ability to perform its intended function physically (e.g., pressure output, fluid delivery) which is verified through engineering tests or comparison to the predicate.

8. Sample Size for the Training Set

Not applicable/Not provided. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable. As there is no training set (point 8), ground truth establishment for it is not relevant.

Summary of what the K972551 does indicate regarding "proof":

The "study that proves the device meets the acceptance criteria" in the context of K972551 is the demonstration of substantial equivalence to predicate devices. This means that the FDA determined, based on the submitted information (which would include engineering specifications, performance data compared to predicate devices, and sometimes bench testing), that the Artisan Pulse Lavage System is as safe and effective as the previously cleared predicate devices. The acceptance criteria essentially align with the performance and safety profiles already established and accepted for the predicate devices listed:

Exeter Lavage System - Howmedica (K790811)
Surgi-Lav 66 System - Stryker Corporation (Preamendment)
Pulsed Irrigation/Suction System - Stryker Corporation (K873466 and K951666)
Davol Simpulse Lavage System - Bard (K870915)
Davol Simpulse SOLO Pulsed Lavage System - Bard

Without access to the full 510(k) submission document, specific engineering test results or performance comparisons are unavailable in this high-level summary.

Summary

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K972551

510(k) Summary

OCT 2 9 1997

Device:

The Artisan Pulse Lavage System is substantially equivalent to several other legally marketed devices. Examples of these are:

1. Exeter Lavage System - Howmedica (K790811)
Surgi-Lav 66 System Stryker Corporation (Preamendment) 2.
1. Pulsed Irrigation/Suction System - Stryker Corporation (K873466 and K951666)
Davol Simpulse Lavage System Bard (K870915) 4.
ട. Davol Simpulse SOLO Pulsed Lavage System - Bard

For information contact:

Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7431 Fax No.: (201) 507-6870

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret F. Crowe Manager, Regulatory Affairs Howmedica Incorporated 359 Veterans Boulevard Rutherford, New Jersey 07070

OCT 29 1997

K972551 Re : Artisan Pulse Lavage System Trade Name: Regulatory Class: II Product Code: FQH Dated: October 6, 1997 Received: October 7, 1997

Dear Ms. Crowe:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Crowe

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to beqin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Us Alatrust

Timot Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

, Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Artisan Pulse Lavage System

Indications for Use:

The Artisan Pulse Lavage System is intended to be used in the preparation of the intramedullary canal and/or bone surfaces in orthopedic procedures, including primary and/or revision total joint arthroplasty. This device may also be used to provide lavage for wound/burn irrigation/debridement in trauma situations, or any other situation where irrigation may be indicated. The pulsatile action of the pump helps to remeve blood, --tissue debris and foreign matter from the operative/wound site. When connected to a suction source the device can be used to aspirate material/fluids from the operative/wound site.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)	Patricia Accosta
Division of Dental, Infection Control, and General Hospital Devices	1972551

Prescription Use (Per 21 CFR 801.109)	OR Over-The-Counter Use
	(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.