(113 days)
Not Found
No
The description focuses on a pneumatic powered lavage system with mechanical components and does not mention any AI/ML terms or functionalities.
No.
The device is used for preparing the intramedullary canal and bone surfaces, and for wound/burn irrigation/debridement, which are procedures rather than direct therapeutic treatments. Its primary function is to clean and prepare sites, not to directly treat a disease or condition.
No
The device is described as a "pulsed lavage system" intended for preparing bone surfaces, wound/burn irrigation, and aspiration of fluids. Its function is to remove debris and tissue, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "hand held pneumatic powered lavage system which utilizes a resterilizable handpiece, and sterile disposable pump cartridge with a choice of tubing configurations". This indicates it is a hardware device with physical components, not software only.
Based on the provided information, the Artisan Pulse Lavage System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function as being used in vivo (within the body) for surgical procedures (preparing bone surfaces, wound irrigation/debridement). IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a hand-held system for delivering fluid and suction to a surgical site. This aligns with a surgical tool, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
The Artisan Pulse Lavage System is a surgical device used for cleaning and preparing tissue during procedures.
N/A
Intended Use / 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 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.
Product codes
FQH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intramedullary canal and/or bone surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic procedures, trauma situations
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K790811, K873466, K951666, K870915
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
OCT 2 9 1997
Device:
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.
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.
The Artisan Pulse Lavage System is substantially equivalent to several other legally marketed devices. Examples of these are:
-
- Exeter Lavage System - Howmedica (K790811)
- Surgi-Lav 66 System Stryker Corporation (Preamendment) 2.
- 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
1
Image /page/1/Picture/2 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" around the perimeter. In the center of the seal is a stylized image of an eagle.
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
2
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
3
Indications for Use
510(k) Number (if known):
Device Name: Artisan Pulse Lavage System
Indications for Use:
י
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)