(50 days)
Not Found
No
The document describes a convenience kit of legally marketed devices for pain management and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for continuous infusion of medications for postoperative pain management, which directly addresses a medical condition (pain) with a therapeutic action (drug delivery).
No.
Explanation: The device is a pump kit for continuous infusion of medications for pain management, not for diagnosing medical conditions.
No
The device description explicitly states it is a "convenience kit that is comprised of legally marketed devices" and is "packaged in tray kits." This indicates the device is a collection of physical components, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "continuous infusion of medications directly into an intraoperative, subcutaneous or epidural site for postoperative pain management." This describes a device used in vivo (within the body) for drug delivery, not a device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description focuses on a "convenience kit" comprised of legally marketed devices for drug delivery. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly intended for administering medication directly to a patient, which is a therapeutic or pain management function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FRN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance and Conclusions: 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. 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.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this kit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
APR 1 3 2005
3 3
Summary of Safety and Effectiveness
| Submitter: | Zimmer Orthopaedic Surgical Products
200 West Ohio Avenue
P.O. Box 10
Dover, Ohio 44622 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy J. Dickey
Regulatory Compliance Manager
Telephone: (330) 364-9493
Fax: (330) 364-9490 |
| Date: | February 21, 2005 |
| Trade Name: | ZIMMER AMBULATORY PUMP PAIN
MANAGEMENT SYSTEM |
| Common Name: | Pump, Infusion, Elastomeric |
| Classification Name
and Reference: | Pump, Infusion, Elastomeric
21 CFR § 880.5725 |
| Predicate Devices: | Accufuser, Accufuser Plus, & Standard Procedure
Kit manufactured by McKinley, Inc., K033039,
cleared October 7, 2003. |
| | PainPump® Local Anesthesia Kit, manufactured by
Stryker Corporation, K031249, cleared July 21,
2003. |
| 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. |
| Indications for Use: | The Zimmer 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. |
| Comparison to Predicate Device: | The Zimmer Ambulatory Pump Pain Management
Kit is substantially equivalent to the legally
marketed pain management kits, specifically the
McKinley Accufuser, Accufuser Plus, & Standard
Procedure Kit and the Stryker PainPump® Local
Anesthesia Kit in that the kits are similar in design,
materials, and indications for use. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
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.
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. |
| Clinical Performance and Conclusions: | Clinical data and conclusions were not needed for
this 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.
3
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
4
Indications for Use
510(k) Number (if known): KOSO4 33
Device Name:
Zimmer Ambulatory Pump Kit, Pain Management System
Indications for Use:
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.
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