(75 days)
Not Found
No
The summary describes a pain management system that administers medication based on pre-set parameters and patient demand (via a PCM), with no mention of AI or ML for decision-making, data analysis, or adaptive control. The performance studies focus on sterilization and biological evaluation, not algorithmic performance.
Yes
The device is indicated for the administration of pain medications and local anesthetics to manage pain, which is a therapeutic function.
No
The device is described as a pain management system used for the administration of medications, not for diagnosis.
No
The device description explicitly states it is comprised of "legally marketed devices" which are packaged and sterilized, indicating physical hardware components. The intended use also describes administration of medication, which requires a physical delivery mechanism.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "slow, continuous or subcutaneous administration of pain medications" and "infusion of a local anesthetic near a nerve for regional anesthesia." This describes a device used on or in the patient for therapeutic purposes (delivering medication), not for testing samples from the patient to diagnose or monitor a condition.
- Device Description: The description focuses on the components of the system (pump, convenience kits, etc.) and how they are assembled and sterilized for administration of medication. There is no mention of analyzing biological samples.
- Performance Studies: The performance studies described relate to the impact of sterilization on the device components and biological evaluation of the materials, which are relevant for devices used in contact with the body, not for IVDs.
- Lack of IVD Indicators: There are no mentions of analyzing blood, urine, tissue, or any other biological sample, which are hallmarks of IVD devices.
In summary, the Zimmer Pain Management System is a drug delivery device, not a diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FRN
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.
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
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.
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 do 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 these kits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K050433, K052171, K033039, K023098
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
s-3226
JAN 3 1 2006
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: | November 15, 2005 |
| Trade Name: | ZIMMER AMBULATORY PUMP Pain
Management System, MULTIRATE INFUSOR
2,4,6 ml/hr and 2.5 inch fenestrated catheter |
| | ZIMMER AMBULATORY PUMP Pain
Management System, MULTIRATE INFUSOR
2,4,6 ml/hr with PCM and 2.5 inch fenestrated
catheter |
| | ZIMMER AMBULATORY PUMP Pain
Management System, MULTIRATE INFUSOR
3,5,8 ml/hr and 2.5 inch fenestrated catheter |
| | ZIMMER AMBULATORY PUMP Pain
Management System, MULTIRATE INFUSOR
3,5,8 ml/hr with PCM and 2.5 inch fenestrated
catheter |
| | ZIMMER AMBULATORY PUMP Pain
Management System, MULTIRATE INFUSOR
2,4,6 ml/hr and 5.0 inch fenestrated catheter |
| | ZIMMER AMBULATORY PUMP Pain
Management System, MULTIRATE INFUSOR
2,4,6 ml/hr with PCM and 5.0 inch fenestrated
catheter |
1
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
2
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.
3
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:
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.
Pump kits with included accessories:
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.
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,
4
Kis3226
| | 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. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | The Zimmer Ambulatory Pump Pain Management
Kit (with and without PCM) and flow splitter wye
and fenestrated catheter kits are substantially
equivalent to the legally marketed pain management
kits, specifically the 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. |
| 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
do 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
these kits. |
5
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
6
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
7
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:
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.
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