(65 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a convenience kit of legally marketed devices without mentioning any advanced computational capabilities.
Yes
The device is indicated for the administration of pain medications, which is a therapeutic purpose.
No
The device is described as an infusion pump for the administration of pain medications, and its function involves delivering substances rather than diagnosing conditions.
No
The device description explicitly states it is a "convenience kit that is comprised of legally marketed devices" and mentions packaging and sterilization, indicating it is a collection of physical medical devices, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the administration of pain medications and local anesthetics to a patient's body (subcutaneous, epidural, near a nerve). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a "convenience kit comprised of legally marketed devices" for administering medication. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Zimmer Pain Management System is a device for delivering medication, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Zimmer Pain Management System and Zimmer Pain Management System with Patient The 2mmer 1 and many are indicated for the slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, subcutaneous, or epidural site for postoperative modically anoothy into continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. allesthesia. The I CH and 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
Kosz171
OCT 1 3 2005
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: | August 8, 2005 |
| Trade Name: | ZIMMER AMBULATORY PUMP KIT, PAIN
MANAGEMENT SYSTEM with PCM |
| | ZIMMER AMBULATORY PUMP KIT, PAIN
MANAGEMENT SYSTEM, 3/5/8 ml/h |
| | Peelable Introducer Needle Kit |
| | Fixed Hub Catheter Kit |
| Common Name: | Pump, Infusion, Elastomeric |
| Classification Name
and Reference: | 21 CFR § 880.5725 |
| Predicate Devices: | Zimmer Ambulatory Pump Kit Pain Management
System manufactured by Zimmer Orthopaedic
Surgical Products, K050433, cleared April 13,
2005. |
| 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 and Zimmer
Pain Management System with Patient Control
Module (PCM) are indicated for the slow,
continuous, subcutaneous or epidural administration
of pain medications. It may also include the slow,
continuous infusion of pain medications directly
into an intraoperative, subcutaneous, or epidural 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 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 (with and without PCM) and alternative
introducer needle and catheter kits are substantially
equivalent to the legally marketed pain management
kits, specifically the Zimmer Ambulatory Pump
Pain Management System in that the kits are similar
in design, materials, and indications for use. |
| Performance Data (Nonclinical | Non-Clinical Performance and Conclusions: |
| and/or Clinical): | 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/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's head and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the eagle in a circular fashion.
Public Health Service
OCT 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: K052171
Trade/Device Name: Zimmer Ambulatory Pump Pain Management System and the Zimmer Ambulatory Pump Pain Management System with PCM Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 19, 2005 Received: September 26, 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 the Pour a Vous Loose, Dough 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.
4
Page 2 - Ms. Dickey
Please be advised that FDA's issuance of a substantial equivalence determination does not r read 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. or mo rec or all , 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 and ibeing (22 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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), 11 you donto 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 responsibilities under the Act from the Inty overn banel Baner Barrational 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-Ling, Ph.D.
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
5
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer Ambulatory Pump Pain Management System and the Zimmer Ambulatory Pump Pain Management System with PCM
Indications for Use:
The Zimmer Pain Management System and Zimmer Pain Management System with Patient The 2mmer 1 and many are indicated for the slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, subcutaneous, or epidural site for postoperative modically anoothy into continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. allesthesia. The I CH and 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)
and Brancurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology General Hospital, Infection Control, Dental Devices
510(k) Number _ ky 5217)