(65 days)
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.
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.
The Zimmer Ambulatory Pump Kit Pain Management System is a convenience kit that combines existing legally marketed devices. The study to prove the device meets acceptance criteria primarily focused on the impact of sterilization on these pre-existing devices.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization impact evaluation | Devices tested to determine the impact of sterilization. Guidance document "Sterilized convenience kits for clinical and surgical use; final guidance for industry," January 7, 2002 was utilized. |
| Biological evaluation of medical devices | Previously cleared devices meet applicable sections of ANSI/AAMI/ISO 10993-1:1997, "Biological evaluation of Medical Devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text, but implies testing was conducted on samples of the devices within the kit.
- Data Provenance: The devices themselves are "previously cleared," suggesting the data for their independent performance (e.g., biological evaluation) predates this submission. The sterilization impact testing would have been done for this specific kit. The text does not specify the country of origin or whether the data was retrospective or prospective, though it would likely be prospective testing for sterilization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. The evaluation seems to be based on adherence to established standards and guidance documents rather than expert consensus on individual cases.
4. Adjudication method for the test set:
This information is not applicable as the evaluation primarily involved technical testing against standards, not subjective assessment requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is a medical device (infusion pump kit) and not an AI or imaging device, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is a medical device and not an algorithm.
7. The type of ground truth used:
The ground truth used was compliance with established standards and guidance documents for sterilization and biological evaluation (e.g., "Sterilized convenience kits for clinical and surgical use; final guidance for industry" and ANSI/AAMI/ISO 10993-1:1997).
8. The sample size for the training set:
Not applicable. This device is not an AI-driven system that requires a "training set." Its evaluation focused on the physical components and their properties after being assembled into a kit and sterilized.
9. How the ground truth for the training set was established:
Not applicable. As stated in point 8, there is no training set for this type of device.
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Kosz171
OCT 1 3 2005
Summary of Safety and Effectiveness
| Submitter: | Zimmer Orthopaedic Surgical Products200 West Ohio AvenueP.O. Box 10Dover, Ohio 44622 |
|---|---|
| Contact Person: | Cindy J. DickeyRegulatory Compliance ManagerTelephone: (330) 364-9493Fax: (330) 364-9490 |
| Date: | August 8, 2005 |
| Trade Name: | ZIMMER AMBULATORY PUMP KIT, PAINMANAGEMENT SYSTEM with PCM |
| ZIMMER AMBULATORY PUMP KIT, PAINMANAGEMENT SYSTEM, 3/5/8 ml/h | |
| Peelable Introducer Needle Kit | |
| Fixed Hub Catheter Kit | |
| Common Name: | Pump, Infusion, Elastomeric |
| Classification Nameand Reference: | 21 CFR § 880.5725 |
| Predicate Devices: | Zimmer Ambulatory Pump Kit Pain ManagementSystem manufactured by Zimmer OrthopaedicSurgical Products, K050433, cleared April 13,2005. |
| Device Description: | The Zimmer Ambulatory Pump Pain ManagementSystem is a convenience kit that is comprised oflegally marketed devices. The devices arepurchased non-sterile and subsequently packaged intray kits by Zimmer. Once packaged, the kit will besent to a contract sterilizer for irradiation |
| sterilization. The proposed convenience kit does notchange the intended use of the legally marketeddevices which comprise the kit. | |
| The Zimmer Ambulatory Pump Pain ManagementSystem (kit) does not raise any new safety andeffectiveness concerns when compared to thesimilar legally marketed devices. The ZimmerAmbulatory Pump Pain Management Systemshould therefore be considered substantiallyequivalent to the existing predicate devices. | |
| Indications for Use: | The Zimmer Pain Management System and ZimmerPain Management System with Patient ControlModule (PCM) are indicated for the slow,continuous, subcutaneous or epidural administrationof pain medications. It may also include the slow,continuous infusion of pain medications directlyinto an intraoperative, subcutaneous, or epidural sitefor postoperative pain management or thecontinuous infusion of a local anesthetic near anerve for regional anesthesia. The PCM allows forintermittent bolus doses of medication onpatient demand. The system is convenient for useby ambulatory patients. It is the responsibility ofthe user to assure that the medication is preparedand administered in accordance with the drugmanufacturer's package insert. |
| Comparison to Predicate Device: | The Zimmer Ambulatory Pump Pain ManagementKit (with and without PCM) and alternativeintroducer needle and catheter kits are substantiallyequivalent to the legally marketed pain managementkits, specifically the Zimmer Ambulatory PumpPain Management System in that the kits are similarin 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 determinethe impact of sterilization as per the guidancedocument, "Sterilized convenience kits for clinicaland surgical use; final guidance for industry,"January 7, 2002 was utilized as guidance for thissubmission. |
| The previously cleared devices have been tested anddoes meet the applicable sections of theANSI/AAMI/ ISO 10993-1:1997, "Biologicalevaluation of Medical Devices." | |
| Clinical Performance and Conclusions: | Clinical data and conclusions were not needed forthis 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.
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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
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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)
§ 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).