(28 days)
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Not Found
No
The description focuses on electromechanical pumping and programmed dosage rates, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to deliver medication for the purpose of managing pain, which is a therapeutic function.
No
The device is described as an electromechanical pump that delivers medication for pain management, not for diagnosing conditions.
No
The device is explicitly described as an "electromechanical pump," indicating it is a hardware device with mechanical and electrical components, not solely software.
Based on the provided information, the PainPump2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The PainPump2 is an electromechanical pump that delivers medication directly to the patient. Its function is to administer treatment, not to analyze biological samples.
The description clearly states its purpose is to "deliver a controlled amount of medication to the patient for the purpose of managing pain." This is a therapeutic function, not a diagnostic one.
N/A
Intended Use / Indications for Use
PainPump2 is an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous, or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump II unit by the physician. The PainPump II is contraindicated for infusion of blood and blood products, insulin, or life-supporting medication.
Product codes (comma separated list FDA assigned to the subject device)
FRN, BSO
Device Description
The Stryker PainPump2 is intended an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump2 unit by the physician.
The Stryker PainPump2 is contraindicated for infusion of blood products, insulin, or lifesupporting medication.
The Stryker PainPump2 2-Site Infusion Set is a kit that is comprised of a 2-Site infusion set, introducer needles, syringe, dressings and catheter securement accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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 8 2003
stryker
INSTRUMENTS
5300 East Milham Avenue
Kalamazoo, MI 49001
Phone (616) 323-7700
(616) 200-8210
Device Name:
| Trade Name: | Stryker PainPump2 |
|---|---|
| Common Name: | Electromechanical Ambulatory Infusion Pump |
| Classification Name: | Pump, Infusion: 21 CFR 880.5725, Class II |
Device Sponsor:
| Manufacturer: | Stryker Instruments |
|---|---|
| 4100 E. Milham Avenue | |
| Kalamazoo, MI 49001 | |
| Registration No.: 1811755 |
Regulatory Class: Class II
Summary of Safety and Effectiveness:
The Stryker PainPump2 is intended an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump2 unit by the physician.
The Stryker PainPump2 is contraindicated for infusion of blood products, insulin, or lifesupporting medication.
The Stryker PainPump2 2-Site Infusion Set is a kit that is comprised of a 2-Site infusion set, introducer needles, syringe, dressings and catheter securement accessories.
The Stryker PainPump2 is substantially equivalent in intended use, safety, and effectiveness to existing infusion pump systems being marketed by I-Flow Corporation.
The Stryker PainPump2 does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker PainPump2 is substantially equivalent to these existing devices.
By: __
Nicole Petty
Nicole Petty
Regulatory Analyst
Dated: 3.20.03
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
APR 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nicole Petty Regulatory Analyst Stryker Instruments 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K030885
Trade/Device Name: Modification to Stryker PainPump 2 Regulation Number: 880.5725, 880.5120 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, BSO Dated: March 20, 2003 Received: March 21, 2003
Dear Ms. Petty:
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 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.
2
Page 2 - Ms. Petty
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 (QS) 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 vour 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 (301) 594-4618. 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 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/dsma/dsmamain.html
Sincerely vours.
Susan Ruane
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1
| 510(k) Number: | |
|---|---|
| Device Name: | Stryker PainPump2 |
| Indications For Use: | PainPump2 is an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous, or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump II unit by the physician. The PainPump II is contraindicated for infusion of blood and blood products, insulin, or life-supporting medication. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-The- Counter Use
(Per 21 CFR 801.109)
Patricia Cusack
(Optional Format 1-2-96)
(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital, Division of Ancolnest, Dental Devices
510(k) Number: K030885