(34 days)
Not Found
No
The device description and intended use focus on a mechanical, fixed-flow rate infusion system with no mention of AI/ML terms or data-driven decision-making.
Yes
The device is intended for the continuous infusion of medications for pain management, which is a therapeutic purpose.
No
This device is an infusion system designed for delivering medication for pain management, not for diagnosing medical conditions.
No
The device description explicitly states it is a "single use infusion device, which incorporates an elastomeric bladder with a permanently attached fixed flow rate administration set designed to deliver medication at a constant flow rate." This describes physical hardware components, not a software-only device.
Based on the provided information, the Solace Infusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the continuous infusion of medications directly into the body (intraoperative site, subcutaneous, intramuscular) for post-operative pain management. This is a therapeutic function, delivering substances into the patient.
- Device Description: The device is described as an infusion system with an elastomeric bladder and administration set designed to deliver medication. This aligns with a drug delivery system, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) taken from the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used in vitro (outside the body) to examine specimens. The Solace Infusion System operates in vivo (inside the body) to deliver medication.
N/A
Intended Use / Indications for Use
The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.
Product codes (comma separated list FDA assigned to the subject device)
MEB, MRZ
Device Description
Apex's Solace Post-Operative Pain Relief Infusion System is a single use infusion device, which incorporates an elastomeric bladder with a permanently attached fixed flow rate administration set designed to deliver medication at a constant flow rate. The medication enters the body via a catheter, which is inserted near a surgical wound site then positioned under the skin. The pump attaches to the catheter at the distal end of the administration set. The catheter consists of four design options (same as predicate devices).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Solace Infusion System is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care site.
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)
Not Found
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.
K051253, K040337, K002380, K982946, K984502, K043456
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
510(k) Premarket Notification STO(R) Premative Pain Management System
Attachment 3 – Summary Page 1 of 3 0977
510(k) Summary
.. .
| Date of Submission: | April 20, 2006 |
|---|---|
| --------------------- | ---------------- |
MAY - 9 2006
| Submitter: | Apex Medical Technologies, Inc.
10064 Mesa Ridge Court, Suite 202
San Diego, CA 92121
Phone: (858) 535 - 0012
Fax: (858) 535 - 9715 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Whitney A. Williams
Development Engineer
Apex Medical Technologies, Inc. |
| Trade Name: | Solace Post-Operative Pain Relief Infusion System |
| Common Name: | Infusion Pump |
| Classification: | Pump, Infusion, Elastomeric (21CFR 880.5725, Product Code
MEB, MRZ) |
| Comparison Device: | Baxter Infusor, K051253
I-Flow Pump, K040337
Baxter Pain Management System, K002380
I-Flow PainBuster Infusion Kit, K982946
I-Flow Nerve Block Infusion Kit, K984502
I-Flow Soaker Catheter, K043456 |
| Device Description: | Apex's Solace Post-Operative Pain Relief Infusion System is a
single use infusion device, which incorporates an elastomeric
bladder with a permanently attached fixed flow rate administration medication enters the body via a catheter, which is inserted near a
surgical wound site then positioned under the skin. The pump
attaches to the catheter at the distal end of the administration set.
The catheter consists of four design options (same as predicate
devices). |
Confidential Property of Apex Medical Technologies, Inc.
な
1
Standard epidural catheter: 3 radial holes at the distal end with an approximate 0.5-inch infusion segment.
Catheter with infusion segment: a modified epidural with multiple holes at the distal end with 2.5 inch, 5.0 inch and 10 inch infusion segments. The holes are arranged so that the flow is evenly distributed along the infusion segment.
The system may also incorporate a dual port site for dual catheter use.
The Solace Infusion System is intended for continuous infusion of Indications for Use: medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.
The Solace Infusion System is for single patient use only. Intended Use:
The Solace Infusion System is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care site.
The Solace Infusion System is not intended for intravenous, intraarterial or epidural drug delivery.
The Solace Infusion System is not intended for the delivery of blood, blood products or lipids or fat emulsions.
Technological The Solace Infusion System and predicate devices are single-use Characteristics: disposable elastomeric infusion pumps designed to deliver solution at a constant flow rate (0.5 ml to 10 ml per hour) via a permanently attached set. The maximum fill volume range is 65 ml to 500 ml (Baxter maximum volume is 270 ml).
The Solace pump utilizes flow restrictive tubing to achieve +/-15% flow accuracy over the infusion system.
The I-Flow pump utilizes a glass capillary and/or flow restrictive tubing to achieve +/- 15% flow accuracy over the infusion system.
The Baxter pump utilizes a glass capillary to achieve +/- 10% flow accuracy over the infusion system.
Confidential Property of Apex Medical Technologies, Inc.
2
The Solace pump balloon is spherical and is made from a proprietary synthetic polyisoprene formulation that contains no natural rubber or accelerators.
The I-Flow and Baxter pump balloons are cylindrical. The I-Flow pump balloon is made from synthetic polyisoprene and natural rubber. The Baxter pump balloon is made from a proprietary synthetic polyisoprene formulation.
The Solace Post-Operative Pain Relief Infusion System is Conclusion: substantially equivalent to the existing pain management kits.
Confidential Property of Apex Medical Technologies, Inc.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three legs and three wings, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Image /page/3/Picture/3 description: The image shows a date written in block letters. The month is "MAY", the day is "9", and the year is "2006". The date is written in black ink on a white background. The date appears to be handwritten.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Apex Medical Technologies, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K060933
Trade/Device Name: Solace Post-Operative Pain Relief Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: April 21, 2006 Received: April 24, 2006
Dear Mr. Mosenkis:
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.
4
Page 2 - Mr. Mosenkis
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 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 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/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
5
| Applicant: | Apex Medical Technologies, Inc. |
|---|---|
| 510(k) Number (if known): | K464933 |
| Device Name: | Solace Post-Operative Pain Relief Infusion System |
| Indications for Use: |
-
- The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.
Prescription Use (Part 21 CFR 801 Subpart D)
- The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
on of Anesthesiology, General Hospital,
ion Control, Dental Devices
Sunton.
Confidential Property of Apex Medical Technologies, Inc.