(148 days)
Not Found
No
The device description focuses on a mechanical, elastomeric pump system for fluid delivery at a constant rate, with no mention of AI or ML capabilities for controlling the rate, analyzing patient data, or any other function. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is intended to provide continuous infusion of prescribed solutions for post-operative pain management, and is also intended to significantly decrease narcotic use and pain. These are therapeutic effects.
No
The device is described as an "infusion system" and "elastomeric infusion pump" intended to deliver prescribed solutions for pain management. Its purpose is to administer medication, not to diagnose a condition.
No
The device description explicitly states it consists of a single-use disposable elastomeric infusion pump and a microcatheter, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the infusion of prescribed solutions into the body (percutaneous infusion, delivery to surgical wound sites or near nerves). IVD devices are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details an infusion pump and microcatheter for delivering fluids into tissue. This is consistent with a therapeutic or drug delivery device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro testing.
The device is a therapeutic device used for pain management through the delivery of medication.
N/A
Intended Use / Indications for Use
The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate.
The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings.
The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions.
When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows:
The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.
Product codes
MEB, BSO
Device Description
The proposed device consists of a single-use disposable elastomeric infusion pump, designed to deliver medication/fluids at a constant flow rate, and a microcatheter for fluid delivery. The device is intended for use in tissue, and is not intended for use in intravascular, epidural or intrathecal modes of delivery. Delivery of medication is achieved via an elastomeric reservoir that maintains relatively constant pressure, forcing solution through a 0.2μ filter and into the associated microcatheter assembly. The device will be provided as a convenience 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
hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings.
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
Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) have been submitted. These results indicate that the proposed device meets or exceeds all functional requirements.
Key Metrics
Not Found
Predicate Device(s)
On-Q Pain Pump (I-Flow Corp), VICRYL* Suture, BAXTER Pain Management System
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
K 052999
JMP-2005-014
MAR 2 2 2006
Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
Submitted by:
Jennifer M. Paine Manager, Regulatory Affairs Ethicon, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876
Name/Classification of Device:
Class II in 21 CFR § 880.5725 (MEB) and 21 CFR § 868.5120 (BSO)
Trade Name:
SEMPERFLO Infusion System
Predicate Devices:
On-Q Pain Pump (I-Flow Corp) VICRYL* Suture BAXTER Pain Management System
Statement of Intended Use:
The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate.
The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings.
The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions.
When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows:
The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.
1
Device Description:
The proposed device consists of a single-use disposable elastomeric infusion pump, designed to deliver medication/fluids at a constant flow rate, and a microcatheter for fluid delivery. The device is intended for use in tissue, and is not intended for use in intravascular, epidural or intrathecal modes of delivery. Delivery of medication is achieved via an elastomeric reservoir that maintains relatively constant pressure, forcing solution through a 0.2μ filter and into the associated microcatheter assembly. The device will be provided as a convenience kit.
Summary of Technological Characteristics of New Device to Predicate Devices:
The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, it is a kit providing a sterile infusion system. The proposed device uses the same or similar materials as those used in other currently marketed implantable or non-implantable medical devices. The mechanism of action is the same as for predicate devices.
Performance Data:
Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) have been submitted. These results indicate that the proposed device meets or exceeds all functional requirements.
Conclusions:
Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
*Trademark of Ethicon, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "U.S. Department of Health and Human Services, USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2006
Ms. Jennifer M. Paine Ethicon, Incorporated Route 22 West P.O. Box 151 Somerville, New Jersey 08876
Re: K052999 Trade/Device Name: SEMPERFLO Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: MEB Dated: February 27, 2006 Received: February 28, 2006
Dear Ms. Paine:
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 approvisions 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 Eederal Register.
3
Page 2 - Ms. Jennifer M. Paine
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 mean that i DA may Federal statutes and regulations administered by other Federal agencies. 01 the Act of ally rederal baker and segments, including, but not limited to: registration ? 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and and listing (21 CFR Part 007), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quarty agon 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) This letter will anow you to objak finding of substantial equivalence of your device to a premarket notification. - The PDF 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), if you desire specific ad rios for Journe 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 may overn built be generational 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 yours,
Sujette y. Michau Oms.
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
4
Indications for Use
510(k) Number (if known): K052999
Device Name: SEMPERFLO Infusion System
Indications for Use:
The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate.
The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings.
The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions.
When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows:
The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.
*Trademark of Ethicon, Inc.
(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)
Cinta Ong
on Man Mogy, General Huspic II 1150 Md Dental Davices
INDICATIONS FOR USE
- 54529999 -