(148 days)
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.
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.
The provided text describes the SEMPERFLO Infusion System and its substantial equivalence to predicate devices, but it does not contain detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to existing legally marketed devices. It states that "functional performance testing (bench and animal testing) have been submitted" and "These results indicate that the proposed device meets or exceeds all functional requirements," but it does not provide the specifics of those tests, the acceptance criteria used, or the performance results in a quantifiable manner.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's an attempt to answer as much as possible based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility: Acceptable per ISO 10993-1. | Material found to be acceptable for its intended use. |
| Functional Performance: Meets or exceeds all functional requirements. | Device meets or exceeds all functional requirements (details of requirements and specific performance values are not provided in this summary). |
| Flow Rate: Constant flow rate. | Designed to deliver medication/fluids at a constant flow rate. (Specific flow rate range or deviation from nominal is not provided). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided document. The document mentions "bench and animal testing" but does not give sample sizes for these tests.
- Data Provenance: Not explicitly stated for specific test data, but the submission is from Ethicon, Inc., a Johnson & Johnson Company, based in Somerville, NJ, USA. The testing likely occurred in a controlled lab or animal setting. The nature of the testing implies prospective data collection for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. The document does not describe a study involving expert assessment of outcomes or image interpretation. The testing focuses on device function and material properties.
4. Adjudication method for the test set
- Adjudication method: Not applicable/Not specified. This typically applies to studies where human interpretation (e.g., of medical images) requires consensus. For functional device testing, "ground truth" is typically established by direct measurement against engineering specifications.
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
- MRMC Study: No, an MRMC study was not done. This device is an infusion system, not an AI-powered diagnostic tool requiring human reader interpretation. The document does mention "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," but it does not present a comparative effectiveness study with human readers or AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The SEMPERFLO Infusion System is a physical medical device, not an algorithm. Its performance is inherent to its design and function, not an AI algorithm.
7. The type of ground truth used
- Ground Truth: For material compatibility, it was "methods specified in ISO Standard 10993-1." For functional performance, it would be engineering specifications and pre-defined acceptance criteria for flow rates, material integrity, sterility, etc., as determined by the manufacturer's R&D and QA processes.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not involve machine learning or AI algorithms that require a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
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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.
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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.
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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.
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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
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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)
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INDICATIONS FOR USE
- 54529999 -
§ 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).