(162 days)
The Nipro Surefuser Ambulatory Balloon Infuser is intended for continuous and accurate infusion of medications at a predetermined flow rate. Routes of administration include intra-arterial, intravenous, percutaneous, subcutaneous, and epidural. An elastomeric reservoir is used eliminating the need for electrical power. The device is designed for single use in hospital, outpatient, and home care settings.
The subject device can be classified as a balloon (elastomeric) infusion pump as described in 21 CFR 880.5725. The following models are included: 50, 100, and 250 ml.
The provided text describes a 510(k) premarket notification for the Nipro Surefuser Ambulatory Balloon Infuser. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or AI.
Therefore, the information requested about acceptance criteria, specific device performance numbers, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details are not available in the provided text because this type of information is typically part of a detailed clinical or performance study, not a 510(k) summary for a substantially equivalent device like a balloon infusion pump.
The 510(k) summary states generalized findings. Here's what can be extracted based on the document's content:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance (functional) | Demonstrated to perform as intended |
| Biocompatibility | Demonstrated to be safe and suitable for human use |
| Appearance | Demonstrated to perform as intended |
| Substantial equivalence to predicate device (Infusor LV (K011317)) | Confirmed by FDA |
2. Sample size used for the test set and the data provenance: Not specified. The document refers to "Performance (functional), biocompatibility, and appearance tests" but does not detail the methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature) of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" concept does not apply to the type of device and testing described in this 510(k) summary, which is focused on demonstrating mechanical and biocompatibility functionality and substantial equivalence.
4. Adjudication method for the test set: Not applicable. No clinical study requiring adjudication of expert opinions is described.
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: Not applicable. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" concept doesn't align with the tests described. The "truth" would be the device meeting pre-defined engineering and safety specifications.
8. The sample size for the training set: Not applicable. This is not an AI/imaging device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/imaging device.
Study Summarized:
The study referenced in the document is the 510(k) premarket notification (K051828) for the Nipro Surefuser Ambulatory Balloon Infuser. This is not a traditional clinical study but rather a regulatory submission demonstrating substantial equivalence to a predicate device.
- Purpose: To demonstrate that the Nipro Surefuser Ambulatory Balloon Infuser is as safe and effective as a legally marketed predicate device (Infusor LV, K011317).
- Methodology (as described in the summary): Comparison of technical characteristics (materials, design, technological characteristics), and unspecified "Performance (functional), biocompatibility, and appearance tests."
- Conclusion: The tests demonstrated the subject devices perform as intended, are safe and suitable for human use, and are substantially equivalent to similar legally marketed devices. The FDA concurred with this assessment.
In essence, the "study" is the entirety of the 510(k) submission process, which includes testing and comparison documentation to satisfy regulatory requirements for market clearance, not an in-depth clinical trial with measurable performance statistics against a clinical gold standard.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Nipro. The logo consists of a stylized, abstract symbol on the left, resembling two interlocked or overlapping shapes, possibly representing the letter 'N'. To the right of the symbol is the word "NIPRO" in bold, sans-serif font. The entire logo is in black against a white background.
3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
DEC 1 5 2005
Kasi828
SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO SUREFUSER AMBULATORY BALLOON INFUSER
807.92 (a)(1)
Contact Person:
Date of Summary Preparation:
Luis Candelario President December 5, 2005
807.92 (a)(2) Trade Name: Common Name: Classification Name:
Nipro Surefuser Ambulatory Balloon Infuser Balloon Infusion pump Pump, Infusion, Elastomeric (880.5725)
807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Infusor LV (K011317), Baxter Healthcare Corporation
807.92 (a)(4)
Description of Device:
The subject device can be classified as a balloon (elastomeric) infusion pump as described in 21 CFR 880.5725. The following models are included: 50, 100, and 250 ml.
807.92 (a)(5)
Intended Use: The Nipro Surefuser Ambulatory Balloon Infuser is intended for continuous and accurate infusion of medications at a predetermined flow rate. Routes of intra-arterial. intravenous. percutaneous, administration include subcutaneous, and epidural. An elastomeric reservoir is used eliminating the need for electrical power. The device is designed for single use in hospital, outpatient, and home care settings.
807.92 (a)(6)
Comparison of Technical Characteristics:
The Nipro subject devices are similar to the predicate devices in materials, design and technological characteristics. Performance (functional), biocompatibility, and appearance tests demonstrated that the subject devices perform as intended and are safe and suitable for human use. They are substantially equivalent to similar legally marketed devices.
510(k) Amendment Nipro® Surefuser Ambulatory Balloon Infuser Nipro Medical Corporation December 5, 2005
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three heads, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 15 2005
Nipro Medical Corporation C/O Ms. Kaelyn Hadley Consultant 1384 Copperfiled Court Lexington, Kentucky 40514
Re: K051828
Trade/Device Name: Nipro Surefuser Ambulatory Balloon Infuser Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: December 5, 2005 Received: December 7, 2005
Dear Ms. Hadley:
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. Hadley
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 DAT has made a aves and regulations administered by other Federal agencies. or the receively 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 ifsing (21 ce received in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet renie 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) I mo feter notification. The FDA finding of substantial equivalence of your device to a premainter heated 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), rf 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 may oveans 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
{3}------------------------------------------------
Indications for Use
K051828 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Nipro Surefuser Ambulatory Balloon Infuser Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use: The Nipro Surefuser Ambulatory Balloon Infuser is intended for continuous and accurate infusion of medications at a predetermined flow rate. Routes of administration include intra-arterial, intravenous, percutaneous, subcutaneous, and epidural. An elastomeric reservoir is used eliminating the need for electrical power. The device is designed for single use in hospital, outpatient, and home care settings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton Vimmer
ു. പ്രാപ്രവ on of Anesthesvilogy, General Nospital, Juan Control, Dental Devices
3 Picmoer __
510(k) Amendment Nipro® Surefuser Ambulatory Balloon Infuser Nipro Medical Corporation December 5, 2005
§ 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).