(15 days)
The NeoMedix SupraFlow Console is an aspiration pump intended for use in general surgery applications where aspiration of irrigation and waste fluid from a surgical site is desired. The device is not indicated for liposuction use.
The Console contains a roller pump to provide aspiration from the surgical site and a pinch valve to initiate the flow of irrigation fluid simultaneously with the optional foot switch con switch con be used to activate both actions.
This document describes the NeoMedix SupraFlow Console Aspiration Pump (K040239).
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics and their targets (e.g., flow rate must be X L/min +/- Y%). Instead, it states that "Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols."
The "performance" discussed is primarily related to safety and functionality, comparing it to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical safety compliance | Demonstrated by compliance to applicable requirements defined in consensus standard IEC 60601-1. |
| Functionality (as an aspiration pump in general surgery) | The Console is similar in function to currently marketed aspiration/suction pumps. The aspiration capabilities are similar to those in the predicate devices, with the exception that aspiration is generated via peristaltic action rather than a direct vacuum source. Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols (specific results not provided in this summary). The device is intended for aspiration of irrigation and waste fluid from a surgical site in general surgery applications. It is not indicated for liposuction. |
| Compliance with NeoMedix test protocols for performance specifications | Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols (specific protocols and results not provided). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide information regarding a "test set" in the context of clinical data, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The performance claims are based on engineering and safety testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable or provided in the context of this 510(k) submission, as it focuses on device functionality and safety rather than a clinical study requiring expert ground truth for, e.g., diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable or provided for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is typically for evaluating the impact of AI or new diagnostic tools on human reader performance, which is not relevant for an aspiration pump.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone algorithm performance study was not performed or described. This device is a mechanical aspiration pump, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering specifications and test protocols: The device must meet its designed performance specifications (e.g., flow rate, pressure, safety features).
- Compliance with consensus standards: Specifically IEC 60601-1 for electrical safety.
- Comparison to predicate devices: Functionality and aspiration capabilities are shown to be similar to legally marketed predicate devices.
There is no mention of pathology, outcomes data, or expert consensus in the clinical sense for establishing "ground truth" for the device's technical performance.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a physical pump, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided as there is no "training set" for this device.
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EB 1 7 2004
NeoMedix Corporation SupraFlow Console Aspiration Pump
K040239 1/2
SECTION 2 - 510 (k) SUMMARY
SUMMARY INFORMATION
Manufacturer and Submitter
NeoMedix Corporation 27452 Calle Arroyo San Juan Capistrano, California 92675 Phone: (949) 248-7029 Fax: (949) 248-7119
Contact Person
Dr. Soheila Mirhashemi
Common, Classification and Proprietary Names
Common Name: Suction Pump
Classification names: Powered suction pump.
Proprietary Name: SupraFlow Console
Predicate Devices
The NeoMedix SupraFlow Console Model numbers 550014, 550019, 550020 are similar in indications, function and features to the following Devices: The Karl Storz KSEA Unimat 45 (K981703), thatSaMS: Tissue Aspiration System (K984363) and the Lysonix Aspiration Pump (K980454 ).
Indications for Use
The NeoMedix SupraFlow Console is to be used in general surgery applications where aspiration of irrigation fluid from a surgical site is desired. The device is not indicated for liposuction use.
Device Description
The Console contains a roller pump to provide aspiration from the surgical site and a pinch valve to initiate the flow of irrigation fluid simultaneously with the optional foot switch con switch con be used to activate both actions.
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K040239 2/2-
Technological Characteristics Comparison
The Console is similar in function to currently marketed aspiration/suction pumps. The aspiration capabilities are similar to those in the predicate devices with the exception is generated via peristialic action rather than a direct vacuum source. The Console is powered by 12VDC provided by a medical grade external 90 - 240 VAC, 50/60 Hz power supply.
Performance and Safety
Electical safety has been demonstrated by compliance to applicable requirements defined in consensus standard IEC 60601-1. Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols. The supplied Operations Manual provides the user with the applicable warnings and cautions during use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2004
Neomedix Corporation c/o Mr. Marc M. Mouser Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, Washington 98607-8542
Re: K040239
Trade/Device Name: SupraFlow Console Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: January 29, 2004 Received: February 2, 2004
Dear Mr. Mouser:
We have reviewed your Scction 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.
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.
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Page 2 - Mr. Marc M. Mouscr
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 (301) 594-4659. 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 yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K040239 |
|---|---|
| Device Name: | SupraFlow Console |
| Indications for use: | The NeoMedix SupraFlow Console is an aspiration pumpintended for use in general surgery applications whereaspiration of irrigation and waste fluid from a surgical site isdesired. |
| The device is not indicated for liposuction use. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: \checkmark OR Over-the-counter: __
Miriam C Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K0406239
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.