(27 days)
The NeoGen One device is indicated for patients who would benefit from a suction device, particularly as the use of that device may promote wound healing. This includes patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under influence of continuous and/or alternating vacuum pressure. This device is restricted to sale by, or on the order of, a physician or licensed practitioner.
NeoGen One. Closed Wound Drain System Part Number: NG9900
The provided text is a 510(k) premarket notification letter from the FDA regarding the NeoGen One. Closed Wound Drain System. This type of document primarily confirms that a new device is "substantially equivalent" to legally marketed predicate devices and does not typically contain detailed information about the acceptance criteria or a comprehensive study proving the device meets those criteria, as one would expect for an AI/ML device.
The document states:
- Trade/Device Name: NeoGen One. Closed Wound Drain System Part Number: NG9900
- Regulation Number: 21 CFR 878.4780
- Regulation Name: Powered Suction Pump
- Regulatory Class: II
- Product Code: OMP
- Intended Use: "The NeoGen One device is indicated for patients who would benefit from a suction device, particularly as the use of that device may promote wound healing. This includes patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under influence of continuous and/or alternating vacuum pressure. This device is restricted to sale by, or on the order of, a physician or licensed practitioner."
Given this, I cannot provide the specific details requested in the bullet points. This device is a powered suction pump, not an AI/ML diagnostic device, and therefore the concepts of "acceptance criteria" and "studies" in the context of AI performance (like sensitivity, specificity, human reader improvement, ground truth establishment for AI models, training sets, etc.) do not apply to this document.
The "substantial equivalence" determination means the FDA reviewed the device information submitted by the manufacturer (likely including performance data, but not in the detailed format requested for AI studies) and concluded it is as safe and effective as a legally marketed predicate device. The letter itself does not contain the study details that would typically be found in an AI/ML device submission summary.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2009
Neo-Gen Technologies. Inc. % Ms. Lydia B. Biggie 5353 NW 35th Avenue Ft. Lauderdale, Florida 33309
Re: K032301
Trade/Device Name: NeoGen One. Closed Wound Drain System Part Number: NG9900
Regulation Number: 21 CFR 878.4780
Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: July 25, 2003 Received: July 25, 2003
Dear Ms. Biggie:
This letter corrects our substantially equivalent letter of August 21, 2003.
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 (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 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
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Page 2 - Ms. Lydia B. Biggie
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 continue 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INTENDED USE -2.0
The NeoGen One device is indicated for patients who would benefit from a suction device, particularly as the use of that device may promote wound healing. This includes patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under influence of continuous and/or alternating vacuum pressure. This device is restricted to sale by, or on the order of, a physician or licensed practitioner.
for Mark N Milken
(Division Sign-Off) Division of General. Festorative nd Neurological Do ices
510(k) Number K032301
§ 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.