(251 days)
The NPD 1000 Negative Pressure Wound Therapy System is a portable, low-powered, battery-operated suction pump intended for the application of suction to remove a small amount of fluid from the wound bed including wound exudate and infectious material which may promote wound healing.
The NPD 1000 Negative Pressure Wound Therapy System includes a small, portable, low powered, battery operated electromechanical pump used with an accessory wound dressing. The system uses controlled negative pressure (vacuum) to remove exudates, which may promote wound healing.
The provided text is a 510(k) Summary for the NPD 1000 Negative Pressure Wound Therapy System. This document outlines the device description, intended use, and claims substantial equivalence to predicate devices based on similarities in principles of operation, technology, and indications for use.
Crucially, the provided text does not contain any acceptance criteria or the results of a study proving the device meets acceptance criteria.
The "Functional and Safety Testing" section only mentions that representative samples underwent "functional and mechanical testing, EMC testing in accordance with IEC 60601-1-2:2001 and electrical safety testing in accordance with UL 60601-1:2006." This indicates that some testing was performed but does not specify the acceptance criteria for these tests, nor does it provide any reported performance data against such criteria. Studies demonstrating clinical effectiveness or specific performance metrics related to wound healing or fluid removal are not detailed.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- 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: This is a medical device, not an AI/imaging device, so this type of study is not applicable and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a medical device, not an AI/imaging device, so this type of study is not applicable and not mentioned.
- The type of ground truth used: This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The 510(k) summary focuses on demonstrating equivalence to predicate devices through design and intended use, rather than presenting detailed performance data from clinical or rigorous non-clinical studies with defined acceptance criteria.
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KOSCQ75
OCT 0 9 2008
510(k) Summary
| Submitter: | Kalypto Medical6393 Oakgreen AvenueHastings, MN 55033 |
|---|---|
| Contact Person: | John Buan, Vice President of Product DevelopmentPhone (612) 703-1204, Fax (763) 287-3836 |
| Date Prepared: | August 14, 2008 |
| Trade Name: | NPD 1000 Negative Pressure Wound Therapy System |
| Classification: | Powered Suction PumpClass II21 CFR 878.4780 |
| Product Code: | BTA JCX |
| Predicate Device(s): | The subject device is equivalent to the following device:• V.A.C. Therapy Systems-ActiV.A.C. Therapy Unit M: K063692• Boehringer Laboratories Suction Pump System: K060277 |
| Device Description: | The NPD 1000 Negative Pressure Wound Therapy System includes asmall, portable, low powered, battery operated electromechanicalpump used with an accessory wound dressing. The system usescontrolled negative pressure (vacuum) to remove exudates, whichmay promote wound healing. |
| Intended Use: | The NPD 1000 Negative Pressure Wound Therapy System is aportable, low-powered, battery-operated suction pump intended for theapplication of suction to remove a small amount of fluid from thewound bed including wound exudate and infectious material whichmay promote wound healing. |
| Functional and SafetyTesting: | To verify that the device design met its functional and performancerequirements, representative samples of the device underwentfunctional and mechanical testing, EMC testing in accordance withIEC 60601-1-2:2001 and electrical safety testing in accordance withUL 60601-1:2006. |
| Conclusion: | Kalypto Medical considers the NPD 1000 Negative Pressure WoundTherapy System to be equivalent to the predicate devices listedabove. This conclusion is based upon the devices' similarities inprinciples of operation, technology, and indications for use. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with flowing lines suggesting movement or flight.
Public Health Service
APR - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kalypto Medical % Mr. John Baun 6393 Oakgreen Avenue Hastings, Minnesota 55033
Re: K080275
Trade/Device Name: NPD 1000 Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 14, 2008 Received: August 15, 2008
Dear Mr. Baun:
This letter corrects our substantially equivalent letter of October 9, 2008.
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 Federal agencies. You must comply with all the Act's requirements, including, but not
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Page 2 - Mr. John Baun
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 (OS) 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,
For Nathan
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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Indications for Use
510(k) Number (if known): K080275
Device Name: NPD 1000 Negative Pressure Wound Therapy System
Indications for Use:
The NPD 1000 Negative Pressure Wound Therapy System is a portable, low-powered, battery-operated suction pump intended for the application of suction to remove a small amount of fluid from the wound bed including wound exudate and infectious material which may promote wound healing.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nad AP Syden for man
Division of General, Restorative, and Neurological Devic
510(k) Number
§ 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.