(251 days)
Not Found
No
The description focuses on a standard electromechanical pump for negative pressure wound therapy and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is intended to remove fluid and infectious material from wounds, which may promote wound healing. This direct effect on the wound healing process classifies it as a therapeutic device.
No
The device is described as a suction pump intended to remove fluid and infectious material from a wound bed to promote healing, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it includes a "small, portable, low powered, battery operated electromechanical pump," which is a hardware component.
Based on the provided information, the NPD 1000 Negative Pressure Wound Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to apply suction to remove fluid from a wound bed to promote healing. This is a therapeutic application directly on the patient's body.
- Device Description: The device is a pump used with a wound dressing to apply negative pressure. This is a physical therapy method.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The NPD 1000 does not perform any such analysis of specimens.
Therefore, the NPD 1000 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP, BTA JCX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To verify that the device design met its functional and performance requirements, representative samples of the device 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KOSCQ75
OCT 0 9 2008
510(k) Summary
| Submitter: | Kalypto Medical
6393 Oakgreen Avenue
Hastings, MN 55033 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Buan, Vice President of Product Development
Phone (612) 703-1204, Fax (763) 287-3836 |
| Date Prepared: | August 14, 2008 |
| Trade Name: | NPD 1000 Negative Pressure Wound Therapy System |
| Classification: | Powered Suction Pump
Class II
21 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 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. |
| Intended 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. |
| Functional and Safety
Testing: | To verify that the device design met its functional and performance
requirements, representative samples of the device 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. |
| Conclusion: | Kalypto Medical considers the NPD 1000 Negative Pressure Wound
Therapy System to be equivalent to the predicate devices listed
above. This conclusion is based upon the devices' similarities in
principles of operation, technology, and indications for use. |
1
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
2
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
3
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