(241 days)
No
The device description and performance studies focus on mechanical components and pressure/irrigation delivery, with no mention of AI/ML terms or data-driven analysis.
Yes.
The device is intended to promote wound healing by removing fluids and is used for patients with various types of wounds, ulcers, flaps, and grafts, directly addressing a therapeutic purpose.
No
Explanation: The device is described as an irrigation tubing set and delivery set for negative pressure wound therapy (NPWT) systems. Its intended use is to promote wound healing by removing fluids, not to diagnose a condition or disease.
No
The device description clearly outlines physical components made of PVC tubing, clamps, flanges, and an integrated irrigation solution bag. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply negative pressure wound therapy and irrigation to wounds to promote healing by removing fluids. This is a therapeutic intervention applied directly to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device consists of tubing sets for delivering irrigation fluid and applying negative pressure. These are physical components used in a treatment process.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is purely therapeutic and supportive of wound healing.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SVED, PRO Family and PRO HC devices, which are indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT system is intended for use in acute, extended and home care settings, however wound irrigation is not intended for use in a home care setting.
Product codes
OMP
Device Description
The Cardinal Health NPWT Irrigation Tubing Set consists of single-lumen PVC tubing, a pinch clamp, an adhesive SpeedConnect flange and a universal luer lock connector wherein the caregiver can attach the universal connector to an irrigation source obtained by the caregiver. The Cardinal Health NPWT Irrigation Delivery Set consists of single-lumen PVC tubing with an integrated irrigation solution bag (to be filled by the caregiver), tubing roller clamp and an adhesive SpeedConnect flange to provide a convenient way for caregivers to utilize the proprietary simultaneous irrigation feature with the various Cardinal Health NPWT devices. The tubing sets are supplied sterile and will be available as new accessories to the PRO HC and PRO family devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
acute, extended and home care settings, however wound irrigation is not intended for use in a home care setting.
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)
The following non-clinical performance data were provided in support of the substantial equivalence determination:
- Pressure stability testing with irrigation using a worst-case dressing set spanning the range of pressure settings.
- Irrigation bag printed scale accuracy test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Cardinal Health Tatyana Bogdan-Curvin Director of Regulatory Affairs 1500 S Waukegan Rd Waukegan, Illinois 60085
Re: K161418
Trade/Device Name: Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: December 9, 2016 Received: December 12, 2016
Dear Tatyana Bogdan-Curvin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161418
Device Name
Cardinal Health NPWT Irrigation Tubing Set and Delivery Set
Indications for Use (Describe)
The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SVED, PRO Family and PRO HC devices, which are indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT system is intended for use in acute, extended and home care settings, however wound irrigation is not intended for use in a home care setting.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K161418 Irrigation Tubing and Delivery Sets Cardinal Health
2. 510(k) SUMMARY
I. Submitter Information
Cardinal Health 1500 S Waukegan Road Waukegan, IL 60085
Contact Person: Tatyana Bogdan-Curvin Director, Global Regulatory Affairs 847-887-2325 (office) tatyana.bogdan-curvin@cardinalhealth.com
Date Prepared: December 7, 2016
II. Device Information
| Name of Device: | Cardinal Health Irrigation Tubing Sets |
|---|---|
| Common Name: | NPWT Tubing Set |
| Classification Name(s): | Powered Suction Pump (21 CFR 878.4780) |
| Regulatory Class: | II |
| Product Code: | OMP |
III. Predicate Device
K150124 Cardinal Health NPWT PRO HC Primary: This predicate has not been subject to a design-related recall.
Reference: K142916 Cardinal Health NPWT SVED K143016 Cardinal Health NPWT PRO Family
1. Device Description
The Cardinal Health NPWT Irrigation Tubing Set consists of single-lumen PVC tubing, a pinch clamp, an adhesive SpeedConnect flange and a universal luer lock connector wherein the caregiver can attach the universal connector to an irrigation source obtained by the caregiver. The Cardinal Health NPWT Irrigation Delivery Set consists of single-lumen PVC tubing with an integrated irrigation solution bag (to be filled by the caregiver), tubing roller clamp and an adhesive SpeedConnect flange to provide a convenient way for caregivers to utilize the proprietary simultaneous irrigation feature with the various Cardinal Health NPWT devices. The tubing sets are supplied sterile and will be available as new accessories to the PRO HC and PRO family devices.
4
2. Intended Use(s)
The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SVED, PRO Family and PRO HC devices, which are indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT system is intended for use in acute, extended and home care settings, however wound irrigation is not intended for use in a home care setting.
3. Comparison of Technological Characteristics
The irrigation delivery sets function identically as currently instructed for use with the NPWT SVED device. The tubing sets deliver irrigant to the wound dressing. The difference in the tubing sets is the Irrigation Delivery Set includes an irrigation solution bag whereas the Irrigation Tubing Set does not; there is no difference in operation of the two tubing sets.
4. Performance Data
The following non-clinical performance data were provided in support of the substantial equivalence determination:
- Pressure stability testing with irrigation using a worst-case dressing set spanning the . range of pressure settings
- . Irrigation bag printed scale accuracy test
5. Conclusions
The non-clinical tests demonstrate that the irrigation tubing sets are compatible with the Cardinal Health NPWT PRO HC and PRO family devices, function as intended and therefore are equivalent to the predicate devices for their intended use.