(71 days)
No
The description focuses on a mechanical, non-powered suction device using springs to generate negative pressure. There is no mention of AI, ML, image processing, or data analysis for decision-making or control.
Yes
The device is described as promoting wound healing and removing infectious material, which are therapeutic functions.
No
Explanation: The device is described as a suction device for wound management and removal of fluids, which is a therapeutic function, not a diagnostic one. It does not mention any capability to diagnose conditions or generate diagnostic information.
No
The device description explicitly states it is a "non-powered, portable, single-use suction device" that utilizes "dedicated constant-force springs to mechanically generate the negative pressure gradient." This indicates a physical hardware component is the primary mechanism of action, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SNaP Wound Care System is a suction device used to remove fluids and debris directly from a wound. It is a therapeutic device applied externally to the body.
- Intended Use: The intended use clearly states it's for wound management through the removal of exudates, infectious material, and tissue debris. This is a physical process applied to the wound itself, not a test performed on a sample taken from the body.
Therefore, the SNaP Wound Care System falls under the category of a medical device used for wound treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.
Product codes
OKO
Device Description
The SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP Wound Care System is designed to provide active wound treatment through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts. The SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient.
The SNaP Wound Care System is used in conjunction with the SNaP Dressing Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound, ulcers, surgically closed incisions, flaps and grafts.
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
Bench testing conducted on the modified SNaP Wound Care System to assess the ability to deliver negative pressure wound therapy comparable to the predicate device (K081406)
Electrical Safety testing
Electromagnetic compatibility (EMC) testing
Software Validation testing
Biocompatibility testing
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SNaP Wound Care System and its components were evaluated under design verification and validation tests to assure conformance to design specifications. The nonclinical tests include:
Bench testing conducted on the modified SNaP Wound Care System to assess the ability to deliver negative pressure wound therapy comparable to the predicate device (K081406)
Electrical Safety testing
Electromagnetic compatibility (EMC) testing
Software Validation testing
Biocompatibility testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SNaP® Wound Care System (K081406)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
(a)
Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
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p.1 of 3
510(k) SUMMARY
JUL 28 2011 510(k) Notification (K111393)
GENERAL INFORMATION
Applicant:
Spiracur Inc. 1180 Bordeaux Drive Sunnyvale, CA 94089 U.S.A. Phone: 408-701-5300 Fax: 408-701-5301
Contact Person:
Sarah Canio Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 408-400-0856 ext. 109 Fax: 408-400-0865 Email: sarah@experiengroup.com
Date Prepared: June 8, 2011
Classification:
21 CFR§878.4683, Class II
Product Code:
ОКО
Trade Name: SNaP® Wound Care System
Generic/Common Name:
Non-powered suction apparatus device intended for negative pressure wound therapy
Predicate Device:
SNaP® Wound Care System (K081406)
1
Intended Use:
The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.
Product Description:
The SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP Wound Care System is designed to provide active wound treatment through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts. The SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient.
The SNaP Wound Care System is used in conjunction with the SNaP Dressing Kit.
Substantial Equivalence:
The modified SNaP System and the predicate device are both non-powered, negative pressure wound therapy devices used for the same intended use and principles of operation. Both systems utilize dedicated constant-force springs to mechanically generate the negative pressure gradient. The minor design modifications implemented to develop the modified SNaP System involve changes to the outer housing and receptacle capacity of the SNaP Cartridge, changes to the activation and deactivation steps, inclusion of an exudate management feature, and an attachment clip to the SNaP System. The modified SNaP System also incorporates an alarm clip which provides an audible alarm that indicates when the receptacle is full and negative pressure wound therapy has stopped. The differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Therefore, the SNaP Wound Care System is substantially equivalent to the cleared predicate device (K081406).
Testing in Support of Substantial Equivalence Determination:
The SNaP Wound Care System and its components were evaluated under design verification and validation tests to assure conformance to design specifications. The nonclinical tests include:
- Bench testing conducted on the modified SNaP Wound Care System to assess the . ability to deliver negative pressure wound therapy comparable to the predicate device (K081406)
2
510(k) Summary
- Electrical Safety testing .
- Electromagnetic compatibility (EMC) testing .
- Software Validation testing .
- . Biocompatibility testing
Summary:
The SNaP Wound Care System is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spiracur. Inc. % Experien Group, LLC Ms. Sarah Canio 744 N. Mathilda Avenue, Suite 100 Sunnyvale. California 94085
JUL 2 8 2011
Re: K111393
Trade/Device Name: SNaP® Wound Care System Regulation Number: 21 CFR 878.4683 Regulation Name: Non-powered suction apparatus device intended for NPWT Regulatory Class: II Product Code: OKO Dated: June 29, 2011 Received: June 30, 2011
Dear Ms. Canio:
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
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Page 2 - Ms. Sarah Canio
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address h11p://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Millkern
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K111393
Device Name: SNaP® Wound Care System
Indications For Use:
The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kione for NKM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111393