(50 days)
Not Found
No
The provided text describes a non-powered suction device for wound management and does not mention any AI or ML capabilities.
Yes
The device is indicated for promoting wound healing and management, which are therapeutic functions.
No
The device is intended for wound management by applying negative pressure to remove fluids and promote healing, not to diagnose medical conditions.
No
The device description explicitly states it is a "portable, non-powered suction device," indicating it is a hardware device that applies negative pressure.
Based on the provided information, the SNaP® Wound Care System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a device for wound management through the application of negative pressure to remove fluids. This is a physical intervention applied directly to the wound, not a test performed on a sample taken from the body.
- Device Description: The description reinforces that it's a portable, non-powered suction device for applying negative pressure and removing fluids. This aligns with a therapeutic or wound management device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SNaP® Wound Care System does not fit this definition.
N/A
Intended Use / Indications for Use
The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious naterial 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, venous or pressure), surgically closed incisions, flaps and grafts.
Product codes
OKO
Device Description
The SNaP® Wound Care System ("SNaP System") is a portable, non-powered suction device intended for wound management via application of negative pressure to the wound bed for removal of fluids, including wound exudate, irrigation fluids and infectious materials.
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)
The SNaP System is an existing device to which no design changes have been made as a result of the labeling changes. As such, no further testing has been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Spiracur Inc.
SNaP® Wound Care System 510(k) Premarket Notification
SECTION 5 510(k) SUMMARY
DEC - 1 2011
510(k) Notification K113032
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 L. 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: October 11, 2011
DEVICE INFORMATION
Trade Name:
SNaP® Wound Care System
Generic/Common Name:
Non-powered suction apparatus device intended for negative pressure wound therapy
Classification: 21 CFR§878.4683, Class II
Product Code:
ОКО
1
SNaP® Wound Care System 510(k) PREMARKET NOTIFICATION
SECTION 5 510(k) SUMMARY
PREDICATE DEVICE(S)
- Spiracur SNaP® Wound Care System (K111393) .
- Spiracur SNaP® Wound Care System (K112341) .
- KCI USA, Inc. V.A.C.® Therapy Systems (K091585) .
DEVICE DESCRIPTION
The SNaP® Wound Care System ("SNaP System") is a portable, non-powered suction device intended for wound management via application of negative pressure to the wound bed for removal of fluids, including wound exudate, irrigation fluids and infectious materials.
INDICATIONS FOR USE
The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, 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, venous or pressure), surgically closed incisions, flaps and grafts.
SUBSTANTIAL EQUIVALENCE
There have been no changes made to the cleared SNaP System as result of the proposed labeling changes. The expanded indications for use to include venous ulcers in the labeling for the SNaP System are substantially equivalent to the indications for use for the predicate device, the KCI V.A.C. Therapy Systems. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness with regard to the treatment of venous ulcers. Thus, the SNaP System is substantially equivalent to the predicate devices.
DEVICE TESTING
The SNaP System is an existing device to which no design changes have been made as a result of the labeling changes. As such, no further testing has been conducted.
SUMMARY
The SNaP System is substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
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 755 N. Mathilda Avenue, Suite 100 Sunnyvale, California 94085
DEC - 1 2011
Re: K113032 Trade/Device Name: The SNaP® Wound Care System Regulation Number: 21 CFR 878.4683 Regulation Name: Non-Powered suction apparatus device intended for negative pressure wound therapy Regulatory Class: II Product Code: OKO Dated: November 21, 2011 Received: November 22, 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
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Page 2 - Ms. Sarah Canio
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-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/ucm1 1 1800 html fr the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF) Pact 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 fire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/défault.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Erin Keith
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Spiracur Inc.
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K113032
Device Name:
Indications For Use:
The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious naterial 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, venous or pressure), surgically closed incisions, flaps and grafts.
Prescription Use _ X (21 CFR Part 801 Subpart D) C)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) ·
Daniel Kline
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113032