(14 days)
No
The description focuses on a mechanical, non-powered suction device and does not mention any AI or ML components or functionalities.
Yes
The device is used for wound care, specifically for removing excess exudates and promoting wound healing, which directly contributes to a therapeutic outcome.
No
The device description clearly states its purpose is for wound management through the application of negative pressure to remove fluids and debris, promoting wound healing. It does not perform any diagnostic functions by identifying or characterizing diseases or conditions.
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 clearly indicates a physical hardware component is the primary mechanism of action, not software.
Based on the provided information, the SNaP® Wound Care System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- SNaP Wound Care System Function: The SNaP Wound Care System is a suction device that applies negative pressure directly to a wound to remove exudate, infectious material, and tissue debris. It is a therapeutic device used for wound management, not for analyzing specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, use of reagents, or providing diagnostic information based on laboratory testing.
Therefore, the SNaP Wound Care System falls under the category of a therapeutic medical device used for wound care, not an IVD.
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
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)
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 (K111393)
Biocompatibility testing
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 SY: SPECIAL 510(k) PREMARKET NOTIFICATION
SECTION 6 510(k) SUMMARY
510(k) Notification K (234) AUG 2 9 2011
GENERAL INFORMATION
Applicant:
Spiracur Inc. 1180 Bordeaux Drive Sunnyvale, CA 94089 U.S.A. Phone: 408-701-5300 408-701-5301 Fax:
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: August 12, 2011
Classification:
21 CFR§878.4683, Class II
Product Code:
OKO
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 (K111393)
1
SPIRACUR INC.
K 112341 Page 2/3
NaP® WOUND CARE SYSTEM SPECIAL 510(k) PREMARKET NOTIFICATION
SECTION 6 510(k) SUMMARY
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:
This Special 510(k) premarket notification is for the SNaP Wound Care System, which is a modified version of the cleared SNaP Wound Care System (K111393). The minor design modification implemented to develop the modified SNaP System includes a change to the SNaP Dressing Kit to incorporate the use of a hydrophobic polyurethane foam. There have been no changes to the other components of the SNaP System as a result of this design change. The design modifications outlined in this Special 510(k) premarket notification do not (1) affect the intended use or (2) alter the fundamental scientific technology of the device. The modified SNaP System shares the same intended use, the same technological characteristics and the same principles of operation as the predicate device. The modified SNaP System and the cleared SNaP System (K111393) are both non-powered, portable, single-use suction devices intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids and infectious materials. Both systems utilize dedicated constant-force springs to mechanically generate the negative pressure gradient. Any differences between the devices do not raise any new issues of safety or effectiveness.
2
Spiracur Inc.
SECTION 6 510(k) Summary
SPECIAL 510(k) PREMARKET NOTIFICATION
Testing in Support of Substantial Equivalence Determination:
The SNaP Wound Care System and its components were evaluated to ensure conformance to design specifications. The testing performed includes:
- 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 (K111393)
- Biocompatibility testing .
Summary:
The SNaP Wound Care System is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
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 Sunnyvale, California 94085
AUG 29 2011
Re: K112341
Trade/Device Name: 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: August 12, 2011 Received: August 15, 2011
Dear Ms. Canio:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in addesice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorement date of the Medical Device Amendments, or to Conninered prilly to May 20, 1978, the econdance 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 r ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls proficions of wactice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Ticase note: "CDree books and 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 If your device to additional controls. Existing major regulations affecting your device can be may be subject to additions, 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 i that FDA has made a determination that your device complies with other requirements of the Act
4
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/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, Paul 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcectorYou/Industry/default.htm.
Sincerely vours.
fo
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SPIRACUR INC.
SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Klo
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)
David Knoeffer MXM
Division Si (Division of Surgical, Orthoped and Restorative Devices
510(k) Number K112341