(71 days)
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.
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.
The provided text is a 510(k) summary for the SNaP® Wound Care System, a non-powered, negative pressure wound therapy device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria based on a clinical study with performance metrics like sensitivity, specificity, or accuracy.
Therefore, many of the questions regarding acceptance criteria, study sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/imaging devices, are not applicable to this type of regulatory submission.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with specific performance metrics (e.g., accuracy percentages, sensitivity, specificity) are stated in the document. The regulatory pathway is based on substantial equivalence to a predicate device, meaning the new device performs "comparably" and does not raise new safety or effectiveness concerns.
The reported "performance" is primarily a demonstration of its ability to deliver negative pressure wound therapy comparable to the predicate device.
| Acceptance Criteria (Explicitly stated in terms of performance metrics) | Reported Device Performance |
|---|---|
| Not applicable; acceptance is based on demonstrating substantial equivalence to a predicate device and comparable functionality. | The modified SNaP Wound Care System was shown to deliver negative pressure wound therapy comparable to the predicate device (K081406) through bench testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable. The "test set" in this context refers to bench testing of the device itself, not a dataset of patient cases. The document does not specify the number of units tested.
- Data provenance: Not applicable. The "data" refers to engineering test results, not patient data. No country of origin for such data is mentioned, nor is it classified as retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of device performance in this 510(k) submission relates to the physical parameters of the device (e.g., negative pressure delivery), not expert interpretation of clinical data. Therefore, no experts were used to establish ground truth in the manner typical for AI/imaging product evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve disagreements among human reviewers (experts) when establishing ground truth for clinical data. This regulatory submission relies on bench testing and engineering verification, not human adjudication of clinical cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC comparative effectiveness study was not done. This device is a mechanical wound therapy system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm. Its performance is inherent to its mechanical function, not an algorithmic output. The "software validation testing" mentioned is likely for internal control software, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's functionality would be based on engineering specifications and measurements (e.g., verifying that the device consistently generates and maintains the specified negative pressure, or that the alarm functions correctly). This is an objective measurement of physical parameters, not a clinical diagnosis or outcome.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no training set and therefore no ground truth established for it.
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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)
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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)
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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
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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
§ 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.