(250 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, venous or pressure), surgically closed incisions, flaps and grafts.
The SNaP® Wound Care System ("SNaP System") is an existing (K081406, K111393, K112341, K 113032) 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 System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The proposed SNaP Wound Care System will have the same indication for use as the predicate device, the SNaP Wound Care System (K113032). In addition, Spiracur has added the SNaP® Bridge Dressing Kit ("SNaP Bridge Dressing") and SNaP® SecurRing" Hydrocolloid ("SNaP SecurRing") to the SNaP Dressing Kit product family.
This document is a 510(k) summary for the SNaP® Wound Care System, focusing on modifications and additions to the existing device and dressing components. It primarily addresses substantial equivalence to predicate devices and does not contain detailed acceptance criteria and study results in the format requested for proving performance.
Based on the provided text, the device in question is the SNaP® Wound Care System, described as a "Non-powered suction apparatus device intended for negative pressure wound therapy." The submission is for modifications and additions (SNaP® Bridge Dressing Kit and SNaP® SecurRing™ Hydrocolloid) to an already cleared device, along with labeling changes.
Therefore, much of the requested information regarding a study that proves the device meets specific acceptance criteria is not present in this 510(k) summary, as the submission focuses on demonstrating substantial equivalence through bench testing rather than a clinical performance study with predefined acceptance criteria for a new device.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics against such criteria in a table format. Instead, it describes various "bench testing" categories performed to ensure "conformance to design specifications" and "substantial equivalence." The performance is generally described qualitatively as being "comparable to the predicate device."
| Acceptance Criteria Category | Reported Device Performance (Qualitative) |
|---|---|
| Verification testing | Conformance to design specifications |
| Simulated wound performance testing | No specific metrics stated; assessed functionality of latent design feature (resetting) and ability to deliver NPWT comparable to predicate. |
| Biocompatibility testing | Conformance to design specifications |
| Packaging and shelf life testing | Conformance to design specifications |
| Oxygen compatibility (Hyperbaric Oxygen Environment) | Characterized probability of self-ignition and potential severity of ignition; evaluated oxygen compatibility of dressing materials. |
| Functionality of resetting feature | Evaluated ability of the SNaP Wound Care System to deliver negative pressure wound therapy comparable to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench testing" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for any of the tests conducted.
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)
This information is not provided. The text describes bench testing, which typically does not involve human expert ground truth establishment in the way clinical studies with diagnostic devices do.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. As the testing is bench-based, an adjudication method for human readers would not be applicable.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any AI assistance. The device is a non-powered wound care system, not a diagnostic or AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of an algorithm or standalone algorithm performance. The device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing described, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. The document states that testing was done "to ensure conformance to design specifications" and to assess "ability... to deliver negative pressure wound therapy comparable to the predicate device." No clinical ground truth (like pathology or outcomes data) is mentioned for these bench tests.
8. The sample size for the training set
There is no mention of a training set. This document describes the submission for a physical medical device undergoing bench testing for substantial equivalence, not an AI or diagnostic algorithm that would require a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, this information is not applicable and not provided.
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MAR 1 2 2014
Spiracur Inc.
SNaP® Wound Care System TRADITIONAL 510(k) PREMARKET NOTIFICATION
SECTION 6 510(k) SUMMARY
510(k) Notification K132080
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 Regulatory Consultant 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: sarahi@experiengroup.com
Date Prepared: March 10, 2014
DEVICE INFORMATION
Classification : 21CFR§878.4683, Class II
Product Code: OKO, Negative Pressure Wound Therapy Non-Powered Suction Apparatus
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, K111393, K112341, K113032)
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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, venous or pressure), surgically closed incisions, flaps and grafts.
PRODUCT DESCRIPTION
The SNaP® Wound Care System ("SNaP System") is an existing (K081406, K111393, K112341, K 113032) 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 System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The proposed SNaP Wound Care System will have the same indication for use as the predicate device, the SNaP Wound Care System (K113032). In addition, Spiracur has added the SNaP® Bridge Dressing Kit ("SNaP Bridge Dressing") and SNaP® SecurRing" Hydrocolloid ("SNaP SecurRing") to the SNaP Dressing Kit product family.
SUBSTANTIAL EQUIVALENCE
The proposed labeling changes did not result in any design modifications to the cleared SNaP Wound Care System (K081406, K111393, K112341, K113032). The only modifications resulting from the labeling changes are to the SNaP System Instructions for Use provided to the physician, that now describes conditions for use of the SNaP System dressing components within enriched oxygen environments, such as hyperbaric oxygen (HBO) chambers, and also now includes instructions for resetting the SNaP Wound Care Cartridge. In addition, Spiracur has added the SNaP Bridge Dressing and SNaP SecurRing to the SNaP Dressing Kit product family. The SNaP Bridge Dressing is a design modification introduced to the SNaP Foam Dressing Kit (K112341) to facilitate dressing use on a variety of anatomical contours. The sterile, moldable hydrocolloid SNaP SecurRing serves the same function as the hydrocolloid layer of standard SNaP Dressing, to improve the seal of the dressing around the wound.
The additions of the SNaP Bridge Dressing Kit and the SNaP SecurRing to the SNaP Dressing Kit product family are to provide clinicians additional dressing options for use with the SNaP System, designed to help achieve a seal during the SNaP Dressing application. The additions to the SNaP Dressing Kit product family are substantially equivalent to existing items of the product family as they have the same intended use in the same wound types, and utilize similar performance specifications and comparable technological features to achieve the same mechanism of action: therefore, the additions do not raise any new issues of safety or effectiveness.
The SNaP System is substantially equivalent to the predicate device as both devices have the same intended use, have been historically cleared for use in the same wound types, and utilize similar performance specifications and comparable technological features to achieve the same
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Spiracur Inc.
SECTION 6 510(k) SUMMARY
mechanism of action: therefore, the modified labeling does not raise any new issues of safety or effectiveness.
Testing in Support of Substantial Equivalence Determination
To support the additions of the SNaP Bridge Dressing Kit and the SNaP SecurRing to the SNaP Dressing Kit product family, Spiracur conducted necessary bench testing to ensure conformance to design specifications and to support a determination of substantial equivalence to existing items of the SNaP Dressing Kit product family. The testing performed includes:
- Verification testing ●
- . Simulated wound performance testing
- Biocompatibility testing .
- Packaging and shelf life testing .
The proposed labeling changes to the cleared SNaP Wound Care System did not result in any design modifications. All necessary bench testing was conducted on the SNaP Wound Care System and its components to ensure conformance to design specifications and to support a determination of substantial equivalence to the predicate device. The testing performed includes:
- Bench testing within a simulated hyperbaric oxygen environment to characterize . the probability of self-ignition and to characterize the potential severity of ignition of the SNaP Wound Care dressing materials, in order to evaluate the oxygen compatibility of the dressing materials.
- Bench testing conducted in conjunction with the modified device Instructions for . Use to evaluate the functionality of a latent design feature allowing for the resetting of the SNaP Wound Care System to assess the ability of the SNaP Wound Care System to deliver negative pressure wound therapy comparable to the predicate device (K081406, K111393, K112341, K113032).
- Simulated wound performance testing conducted in conjunction with the modified . device Instructions for Use to evaluate the functionality of a latent design feature allowing for the resetting of the SNaP Wound Care System to assess the ability of the SNaP Wound Care System to deliver negative pressure wound therapy comparable to the predicate device (K081406, K111393, K112341, K113032) when used in conjunction with the SNaP Bridge Dressing Kit and the SNaP SecurRing and all other dressing configurations after resetting.
SUMMARY
The SNaP® Wound Care System is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, represented by three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2014
Spiracur Incorporated % Ms. Sarah L. Canio Experien Group, LLC 755 North Mathilda Avenue Sunnyvale, California 94085
Re: K132080
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: Class II Product Code: OKO Dated: February 7, 2014 Received: February 10, 2014
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 commence 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 or any i with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Sarah L. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. 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 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. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132080
Devica Name SNaP® Wound Care System
Indications for Use (Describe)
miliations of to to total vir 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
. .
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Jiyoung Dang
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FORM FDA 3881 (1/14)
§ 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.