The SNaP® Wound Care System is indicated for patients who would 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.

SNaP System with SNaP Plus Cartridge (150cc):

The SNaP® Wound Care System is indicated for patients who would 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 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.

Device Description

The SNaP® Wound Care System ("SNaP System") is a non-powered, portable, singleuse, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management via application of negative pressure to the wound or closed incision for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System is based on the concept of forced expansion of volume to produce negative pressure at the wound bed or at the closed incision, utilizing dedicated constantforce springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. It is capable of delivering negative pressure wound therapy at a near-constant pressure level over several days without any required adjustments by the patient or clinician.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "SNaP® Wound Care System." It describes modifications to an already cleared device, not a new device requiring a full efficacy study. As such, the information typically found in a study proving a device meets acceptance criteria, such as detailed clinical study results with specific sample sizes, ground truth establishment, adjudication methods, or multi-reader multi-case studies, is not present here.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through nonclinical, bench testing. The acceptance criteria are essentially met by showing the modified device performs similarly to the predicate devices and existing specifications, and that the changes do not raise new questions of safety or effectiveness.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not applicable in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Device design verification: Conformance to design specifications at baseline and after 2-years accelerated aging	Testing ensured conformance to design specifications at baseline and after 2-years accelerated aging.
Device user requirements verification: For the SNaP Plus Strap	Testing confirmed user requirements for the SNaP Plus Strap.
7-day use verification: For SNaP cartridges	Verification testing supported 7-day use of the SNaP cartridges.
Sterilization validation: For the additional dressing kit	Sterilization validation was performed for the additional dressing kit.
Biocompatibility: Of device materials	Biocompatibility testing was conducted.
Packaging and shelf life: Integrity and stability	Packaging and shelf life testing was performed.
Safety and Effectiveness: No new questions of safety or effectiveness compared to predicate devices	The collective nonclinical testing demonstrates that the SNaP Wound Care System does not raise new questions of safety or effectiveness.
Intended Use: Identical to predicate devices	The proposed Indications for Use statements are identical to the FDA-cleared Indications for Use of the predicate devices.
Performance: Consistent performance during intended use	The collective results demonstrate the materials and design meet established specifications for consistent performance during intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The testing was nonclinical (bench testing), not a clinical trial with a "test set" of patients. The sample sizes would refer to the number of devices or components tested.
Data Provenance: Not applicable in the context of clinical trial data. This refers to in-house laboratory testing of the device components and system.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a nonclinical submission. "Ground truth" in this context would refer to the established performance requirements and specifications for the device, likely determined by engineering and regulatory standards, and internal quality control. No external experts or medical professionals were involved in establishing "ground truth" for nonclinical bench testing results presented here.

4. Adjudication Method for the Test Set

Not applicable. This was a nonclinical submission. Adjudication methods are typically relevant for clinical studies where expert consensus or review is needed to classify findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. An MRMC study was not done. This is a nonclinical submission for a wound care system, not an imaging device requiring human reader interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a hardware medical device, not an AI/algorithm-based diagnostic or therapeutic tool.

7. The Type of Ground Truth Used

Engineering Specifications and Standardized Test Methods: For nonclinical bench testing, the "ground truth" is defined by established engineering design specifications, internationally recognized standards for medical devices (e.g., for materials, sterilization, pressure levels, and biocompatibility), and internal test protocols. The device's performance is compared against these predetermined specifications.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm or training set, this question is irrelevant to this submission.

Summary of the Study (Bench Testing):

The "study" described in the 510(k) notification is a series of nonclinical, bench tests designed to demonstrate that minor design changes and additions to the SNaP Wound Care System do not alter its safety or effectiveness compared to its predicate devices. The modifications included a simplified reset feature, minor material/design changes for commercial scale production, and the addition of a Long Dressing Kit and a SNaP Plus Strap.

The testing covered:

Device design verification at baseline and after 2-year accelerated aging.
User requirements verification for the SNaP Plus Strap.
Verification of 7-day use for the SNaP cartridges.
Sterilization validation for the new dressing kit.
Biocompatibility testing.
Packaging and shelf life testing.

No clinical testing was performed. The collective results of these nonclinical tests formed the basis for concluding that the device meets established specifications and is substantially equivalent to the predicate devices, not raising new questions concerning safety or effectiveness. The removal of a contraindication for use on actively infected wounds was supported by comparison to other NPWT products and published clinical evidence (though not clinical evidence specifically generated for this submission).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 19, 2015

Spiracur Incorporated Mr. Ronald S. Warren Experien Group, LLC 755 North Mathilda Avenue, Suite 100 Sunnyvale, California 94085

Re: K151710

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: October 16, 2015 Received: October 19, 2015

Dear Mr. Warren:

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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CFR Part 807); labeling (21 CFR Part 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151710

Device Name SNaP® Wound Care System

Indications for Use (Describe) SNaP System with SNaP Cartridge (60cc):

SNaP System with SNaP Plus Cartridge (150cc):

The SNaP® Wound Care System is indicated for patients who would 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 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)

2 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

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510(k) Notification K151710

I. GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Spiracur Inc. 1180 Bordeaux Drive Sunnyvale, CA 94089 U.S.A. Phone: 408-701-5300 Fax: 408-701-5301

Contact Person:

Ronald S. Warren Regulatory Consultant for Spiracur Inc. Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. 408-505-3926 Phone: Fax: 408-400-0865 Email: Ron@experiengroup.com

Date Prepared: November 19, 2015

II. DEVICE INFORMATION [807.92(a)(2)]

Trade/Proprietary Name: SNaP® Wound Care System

Generic/Common Name:

Negative Pressure Wound Therapy (NPWT) non-powered suction apparatus

Classification Name:

Non-powered suction apparatus device intended for negative pressure wound therapy (21 CFR§878.4683)

Regulatory Class: Class II

Product Code: OKO

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III. PREDICATE DEVICES [807.92(a)(3)]

Spiracur Inc. SNaP® Wound Care Systems (K142272 and K132080) are cited as predicate devices for this premarket notification.

In addition, to support changes that are the subject of this 510(k), reference is also made to the KCI V.A.C. Therapy System (K120033) and the ciSNaP Closed Incision System (K133137).

IV. DEVICE DESCRIPTION [807.92(a)(4)]

SNaP® Wound Care System

V. INDICATIONS FOR USE [807.92(a)(5)]

SNaP® Wound Care System

The Indications for Use statements for the proposed SNaP System with the available cartridges [SNaP Cartridge (60cc), SNaP Cartridge with Reset (60cc), and SNaP Plus Cartridge (150cc)] are identical to those of the respective predicate devices:

● SNaP System with SNaP Cartridge [SNaP Cartridge (60cc) and SNaP Cartridge with Reset (60cc)]

The indications for use for the SNaP System with SNaP Cartridge (60cc) and SNaP Cartridge with Reset (60cc) are identical to those of the predicate SNaP System with SNaP Cartridge (K132080). The Indications for Use are as follows:

"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."

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● SNaP System with SNaP Plus Cartridge (150cc)

The SNaP System wtih SNaP Plus Cartridge indications for use are identical to those of the predicate SNaP System with SNaP Plus Cartridge (K142272). The Indications for Use are as follows:

"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 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."

As such, the proposed device and the predicate devices are substantially equivalent with respect to indications for use.

This 510(k) also includes information to support the removal of a contraindication for use of the SNaP System over actively infected wounds. This labeling modification was supported based on a comparison with other NPWT products that have the same intended use and similar technological characteristics as the proposed device, and are not contraindicated for use with actively infected wounds. Removal of this contraindication was also supported by reference to numerous medical publications that indicated that the risks of use did not clearly outweigh any possible benefit.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES VI. [807.92(a)(6)]

The predicate SNaP System (K132080) has a 60cc capacity SNaP Cartridge (available in three configurations capable of generating 75mmHg, 100mmHg or 125mmHg of negative pressure) and the predicate SNaP System (K142272) has a 150cc capacity SNaP Plus Cartridge capable of generating 125mmHg of negative pressure. Both predicate devices are used with Spiracur's dressing kits: SNaP Dressing Kit, SNaP Foam Dressing Kit, and SNaP Bridge Dressing Kit as well as with Spiracur's SNaP SecurRing accessory.

The proposed device encompasses both cartridge capacity options (i.e., 60cc and 150cc) with the same pressure features as available in the predicate devices. Additionally, the proposed device is available for use with all aforementioned Spiracur dressing kits used by the predecessor predicate devices. The proposed device has minor design differences as compared to the existing Spiracur SNaP Systems predicate devices.

Compared with the SNaP Cartridge cleared with the SNaP System (K132080), the proposed SNaP Cartridge with Reset (60cc) has a more simplified design of the reset feature. The SNaP Cartridge with Reset (60cc) of the proposed SNaP System enables the user to purge air from the cartridge without having to disconnect the tube fitting.

The SNaP Plus Cartridge (150cc) of the proposed device has component modifications as compared to the predicate SNaP Plus Cartridge (K142272). These were minor material or design modifications primarily related to changing the components from prototype scale to commercial scale production.

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510(k) SUMMARY

In addition to the identical dressing kits also used with the predicate systems, the proposed SNaP System incorporates a Long Dressing Kit. The Long Dressing Kit is a version of the commercial SNaP Foam Dressing Kit. The Long Dressing is used in the same way as does the SNaP Foam Dressing, cleared with the predicate SNaP Systems K132080 and K142272.

Finally, the proposed device includes addition of the SNaP Plus Strap which is intended to provide customers with the convenience of an additional product offering to secure the SNaP Plus Cartridge (150cc) to the patient. This optional SNaP Plus Strap is similar to the strap (SNaP Strap) available with the predicate SNaP Cartridge (60cc) (K132080).

VII. PERFORMANCE DATA [807.92(b)]

To support the device modifications covered by this premarket notification, additional testing was performed on the SNaP System to ensure conformance to design specifications and to support a determination of substantial equivalence to the predicate devices.

[807.92(b)(1)]

The nonclinical, bench testing performed included:

Device design verification testing at baseline and after 2-years accelerated aging; ●
. Device user requirements verification for the SNaP Plus Strap;
Verification testing to support 7-day use of the SNaP cartridges;
Sterilization validation of the additional dressing kit;
Biocompatibility testing; and ●
Packaging and shelf life testing.

[807.92(b)(2)]

No clinical testing was performed in support of this premarket notification.

[807.92(b)(3)]

The collective results of the nonclinical testing demonstrate that the materials chosen and the design of the SNaP Wound Care System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the SNaP Wound Care System does not raise new questions of safety or effectiveness for negative pressure wound therapy when compared to the predicate devices.

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VIII. CONCLUSIONS

This 510(k) premarket notification is for minor design changes, labeling modifications and addition of two components (Long Dressing and SNaP Plus Strap) to the SNaP Wound Care System previously cleared under K132080 and K142272. The modifications to the SNaP System do not raise any new issues of safety or effectiveness, as both the proposed device and the predicate 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 mechanism of action. The proposed Indications for Use statements for the SNaP System is identical to the FDA-cleared Indications for Use statements for the primary predicate devices. The removal of the contraindication for use on actively infected wounds is supported by comparison to labeling of other NPWT devices and published clinical evidence. Any differences in the technological characteristics between the proposed device as compared to the primary predicate devices do not raise any new issues of safety or effectiveness. The SNaP® Wound Care System subject of this 510(k) is substantially equivalent to the predicate Spiracur Inc. SNaP® Wound Care System cleared under K132080 and K142272.

Regulation Number and Section

§ 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.