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.

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.

AI/ML Overview

This document describes a Special 510(k) premarket notification for the SNaP® Wound Care System, focusing on a minor design modification. Due to the nature of a Special 510(k) and the specific information provided, a detailed performance study with acceptance criteria in the typical sense for a new diagnostic device is not presented. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device through bench testing.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Preamble: The special 510(k) is for a modified version of the SNaP® Wound Care System (K111393). The modification involves a change to the SNaP Dressing Kit to incorporate a hydrophobic polyurethane foam. The core argument is that this modification does not change the intended use or alter the fundamental scientific technology.
Ability to deliver negative pressure wound therapy comparable to the predicate device (K111393)	Bench testing was conducted on the modified SNaP Wound Care System to assess this ability. The summary statement is that the SNaP Wound Care System is "substantially equivalent to the predicate device." While specific performance metrics (e.g., precise pressure levels, consistency over time) are not detailed, the implication is that the bench testing confirmed comparable negative pressure delivery.
Biocompatibility	Biocompatibility testing was performed. The overall conclusion of "substantial equivalence" implies that the new material (hydrophobic polyurethane foam) met biocompatibility requirements.
No new issues of safety or effectiveness	The document explicitly states: "Any differences between the devices do not raise any new issues of safety or effectiveness." This is a key acceptance criterion for a Special 510(k).

2. Sample sized 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" and "Biocompatibility testing." For bench testing, typical sample sizes would involve a certain number of manufactured units or material samples. However, specific sample sizes for the bench tests are not provided in the supplied text. Similarly, data provenance (country of origin, retrospective/prospective) is not specified. Biocompatibility testing usually follows ISO standards, which dictate the types and number of samples.

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 is not applicable in the context of this Special 510(k). The evaluation is based on bench testing and biocompatibility assessments related to the physical performance and material properties of the device, not on diagnostic accuracy requiring expert interpretation of results. Therefore, there are no "experts to establish ground truth" in the clinical diagnostic sense. The "ground truth" here is adherence to design specifications and comparable performance to the predicate device, assessed through engineering and material science testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this submission focuses on bench testing and biocompatibility, not clinical diagnostic performance requiring adjudication of interpretations.

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

Not applicable. This device is a non-powered suction apparatus for negative pressure wound therapy, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is outside the scope of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical device for wound therapy, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this submission is related to the engineering specifications and performance characteristics of the device, as well as biocompatibility standards. This is established through:

Design specifications: The device is evaluated to ensure conformance to its own design specifications.
Predicate device performance: The modified device's ability to deliver negative pressure is compared to that of the already cleared predicate device (K111393). The established performance profile of the predicate serves as a benchmark for "ground truth" comparability.
Biocompatibility standards: The materials used are tested against established biocompatibility standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a medical device, not a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

Summary

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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)

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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 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.

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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.

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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

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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/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.

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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SPIRACUR INC.

SECTION 5 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Klo

Device Name: SNaP® Wound Care System

Indications For Use:

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

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.