(101 days)
The CI-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 small amounts of exudates from surgical incisions that continue to drain following sutured or stapled closure.
The CI-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 exudate, irrigation fluids and infectious materials. The CI-SNaP Wound Care System is designed to provide active wound treatment to help promote healing in surgical incisions that continue to drain following sutured or stapled closure. The CI-SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The CI-SNaP™ Wound Care System is used in conjunction with the CI-SNaP™ Dressing Kit.
This 510(k) premarket notification for the CI-SNaP™ Wound Care System (K111006) does not contain specific acceptance criteria or an analytical study demonstrating device performance against such criteria in the way a diagnostic AI/ML device submission would.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (SNaP™ Wound Care System, K081406). The testing described is primarily design verification rather than a clinical effectiveness study.
Here's a breakdown based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for Performance (e.g., a specific pressure range with a tolerance) | The device was evaluated under "design verification tests to assure conformance to design specifications" including: |
| Biocompatibility | "Biocompatibility testing" was performed. |
| Functionality (based on changes from predicate) | Minor design modifications (outer housing, receptacle capacity, activation/deactivation, attachment clip) were made, and the "CI-SNaP Cartridge is provided terminally sterile." |
| Substantial Equivalence | The document concludes that "The CI-SNaP Wound Care System is substantially equivalent to the predicate device." |
Explanation: The document states that bench testing was done to "assess the ability to deliver negative pressure wound therapy." However, it does not specify what negative pressure range it must deliver, for how long, or with what accuracy/consistency, which would be typical acceptance criteria for performance. Similarly, while biocompatibility testing was done, the specific acceptance criteria (e.g., passing ISO 10993 cytotoxicity, sensitization, irritation tests) are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The "bench testing" would likely involve a sample of manufactured devices, but the number is not provided.
- Data Provenance: The device is a physical, non-powered suction apparatus. The testing described is non-clinical bench testing rather than testing on patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is a mechanical negative pressure wound therapy system, not a diagnostic device requiring expert interpretation for "ground truth" establishment in a test set. The efficacy is based on the physical application of negative pressure.
4. Adjudication Method for the Test Set
- Not applicable. As there's no "ground truth" derived from expert consensus on a test set (e.g., imaging, clinical diagnoses), no adjudication method is relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is relevant for diagnostic devices where human readers interpret cases (e.g., radiology images) and compare performance with and without AI assistance. This is a non-powered wound care device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device does not involve an algorithm. It's a mechanical device.
7. The Type of Ground Truth Used
- The "ground truth" for this type of device is its physical performance specifications (e.g., ability to generate and maintain negative pressure, fluid removal capacity, biocompatibility, sterility). The testing described aims to verify these engineering and safety specifications through bench testing and biocompatibility assessments, rather than comparing against a clinical "ground truth" like pathology or patient outcomes for a diagnostic claim. The "intended use" is based on the predicate device's established efficacy.
8. The Sample Size for the Training Set
- Not applicable. This device does not utilize AI/ML and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set.
In summary: The provided 510(k) notification for the CI-SNaP™ Wound Care System focuses on demonstrating substantial equivalence to a predicate device through engineering design verification and biocompatibility testing. It does not involve the types of clinical studies, expert-adjudicated ground truth, or AI/ML specific evaluations that would be described for a diagnostic device. The acceptance criteria are implicitly tied to the device's design specifications and its ability to perform its mechanical function (delivering negative pressure and removing exudate) safely and effectively, as demonstrated by bench testing and biocompatibility.
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Spiracur Inc.
SECTION 6 510(k) SUMMARY
CI-SNaP™ WOUND CARE SYSTEM 510(k) PREMARKET NOTIFICATION
510(k) Notification K111006
JUL 2 1 2011
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 Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 U.S.A. Phone: 408-400-0856 Fax: 408-400-0865 Email: sarah@experiengroup.com
Date Prepared: July 6, 2011
Classification:
21 CFR§878.4683, Class II
Product Code:
ОКО
Trade Name:
CI-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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CI-SNaP™ WOUND CARE SYSTEM 510(k) PREMARKET NOTIFICATION
Spiracur Inc.
SECTION 6 510(k) SUMMARY
Intended Use
The CI-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 small amounts of exudates from surgical incisions that continue to drain following sutured or stapled closure.
Product Description
The CI-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 exudate, irrigation fluids and infectious materials. The CI-SNaP Wound Care System is designed to provide active wound treatment to help promote healing in surgical incisions that continue to drain following sutured or stapled closure. The CI-SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient.
The CI-SNaP™ Wound Care System is used in conjunction with the CI-SNaP™ Dressing Kit.
Substantial Equivalence
The SNaP® System and the CI-SNaP Wound Care System 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. The minor design modifications implemented to develop the CI-SNaP System involve changes to the outer housing and receptacle capacity of the SNaP Cartridge, changes to the activation and deactivation steps, and inclusion of an attachment clip to the CI-SNaP. Additionally, the CI-SNaP Cartridge is provided terminally sterile to enable use of the CI-SNaP System in the operating room suite for the patients with surgically closed incisions. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Therefore, the Cl-SNaP Wound Care System is substantially equivalent to the cleared predicate device (K081406).
Testing in Support of Substantial Equivalence Determination
The CI-SNaP Wound Care System and its components were evaluated under design verification tests to assure conformance to design specifications. The nonclinical tests include:
- . Bench testing conducted on the CI-SNaP Wound Care System to assess the ability to deliver negative pressure wound therapy
- Biocompatibility testing .
Summary
The CI-SNaP Wound Care System is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spiracur % Experien Group, LLC Ms. Sarah Canio 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089
JUL 2 1 2011
Re: K111006
Trade/Device Name: CI-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: QKO Dated: July 11, 2011 Received: July 13, 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. Jane Weber
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/ucm115800.html 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vaurs.
For Dick Dr.
Dr. eln
Dr.
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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SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K111006
Device Name: CI-SNaP™ Wound Care System
Indications For Use:
The CI-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 small amounts of exudates from surgical incisions that continue to drain following sutured or stapled closure.
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 Krone for NSM
Sign Off
(Division Sign-Off)
Division of Surgical, Orthopedic, Division of Surgices Division of Surges and Restorative Devices
510(k) Number K111006
§ 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.