(7 days)
The Sved® Wound Treatment System is indicated for patients who would benefit from an AC-powered, portable suction device with battery backup that provides vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The Sved® Wound Treatment System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts. The specifically designed SVAMP® dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.
The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the 300cc Sved® collection canister. The Svamp™ Wound Dressing components remain the same and are provided in Small, Medium, Large and XL sizes of the polyurethane foam dressing.
This document is a 510(k) summary for the Sved® Wound Treatment System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth is not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, accuracy, or any functional performance thresholds. The submission is based on demonstrating "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (Focus is on substantial equivalence to predicate) | Not explicitly stated (Focus is on technological characteristics and identical functions to predicate) |
The document states: "The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure..." and "The Sved® Wound Treatment System Unit is smaller in size and weighs less compared to the predicate powered suction pump, yet and when same technological characteristics and identical functions."
This implies the "acceptance criteria" are met if the new device functions identically to the predicate, even with physical changes like size and weight.
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding a test set sample size or data provenance. This document is a regulatory submission for premarket notification (510(k)), not a clinical trial report. Equivalence is typically established through engineering comparisons, bench testing, and comparisons of indications for use and technological features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This type of information is pertinent to studies involving human interpretation or performance evaluation against a gold standard, which is not described here.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No MRMC study is mentioned. This document is not a clinical study report.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical wound treatment system, not an AI algorithm.
7. The Type of Ground Truth Used:
Not applicable in the context of an AI device. For this physical device, the "ground truth" for substantial equivalence would be the established safe and effective performance of the predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
Summary of what the document does provide regarding "acceptance criteria" and "proof":
The core "acceptance criteria" for this 510(k) submission revolve around substantial equivalence to an existing legally marketed predicate device (ANTILIA™ Wound Irrigation System, K071301).
The "study" or "proof" presented is a comparison of:
- Indications for Use: The Sved® Wound Treatment System has the same indications for use as the predicate.
- Intended Use: The intended use for both devices is the same.
- Technological Characteristics: The new device employs the "same technological characteristics and identical functions" as the predicate's powered suction pump components, despite being housed in a smaller, lighter enclosure. The Svamp™ Wound Dressing components remain the same.
The document concludes that "The substantial equivalence for the Sved® Wound Treatment System is based on the same indications, intended use, and technological features of the predicate device." This is the "proof" presented in this regulatory context.
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102
510(k) Summary Sved® Wound Treatment System Innovative Therapies, Inc.
Confidential
な 510(k) Summary SVED® WOUND TREATMENT SYSTEM
NOV 2 5 2009
Innovative Therapies, Inc. Name/Address of Submitter: 1. 12 Meem Ave., Suite C Gaithersburg. MD 20877 Judith Harbour 2. Contact Person: Director, Regulatory and Quality 866.484.6798 x 105 3. Date Summary Prepared: October 26, 2009 Sved® Wound Treatment System Name of Device: 4. Powered Suction Pump న. Classification Name: 21 CFR 878.4780 Class II ANTLIA ITM Wound Irrigation System 6. Predicate Device: 510(k) No.K071301
Description of Device 7.
The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the 300cc Sved® collection canister. The Svamp™ Wound Dressing components remain the same and are provided in Small, Medium, Large and XL sizes of the polyurethane foam dressing.
8. Indication For Use
The Sved ® Wound Treatment System is indicated for patients who would benefit from an AC-powered, portable suction device with battery backup that provides vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The Sved® Wound Treatment System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts. The specifically designed SVAMP® dressing components are provided for irrigation to a wound with sterile saline or other applicable topical
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Confidential
K6933864
solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.
9. Technological Characteristics and Substantial Equivalence
The Sved® Wound Treatment System Unit is smaller in size and weighs less compared to the predicate powered suction pump, yet and when same technological characteristics and identical functions.
10. Conclusion
The substantial equivalence for the Sved® Wound Treatment System is based on the same indications, intended use, and technological features of the predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
NUV 2 5 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Innovative Therapies, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K093564
Trade/Device Name: Sved® Wound Treatment System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: November 16, 2009 Received: November 18, 2009
Dear Mr. Job:
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.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Mark Job
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/CDRHQffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milkman
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
510(k) Number (if known):
Device Name: _Sved® Wound Treatment System
Indications for Use:
The Sved® Wound Treatment System is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The intended use for the Sved® Wound Treatment System is for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Milkeves
(Division Sign-Oft) (Division Sign-One), Orthopedic, Division of Restorative Devices
510(k) Number .
Page 1 of 1
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.