(395 days)
The extriCARE 2400 Negative Pressure Wound Therapy Pump System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.
The system consists of a vacuum pump, canister, and tubing. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage. Maximum pressure and mode selection are digitally programmable. The extriCARE pump can be sold alone or as a part of the extriCARE 2400 system with extriCARE bandages. The extriCARE bandages are an all-in-one wound dressing, with no wound packing required.
The provided text describes the extriCARE 2400 Negative Pressure Wound Therapy System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria related to AI or a diagnostic performance claim.
Instead, the document focuses on:
- Device Description and Intended Use: Explaining what the extriCARE 2400 system is and what it's designed to do (generate negative pressure to remove wound exudates, infectious material, and tissue debris).
- Substantial Equivalence: Arguing that the device is technologically similar to existing predicate devices (NPD 1000, MobIVAC W.C., Renasys Gauze Dressing Kit).
- Performance Testing: Listing functional and mechanical tests (e.g., vacuum pressure calibration, flow rate, alarm verification, battery verification, exudate removal, bandage tests like peel strength, shear adhesion, leakage), and compliance with EMC and electrical safety standards (IEC 60601-1-2, UL 60601-1). These are engineering performance tests, not diagnostic accuracy studies.
- Biocompatibility Testing: Reporting results for tests on the bandage (Guinea Pig Maximization Sensitization, Cytotoxicity, Intracutaneous Irritation) to ensure it's safe for body contact.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving a device meets them, especially regarding diagnostic accuracy, AI performance, or MRMC studies, as this information is not present in the provided text.
Specifically, the following points from your request cannot be answered from the provided document:
- A table of acceptance criteria and the reported device performance: While performance tests are listed, the acceptance criteria for these tests (e.g., "vacuum pressure must be within X% of target") are not explicitly stated, nor are the detailed quantitative results ("reported device performance") beyond "successfully passed" or "did not elicit sensitization/non-cytotoxic/non-irritant" for biocompatibility tests.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
- 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): Not applicable as this is not a diagnostic device or AI study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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510(K) SUMMARY
Submitter:
Devon Medical Products, Inc.
Contact Person:
Ruth Wu, COO 1100 First Avenue, Suite 202 King of Prussia, PA 19406 Phone: 866.446.0092 484.636.0211 Fax:
Common Classification & Proprietary Names:
| Common Names: | Negative Pressure Wound Therapy System |
|---|---|
| Proprietary Name: | extriCARE 2400 |
Date Prepared:
August 29, 2011
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the extriCARE 2400:
| FDA | Classification | Product Code | Class | |
|---|---|---|---|---|
| 21 CFR 878.4780 | Powered Suction Pump | OMP | II |
Predicate Devices:
The extriCARE 2400 Negative Pressure Wound Therapy System is substantially equivalent to the following.
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| NPD 1000 | Kalypto Medical | K080275 |
| MobIVAC W.C. | Ohio Medical | K081185 |
| Renasys GauzeDressing Kit | Smith & Nephew | K110647 |
Device Description
The system consists of a vacuum pump, canister, and tubing. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage. Maximum pressure and mode selection are digitally programmable. The extriCARE pump can be sold alone or as a part of the extriCARE 2400 system with extriCARE bandages. The extriCARE bandages are an all-in-one wound dressing, with no wound packing required.
Intended Use:
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The extriCARE 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.
0078
Technological Characteristics:
The manufacturer believes that the technological characteristic of the extriCARE 2400 are substantially similar to those of the predicate devices. The extriCARE 2400 has very similar components to its predicate devices and very similar principles of operation. The device consists of an electrically generated source of vacuum, a canister. Like the predicates, vacuum, is applied for a specified period of time and intensity, according to the physician's prescription.
Performance Testing
To verify that the device design met it's functional and performance requirements, representative samples of the device underwent function and mechanical testing, EMC testing in accordance with IEC 60601-1-2 and electrical safety testing in accordance with UL 60601-1.
| Function Performance Tests |
|---|
| PQ-01 extriCARE 2400 Vacuum Pressure Calibration |
| PQ-02 Comparison on SE for Vacuum Pressure Calibration |
| PQ-03 Treat Time verification on Intermittent Mode for extriCARE 2400 |
| PQ-04 Flow Rate Performance on for extriCARE 2400 |
| PQ-05 Alarm Verification for extriCARE 2400 |
| PQ-06 Battery Verification for extriCARE 2400 |
| PQ-07 Exudate Removal test on extriCARE 2400 and extriCARE bandage |
| PQ-08 Peel strength test on extriCARE Bandage T-ZG-027 |
| PQ-09 Shear Adhesion test on extriCARE Bandage T-ZG-065 |
| PQ-10 Leakage test on extriCARE Bandage |
Biocompatibility
The extriCARE 2400 system consists of both the pump and the bandage. While the pump has no direct body contact when used as indicated, the bandage does have direct body contact. Per ISO-10993 B-prolonged contact(24h - 30 days) requirements, the bandage samples were tested for the following items and all tests were successfully passed.
| Date | Protocol # | Result Summary | ||
|---|---|---|---|---|
| Test 1 | ISO Guinea PigMaximizationSensitization Test(GLP) | Oct 8, 2010 | Wuxi AppTec900850-23 | The test articledid not elicitsensitizationresponse. |
| Test 2 | Cytotoxicity - MEM | Oct 29, 2010 | Nelson | Non-cytotoxic |
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| Elution without silver (ISO) | 201003532 Rev 01 | |||
|---|---|---|---|---|
| Test 3 | Cytotoxicity – MEMElution with silver (ISO) | Oct 21, 2010 | Nelson201003441 Rev 01 | Non-cytotoxic |
| Test 4 | Intracutaneous Irritation | Nov 11, 2010 | NLI# 550001 | Non-irritant |
Statement of Substantial Equivalence
The extriCARE 2400 system is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Products, believes that the extriCARE 2400, is safe and effective and substantially equivalent to the predicate devices as described herein.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Devon Medical Products, Inc. % Ms. Ruth Wu. COO 1100 First Avenue, Suite 202 King of Prussia, Pennsylvania 19406
Re: K110078
Trade/Device Name: extriCARE 2400 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 18, 2012 Received: January 31, 2012
Dear Ms. Wu:
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 0 2012
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Page 2 - Ms. Ruth Woo, COO
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 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/Resourcesfor You/Industry/default.htm.
Sincerely y
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 4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _
Device Name: extriCARE 2400
The extriCARE 2400 Negative Pressure Wound Therapy Pump System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kucera for MIXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110078
§ 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.