(149 days)
The TransCu O2 low dose tissue oxygenation system is intended for use with wound dressings to treat the following: Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions Pressure ulcers Infected residual limbs Skin grafts Burns Frostbite
TransCu O2 is a low dose tissue oxygenation system for the treatment of wounds such as venous leg ulcers, diabetic foot ulcers and pressure ulcers. TransCu O2 is intended for use with wound dressings. TransCu O2 consists of a handheld electrochemical oxygen concentrator, an oxygen delivery extension set and a wound site oxygen delivery cannula. The TransCu O2 device incorporates enhanced fuel cell chemistry, utilizing a Proton Exchange Membrane to electrochemically generate the low dose pure oxygen. The battery operated device is lightweight, portable and can be worn discretely, functioning in remote communication with the wound site through long microbore tubing. TransCu O2 extracts oxygen from room air; concentrates the oxygen through the PEM; and then creates an oxygen rich environment by increasing the available oxygen at the wound site under the dressing.
The provided text describes a medical device, TransCu O2, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document is a regulatory filing for a medical device (TransCu O2) and primarily focuses on its substantial equivalence to a predicate device (OxyBox System - K023456). It outlines the device's description, intended use, indications, and classification.
The "Performance Testing" section simply states: "Bench testing validates that the TransCu O2 performs according to its specifications." This is a general statement and does not provide any specific acceptance criteria, study details, performance metrics, or data.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication, or comparative effectiveness studies, as these details are not present in the provided text.
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KO90681
5. 510(k) Summary
រុ
AUG 12 2009
TransCu O2
| Date of Summary | 06/29/09 |
|---|---|
| Submitter/ContactPerson | H. Carl JenkinsThe Wood Burditt Group10 E. Scranton Ave., Suite 201(ph) (847) 234-7500 x 205(fax) (847) 574-0728(email) hcjenkins@woodburditt.com |
| Applicant | Electrochemical Oxygen Concepts, Inc2 Amber GlenSan Antonio, TX 78257 |
| Device Name | TransCu O2 |
| Common Name | Low Dose Tissue Oxygenation System(classified as a "Topical Oxygen Chamber for Extremities" devicetype) |
| Classification | "Topical Oxygen Chamber for Extremities"Regulation Number: 21 CFR §878.5650Product Code: KPJPanel Code: General and Plastic SurgeryDevice Class: III (proposed as Class II (71 FR 17390)). |
| Legally MarketedPredicate Devices | The TransCu O2 is substantially equivalent in respect to theintended use, design and method of operation to:Name: OxyBox System510(k) number: K023456Manufacturer: OxyFast Corporation |
| Device Description | TransCu O2 is a low dose tissue oxygenation system for thetreatment of wounds such as venous leg ulcers, diabetic foot ulcersand pressure ulcers. TransCu O2 is intended for use with wound |
| dressings. TransCu O2 consists of a handheld electrochemical | |
| oxygen concentrator, an oxygen delivery extension set and a | |
| wound site oxygen delivery cannula. The TransCu O2 device | |
| incorporates enhanced fuel cell chemistry, utilizing a Proton | |
| Exchange Membrane to electrochemically generate the low dose | |
| pure oxygen. The battery operated device is lightweight, portable | |
| and can be worn discretely, functioning in remote communication | |
| with the wound site through long microbore tubing. TransCu O2 | |
| extracts oxygen from room air; concentrates the oxygen through | |
| the PEM; and then creates an oxygen rich environment by | |
| increasing the available oxygen at the wound site under the | |
| dressing. | |
| Intended Use and | The TransCu O2 low dose tissue oxygenation system is intendedfor use with wound dressings to treat the following: |
| Indications | Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions Pressure ulcers Infected residual limbs Skin grafts Burns Frostbite |
| Performance Testing | Bench testing validates that the TransCu O2 performs according to |
| its specifications. |
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5. 510(k) Summary
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. 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 Mail Center - WO66-G609 Silver Spring, MD 20993-0002
The Wood Burditt Group % Mr. H. Carl Jenkins 10 E. Scranton Avenue, Suite 201 Lake Bluff, Illinois 60044
AUG 12 2009
Re: K090681
Trade/Device Name: TransCu O2 Regulation Number: 21 CFR 878.5650 Regulation Name: Topical oxygen chamber for extremities Regulatory Class: Class III Product Code: KPJ Dated: July 6, 2009 Received: July 7, 2009
Dear Mr. Jenkins:
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 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.
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Page 2 - Mr. H. Carl Jenkins
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/ucm11.5809.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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
for
Mark N. Melkerson
Director
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 Statement
| Indications for Use |
|---|
| --------------------- |
K09068 510(k) Number (if known):
Device Name: TransCu O2
Indications for Use:
The TransCu O2 low dose tissue oxygenation system is intended for use with wound dressings to treat the following:
- Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous . lesions
- Pressure ulcers .
- Infected residual limbs ●
- Skin grafts .
- Burns
- Frostbite
Prescription Use X (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)
Daniel Kroneberger
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090651
Page 1 of 1
- Indications for Use Statement
Page 4.1 of 4.1
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.