(149 days)
Not Found
No
The description focuses on electrochemical oxygen generation and delivery, with no mention of AI or ML technologies.
Yes
The device is described as a "low dose tissue oxygenation system for the treatment of wounds," directly indicating its purpose is to treat medical conditions.
No
The device description states it is a "low dose tissue oxygenation system for the treatment of wounds," indicating a therapeutic purpose rather than diagnosis.
No
The device description explicitly states that the TransCu O2 system consists of hardware components: a handheld electrochemical oxygen concentrator, an oxygen delivery extension set, and a wound site oxygen delivery cannula.
Based on the provided information, the TransCu O2 low dose tissue oxygenation system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- TransCu O2 Function: The description clearly states that the TransCu O2 system is used to treat wounds by delivering oxygen directly to the wound site. It is a therapeutic device, not a diagnostic one. It does not examine specimens from the body to provide diagnostic information.
Therefore, the TransCu O2 system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
KPJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing validates that the TransCu O2 performs according to its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KO90681
5. 510(k) Summary
រុ
AUG 12 2009
TransCu O2
| Date of Summary | 06/29/09 |
|---|---|
| Submitter/Contact | |
| Person | H. Carl Jenkins |
| The Wood Burditt Group | |
| 10 E. Scranton Ave., Suite 201 | |
| (ph) (847) 234-7500 x 205 | |
| (fax) (847) 574-0728 | |
| (email) hcjenkins@woodburditt.com | |
| Applicant | Electrochemical Oxygen Concepts, Inc |
| 2 Amber Glen | |
| San Antonio, TX 78257 | |
| Device Name | TransCu O2 |
| Common Name | Low Dose Tissue Oxygenation System |
| (classified as a "Topical Oxygen Chamber for Extremities" device | |
| type) | |
| Classification | "Topical Oxygen Chamber for Extremities" |
| Regulation Number: 21 CFR §878.5650 | |
| Product Code: KPJ | |
| Panel Code: General and Plastic Surgery | |
| Device Class: III (proposed as Class II (71 FR 17390)). | |
| Legally Marketed | |
| Predicate Devices | The TransCu O2 is substantially equivalent in respect to the |
| intended use, design and method of operation to: | |
| Name: OxyBox System | |
| 510(k) number: K023456 | |
| Manufacturer: OxyFast Corporation | |
| Device Description | 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. | |
| Intended Use and | The TransCu O2 low dose tissue oxygenation system is intended |
| for 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. |
1
5. 510(k) Summary
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2
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.
3
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
4
- 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