(298 days)
Not Found
No
The description focuses on the mechanical and chemical process of oxygen generation and delivery, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to provide topical oxygen to aid in the healing of chronic wounds." Healing wounds is a therapeutic function.
No
The device is described as an oxygen delivery system intended to aid in the healing of chronic wounds by providing topical oxygen, not for diagnosing conditions.
No
The device description explicitly states it is a "small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator." This indicates a physical hardware component, not a software-only device.
Based on the provided information, the NATROX™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- NATROX™ System Function: The NATROX™ System is a device that delivers oxygen topically to a wound. It does not analyze or examine any biological specimens from the patient. Its function is to directly interact with the wound bed to aid in healing.
Therefore, the NATROX™ System falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:
- . Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions,
- . Decubitis ulcers (bedsores),
- Amputations/infected stumps, .
- . Skin grafts,
- Burns, and .
- Frostbite
Product codes
KPJ
Device Description
The NATROX™ Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces 99% oxygen from room air at a rate of approximately 13 mL/hour. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), Island Oxygen Delivery Pad (IODP) wound dressing or into the patient's own wound dressing, The NATROX™ System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.
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: The NATROX™ Topical Oxygen Delivery System has been tested according to IEC 60601-1, IEC 60601-1-2 and was found to meet all requirements. Performance data also support that the NATROX™ device and accessories meet the specified criteria.
Clinical Evaluation: A clinical study in 10 patients was conducted using to support the safety, efficacy and usability of the VELOX device, which is an earlier version of the NATROXIM that produces the same oxygen concentration and oxygen flow. This 6-week study demonstrated that use of the VELOX device significantly reduced wound size and wound pain, did not result in adverse effects, and supported the usability of the device.
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
K112634 page 1/2
Inotec AMD Ltd
3 2012
JUL
510(k) Summary of Safety and Effectiveness
Manufacturer and Submitter
Company Name: Inotec AMD Ltd. Company Address: Unit 4a Butts Business Centre, Fowlmere, Cambridge Cambridgeshire SG8 7TS, UK Tel 44(0) 1763 207222 Contact Person: Nicholas Hyde Date Summary Prepared: April 16, 2012
| Device | |
|---|---|
| Trade/Device Name: | NATROX™ Topical Oxygen Delivery System with Accessories |
| Common/Usual Name: | Topical Oxygen Chamber |
| Classification Name: | Chamber, Oxygen, Topical, Extremity |
| Regulation Number: | 21 CFR 878.5650 |
| Product Code: | KPJ |
| Classification Panel: | General & Plastic Surgery |
| Classification: | Class II |
Substantial Equivalence
This 510(k) submission demonstrates that the NATROX™ Topical Oxygen Delivery System is substantially equivalent to the Oxybox System (Oxyfast Corporation, K023456) and the TransCu O2 (Electrochemical Oxygen Concepts, Inc., K090681), which are similar in both technology and intended use to the subject device.
Device Description
The NATROX™ Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces 99% oxygen from room air at a rate of approximately 13 mL/hour. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), Island Oxygen Delivery Pad (IODP) wound dressing or into the patient's own wound dressing, The NATROX™ System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.
Intended Use/Indications for Use
The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:
- . Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions,
- . Decubitis ulcers (bedsores),
- Amputations/infected stumps, .
- . Skin grafts,
- Burns, and .
- Frostbite
NATROX™ System Premarket Notification Application
1
K112634 Page 2/2
Inotec AMD Ltd
Performance - Bench Testing
The NATROX™ Topical Oxygen Delivery System has been tested according to IEC 60601-1, IEC 60601-1-2 and was found to meet all requirements. Performance data also support that the NATROX™ device and accessories meet the specified criteria.
Performance - Clinical Evaluation
A clinical study in 10 patients was conducted using to support the safety, efficacy and usability of the VELOX device, which is an earlier version of the NATROXIM that produces the same oxygen concentration and oxygen flow. This 6-week study demonstrated that use of the VELOX device significantly reduced wound size and wound pain, did not result in adverse effects, and supported the usability of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Inotec AMD Limited % Mandell Horwitz Consultants, LLC Ms. Diane Horwitz 2995 Steven Martin Drive Fairfax, Virginia 22031
3 2012 JUL
Re: K112634
Trade/Device Name: NATROX™ Topical Oxygen Delivery System with Accesories Regulation Number: 21 CFR 878.5650 Regulation Name: Topical oxygen chamber for extremities Regulatory Class: Class II Product Code: KPJ Dated: June 15, 2012 Received: June 15, 2012
Dear Ms. Horwitz:
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.
3
Page 2- Ms. Diane Horwitz
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.
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 yours,
Eunel Keith
Fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K112634
Device Name: NATROX™ Topical Oxygen Delivery System
Indications For Use:
The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:
- Skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions,
- Decubitis ulcers (bedsores), .
- Amputations/infected stumps, .
- Skin grafts,
- Burns, and
- 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kane for M/M
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112634