(298 days)
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
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.
The provided text describes the NATROX™ Topical Oxygen Delivery System and its safety and effectiveness. However, it does not contain specific acceptance criteria in a quantifiable format (e.g., "wound size reduction of X% with p-value < Y"). Instead, it broadly states that the device "meets all requirements" and "meets the specified criteria." The clinical study details are also very high-level.
Based on the provided text, here's an attempt to structure the information, acknowledging the missing acceptance criteria and detailed performance metrics:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safe for use and does not result in adverse effects. | A 6-week clinical study on 10 patients using the VELOX device (an earlier version of NATROX™ producing the same oxygen concentration and flow) "did not result in adverse effects." The NATROX™ system has also been tested according to IEC 60601-1 and IEC 60601-1-2 and "was found to meet all requirements." |
| Efficacy: Aids in the healing of chronic wounds, specifically by reducing wound size and pain. | The 6-week clinical study on 10 patients using the VELOX device "demonstrated that use of the VELOX device significantly reduced wound size and wound pain." The system provides topical oxygen to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. Performance data also supports that the NATROX™ device and accessories "meet the specified criteria." |
| Usability: The device is usable in a clinical setting. | The 6-week clinical study implicitly supported the usability of the device, as it was successfully used in 10 patients. Specific metrics or user feedback details are not provided. |
| Technical Conformance: Meets relevant electrical safety and electromagnetic compatibility standards. | The NATROX™ Topical Oxygen Delivery System has been tested according to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests), and "was found to meet all requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 10 patients.
- Data Provenance: The text does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given the manufacturer is based in Cambridge, UK, it's plausible the study was conducted in the UK. The description of it as "A clinical study was conducted" suggests it was a prospective study, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention using experts to establish ground truth for the clinical study's outcomes (wound size reduction, pain, adverse effects). The evaluation appears to be based on direct clinical observation and measurement.
4. Adjudication Method for the Test Set
The document does not provide any information on an adjudication method for the clinical study results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with AI vs. without AI assistance. The device is a topical oxygen delivery system, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance
This question is not applicable as the NATROX™ System is a medical device for delivering oxygen, not an algorithm for diagnosis or analysis. Therefore, there is no "standalone algorithm performance" to report.
7. Type of Ground Truth Used (Clinical Study)
The ground truth for the clinical evaluation was based on direct clinical measurements and observations of "wound size" reduction, "wound pain" reduction, and the occurrence of "adverse effects" in patients.
8. Sample Size for the Training Set
- The document does not mention a 'training set' as the device is a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no mention of a training set for an algorithm.
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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
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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.
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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.
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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
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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
§ 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.