(88 days)
Not Found
Not Found
No
The summary describes a mechanical device for oxygen enrichment and contains no mention of AI or ML.
Yes
The device is designed to provide higher concentrations of oxygen to patients, which is a therapeutic intervention.
No
The device is described as an "Oxygen Enrichment Kit" designed to provide higher concentrations of oxygen to patients by mixing room air with an oxygen source. Its purpose is to deliver therapeutic oxygen, not to diagnose a condition.
No
The device description clearly states "Oxygen Enrichment Kit" and describes its function as mixing room air with an oxygen source, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide higher concentrations of oxygen to a patient by mixing gases at the proximal airway. This is a direct interaction with the patient's respiratory system, not an in vitro (outside the body) examination of specimens.
- Device Description: The device is described as an "Oxygen Enrichment Kit," which aligns with its function of modifying the gas delivered to the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
Therefore, the SG 066 and SG 067 Oxygen Enrichment Kits are considered medical devices used for respiratory support, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SG 066 and SG 067 Oxygen Enrichment Kits are designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
Device Description
The SG 066 and SG 067 Oxygen Enrichment Kits are designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal airway
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)
Not Found
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.
Not Found
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1999
Ms. Tricia Wood Regulatory Affairs/Quality Assurance Manager Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102
Re: K992670 Oxygen Enrichment Kit Regulatory Class: II (two) Product Code: 73 CBK Dated: June 16, 1999 Received: June 21, 1999
Dear Ms. Wood:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for
1
Page 2 - Ms. Tricia Wood
devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Sincerely yours,
Thomas J. Oblek
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
INDICATION FOR USE STATEMENT
SG 066 and SG 067 Oxygen Enrichment Kit Device:
The SG 066 and SG 067 Oxygen Enrichment Kits are designed for use on certain
t The SG 066 and SG 067 Oxygen Enficiance fers are assigned 1007
ventilators to provide higher concentrations of oxygen to the patient by mixing room
in the provide higher conc venthators to provide ing-on-goodimal airway.
air with an oxygen source at the proximal airway.
Tricia Wl
Signature
Signature
Tricia Wood Typed Name
6/16/99
Date
Premarket notification (510(k)) number
Premarket not
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 997 510(k) Number
- prescription use
71 CFR 801.109
4-1 OTC