(88 days)
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.
Oxygen Enrichment Kit
I apologize, but this document is a 510(k) clearance letter from the FDA for an "Oxygen Enrichment Kit" and does not contain the information requested in your prompt.
Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study proving the device meets acceptance criteria.
- Information on sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- Details about the type or establishment of ground truth for a test or training set.
- Sample size for a training set.
This letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed technical and clinical study data you are asking for.
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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
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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
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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
§ 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).