(66 days)
Not Found
No
The summary describes a passive, single-use medical device for gas scavenging and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device's purpose is to scavenge gases during conscious sedation procedures, not to treat a specific medical condition or dysfunction.
No
Explanation: The device is intended for the delivery and removal of gases during conscious sedation procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "single-use Nasal Scavenging Circuit," which is a physical hardware component used for gas delivery and removal.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location." This describes a system for managing gases during a medical procedure, not for testing samples taken from the body to diagnose a condition.
- Device Description: The description reinforces this by stating it's for the "removal of patient expired and excess gases during conscious sedation procedures." Again, this is about gas management during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Intended Use: "For Relative Analgesia [Conscious Sedation]"
- Indications for Use: "This disposable device is to be used in conjunction with conscious sedation systems for the delivery to a patient a mixture of analgesic agent and oxygen gases, or analgesic agent and air, for the removal from the treatment location of gases expired by the patient, and removal from the treatment location any excess gases delivered to a patient. The device is supplied non-sterile and latex-free." and "The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a conscious sedation system for the delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location."
Product codes (comma separated list FDA assigned to the subject device)
CBN
Device Description
"The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures."
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)
"In order to verify that the Nasal Scavenging Circuit does not raise new issues of safety or effectiveness and, thus, is substantially equivalent to the predicate device, bench testing was performed. These tests confirmed that the device causes no additional safety issues for the patient."
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
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).
0
NASAL SCAVENGING CIRCUIT PREMARKET NOTIFICATION 510(k)
ULL 1 8 2007
Image /page/0/Picture/2 description: This document is a 510(k) summary for MINRAD Inc. It includes the owner's name, address, contact information, preparation date of August 10th, 2007, device name (Nasal Scavenging Circuit), common name (Gas Scavenging Apparatus), product classification, predicate device (Fraser Harlake Dental Anti-Pollution System (K833692)), and a description of the device. The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures.
i0 Cobham Drive • Orchard Park, New York 14127 • Tel: (800) 832-3303 • (716) 855-1068 • Fax: (716) 855-1078
1
NASAL SCAVENGING CIRCUIT PREMARKET NOTIFICATION 510(k)
| 9. | Voluntary standards: | Performance Standards have not been promulgated for this
device, however pertinent sections of the standards listed
below were followed during the design of the device:
National Institute for Occupational Safety and Health
(NIOSH) Publication No. 94-129 Technical Report –
Control of Nitrous Oxide in Dental Operatories International Standards Organization ISO 5356-1:
2004(E) Anaesthetic and respiratory equipment –
conical connectors, Part 1: Cones and sockets International Standards Organization ISO 5367:2000(E)
Breathing Tubes intended for use with anaesthetic
apparatus and ventilators American National Standards Institute ANSI Z79.11-
1982 for anesthetic equipment – scavenging systems for
excess anesthetic gases CGA V-5 – 2005 Diameter Index Safety System (DISS)
(Non-interchangeable Low Pressure Connections for
Medical Gas Applications) |
|-----|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 10. | Intended use: | For Relative Analgesia [Conscious Sedation] |
| 11. | Indication for Use: | This disposable device is to be used in conjunction with
conscious sedation systems for the delivery to a patient a
mixture of analgesic agent and oxygen gases, or analgesic agent
and air, for the removal from the treatment location of gases
expired by the patient, and removal from the treatment location
any excess gases delivered to a patient. The device is supplied
non-sterile and latex-free. |
| 12. | Technological
characteristics: | The indications for use, the technology, and the performance
specifications are the same for the Nasal Scavenging Circuit and
the predicate device. |
| 13. | Non-Clinical Testing | In order to verify that the Nasal Scavenging Circuit does not
raise new issues of safety or effectiveness and, thus, is
substantially equivalent to the predicate device, bench testing
was performed. These tests confirmed that the device causes no
additional safety issues for the patient. |
This concludes the 510(k) summary.
50 Cobham Drive • Orchard Park, New York 14127 • Tel: (800) 832-3303 • (716) 855-1068 • Fax: (716) 855-1078
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Mr. John McNeirney Vice President and Chief Technical Officer MINRAD, Incorporated 50 Cobham Drive Orchard Park, New York 14127
Re: K072255
Trade/Device Name: Nasal Scavenging Circuit Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: October 12, 2007 Received: October 15, 2007
Dear Mr. McNeirney:
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 such 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 - Mr. McNeirney
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sandite Y. Michie DMD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NASAL SCAVENGING CIRCUIT PREMARKET NOTIFICATION 510(k)
Additional information per 510(k) response letter received August 31, 2007 from Dr. Chiu Lin: ISSUE 1, ATTACHMENT 1 K072255
4.0 Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: Nasal Scavenging Circuit
Indications for Use:
The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a conscious sedation system for the delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location.
Mirt Thilal
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
07 2255 510(k) Number:
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)