(29 days)
Not Found
No
The description focuses on mechanical and functional aspects of controlling vacuum flow and interlocking, with no mention of AI/ML terms or concepts.
No
The device is described as an accessory to control vacuum flow in a gas scavenging apparatus used with nitrous oxide sedation systems, and its purpose is to ensure the presence of an activated scavenging system. It does not directly treat or diagnose a disease or condition.
No
Explanation: The device, an automatic interlock switch (AVS), is described as an accessory for controlling vacuum flow in a gas scavenging apparatus, ensuring analgesic gases cannot be turned on without an activated scavenging system. Its function is to regulate gas flow for safety, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is an "automatic interlock switch (AVS)," which is a physical device intended to control vacuum flow. The performance studies also describe functional and visual inspections of a "finished product," indicating a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as controlling vacuum flow in a gas scavenging apparatus used with dental analgesia gas machines. This is a mechanical function related to gas delivery and scavenging, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as an automatic interlock switch to ensure a scavenging system is present before analgesic gases can be turned on. This is a safety mechanism related to gas delivery, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information
- Using reagents or assays
The device is an accessory for a medical gas delivery system used in a clinical setting, but its function is mechanical and related to the delivery and scavenging of gases, not the analysis of biological specimens.
N/A
Intended Use / Indications for Use
For control of vacuum flow in a gas scavenging apparatus, used as an accessory in Porter Instrument Company's Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines (flowmeters).
The intended use of the AVS accessory is to control the vacuum flow in a gas scavenging apparatus.
Product codes (comma separated list FDA assigned to the subject device)
73 CBN
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Porter Instrument Company, Inc. intends to introduce into interstate commerce the Automatic Vacuum Switch (AVS) device. The automatic interlock switch (AVS) is a device intended to assure that analgesic gases cannot be turned on unless an activated scavenging system is present.
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)
All finished products are function tested and must meet all required specifications before release to distribution. A range of tests is required for release, which include, but are not limited to; a functional test and a visual inspection (both in process and finished product).
The function test and the visual inspection are defined in both Porter's manufacturing procedure and inspection procedure. These documents are established test procedures, which conform to the product design specifications.
Qualification of the Automatic Vacuum Switch (AVS) included a detailed risk assessment, which attended to a Failure Mode Effects Analysis and a Hazard Analysis. Additional testing covered: backpressure, delivery and vacuum flow, internal and external leak testing, complete system testing and simulated use testing.
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
JUN 16 1998
510(k) Summary of Safety and Effectiveness In accordance with SMDA '90
May 15, 1998
Porter Instrument Co., Inc 245 Township Line Road PO Box 907 Hatfield PA 19440-0907
Stephen D. Loeffler, Manager of Engineering and Quality Contact: Telephone: 215-723-4000 Automatic Vacuum Switch, dental Common/Usual Product Name:
Porter Instrument Company, Inc., Trade/Proprietary Name: Automatic Vacuum Switch (AVS)
Classification Name:
Anesthesiology Non-classified* Accessory to § 868.5430 Gas scavenging apparatus. Class 2
Substantial Equivalence1 to:
| 510(k) # | Name | Applicant |
|---|---|---|
| K761140 | Double Mask | Fraser Sweatman |
| K802067 | Clean Air Pollution Reduction System | Porter Instrument Co., Inc. |
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Porter Instrument Company, Inc. intends to introduce into interstate commerce the Automatic Vacuum Switch (AVS) device. The automatic interlock switch (AVS) is a device intended to assure that analgesic gases cannot be turned on unless an activated scavenging system is present.
Porter Instrument Company, Inc. 510(k) for the Automatic Vacuum Switch
Porter Instrument Company, Inc. - 510(k) Submission for the Automatic
Attachment # 11.01
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patient point of view. The term "substantially equivalent" is not applicable to and does not diminish any patient claims related to this product or the technology used to manufacture the product.
1
Intended Use
For control of vacuum flow in a gas scavenging apparatus, used as an accessory in Porter Instrument Company's Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines (flowmeters).
Substantial Equivalence
The Automatic Vacuum Switch (AVS) is substantially equivalent, in comparison to the legally marketed device, because it:
- . has the same intended use as the predicate device; and
- has different technological characteristics, and
- the information submitted to FDA; .
- does not raise new questions of safety and effectiveness, and ・
- demonstrates that the Automatic Vacuum Switch (AVS) is as safe and as effective as the legally marketed device
Different technological characteristics include, but are not limited to, changes in materials, design, energy sources, and principles of operation.
Porter Instrument Company's claim of substantial equivalence does not mean the compared devices are identical but that the substantial equivalence is established with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics.
Safety and Effectiveness
- 3
All finished products are function tested and must meet all required specifications before release to distribution. A range of tests is required for release, which include, but are not limited to; a functional test and a visual inspection (both in process and finished product).
The function test and the visual inspection are defined in both Porter's manufacturing procedure and inspection procedure. These documents are established test procedures, which conform to the product design specifications.
All procedures and records for this product are approved, released, distributed and revised according to Porter Instrument Company's Document & Data Control procedure QSP 5-1.
Qualification of the Automatic Vacuum Switch (AVS) included a detailed risk assessment, which attended to a Failure Mode Effects Analysis and a Hazard Analysis. Additional testing covered: backpressure, delivery and vacuum flow, internal and external leak testing, complete system testing and simulated use testing.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 16 1998
Mr. Stephen D. Loeffler Porter Instrument Company, Inc. 245 Township Line Road P.O. Box 907 Hatfield, PA 19440-0907
K981754 Re: Trade Name: Automatic Vacuum Switch (AVS) Regulatory Class: Unclassified Product Code: 73 CBN May 15, 1998 Dated: Received: May 18, 1998
Dear Mr. Loeffler:
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 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). 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 (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 Good Manufacturing Practice for Medical Devices: . General ... . (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Stephen D. Loeffler
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 note 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/dsmamain.html".
Sincerely yours,
Thomas J. Callalon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
4
Statement of Indications for Use
The intended use of the AVS accessory is to control the vacuum flow in a gas scavenging apparatus.
Special 510(k) statement: The intended use of the modified device, as described in our labeling, has not changed as a result of the modifications.
Wolf Sepulveda MD
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ E
Page 7 of 61 Porter Instrument Company, Inc. - 510(k) Submission for the Automatic Vacuum Switch
的
್ಕೆ ಪ್ರಿಕಾರ