(52 days)
K903056A, K903058A, K902383
Not Found
No
The summary describes a simple mechanical sleeve for covering breathing circuits and makes no mention of AI or ML.
No
The device is described as a protective sleeve to reduce contamination on breathing circuit components, not to treat or diagnose a disease or condition.
No
This device is designed to reduce contamination on breathing circuits by covering them with a protective sleeve, similar to a sleeved suction catheter. Its purpose is to prevent contamination, not to detect, diagnose, or monitor a medical condition or disease.
No
The device description clearly states it is a "thin-wall sleeve" and a "modification of our ARC Filter and ARC Filter / HME," indicating it is a physical, hardware-based 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 "reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve." This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "thin-wall sleeve" that covers breathing circuit components. This aligns with a physical barrier device, not a diagnostic instrument or reagent.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The comparison to a "sleeved suction catheter" further reinforces that this is a device designed for physical protection and contamination reduction, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
To reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.
Product codes
73 CAH
Device Description
The Circuit Guard is a thin-wall sleeve which when attached to a Filter / HME housing, is pulled over the breathing circuit wye and tubing to cover these items to reduce gross contamination of the circuit components. It is viewed to be similar the intended use of a sleeved suction catheter. This is a modification of our ARC Filter and ARC Filter / HME.
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
Hospital, OR, anesthesia, ICU
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)
K903056A, K903058A, K902383
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).
0
Non-Confidential Summary of Safety and Effectiveness
page 1 of 2 June 23, 1998
ARC Medical, Inc. 322 Patterson Ave. Scottsdale, GA 30079
AUG 1 4 1998
Tel - (404) 373-8300 Fax - (404) 373-8385
Official Contact:
Proprietary or Trade Name: Common/Usual Name: Classification Name: Device: Predicate Devices:
Harold B. Norris - President Circuit Guard Bacteria Filter accessory Bacterial filter, breathing circuit Circuit Guard ARC Filter and Filter / HME - K903056A, K903058A, Concord-Portex - Steri-Cath - K902383.
Device Description:
The Circuit Guard is a thin-wall sleeve which when attached to a Filter / HME housing, is pulled over the breathing circuit wye and tubing to cover these items to reduce gross contamination of the circuit components. It is viewed to be similar the intended use of a sleeved suction catheter. This is a modification of our ARC Filter and ARC Filter / HME.
Intended Use:
র মাহমুদ
Indicated Use --
Environment of Use --
To reduce gross contamination on breathing circuit by covering the patient end of the circuit. Hospital, OR, anesthesia, ICU
1
Non-Confidential Summary of Safety and Effectiveness
page 2 of 2
June 23, 1998
| Attribute | ARC
Circuit Guard | ARC
Filter/
Filter/HME
K903056A
K903058A | Concord-
Portex
Steri-Cath
K902383 |
|---------------------------------------------------------------------|----------------------|------------------------------------------------------|---------------------------------------------|
| Use | | | |
| Intended to reduce gross
contamination on a surface | Yes | -- | Yes |
| Used with breathing circuits,
ventilator circuits, resuscitators | Yes | Yes | -- |
| Environment of use - Hospital, OR,
anesthesia, ICU | Yes | Yes | Yes |
| Indicated for single use | Yes | Yes | Yes |
| Design | | | |
| Placed in the breathing circuit | Yes | Yes | Yes |
| Incorporates a thin-walled
protective sleeve | Yes | -- | Yes |
| Performance Standards / Specifications | | | |
| None applicable for proposed
modification | Yes | -- | Yes |
| Materials | | | |
| Sleeve - Polyethylene | Yes | -- | Yes |
Differences between Other Legally Marketed Predicate Devices ----------
The proposed modification to the ARC products does not alter their original intended uses. There is no significant differences between the intended device and the predicate devices.
. 189
2
Image /page/2/Picture/3 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble human profiles or faces, stacked on top of each other.
AUG 1 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Harold B. Norris ARC Medical, Inc. 322 Patterson Avenue Scottdale, GA 30079
K982239 Re: Circuit Guard Regulatory Class: II (two) Product Code: 73 CAH Dated: June 23, 1998 Received: June 25, 1998
Dear Mr. Norris:
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, 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 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, 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. Harold B. Norris
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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | K982239 | (To be assigned) |
|---|---|---|
| Modification to K903056A and K903058A | ||
| Device Name: | Circuit Guard | |
| Intended Use : | To reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
11 11
Waste Kernel
(Division Sign-Off) Division of Cardiova and Neurological D 510(k) Number
Prescription Use (Per CFR 801.109)
Over-the-counter use