(52 days)
To reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.
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.
The provided document is a 510(k) summary for a medical device called "Circuit Guard." It describes a modification to an existing device and compares it to predicate devices to establish substantial equivalence.
Based on the information provided, here's a breakdown of the requested details:
Acceptance Criteria and Study to Prove Device Meets Criteria
The submission does not contain details about a study to prove the device meets specific performance acceptance criteria in the traditional sense of a clinical trial or performance validation study. Instead, this 510(k) notification focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" can be inferred from the attributes compared between the proposed device and the predicate devices, aiming to show that the Circuit Guard is equivalent in terms of use, design, and materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Devices' Performance) | Reported Device Performance (ARC Circuit Guard) |
|---|---|---|
| Intended to reduce gross contamination on a surface | Yes (based on predicate Concord-Portex Steri-Cath) | Yes |
| Used with breathing circuits, ventilator circuits, resuscitators | Yes (based on predicate ARC Filter/HME) | Yes |
| Environment of use - Hospital, OR, anesthesia, ICU | Yes (based on both predicates) | Yes |
| Indicated for single use | Yes (based on both predicates) | Yes |
| Placed in the breathing circuit | Yes (based on both predicates) | Yes |
| Incorporates a thin-walled protective sleeve | Yes (based on predicate Concord-Portex Steri-Cath) | Yes |
| Performance Standards / Specifications | None applicable for proposed modification | Yes (meaning it adheres to this statement) |
| Materials - Sleeve - Polyethylene | Yes (based on predicate Concord-Portex Steri-Cath) | Yes |
Interpretation of "Acceptance Criteria": For a 510(k) submission like this, the "acceptance criteria" are not explicit numerical thresholds from a pre-defined performance study. Instead, they are met by demonstrating that the proposed device shares the same fundamental scientific technology, intended use, and similar design and materials as predicate devices. The "performance" of the Circuit Guard is "reported" as being "Yes" for all these attributes, indicating it meets the implicit equivalence criteria by sharing these characteristics with the predicates.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a "test set" in the context of typical algorithm performance evaluation (e.g., a set of images or patient data used to evaluate AI accuracy). The evaluation is based on a comparison of device characteristics to predicate devices, not on a test of its effectiveness with a specific sample of users or operating conditions.
- Data Provenance: Not applicable. There is no "data" in the sense of patient data, images, or outcomes being evaluated. The comparison is based on the design, intended use, and materials of the device itself and its predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No ground truth was established by experts for a test set. The review process by the FDA involves regulatory experts, but that's different from experts establishing "ground truth" for a device's performance data.
4. Adjudication Method for the Test Set
- Not applicable. There was no test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is a mechanical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical accessory, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable. The concept of "ground truth" as used in AI/performance evaluation (e.g., pathology, outcomes data) is not relevant here. The "truth" in this context is the documented characteristics and intended use of both the proposed device and its legally marketed predicate devices, which the FDA then reviews for substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
In summary: The K982239 submission is a traditional 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence to predicate devices based on intended use, design, and materials, rather than through performance studies involving patient data, AI algorithms, or expert ground truth establishment for a test set. The "study" referenced is the submission itself, which details the comparison between the new device and existing ones.
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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
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Non-Confidential Summary of Safety and Effectiveness
page 2 of 2
June 23, 1998
| Attribute | ARCCircuit Guard | ARCFilter/Filter/HMEK903056AK903058A | Concord-PortexSteri-CathK902383 |
|---|---|---|---|
| Use | |||
| Intended to reduce grosscontamination 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-walledprotective sleeve | Yes | -- | Yes |
| Performance Standards / Specifications | |||
| None applicable for proposedmodification | 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
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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.
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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
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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
§ 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).