(80 days)
The Contami-Shield ™ Breathing Circuit Sleeve, indicated for use with mechanically-ventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. For Single Patient Use.
The Contami-Shield Breathing Circuit Sleeve, indicated for use with mechanicallyventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. The disclosed device is an external device, not in physical contact with the patient, intended for use with ventilators, anesthesia machines, and open flow systems where the external protection of the breathing circuit is desired. The disclosed device shall be slipped over the external surface of the breathing circuit prior to use. A filter or HME filter may be changed or removed from the breathing circuit, while the Contami-Shield is present and in use, if desired.
This document is a 510(k) summary for the RenMed Contami-Shield™ Breathing Circuit Sleeve. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, and expert qualifications are not present in this type of submission.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in numerical or quantifiable terms for the RenMed Contami-Shield™ Breathing Circuit Sleeve, nor does it provide a study with "reported device performance" against such criteria. The submission is a comparison to a predicate device to demonstrate substantial equivalence, rather than a performance study with defined metrics.
The comparison table (on page 2) focuses on design and intended use similarities:
| Aspect | RenMed Contami-Guard | ARC Medical circuit-Guard |
|---|---|---|
| Intended to provide protection for the breathing circuit against gross exterior contamination. | YES | YES |
| To be used in conjunction with a bacterial/viral breathing filter to reduce internal and external contamination of the breathing circuit. | YES | YES |
| Single Patient Use. | YES | YES |
| Clear polyethylene/polypropylene sleeve. | YES | YES |
The "reported device performance" is essentially the statement: "None of the differences noted in the performance specifications for each device are significant when the Contami-Guard is used as intended." This is a qualitative statement of equivalence, not a quantitative performance metric.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) summary based on a comparison to a predicate device, not a clinical or performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts is described as this is not a study assessing diagnostic or predictive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical breathing circuit sleeve, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is used as this is not a study requiring such data. The basis of the submission is a comparison of product features and intended use to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a physical device, and the submission does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is relevant to this submission.
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DEC 1 4 2001
NON-CONFIDENTIAL 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pages VI - VII)
510(k) Summary
Company Information:
Rennels Medical Corp. 203 Northwood Drive Morganton, NC 28655 (828)437-1085 Contact: David Lee, President
Preparation Date of Summary:
September 20, 2001
Trade Name:
RenMed Contami-Shield™ Breathing Circuit Sleeve.
Common Name:
Filter, Bacterial, Breathing Circuit
Product Class/Classification:
Class II, 73CAH, 21CFR 868.5260
Predicate Device:
ARC Medical, Inc., Circuit Guard
Description of the Device:
The Contami-Shield Breathing Circuit Sleeve, indicated for use with mechanicallyventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone.
The disclosed device is an external device, not in physical contact with the patient, intended for use with ventilators, anesthesia machines, and open flow systems where the
Rennels Medical Corp.
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=RenMedz
external protection of the breathing circuit is desired. The disclosed device shall be slipped over the external surface of the breathing circuit prior to use. A filter or HME filter may be changed or removed from the breathing circuit, while the Contami-Shield is present and in use, if desired.
Indications for Use
Indications (from labeling): The Contami-Shield™ Breathing Circuit Sleeve, indicated for use with mechanically-ventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone.
For Single Patient Use.
The device is neither intended to be in contact with the patient nor does it use or impart electrical energy.
Contraindications
The device is not intended for use with breathing circuits equipped with exhalation valves, water traps, nebulizers, or heated wires.
Comparison to Predicate Device
The following table includes the various aspects of the Contami-Guard Breathing Circuit Sleeve, compared with those of the predicate device:
| RenMed Contami-Guard | ARC Medical circuit-Guard | |
|---|---|---|
| Use | ||
| Intended to provide protection forthe breathing circuit against grossexterior contamination. | YES | YES |
| To be used in conjunction with abacterial/viral breathing filter toreduce internal and externalcontamination of the breathingcircuit. | YES | YES |
| Single Patient Use. | YES | YES |
| Design | ||
| Clear polyethylene/polypropylenesleeve. | YES | YES |
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=RenMed#
None of the differences noted in the performance specifications for each device are None of the differences nificant when the Contami-Guard is used as intended.
Relevant Standards
None known.
CONCLUSION
The comparison of the Contami-Guard Breathing Circuit Sleeve with the selected I no comparison of the strates that the device is safe and effective for its intended use and is substantially equivalent to the predicate device.
Sincerely, Rennels Medical Corp.
David Lee
President
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Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2001
Mr. David Lee Rennels Medical Corp. P.O. Box 3626 Morganton, NC 28680
Re: K013200
RenMed Contami-Shield Breathing Circuit Sleeve Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II (two) Product Code: 73 CAH Dated: September 20, 2001 Received: September 25, 2001
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have 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 for ass surver in the encreatery76, the enactment date of the Medical Device Amendments, or to commerce pror to this) 2017-11-17 accordance with the provisions of the Federal Food, Drug, de necs that have been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, mains 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 rr your device is elassinod (60 as controls. Existing major regulations affecting your device can thay be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. David Lee
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
H. Garth Tellam
am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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=RenMedま
510(k) Number, if known:
| Device Name: | RenMed Contami-Guard M Breathing Circuit Sleeve, Model 9999/01 |
|---|---|
| Indications for Use: | The Contami-Shield TM Breathing Circuit Sleeve, indicated for use with mechanically-ventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. |
For Single Patient Use.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013200
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
.
§ 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).