RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "RenMed" in a bold, sans-serif font. There are three horizontal lines to the left of the word and three horizontal lines to the right of the word. The lines are stacked on top of each other. DEC 1 4 2001 K013200 # 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. {1}------------------------------------------------ # =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 for<br>the breathing circuit against gross<br>exterior contamination. | YES | YES | | To be used in conjunction with a<br>bacterial/viral breathing filter to<br>reduce internal and external<br>contamination of the breathing<br>circuit. | YES | YES | | Single Patient Use. | YES | YES | | Design | | | | Clear polyethylene/polypropylene<br>sleeve. | YES | YES | {2}------------------------------------------------ # =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 {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ # =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) .