(158 days)
The Sidestream Plus is a handheld nebulizer designed to aerosolize medication approved for nebulization and prescribed by a physician. The Sidestream Plus is intended for adult and pediatric patients consistent with the indications for the aerosol medication.
Sidestream Plus is a Class II device. It is a breath-enhanced reusable nebulizer to be used with a compressor that is capable of providing appropriate air pressure and flow to operate the device according to specification. The Sidestream Plus is a breath-enhanced nebulizer and works utilizing the same operating principles as the Ventstream (K933535), the Pari LC Star (K963924) and the Pari LC + (K935540).
The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets those criteria, as typically found in comprehensive medical device studies. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical or performance study with specific acceptance criteria and outcome metrics.
The document states that the "Sidestream Plus is a Class II device. It is a breath-enhanced reusable nebulizer to be used with a compressor that is capable of providing appropriate air pressure and flow to operate the device according to specification." It also mentions that it "works utilizing the same operating principles as the Ventstream (K933535), the Pari LC Star (K963924) and the Pari LC + (K935540)."
Without a dedicated section detailing performance criteria and a study to meet them, I cannot populate the requested tables and information. The 510(k) process primarily relies on demonstrating equivalence through design, operating principles, and intended use as compared to legally marketed predicate devices, along with some basic performance testing, which is generally not detailed in the summary itself.
Therefore, many of the requested fields cannot be filled based on the provided text.
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Section 5
FEB 1 6 2007
510(K) SUMMARY
Prepared: August 1, 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is:
Submitter's Identification: 1.
Respironics Ltd. Heath Place West Sussex, PO 22 9SL UK Phone: +44 870 770 3548 Fax: +44 870 770 2002 Contact Name: Henry Marshall, Manager, OA/RA e-mail: henry.marshall(@respironics.com
Establishment Registration Number :0681154
Foreign Manufacturer:
Respironics Medical Products (Shenzhen) Co., Ltd. Tong Xi Chong Village, Boa on Districts Shenzhen, People's Republic of China
· Establishment Registration Number: 3003001596
Official Correspondent:
Lauren Ziegler Sr. Manager, QA, RA, and Clinical Affairs 41 Canfield Road Cedar Grove, NJ 07009 Phone: 973-571-2608 Fax: 973-857-9521 e-mail: Lauren.ziegler@respironics.com
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2. · Name of the Device:
Sidestream Plus Nebulizer Common Name or Classification Name (21 CFR Part 807.87) of Device: Nebulizer, 21 CFR Part 868.5630
3. Predicate Device Information:
Identification of legally marketed device which we claim substantial equivalence to: Pari LC+ K935540 Pari Respiratory Equipment 2943 Oak Lake Boulevard Mindlothian, Va 23112-3998
4. Device Description:
Sidestream Plus is a Class II device. It is a breath-enhanced reusable nebulizer to be used with a compressor that is capable of providing appropriate air pressure and flow to operate the device according to specification.
The Sidestream Plus is a breath-enhanced nebulizer and works utilizing the same operating principles as the Ventstream (K933535), the Pari LC Star (K963924) and the Pari LC + (K935540).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics, Limited C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Twinsburg, Ohio 44087
FEB ] & 2007
Re: K062689
Trade/Device Name: Sidestream Plus Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 5, 2007 Received: February 6, 2007
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lehtonen
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Sidestream Plus Nebulizer
Indications for Use:
The Sidestream Plus is a handheld nebulizer designed to aerosolize medication approved for nebulization and prescribed by a physician. The Sidestream Plus is intended for adult and pediatric patients consistent with the indications for the aerosol medication.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mhhl Vhhl
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).