(139 days)
The Sevoflurane Vaporizer Adaptor is intended to be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
The Sevoflurane Vaporizer Adaptor will fit securely to the bottle and the vaporizer, ensuring minimal leakage. The adaptor is designed for use with QuikFil™ vaporizer filling technology and it is intended for multiple uses. The device complies with the requirements of ISO 5360:2006.
The provided text is a 510(k) summary for a Sevoflurane Vaporizer Adaptor, which is a medical device for filling anesthetic vaporizers. This document does not contain information about acceptance criteria, device performance, a study design, or ground truth establishment typically associated with an AI/ML medical device. The device described is a physical adaptor, not a software algorithm.
Therefore, I cannot provide the requested information in the format of acceptance criteria and study details as it pertains to AI/ML device validation.
Instead, the document details the device's classification, intended use, and its substantial equivalence to a predicate device (Keyed Filler Bottle Adaptor K053564). The evidence provided for its safety and effectiveness relies on its similarity to the predicate device and compliance with ISO 5360:2006 for anesthetic vaporizers.
The relevant information from the provided text is:
Device Name: Sevoflurane Vaporizer Adaptor
Intended Use: To be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
Predicate Device: Keyed Filler Bottle Adaptor (K053564)
Key Statement for Equivalence: "The general design and materials of the Sevoflurane Vaporizer Adaptor is very similar to the predicate device. The only differences are the connection into the vaporizer and the model types... These differences do not make the Sevoflurane Vaporizer Adaptor any less safe or less effective than the predicate device."
Standard Compliance: "The device complies with the requirements of ISO 5360:2006."
To reiterate, the original request is designed for AI/ML device submissions, and this document does not contain any information relevant to those specific criteria.
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Piramal Critical Care
510(k) Summary or 510(k) Statement
JUL 20 2011
510(k) Summary
Per 21 CFR 807.87(h), the following 510(k) summary is provided:
| 510(k) owner's name: | Piramal Critical Care, Inc. |
|---|---|
| Address: | 50 Cobham DriveOrchard Park, NY 14127Phone: (716) 855-1068Fax: (716) 855-1078 |
| Contact: | Jamie KellerRegulatory Compliance Specialist |
| Preparation Date: | March 2, 2011 |
| Device Name: | Sevoflurane Vaporizer Adaptor |
| Common Name: | Vaporizer Filling Adaptor |
| Classification: | Anesthetic Vaporizer (21 CFR 868.5880, Product Code CAD) |
| Predicate Device: | Keyed Filler Bottle Adaptor (K053564) |
| Description of Device: | The Sevoflurane Vaporizer Adaptor will fit securely to the bottle and thevaporizer, ensuring minimal leakage. The adaptor is designed for usewith QuikFil™ vaporizer filling technology and it is intended for multipleuses. The device complies with the requirements of ISO 5360:2006. |
| Intended Use: | The Sevoflurane Vaporizer Adaptor is intended to be used by qualifiedpersonnel as a means of filling Sevoflurane from a Piramal Sevofluranebottle into a user-owned QuikFil™ Sevoflurane vaporizer. |
| Technological Characteristics: | The general design and materials of the Sevoflurane Vaporizer Adaptor isvery similar to the predicate device. The only differences are theconnection into the vaporizer and the model types. The SevofluraneVaporizer Adaptor connects to QuikFil™ vaporizers for filling sevofluraneanesthetic only. The predicate device connects to Key-Fill vaporizers onlyand has four model types for filling halothane, enflurane, isoflurane andsevoflurane anesthetics. These differences do not make the SevofluraneVaporizer Adaptor any less safe or less effective than the predicatedevice. |
This concludes the 510(k) summary.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jamie Keller Regulatory Compliance Specialist Piramal Critical Care, Incorporated 50 Cobham Drive Orchard Park, New York 14127
JUL 20 2011
Re: K110608
Trade/Device Name: Sevoflurane Vaporizer Adaptor Regulation Number: 21 CFR 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: II Product Code: CAD Dated: July 8, 2011 Received: July 11, 2011
Dear Ms. Keller:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Keller
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOff ices/CDRH/CDRHOffices/u cm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony V. Onstott
Anthony D. Watson, B.S., M.S., M.B.A. 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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Piramal Critical Care
Indications for Use Statement
510(k) Number (if known):
Device Name:
Sevoflurane Vaporizer Adaptor
Indications For Use:
The Sevoflurane Vaporizer Adaptor is intended to be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
X Prescription Use __ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Division of Anesthesiology, General Hospital Infection Control o
L. Arhurns
-iJ(K) Iunuri. K 110608
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).