SEVOFLURANE VAPORIZER ADAPTOR

K110608 · Piramal Critcal Care, Inc (Formerly Minrad, Inc) · CAD · Jul 20, 2011 · Anesthesiology

Device Facts

• Record ID: K110608
• Device Name: SEVOFLURANE VAPORIZER ADAPTOR
• Applicant: Piramal Critcal Care, Inc (Formerly Minrad, Inc)
• Product Code: CAD · Anesthesiology
• Decision Date: Jul 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5880
• Device Class: Class 2

Intended 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.

Device Story

The Sevoflurane Vaporizer Adaptor is a mechanical filling device used by qualified personnel in clinical settings to transfer Sevoflurane anesthetic from a manufacturer bottle into a QuikFil™ vaporizer. The adaptor attaches securely to both the bottle and the vaporizer to facilitate the transfer process while minimizing leakage. It is designed for multiple uses. By providing a secure, compatible connection, the device ensures the safe and efficient filling of anesthetic vaporizers, supporting clinical anesthesia delivery.

Clinical Evidence

No clinical data; bench testing only. The device complies with ISO 5360:2006 requirements.

Technological Characteristics

Mechanical filling adaptor; complies with ISO 5360:2006. Designed for secure connection between Piramal Sevoflurane bottles and QuikFil™ vaporizers. Multi-use, non-powered, manual operation.

Indications for Use

Indicated for use by qualified personnel to transfer Sevoflurane anesthetic from a Piramal bottle into a QuikFil™ vaporizer.

Regulatory Classification

Identification

An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

Predicate Devices

• Keyed Filler Bottle Adaptor (K053564)

Submission Summary (Full Text)

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# Piramal Critical Care

K110608

## 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 Drive<br>Orchard Park, NY 14127<br>Phone: [phone]<br>Fax: [phone] |
| Contact: | Jamie Keller<br>Regulatory 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 the<br>vaporizer, ensuring minimal leakage. The adaptor is designed for use<br>with QuikFil™ vaporizer filling technology and it is intended for multiple<br>uses. The device complies with the requirements of ISO 5360:2006. |
| Intended Use: | The Sevoflurane Vaporizer Adaptor is intended to be used by qualified<br>personnel as a means of filling Sevoflurane from a Piramal Sevoflurane<br>bottle into a user-owned QuikFil™ Sevoflurane vaporizer. |
| Technological Characteristics: | The general design and materials of the Sevoflurane Vaporizer Adaptor is<br>very similar to the predicate device. The only differences are the<br>connection into the vaporizer and the model types. The Sevoflurane<br>Vaporizer Adaptor connects to QuikFil™ vaporizers for filling sevoflurane<br>anesthetic only. The predicate device connects to Key-Fill vaporizers only<br>and has four model types for filling halothane, enflurane, isoflurane and<br>sevoflurane anesthetics. These differences do not make the Sevoflurane<br>Vaporizer Adaptor any less safe or less effective than the predicate<br>device. |

This concludes the 510(k) summary.

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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 [phone] or [phone] 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):

K110608

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)