SIGMA ALPHA VAPORIZER

K060331 · Penlon Limited · CAD · May 10, 2006 · Anesthesiology

Device Facts

• Record ID: K060331
• Device Name: SIGMA ALPHA VAPORIZER
• Applicant: Penlon Limited
• Product Code: CAD · Anesthesiology
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5880
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent -Suprane®, also know as Desflurane - and delivers controlled concentrations of the vaporized anaesthetic agent into a fresh gas that is then breathed by the patient. The Sigma Alpha vaporizer is indicated for use by both adult and pediatric patients. The Sigma Alpha vaporizer is not intended to be used with Enflurane, Halothane, Isoflurane or Sevoflurane, or for use in a breathing circuit. The Sigma Alpha vaporizer is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.

Device Story

Electronic calibrated vaporizer; enriches fresh gas flow of continuous flow anesthesia machine; connected between flowmeter and common gas outlet. Vaporizes Desflurane (Suprane) to deliver controlled concentrations for patient inhalation. Used in clinical settings by nurses and technicians under physician direction. Provides precise anesthetic delivery; enables controlled anesthesia administration for adult and pediatric patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Electronic calibrated vaporizer; designed for Desflurane (Suprane) delivery; connects to anesthesia machine fresh gas flow path. Similar architecture to predicate Tec 6 and D-Vapor series. Restricted to specific anesthetic agent; not for use with other volatile agents or breathing circuits.

Indications for Use

Indicated for adult and pediatric patients requiring delivery of controlled concentrations of vaporized Desflurane (Suprane) via fresh gas flow in an anesthesia machine. Contraindicated for use with Enflurane, Halothane, Isoflurane, or Sevoflurane, and not for use in a breathing circuit.

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

• Penlon Limited Sigma Delta Vaporizer (K002343)
• Datex-Ohmeda Inc. Tec 6 Plus and Tec 6 Plus NAD Variant Anaesthesia Vaporizer (K000275)
• Drägar Medical D-Vapor Anaesthesia Vaporizer (K042276)

Submission Summary (Full Text)

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Ka6033/

#### Section 5 Sigma Alpha Vaporizer 510(k)

## 510(k) Summarv (in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)

- 1. Submitter's name and address: Penlon Limited Abingdon Science Park Barton Lane Abingdon Oxfordshire, OX14 3PH United Kingdom
MAY 10 1123

- 2. Submitter's telephone number and fax number: Tel. [phone] Fax: [phone]
- 3. Contact person: Mr. Alan Green - Technical Director
- 4. Date this 510(k) summary prepared: February 3, 2006
- 5. Trade/proprietary name of the device: Sigma Alpha Vaporizer
- 6. Classification name and number of the device: Anesthetic Vaporizer 21CFR 868.5880
- 7. Legally marketed predicate devices to which substantial equivalence is claimed:
- 1. Penlon Limited Sigma Delta Vaporizer FDA 510(k) No. K002343 Approval to market this device given by FDA on June 8, 2001. FDA Device Classification: Class 2 FDA Regulation Number: 21CFR 868.5880 FDA Product Code: CAD
- 2. Datex-Ohmeda Inc. Tec 6 Plus and Tec 6 Plus NAD Variant Anaesthesia Vaporizer - FDA 510(k) No. K000275 Approval to market this device given by FDA on April 12, 2000. FDA Device Classification: Class 2 FDA Regulation Number: 21CFR 868.5880 FDA Product Code: CAD
- 3. Drägar Medical D-Vapor Anaesthesia Vaporizer FDA 510(k) No. K042276 Approval to market this device given by FDA on September 23, 2004. FDA Device Classification: Class 2 FDA Regulation Number: 21CFR 868.5880 FDA Product Code: CAD
- 8. Description of the device that is the subject of this premarket notification:

The Sigma Alpha Vaporizer is an electronic calibrated vaporizer that is

Section 5 Page 1 of 2

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## Section 5 Sigma Alpha Vaporizer 510(k)

# 510(k) Summary (continued) (in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)

designed to enrich the fresh gas flow of a continuous flow anaesthesia machine, when the vaporizer is connected directly between the flowmeter and the common gas outlet of the machine. The device has been developed in close co-operation with clinicians and the anaesthetic agent manufacturer.

This description applies equally to the above named predicate devices.

#### 9. Intended use and indication for use:

The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent -Suprane®, also know as Desflurane - and delivers controlled concentrations of the vaporized anaesthetic agent into a fresh gas that is then breathed by the patient.

The Sigma Alpha vaporizer is indicated for use by both adult and pediatric patients.

The Sigma Alpha vaporizer is not intended to be used with Enflurane, Halothane, Isoflurane or Sevoflurane, or for use in a breathing circuit.

The Sigma Alpha vaporizer is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.

The intended use and indications for use apply equally to the above named predicate devices.

#### 10. Technological characteristics:

The technological characteristics of the Sigma Alpha and the predicate Devices (the Penlon Sigma, Datex-Ohmeda Inc. Tec 6 Plus, Datex-Ohmeda Inc Tec 6 Plus NAD Variant, and Drägar Medical D-Vapor Anaesthesia Vaporizer are very similar, and any minor differences do not make the Sigma Alpha any less safe and effective than the predicate devices.

From the above information it is concluded that the Penlon Sigma Alpha Vaporizer is substantially equivalent to the above named predicate devices.

This concludes the 510(k) Summary.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 10 2006

Penlon Limited C/O Mr. Barry Pearce Vice President Shotwell & Carr, Incorporated 25 Barker Close Fishbourne, Chichester West Sussex, P0188BJ United Kingdom

Re: K060331

Trade/Device Name: Sigma Alpha Vaporizer Regulation Number: 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: II Product Code: CAD Dated: February 3, 2006 Received: February 9, 2006

Dear Mr. Pearce:

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. Pearce

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylvia Y. Michienzi m.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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# Section 4 Sigma Alpha Vaporizer 510(k)

### Indications For Use

# 510(k) number (if known):

Page 1 of 1

Unknown - not yet assigned by FDA.

## Device name:

Sigma Alpha Vaporizer

#### Indications for use:

The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent - Suprane®, also know as Desflurane - and delivers controlled concentrations of the vaporized anaesthetic agent into a fresh gas that is then breathed by the patient.

The Sigma Alpha Vaporizer is indicated for use by both adult and pediatric patients.

The Sigma Alpha Vaporizer is not intended to be used with Enflurane, Halothane, Isoflurane or Sevoflurane, or for use in a breathing circuit.

The Sigma Alpha Vaporizer is a restricted medical device intended for use by qualifier trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.

AND/OR Prescription Use Yes (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

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