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 Description

The Sigma Alpha Vaporizer is an electronic calibrated vaporizer that is 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.

AI/ML Overview

This document is a 510(k) summary for the Sigma Alpha Vaporizer. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically associated with AI/ML-based medical devices.

Therefore, many of the requested items related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable or not present in this document.

Here’s an analysis based on the provided text, addressing what can be extracted:

Acceptance Criteria and Device Performance Study for Sigma Alpha Vaporizer

This 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a detailed clinical study with quantifiable metrics as one would expect for a novel AI/ML device.

The "study" in this context refers to the comparison of the Sigma Alpha Vaporizer's technological characteristics, intended use, and indications for use against predicate devices. The implicit acceptance criterion is that the new device is "as safe and effective" as the predicates, and that its technological characteristics are "very similar" without any "minor differences" making it "any less safe and effective."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implicit)	Reported Device Performance (as per 510(k))
Substantial Equivalence (Overall Safety & Effectiveness to Predicates): The device must be "as safe and effective" as analogous legally marketed predicate devices. This implies meeting performance standards for anesthetic vaporizers in terms of vaporizing specific agents and delivering controlled concentrations.	The document concludes: "From the above information it is concluded that the Penlon Sigma Alpha Vaporizer is substantially equivalent to the above named predicate devices." It explicitly states that "any minor differences do not make the Sigma Alpha any less safe and effective than the predicate devices."
Intended Use & Indications for Use Match Predicates: The device's intended use and indications for use should align with the predicate devices.	"The intended use and indications for use apply equally to the above named predicate devices." The device is intended to vaporize Suprane® (Desflurane) and deliver controlled concentrations to patients (adult and pediatric).
Technological Characteristics Similarity: The device's technological characteristics must be very similar to predicate devices.	"The technological characteristics of the Sigma Alpha and the predicate Devices... are very similar."

Sample size used for the test set and the data provenance:
- N/A. This is a 510(k) for a medical device (anesthetic vaporizer), not an AI/ML diagnostic or predictive tool. There is no "test set" of observational data in the AI/ML sense mentioned in this document. The evaluation is based on device design, engineering specifications, and comparison to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No "ground truth" establishment in the AI/ML sense. The approval process relies on regulatory review by FDA experts based on the device's documentation and demonstrated substantial equivalence, rather than expert consensus on a dataset.
Adjudication method for the test set:
- N/A.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is an anesthetic vaporizer, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not involve an algorithm with standalone performance.
The type of ground truth used:
- N/A. For this type of device, "ground truth" would relate to engineering measurements verifying the vaporizer's output accuracy against its calibrated settings under various operating conditions. Such detailed test results are typically presented in the full 510(k) submission, but only the summary is provided here, which focuses on substantial equivalence. The summary does not provide specific performance data beyond the claim of substantial equivalence.
The sample size for the training set:
- N/A. There is no "training set" in the AI/ML sense for this device.
How the ground truth for the training set was established:
- N/A.

Summary

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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
1. Submitter's telephone number and fax number: Tel. 011 44 1235 547000 Fax: 011 44 1235 547041
1. Contact person: Mr. Alan Green - Technical Director
1. Date this 510(k) summary prepared: February 3, 2006
1. Trade/proprietary name of the device: Sigma Alpha Vaporizer
1. Classification name and number of the device: Anesthetic Vaporizer 21CFR 868.5880
1. 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
- 1. 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
- 1. 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
1. 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 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 (240) 276-0115. 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 (301) 443-6597 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 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)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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on of Anesthestology, General Hospital, In socion Control. Dental Device

Section 4 Page 1 of 1

Regulation Number and Section

§ 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).