PPV VAPORIZER (MODIFICATION)

• K Number: K960944
• Device Name: PPV VAPORIZER (MODIFICATION)
• Manufacturer: PENLON LTD.
• Date Cleared: 1996-04-02 ( 49 days)
• Product Code: CAD
• Regulation Number: 868.5880
• Type: Traditional
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

Penlon PPV Vaporizers

AI/ML Overview

This document is a summary of safety and effectiveness for Penlon PPV Vaporizers, submitted in accordance with SMDA 1990. It describes compliance with "ASTM F1161:1988 Clause 12" and "Clause 4" of the same standard. It also mentions a hazard analysis and user manual improvements.

However, the provided text does not contain the specific information required to complete your request, which focuses on:

• Acceptance Criteria Table and Device Performance: The document states compliance with a standard but doesn't list specific acceptance criteria (e.g., performance metrics, thresholds) or reported device performance against those criteria. It only mentions general compliance.
• Sample size and data provenance for test set: No information.
• Number of experts and qualifications for ground truth: No information.
• Adjudication method for test set: No information.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No information on human reader improvement with/without AI.
• Standalone algorithm performance: This document describes a medical device (vaporizer), not an AI algorithm, so standalone performance is not applicable in the requested context.
• Type of ground truth used: Not applicable as it's not a diagnostic AI study.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

The document is purely a regulatory submission summary for a physical medical device, not a study report for an AI/software-as-medical-device (SaMD) that would typically involve the requested performance evaluation details.

Summary

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Your Ref:

Our Ref:

Image /page/0/Picture/2 description: The image shows the text "ATTACHMENT 5". The text is in a large, bold font and is underlined. The word "ATTACHMENT" is in all capital letters, and the number "5" is also in a large font.

Image /page/0/Picture/3 description: The image shows the logo for Penlon InterMed. The logo consists of the word "Penlon" in a large, bold font, with the words "Inter Med" inside of a black diamond shape to the left of the word "Penlon". Below the logo is the number "K960944" written in a handwritten style.

APR - 2 1550

Penlon Limited Radley Road Abingdon

Oxon OX14 3PH Telephone: Abingdon [phone] Fax: [phone] Sales Fax: [phone] Telex Agency: 826715 AERO G Cables: Penlon Abingdon

SUMMARY OF SAFETY AND EFFECTIVENE

This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and in connection with our supplement in respect of the Penlon PPV Vaporizers.

• 1. Compliance With Standards
     We confirm that sample vaporizers have been subjected to the tests listed in ASTM F1161:1988 Clause 12, and have been shown to comply with this standard. We also confirm that the test equipment and test conditions used complied with Clause 4 of this standard.

The User Manual has been examined and contains the information required by the above standard.

• 2. An appendix to the hazard analysis has been performed on the design, based on study of literature and evaluation reports, together with in-house experience covering more than 30 years' manufacture and marketing of vaporizers.
• 3. The test work to show compliance with ASTM F1161:1988 Clause 12 has been extended to cover the external influences noted during the hazard analysis appendix and the results are incorporated as WARNINGS, Caution or Information in the User Manual
  • (a) Vaporizer filling instructions clarification 12.1.13
• 4. Incorrect and overfilling protection is provided by the combination of (a) an air lock; (b) agent specific fillers; (c) level indicator with visual indication; (d) an overspill passage open during filling.

Registered Office: Silvertown House Vincent Square

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Attachment 5 cont'd

We certify that this summary only includes information which is included in the 510(K)
supplement submission supplement submission.

for PENLON LIMITED

Avan leven

Alan C Green Technical Director

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).